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A Quantification Method to Compare the Value of Surgery and Palliative Care in Patients With Complex Cardiac Disease: A Concept
From the Department of Cardiothoracic Surgery, Stanford University, Stanford, CA.
Abstract
Complex cardiac patients are often referred for surgery or palliative care based on the risk of perioperative mortality. This decision ignores factors such as quality of life or duration of life in either surgery or the palliative path. Here, we propose a model to numerically assess and compare the value of surgery vs palliation. This model includes quality and duration of life, as well as risk of perioperative mortality, and involves a patient’s preferences in the decision-making process.
For each pathway, surgery or palliative care, a value is calculated and compared to a normal life value (no disease symptoms and normal life expectancy). The formula is adjusted for the risk of operative mortality. The model produces a ratio of the value of surgery to the value of palliative care that signifies the superiority of one or another. This model calculation presents an objective estimated numerical value to compare the value of surgery and palliative care. It can be applied to every decision-making process before surgery. In general, if a procedure has the potential to significantly extend life in a patient who otherwise has a very short life expectancy with palliation only, performing high-risk surgery would be a reasonable option. A model that provides a numerical value for surgery vs palliative care and includes quality and duration of life in each pathway could be a useful tool for cardiac surgeons in decision making regarding high-risk surgery.
Keywords: high-risk surgery, palliative care, quality of life, life expectancy.
Patients with complex cardiovascular disease are occasionally considered inoperable due to the high risk of surgical mortality. When the risk of perioperative mortality (POM) is predicted to be too high, surgical intervention is denied, and patients are often referred to palliative care. The risk of POM in cardiac surgery is often calculated using large-scale databases, such as the Society of Thoracic Surgeons (STS) records. The STS risk models, which are regularly updated, are based on large data sets and incorporate precise statistical methods for risk adjustment.1 In general, these calculators provide a percentage value that defines the magnitude of the risk of death, and then an arbitrary range is selected to categorize the procedure as low, medium, or high risk or inoperable status. The STS database does not set a cutoff point or range to define “operability.” Assigning inoperable status to a certain risk rate is problematic, with many ethical, legal, and moral implications, and for this reason, it has mostly remained undefined. In contrast, the low- and medium-risk ranges are easier to define. Another limitation encountered in the STS database is the lack of risk data for less common but very high-risk procedures, such as a triple valve replacement.
A common example where risk classification has been defined is in patients who are candidates for surgical vs transcatheter aortic valve replacement. Some groups have described a risk of <4% as low risk, 4% to 8% as intermediate risk, >8% as high risk, and >15% as inoperable2; for some other groups, a risk of POM >50% is considered extreme risk or inoperable.3,4 This procedure-specific classification is a useful decision-making tool and helps the surgeon perform an initial risk assessment to allocate a specific patient to a group—operable or nonoperable—only by calculating the risk of surgical death. However, this allocation method does not provide any information on how and when death occurs in either group. These 2 parameters of how and when death occurs define the quality of life (QOL) and the duration of life (DOL), respectively, and together could be considered as the value of life in each pathway. A survivor of a high-risk surgery may benefit from good quality and extended life (a high value), or, on the other end of the spectrum, a high-risk patient who does not undergo surgery is spared the mortality risk of the surgery but dies sooner (low value) with symptoms due to the natural course of the untreated disease.
The central question is, if a surgery is high risk but has the potential of providing a good value (for those who survive it), what QOL and DOL values are acceptable to risk or to justify accepting and proceeding with a risky surgery? Or how high a POM risk is justified to proceed with surgery rather than the alternative palliative care with a certain quality and duration? It is obvious that a decision-making process that is based on POM cannot compare the value of surgery (Vs) and the value of palliation (Vp). Furthermore, it ignores patient preferences and their input, as these are excluded from this decision-making process.
To be able to include QOL and DOL in any decision making, one must precisely describe these parameters. Both QOL and DOL are used for estimation of disease burden by health care administrators, public health experts, insurance agencies, and others. Multiple models have been proposed and used to estimate the overall burden of the disease. Most of the models for this purpose are created for large-scale economic purposes and not for decision making in individual cases.
An important measure is the quality-adjusted life year (QALY). This is an important parameter since it includes both measures of quality and quantity of life.5,6 QALY is a simplified measure to assess the value of health outcomes, and it has been used in economic calculations to assess mainly the cost-effectiveness of various interventions. We sought to evaluate the utility of a similar method in adding further insight into the surgical decision-making process. In this article, we propose a simple model to compare the value of surgery vs palliative care, similar to QALY. This model includes and adjusts for the quality and the quantity of life, in addition to the risk of POM, in the decision-making process for high-risk patients.
The Model
The 2 decision pathways, surgery and palliative care, are compared for their value. We define the value as the product of QOL and DOL in each pathway and use the severity of the symptoms as a surrogate for QOL. If duration and quality were depicted on the x and y axes of a graph (Figure 1), then the area under the curve would represent the collective value in each situation. Figure 2 shows the timeline and the different pathways with each decision. The value in each situation is calculated in relation to the full value, which is represented as the value of normal life (Vn), that is, life without disease and with normal life expectancy. The values of each decision pathway, the value of surgery (Vs) and the value of palliation (Vp), are then compared to define the benefit for each decision as follows:
If Vs/Vp > 1, the benefit is toward surgery;
If Vs/Vp < 1, the benefit is for palliative care.
Definitions
Both quality and duration of life are presented on a 1-10 scale, 1 being the lowest and 10 the highest value, to yield a product with a value of 100 in normal, disease-free life. Any lower value is presented as a percentage to represent the comparison to the full value. QOL is determined by degradation of full quality with the average level of symptoms. DOL is calculated as a lost time (
For the DOL under any condition, a 10-year survival rate could be used as a surrogate in this formula. Compared to life expectancy value, using the 10-year survival rate simplifies the calculation since cardiac diseases are more prevalent in older age, close to or beyond the average life expectancy value.
Using the time intervals from the timeline in Figure 2:
dh = time interval from diagnosis to death at life expectancy
dg = time interval from diagnosis to death after successful surgery
df = time interval from diagnosis to death after palliative care
Duration for palliative care:
Duration for surgery:
Adjustment: This value is calculated for those who survive the surgery. To adjust for the POM, it is multiplied by the 100 − POM risk.
Since value is the base for comparison in this model, and it is the product of 2 equally important factors in the formula (
After elimination of normal life expectancy, form the numerator and denominator:
To adjust for surgical outcomes in special circumstances where less than optimal or standard surgical results are expected (eg, in very rare surgeries, limited resource institutions, or suboptimal postoperative surgical care), an optional coefficient R can be added to the numerator (surgical value). This optional coefficient, with values such as 0.8, 0.9 (to degrade the value of surgery) or 1 (standard surgical outcome), adjusts for variability in interinstitutional surgical results or surgeon variability. No coefficient is added to the denominator since palliative care provides minimal differences between clinicians and hospitals. Thus, the final adjusted formula would be as follows:
Example
A 60-year-old patient with a 10% POM risk needs to be allocated to surgical or palliative care. With palliative care, if this patient lived 6 years with average symptoms grade 4, the Vp would be 20; that is, 20% of the normal life value (if he lived 18 years instead without the disease).
Using the formula for calculation of value in each pathway:
If the same patient undergoes a surgery with a 10% risk of POM, with an average grade 2 related to surgical recovery symptoms for 1 year and then is symptom-free and lives 12 years (instead of 18 years [life expectancy]), his Vs would be 53, or 53% out of the normal life value that is saved if the surgery is 100% successful; adjusted Vs with (chance of survival of 90%) would be 53 × 90% = 48%.
With adjustment of 90% survival chance in surgery, 53 × 90% = 48%. In this example, Vs/Vp = 48/20 = 2.4, showing a significant benefit for surgical care. Notably, the unknown value of normal life expectancy is not needed for the calculation of Vs/Vp, since it is the same in both pathways and it is eliminated by calculation in fraction.
Based on this formula, since the duration of surgical symptoms is short, no matter how severe these are, if the potential duration of life after surgery is high (represented by smaller area under the curve in Figure 1), the numerator becomes larger and the value of the surgery grows. For example, if a patient with a 15% risk of POM, which is generally considered inoperable, lives 5 years, as opposed to 2 years with palliative care with mild symptoms (eg 3/10), Vs/Vp would be 2.7, still showing a significant benefit for surgical care.
Discussion
Any surgical intervention is offered with 2 goals in mind, improving QOL and extending DOL. In a high-risk patient, surgery might be declined due to a high risk of POM, and the patient is offered palliative care, which other than providing symptom relief does not change the course of disease and eventually the patient will die due to the untreated disease. In this decision-making method, mostly completed by a care team only, a potential risk of death due to surgery which possibly could cure the patient is traded for immediate survival; however, the symptomatic course ensues until death. This mostly unilateral decision-making process by a care team, which incorporates minimal input from the patient or ignores patient preferences altogether, is based only on POM risk, and roughly includes a single parameter: years of potential life lost (YPLL). YPLL is a measure of premature mortality, and in the setting of surgical intervention, YPLL is the number of years a patient would lose unless a successful surgery were undertaken. Obviously, patients would live longer if a surgery that was intended to save them failed.
In this article, we proposed a simple method to quantify each decision to decide whether to operate or choose surgical care vs palliative care. Since quality and duration of life are both end factors clinicians and patients aspire to in each decision, they can be considered together as the value of each decision. We believe a numerical framework would provide an objective way to assist both the patient at high risk and the care team in the decision-making process.
The 2 parameters we consider are DOL and QOL. DOL, or survival, can be extracted from large-scale data using statistical methods that have been developed to predict survival under various conditions, such as Kaplan-Meier curves. These methods present the chance of survival in percentages in a defined time frame, such as a 5- or 10-year period.
While the DOL is a numerical parameter and quantifiable, the QOL is a more complex entity. This subjective parameter bears multiple definitions, aspects, and categories, and therefore multiple scales for quantification of QOL have been proposed. These scales have been used extensively for the purpose of health determination in health care policy and economic planning. Most scales acknowledge that QOL is multifactorial and includes interrelated aspects such as mental and socioeconomic factors. We have also noticed that QOL is better determined by the palliative care team than surgeons, so including these care providers in the decision-making process might reduce surgeon bias.
Since our purpose here is only to assist with the decision on medical intervention, we focus on physical QOL. Multiple scales are used to assess health-related QOL, such as the Assessment of Quality of Life (AQoL)-8D,7 EuroQol-5 Dimension (EQ-5D),8 15D,9 and the 36-Item Short Form Survey (SF-36).10 These complex scales are built for systematic reviews, and they are not practical for a clinical user. To simplify and keep this practical, we define QOL by using the severity or grade of symptoms related to the disease the patient has on a scale of 0 to 10. The severity of symptoms can be easily determined using available scales. An applicable scale for this purpose is the Edmonton Symptom Assessment Scale (ESAS), which has been in use for years and has evolved as a useful tool in the medical field.11
Once DOL and QOL are determined on a 1-10 scale, the multiplied value then provides a product that we consider a value. The highest value hoped for in each decision is the achievement of the best QOL and DOL, a value of 100. In Figure 1, a graphic presentation of value in each decision is best seen as the area under the curve. As shown, a successful surgery, even when accompanied by significant symptoms during initial recovery, has a chance (100 – risk of POM%) to gain a larger area under curve (value) by achieving a longer life with no or fewer symptoms. However, in palliative care, progressing disease and even palliated symptoms with a shorter life expectancy impose a large burden on the patient and a much lower value. Note that in this calculation, life expectancy, which is an important but unpredictable factor, is initially included; however, by ratio comparison, it is eliminated, simplifying the calculation further.
Using this formula in different settings reveals that high-risk surgery has a greater potential to reduce YPLL in the general population. Based on this formula, compared to a surgery with potential to significantly extend DOL, a definite shorter and symptomatic life course with palliative care makes it a significantly less favorable option. In fact, in the cardiovascular field, palliative care has minimal or no effect on natural history, as the mechanism of illness is mechanical, such as occlusion of coronary arteries or valve dysfunction, leading eventually to heart failure and death. In a study by Xu et al, although palliative care reduced readmission rates and improved symptoms on a variety of scales, there was no effect on mortality and QOL in patients with heart failure.12
No model in this field has proven to be ideal, and this model bears multiple limitations as well. We have used severity of symptoms as a surrogate for QOL based on the fact that cardiac patients with different pathologies who are untreated will have a common final pathway with development of heart failure symptoms that dictate their QOL. Also, grading QOL is a difficult task at times. Even a model such as QALY, which is one of the most used, is not a perfect model and is not free of problems.6 The difference in surgical results and life expectancy between sexes and ethnic groups might be a source of bias in this formula. Also, multiple factors directly and indirectly affect QOL and DOL and create inaccuracies; therefore, making an exact science from an inexact one naturally relies on multiple assumptions. Although it has previously been shown that most POM occurs in a short period of time after cardiac surgery,13 long-term complications that potentially degrade QOL are not included in this model. By applying this model, one must assume indefinite economic resources. Moreover, applying a single mathematical model in a biologic system and in the general population has intrinsic shortcomings, and it must overlook many other factors (eg, ethical, legal). For example, it will be hard to justify a failed surgery with 15% risk of POM undertaken to eliminate the severe long-lasting symptoms of a disease, while the outcome of a successful surgery with a 20% risk of POM that adds life and quality would be ignored in the current health care system. Thus, regardless of the significant potential, most surgeons would waive a surgery based solely on the percentage rate of POM, perhaps using other terms such as ”peri-nonoperative mortality.”
Conclusion
We have proposed a simple and practical formula for decision making regarding surgical vs palliative care in high-risk patients. By assigning a value that is composed of QOL and DOL in each pathway and including the risk of POM, a ratio of values provides a numerical estimation that can be used to show preference over a specific decision. An advantage of this formula, in addition to presenting an arithmetic value that is easier to understand, is that it can be used in shared decision making with patients. We emphasize that this model is only a preliminary concept at this time and has not been tested or validated for clinical use. Validation of such a model will require extensive work and testing within a large-scale population. We hope that this article will serve as a starting point for the development of other models, and that this formula will become more sophisticated with fewer limitations through larger multidisciplinary efforts in the future.
Corresponding author: Rabin Gerrah, MD, Good Samaritan Regional Medical Center, 3640 NW Samaritan Drive, Suite 100B, Corvallis, OR 97330; [email protected].
Disclosures: None reported.
1. O’Brien SM, Feng L, He X, et al. The Society of Thoracic Surgeons 2018 Adult Cardiac Surgery Risk Models: Part 2-statistical methods and results. Ann Thorac Surg. 2018;105(5):1419-1428. doi: 10.1016/j.athoracsur.2018.03.003
2. Hurtado Rendón IS, Bittenbender P, Dunn JM, Firstenberg MS. Chapter 8: Diagnostic workup and evaluation: eligibility, risk assessment, FDA guidelines. In: Transcatheter Heart Valve Handbook: A Surgeons’ and Interventional Council Review. Akron City Hospital, Summa Health System, Akron, OH.
3. Herrmann HC, Thourani VH, Kodali SK, et al; PARTNER Investigators. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis. Circulation. 2016;134:130-140. doi:10.1161/CIRCULATIONAHA
4. Ho C, Argáez C. Transcatheter Aortic Valve Implantation for Patients with Severe Aortic Stenosis at Various Levels of Surgical Risk: A Review of Clinical Effectiveness. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; March 19, 2018.
5. Rios-Diaz AJ, Lam J, Ramos MS, et al. Global patterns of QALY and DALY use in surgical cost-utility analyses: a systematic review. PLoS One. 2016:10;11:e0148304. doi:10.1371/journal.pone.0148304
6. Prieto L, Sacristán JA. Health, Problems and solutions in calculating quality-adjusted life years (QALYs). Qual Life Outcomes. 2003:19;1:80.
7. Centre for Health Economics. Assessment of Quality of Life. 2014. Accessed May 13, 2022. http://www.aqol.com.au/
8. EuroQol Research Foundation. EQ-5D. Accessed May 13, 2022. https://euroqol.org/
9. 15D Instrument. Accessed May 13, 2022. http://www.15d-instrument.net/15d/
10. Rand Corporation. 36-Item Short Form Survey (SF-36).Accessed May 12, 2022. https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form.html
11. Hui D, Bruera E. The Edmonton Symptom Assessment System 25 years later: past, present, and future developments. J Pain Symptom Manage. 2017:53:630-643. doi:10.1016/j.jpainsymman.2016
12. Xu Z, Chen L, Jin S, Yang B, Chen X, Wu Z. Effect of palliative care for patients with heart failure. Int Heart J. 2018:30;59:503-509. doi:10.1536/ihj.17-289
13. Mazzeffi M, Zivot J, Buchman T, Halkos M. In-hospital mortality after cardiac surgery: patient characteristics, timing, and association with postoperative length of intensive care unit and hospital stay. Ann Thorac Surg. 2014;97:1220-1225. doi:10.1016/j.athoracsur.2013.10.040
From the Department of Cardiothoracic Surgery, Stanford University, Stanford, CA.
Abstract
Complex cardiac patients are often referred for surgery or palliative care based on the risk of perioperative mortality. This decision ignores factors such as quality of life or duration of life in either surgery or the palliative path. Here, we propose a model to numerically assess and compare the value of surgery vs palliation. This model includes quality and duration of life, as well as risk of perioperative mortality, and involves a patient’s preferences in the decision-making process.
For each pathway, surgery or palliative care, a value is calculated and compared to a normal life value (no disease symptoms and normal life expectancy). The formula is adjusted for the risk of operative mortality. The model produces a ratio of the value of surgery to the value of palliative care that signifies the superiority of one or another. This model calculation presents an objective estimated numerical value to compare the value of surgery and palliative care. It can be applied to every decision-making process before surgery. In general, if a procedure has the potential to significantly extend life in a patient who otherwise has a very short life expectancy with palliation only, performing high-risk surgery would be a reasonable option. A model that provides a numerical value for surgery vs palliative care and includes quality and duration of life in each pathway could be a useful tool for cardiac surgeons in decision making regarding high-risk surgery.
Keywords: high-risk surgery, palliative care, quality of life, life expectancy.
Patients with complex cardiovascular disease are occasionally considered inoperable due to the high risk of surgical mortality. When the risk of perioperative mortality (POM) is predicted to be too high, surgical intervention is denied, and patients are often referred to palliative care. The risk of POM in cardiac surgery is often calculated using large-scale databases, such as the Society of Thoracic Surgeons (STS) records. The STS risk models, which are regularly updated, are based on large data sets and incorporate precise statistical methods for risk adjustment.1 In general, these calculators provide a percentage value that defines the magnitude of the risk of death, and then an arbitrary range is selected to categorize the procedure as low, medium, or high risk or inoperable status. The STS database does not set a cutoff point or range to define “operability.” Assigning inoperable status to a certain risk rate is problematic, with many ethical, legal, and moral implications, and for this reason, it has mostly remained undefined. In contrast, the low- and medium-risk ranges are easier to define. Another limitation encountered in the STS database is the lack of risk data for less common but very high-risk procedures, such as a triple valve replacement.
A common example where risk classification has been defined is in patients who are candidates for surgical vs transcatheter aortic valve replacement. Some groups have described a risk of <4% as low risk, 4% to 8% as intermediate risk, >8% as high risk, and >15% as inoperable2; for some other groups, a risk of POM >50% is considered extreme risk or inoperable.3,4 This procedure-specific classification is a useful decision-making tool and helps the surgeon perform an initial risk assessment to allocate a specific patient to a group—operable or nonoperable—only by calculating the risk of surgical death. However, this allocation method does not provide any information on how and when death occurs in either group. These 2 parameters of how and when death occurs define the quality of life (QOL) and the duration of life (DOL), respectively, and together could be considered as the value of life in each pathway. A survivor of a high-risk surgery may benefit from good quality and extended life (a high value), or, on the other end of the spectrum, a high-risk patient who does not undergo surgery is spared the mortality risk of the surgery but dies sooner (low value) with symptoms due to the natural course of the untreated disease.
The central question is, if a surgery is high risk but has the potential of providing a good value (for those who survive it), what QOL and DOL values are acceptable to risk or to justify accepting and proceeding with a risky surgery? Or how high a POM risk is justified to proceed with surgery rather than the alternative palliative care with a certain quality and duration? It is obvious that a decision-making process that is based on POM cannot compare the value of surgery (Vs) and the value of palliation (Vp). Furthermore, it ignores patient preferences and their input, as these are excluded from this decision-making process.
To be able to include QOL and DOL in any decision making, one must precisely describe these parameters. Both QOL and DOL are used for estimation of disease burden by health care administrators, public health experts, insurance agencies, and others. Multiple models have been proposed and used to estimate the overall burden of the disease. Most of the models for this purpose are created for large-scale economic purposes and not for decision making in individual cases.
An important measure is the quality-adjusted life year (QALY). This is an important parameter since it includes both measures of quality and quantity of life.5,6 QALY is a simplified measure to assess the value of health outcomes, and it has been used in economic calculations to assess mainly the cost-effectiveness of various interventions. We sought to evaluate the utility of a similar method in adding further insight into the surgical decision-making process. In this article, we propose a simple model to compare the value of surgery vs palliative care, similar to QALY. This model includes and adjusts for the quality and the quantity of life, in addition to the risk of POM, in the decision-making process for high-risk patients.
The Model
The 2 decision pathways, surgery and palliative care, are compared for their value. We define the value as the product of QOL and DOL in each pathway and use the severity of the symptoms as a surrogate for QOL. If duration and quality were depicted on the x and y axes of a graph (Figure 1), then the area under the curve would represent the collective value in each situation. Figure 2 shows the timeline and the different pathways with each decision. The value in each situation is calculated in relation to the full value, which is represented as the value of normal life (Vn), that is, life without disease and with normal life expectancy. The values of each decision pathway, the value of surgery (Vs) and the value of palliation (Vp), are then compared to define the benefit for each decision as follows:
If Vs/Vp > 1, the benefit is toward surgery;
If Vs/Vp < 1, the benefit is for palliative care.
Definitions
Both quality and duration of life are presented on a 1-10 scale, 1 being the lowest and 10 the highest value, to yield a product with a value of 100 in normal, disease-free life. Any lower value is presented as a percentage to represent the comparison to the full value. QOL is determined by degradation of full quality with the average level of symptoms. DOL is calculated as a lost time (
For the DOL under any condition, a 10-year survival rate could be used as a surrogate in this formula. Compared to life expectancy value, using the 10-year survival rate simplifies the calculation since cardiac diseases are more prevalent in older age, close to or beyond the average life expectancy value.
Using the time intervals from the timeline in Figure 2:
dh = time interval from diagnosis to death at life expectancy
dg = time interval from diagnosis to death after successful surgery
df = time interval from diagnosis to death after palliative care
Duration for palliative care:
Duration for surgery:
Adjustment: This value is calculated for those who survive the surgery. To adjust for the POM, it is multiplied by the 100 − POM risk.
Since value is the base for comparison in this model, and it is the product of 2 equally important factors in the formula (
After elimination of normal life expectancy, form the numerator and denominator:
To adjust for surgical outcomes in special circumstances where less than optimal or standard surgical results are expected (eg, in very rare surgeries, limited resource institutions, or suboptimal postoperative surgical care), an optional coefficient R can be added to the numerator (surgical value). This optional coefficient, with values such as 0.8, 0.9 (to degrade the value of surgery) or 1 (standard surgical outcome), adjusts for variability in interinstitutional surgical results or surgeon variability. No coefficient is added to the denominator since palliative care provides minimal differences between clinicians and hospitals. Thus, the final adjusted formula would be as follows:
Example
A 60-year-old patient with a 10% POM risk needs to be allocated to surgical or palliative care. With palliative care, if this patient lived 6 years with average symptoms grade 4, the Vp would be 20; that is, 20% of the normal life value (if he lived 18 years instead without the disease).
Using the formula for calculation of value in each pathway:
If the same patient undergoes a surgery with a 10% risk of POM, with an average grade 2 related to surgical recovery symptoms for 1 year and then is symptom-free and lives 12 years (instead of 18 years [life expectancy]), his Vs would be 53, or 53% out of the normal life value that is saved if the surgery is 100% successful; adjusted Vs with (chance of survival of 90%) would be 53 × 90% = 48%.
With adjustment of 90% survival chance in surgery, 53 × 90% = 48%. In this example, Vs/Vp = 48/20 = 2.4, showing a significant benefit for surgical care. Notably, the unknown value of normal life expectancy is not needed for the calculation of Vs/Vp, since it is the same in both pathways and it is eliminated by calculation in fraction.
Based on this formula, since the duration of surgical symptoms is short, no matter how severe these are, if the potential duration of life after surgery is high (represented by smaller area under the curve in Figure 1), the numerator becomes larger and the value of the surgery grows. For example, if a patient with a 15% risk of POM, which is generally considered inoperable, lives 5 years, as opposed to 2 years with palliative care with mild symptoms (eg 3/10), Vs/Vp would be 2.7, still showing a significant benefit for surgical care.
Discussion
Any surgical intervention is offered with 2 goals in mind, improving QOL and extending DOL. In a high-risk patient, surgery might be declined due to a high risk of POM, and the patient is offered palliative care, which other than providing symptom relief does not change the course of disease and eventually the patient will die due to the untreated disease. In this decision-making method, mostly completed by a care team only, a potential risk of death due to surgery which possibly could cure the patient is traded for immediate survival; however, the symptomatic course ensues until death. This mostly unilateral decision-making process by a care team, which incorporates minimal input from the patient or ignores patient preferences altogether, is based only on POM risk, and roughly includes a single parameter: years of potential life lost (YPLL). YPLL is a measure of premature mortality, and in the setting of surgical intervention, YPLL is the number of years a patient would lose unless a successful surgery were undertaken. Obviously, patients would live longer if a surgery that was intended to save them failed.
In this article, we proposed a simple method to quantify each decision to decide whether to operate or choose surgical care vs palliative care. Since quality and duration of life are both end factors clinicians and patients aspire to in each decision, they can be considered together as the value of each decision. We believe a numerical framework would provide an objective way to assist both the patient at high risk and the care team in the decision-making process.
The 2 parameters we consider are DOL and QOL. DOL, or survival, can be extracted from large-scale data using statistical methods that have been developed to predict survival under various conditions, such as Kaplan-Meier curves. These methods present the chance of survival in percentages in a defined time frame, such as a 5- or 10-year period.
While the DOL is a numerical parameter and quantifiable, the QOL is a more complex entity. This subjective parameter bears multiple definitions, aspects, and categories, and therefore multiple scales for quantification of QOL have been proposed. These scales have been used extensively for the purpose of health determination in health care policy and economic planning. Most scales acknowledge that QOL is multifactorial and includes interrelated aspects such as mental and socioeconomic factors. We have also noticed that QOL is better determined by the palliative care team than surgeons, so including these care providers in the decision-making process might reduce surgeon bias.
Since our purpose here is only to assist with the decision on medical intervention, we focus on physical QOL. Multiple scales are used to assess health-related QOL, such as the Assessment of Quality of Life (AQoL)-8D,7 EuroQol-5 Dimension (EQ-5D),8 15D,9 and the 36-Item Short Form Survey (SF-36).10 These complex scales are built for systematic reviews, and they are not practical for a clinical user. To simplify and keep this practical, we define QOL by using the severity or grade of symptoms related to the disease the patient has on a scale of 0 to 10. The severity of symptoms can be easily determined using available scales. An applicable scale for this purpose is the Edmonton Symptom Assessment Scale (ESAS), which has been in use for years and has evolved as a useful tool in the medical field.11
Once DOL and QOL are determined on a 1-10 scale, the multiplied value then provides a product that we consider a value. The highest value hoped for in each decision is the achievement of the best QOL and DOL, a value of 100. In Figure 1, a graphic presentation of value in each decision is best seen as the area under the curve. As shown, a successful surgery, even when accompanied by significant symptoms during initial recovery, has a chance (100 – risk of POM%) to gain a larger area under curve (value) by achieving a longer life with no or fewer symptoms. However, in palliative care, progressing disease and even palliated symptoms with a shorter life expectancy impose a large burden on the patient and a much lower value. Note that in this calculation, life expectancy, which is an important but unpredictable factor, is initially included; however, by ratio comparison, it is eliminated, simplifying the calculation further.
Using this formula in different settings reveals that high-risk surgery has a greater potential to reduce YPLL in the general population. Based on this formula, compared to a surgery with potential to significantly extend DOL, a definite shorter and symptomatic life course with palliative care makes it a significantly less favorable option. In fact, in the cardiovascular field, palliative care has minimal or no effect on natural history, as the mechanism of illness is mechanical, such as occlusion of coronary arteries or valve dysfunction, leading eventually to heart failure and death. In a study by Xu et al, although palliative care reduced readmission rates and improved symptoms on a variety of scales, there was no effect on mortality and QOL in patients with heart failure.12
No model in this field has proven to be ideal, and this model bears multiple limitations as well. We have used severity of symptoms as a surrogate for QOL based on the fact that cardiac patients with different pathologies who are untreated will have a common final pathway with development of heart failure symptoms that dictate their QOL. Also, grading QOL is a difficult task at times. Even a model such as QALY, which is one of the most used, is not a perfect model and is not free of problems.6 The difference in surgical results and life expectancy between sexes and ethnic groups might be a source of bias in this formula. Also, multiple factors directly and indirectly affect QOL and DOL and create inaccuracies; therefore, making an exact science from an inexact one naturally relies on multiple assumptions. Although it has previously been shown that most POM occurs in a short period of time after cardiac surgery,13 long-term complications that potentially degrade QOL are not included in this model. By applying this model, one must assume indefinite economic resources. Moreover, applying a single mathematical model in a biologic system and in the general population has intrinsic shortcomings, and it must overlook many other factors (eg, ethical, legal). For example, it will be hard to justify a failed surgery with 15% risk of POM undertaken to eliminate the severe long-lasting symptoms of a disease, while the outcome of a successful surgery with a 20% risk of POM that adds life and quality would be ignored in the current health care system. Thus, regardless of the significant potential, most surgeons would waive a surgery based solely on the percentage rate of POM, perhaps using other terms such as ”peri-nonoperative mortality.”
Conclusion
We have proposed a simple and practical formula for decision making regarding surgical vs palliative care in high-risk patients. By assigning a value that is composed of QOL and DOL in each pathway and including the risk of POM, a ratio of values provides a numerical estimation that can be used to show preference over a specific decision. An advantage of this formula, in addition to presenting an arithmetic value that is easier to understand, is that it can be used in shared decision making with patients. We emphasize that this model is only a preliminary concept at this time and has not been tested or validated for clinical use. Validation of such a model will require extensive work and testing within a large-scale population. We hope that this article will serve as a starting point for the development of other models, and that this formula will become more sophisticated with fewer limitations through larger multidisciplinary efforts in the future.
Corresponding author: Rabin Gerrah, MD, Good Samaritan Regional Medical Center, 3640 NW Samaritan Drive, Suite 100B, Corvallis, OR 97330; [email protected].
Disclosures: None reported.
From the Department of Cardiothoracic Surgery, Stanford University, Stanford, CA.
Abstract
Complex cardiac patients are often referred for surgery or palliative care based on the risk of perioperative mortality. This decision ignores factors such as quality of life or duration of life in either surgery or the palliative path. Here, we propose a model to numerically assess and compare the value of surgery vs palliation. This model includes quality and duration of life, as well as risk of perioperative mortality, and involves a patient’s preferences in the decision-making process.
For each pathway, surgery or palliative care, a value is calculated and compared to a normal life value (no disease symptoms and normal life expectancy). The formula is adjusted for the risk of operative mortality. The model produces a ratio of the value of surgery to the value of palliative care that signifies the superiority of one or another. This model calculation presents an objective estimated numerical value to compare the value of surgery and palliative care. It can be applied to every decision-making process before surgery. In general, if a procedure has the potential to significantly extend life in a patient who otherwise has a very short life expectancy with palliation only, performing high-risk surgery would be a reasonable option. A model that provides a numerical value for surgery vs palliative care and includes quality and duration of life in each pathway could be a useful tool for cardiac surgeons in decision making regarding high-risk surgery.
Keywords: high-risk surgery, palliative care, quality of life, life expectancy.
Patients with complex cardiovascular disease are occasionally considered inoperable due to the high risk of surgical mortality. When the risk of perioperative mortality (POM) is predicted to be too high, surgical intervention is denied, and patients are often referred to palliative care. The risk of POM in cardiac surgery is often calculated using large-scale databases, such as the Society of Thoracic Surgeons (STS) records. The STS risk models, which are regularly updated, are based on large data sets and incorporate precise statistical methods for risk adjustment.1 In general, these calculators provide a percentage value that defines the magnitude of the risk of death, and then an arbitrary range is selected to categorize the procedure as low, medium, or high risk or inoperable status. The STS database does not set a cutoff point or range to define “operability.” Assigning inoperable status to a certain risk rate is problematic, with many ethical, legal, and moral implications, and for this reason, it has mostly remained undefined. In contrast, the low- and medium-risk ranges are easier to define. Another limitation encountered in the STS database is the lack of risk data for less common but very high-risk procedures, such as a triple valve replacement.
A common example where risk classification has been defined is in patients who are candidates for surgical vs transcatheter aortic valve replacement. Some groups have described a risk of <4% as low risk, 4% to 8% as intermediate risk, >8% as high risk, and >15% as inoperable2; for some other groups, a risk of POM >50% is considered extreme risk or inoperable.3,4 This procedure-specific classification is a useful decision-making tool and helps the surgeon perform an initial risk assessment to allocate a specific patient to a group—operable or nonoperable—only by calculating the risk of surgical death. However, this allocation method does not provide any information on how and when death occurs in either group. These 2 parameters of how and when death occurs define the quality of life (QOL) and the duration of life (DOL), respectively, and together could be considered as the value of life in each pathway. A survivor of a high-risk surgery may benefit from good quality and extended life (a high value), or, on the other end of the spectrum, a high-risk patient who does not undergo surgery is spared the mortality risk of the surgery but dies sooner (low value) with symptoms due to the natural course of the untreated disease.
The central question is, if a surgery is high risk but has the potential of providing a good value (for those who survive it), what QOL and DOL values are acceptable to risk or to justify accepting and proceeding with a risky surgery? Or how high a POM risk is justified to proceed with surgery rather than the alternative palliative care with a certain quality and duration? It is obvious that a decision-making process that is based on POM cannot compare the value of surgery (Vs) and the value of palliation (Vp). Furthermore, it ignores patient preferences and their input, as these are excluded from this decision-making process.
To be able to include QOL and DOL in any decision making, one must precisely describe these parameters. Both QOL and DOL are used for estimation of disease burden by health care administrators, public health experts, insurance agencies, and others. Multiple models have been proposed and used to estimate the overall burden of the disease. Most of the models for this purpose are created for large-scale economic purposes and not for decision making in individual cases.
An important measure is the quality-adjusted life year (QALY). This is an important parameter since it includes both measures of quality and quantity of life.5,6 QALY is a simplified measure to assess the value of health outcomes, and it has been used in economic calculations to assess mainly the cost-effectiveness of various interventions. We sought to evaluate the utility of a similar method in adding further insight into the surgical decision-making process. In this article, we propose a simple model to compare the value of surgery vs palliative care, similar to QALY. This model includes and adjusts for the quality and the quantity of life, in addition to the risk of POM, in the decision-making process for high-risk patients.
The Model
The 2 decision pathways, surgery and palliative care, are compared for their value. We define the value as the product of QOL and DOL in each pathway and use the severity of the symptoms as a surrogate for QOL. If duration and quality were depicted on the x and y axes of a graph (Figure 1), then the area under the curve would represent the collective value in each situation. Figure 2 shows the timeline and the different pathways with each decision. The value in each situation is calculated in relation to the full value, which is represented as the value of normal life (Vn), that is, life without disease and with normal life expectancy. The values of each decision pathway, the value of surgery (Vs) and the value of palliation (Vp), are then compared to define the benefit for each decision as follows:
If Vs/Vp > 1, the benefit is toward surgery;
If Vs/Vp < 1, the benefit is for palliative care.
Definitions
Both quality and duration of life are presented on a 1-10 scale, 1 being the lowest and 10 the highest value, to yield a product with a value of 100 in normal, disease-free life. Any lower value is presented as a percentage to represent the comparison to the full value. QOL is determined by degradation of full quality with the average level of symptoms. DOL is calculated as a lost time (
For the DOL under any condition, a 10-year survival rate could be used as a surrogate in this formula. Compared to life expectancy value, using the 10-year survival rate simplifies the calculation since cardiac diseases are more prevalent in older age, close to or beyond the average life expectancy value.
Using the time intervals from the timeline in Figure 2:
dh = time interval from diagnosis to death at life expectancy
dg = time interval from diagnosis to death after successful surgery
df = time interval from diagnosis to death after palliative care
Duration for palliative care:
Duration for surgery:
Adjustment: This value is calculated for those who survive the surgery. To adjust for the POM, it is multiplied by the 100 − POM risk.
Since value is the base for comparison in this model, and it is the product of 2 equally important factors in the formula (
After elimination of normal life expectancy, form the numerator and denominator:
To adjust for surgical outcomes in special circumstances where less than optimal or standard surgical results are expected (eg, in very rare surgeries, limited resource institutions, or suboptimal postoperative surgical care), an optional coefficient R can be added to the numerator (surgical value). This optional coefficient, with values such as 0.8, 0.9 (to degrade the value of surgery) or 1 (standard surgical outcome), adjusts for variability in interinstitutional surgical results or surgeon variability. No coefficient is added to the denominator since palliative care provides minimal differences between clinicians and hospitals. Thus, the final adjusted formula would be as follows:
Example
A 60-year-old patient with a 10% POM risk needs to be allocated to surgical or palliative care. With palliative care, if this patient lived 6 years with average symptoms grade 4, the Vp would be 20; that is, 20% of the normal life value (if he lived 18 years instead without the disease).
Using the formula for calculation of value in each pathway:
If the same patient undergoes a surgery with a 10% risk of POM, with an average grade 2 related to surgical recovery symptoms for 1 year and then is symptom-free and lives 12 years (instead of 18 years [life expectancy]), his Vs would be 53, or 53% out of the normal life value that is saved if the surgery is 100% successful; adjusted Vs with (chance of survival of 90%) would be 53 × 90% = 48%.
With adjustment of 90% survival chance in surgery, 53 × 90% = 48%. In this example, Vs/Vp = 48/20 = 2.4, showing a significant benefit for surgical care. Notably, the unknown value of normal life expectancy is not needed for the calculation of Vs/Vp, since it is the same in both pathways and it is eliminated by calculation in fraction.
Based on this formula, since the duration of surgical symptoms is short, no matter how severe these are, if the potential duration of life after surgery is high (represented by smaller area under the curve in Figure 1), the numerator becomes larger and the value of the surgery grows. For example, if a patient with a 15% risk of POM, which is generally considered inoperable, lives 5 years, as opposed to 2 years with palliative care with mild symptoms (eg 3/10), Vs/Vp would be 2.7, still showing a significant benefit for surgical care.
Discussion
Any surgical intervention is offered with 2 goals in mind, improving QOL and extending DOL. In a high-risk patient, surgery might be declined due to a high risk of POM, and the patient is offered palliative care, which other than providing symptom relief does not change the course of disease and eventually the patient will die due to the untreated disease. In this decision-making method, mostly completed by a care team only, a potential risk of death due to surgery which possibly could cure the patient is traded for immediate survival; however, the symptomatic course ensues until death. This mostly unilateral decision-making process by a care team, which incorporates minimal input from the patient or ignores patient preferences altogether, is based only on POM risk, and roughly includes a single parameter: years of potential life lost (YPLL). YPLL is a measure of premature mortality, and in the setting of surgical intervention, YPLL is the number of years a patient would lose unless a successful surgery were undertaken. Obviously, patients would live longer if a surgery that was intended to save them failed.
In this article, we proposed a simple method to quantify each decision to decide whether to operate or choose surgical care vs palliative care. Since quality and duration of life are both end factors clinicians and patients aspire to in each decision, they can be considered together as the value of each decision. We believe a numerical framework would provide an objective way to assist both the patient at high risk and the care team in the decision-making process.
The 2 parameters we consider are DOL and QOL. DOL, or survival, can be extracted from large-scale data using statistical methods that have been developed to predict survival under various conditions, such as Kaplan-Meier curves. These methods present the chance of survival in percentages in a defined time frame, such as a 5- or 10-year period.
While the DOL is a numerical parameter and quantifiable, the QOL is a more complex entity. This subjective parameter bears multiple definitions, aspects, and categories, and therefore multiple scales for quantification of QOL have been proposed. These scales have been used extensively for the purpose of health determination in health care policy and economic planning. Most scales acknowledge that QOL is multifactorial and includes interrelated aspects such as mental and socioeconomic factors. We have also noticed that QOL is better determined by the palliative care team than surgeons, so including these care providers in the decision-making process might reduce surgeon bias.
Since our purpose here is only to assist with the decision on medical intervention, we focus on physical QOL. Multiple scales are used to assess health-related QOL, such as the Assessment of Quality of Life (AQoL)-8D,7 EuroQol-5 Dimension (EQ-5D),8 15D,9 and the 36-Item Short Form Survey (SF-36).10 These complex scales are built for systematic reviews, and they are not practical for a clinical user. To simplify and keep this practical, we define QOL by using the severity or grade of symptoms related to the disease the patient has on a scale of 0 to 10. The severity of symptoms can be easily determined using available scales. An applicable scale for this purpose is the Edmonton Symptom Assessment Scale (ESAS), which has been in use for years and has evolved as a useful tool in the medical field.11
Once DOL and QOL are determined on a 1-10 scale, the multiplied value then provides a product that we consider a value. The highest value hoped for in each decision is the achievement of the best QOL and DOL, a value of 100. In Figure 1, a graphic presentation of value in each decision is best seen as the area under the curve. As shown, a successful surgery, even when accompanied by significant symptoms during initial recovery, has a chance (100 – risk of POM%) to gain a larger area under curve (value) by achieving a longer life with no or fewer symptoms. However, in palliative care, progressing disease and even palliated symptoms with a shorter life expectancy impose a large burden on the patient and a much lower value. Note that in this calculation, life expectancy, which is an important but unpredictable factor, is initially included; however, by ratio comparison, it is eliminated, simplifying the calculation further.
Using this formula in different settings reveals that high-risk surgery has a greater potential to reduce YPLL in the general population. Based on this formula, compared to a surgery with potential to significantly extend DOL, a definite shorter and symptomatic life course with palliative care makes it a significantly less favorable option. In fact, in the cardiovascular field, palliative care has minimal or no effect on natural history, as the mechanism of illness is mechanical, such as occlusion of coronary arteries or valve dysfunction, leading eventually to heart failure and death. In a study by Xu et al, although palliative care reduced readmission rates and improved symptoms on a variety of scales, there was no effect on mortality and QOL in patients with heart failure.12
No model in this field has proven to be ideal, and this model bears multiple limitations as well. We have used severity of symptoms as a surrogate for QOL based on the fact that cardiac patients with different pathologies who are untreated will have a common final pathway with development of heart failure symptoms that dictate their QOL. Also, grading QOL is a difficult task at times. Even a model such as QALY, which is one of the most used, is not a perfect model and is not free of problems.6 The difference in surgical results and life expectancy between sexes and ethnic groups might be a source of bias in this formula. Also, multiple factors directly and indirectly affect QOL and DOL and create inaccuracies; therefore, making an exact science from an inexact one naturally relies on multiple assumptions. Although it has previously been shown that most POM occurs in a short period of time after cardiac surgery,13 long-term complications that potentially degrade QOL are not included in this model. By applying this model, one must assume indefinite economic resources. Moreover, applying a single mathematical model in a biologic system and in the general population has intrinsic shortcomings, and it must overlook many other factors (eg, ethical, legal). For example, it will be hard to justify a failed surgery with 15% risk of POM undertaken to eliminate the severe long-lasting symptoms of a disease, while the outcome of a successful surgery with a 20% risk of POM that adds life and quality would be ignored in the current health care system. Thus, regardless of the significant potential, most surgeons would waive a surgery based solely on the percentage rate of POM, perhaps using other terms such as ”peri-nonoperative mortality.”
Conclusion
We have proposed a simple and practical formula for decision making regarding surgical vs palliative care in high-risk patients. By assigning a value that is composed of QOL and DOL in each pathway and including the risk of POM, a ratio of values provides a numerical estimation that can be used to show preference over a specific decision. An advantage of this formula, in addition to presenting an arithmetic value that is easier to understand, is that it can be used in shared decision making with patients. We emphasize that this model is only a preliminary concept at this time and has not been tested or validated for clinical use. Validation of such a model will require extensive work and testing within a large-scale population. We hope that this article will serve as a starting point for the development of other models, and that this formula will become more sophisticated with fewer limitations through larger multidisciplinary efforts in the future.
Corresponding author: Rabin Gerrah, MD, Good Samaritan Regional Medical Center, 3640 NW Samaritan Drive, Suite 100B, Corvallis, OR 97330; [email protected].
Disclosures: None reported.
1. O’Brien SM, Feng L, He X, et al. The Society of Thoracic Surgeons 2018 Adult Cardiac Surgery Risk Models: Part 2-statistical methods and results. Ann Thorac Surg. 2018;105(5):1419-1428. doi: 10.1016/j.athoracsur.2018.03.003
2. Hurtado Rendón IS, Bittenbender P, Dunn JM, Firstenberg MS. Chapter 8: Diagnostic workup and evaluation: eligibility, risk assessment, FDA guidelines. In: Transcatheter Heart Valve Handbook: A Surgeons’ and Interventional Council Review. Akron City Hospital, Summa Health System, Akron, OH.
3. Herrmann HC, Thourani VH, Kodali SK, et al; PARTNER Investigators. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis. Circulation. 2016;134:130-140. doi:10.1161/CIRCULATIONAHA
4. Ho C, Argáez C. Transcatheter Aortic Valve Implantation for Patients with Severe Aortic Stenosis at Various Levels of Surgical Risk: A Review of Clinical Effectiveness. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; March 19, 2018.
5. Rios-Diaz AJ, Lam J, Ramos MS, et al. Global patterns of QALY and DALY use in surgical cost-utility analyses: a systematic review. PLoS One. 2016:10;11:e0148304. doi:10.1371/journal.pone.0148304
6. Prieto L, Sacristán JA. Health, Problems and solutions in calculating quality-adjusted life years (QALYs). Qual Life Outcomes. 2003:19;1:80.
7. Centre for Health Economics. Assessment of Quality of Life. 2014. Accessed May 13, 2022. http://www.aqol.com.au/
8. EuroQol Research Foundation. EQ-5D. Accessed May 13, 2022. https://euroqol.org/
9. 15D Instrument. Accessed May 13, 2022. http://www.15d-instrument.net/15d/
10. Rand Corporation. 36-Item Short Form Survey (SF-36).Accessed May 12, 2022. https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form.html
11. Hui D, Bruera E. The Edmonton Symptom Assessment System 25 years later: past, present, and future developments. J Pain Symptom Manage. 2017:53:630-643. doi:10.1016/j.jpainsymman.2016
12. Xu Z, Chen L, Jin S, Yang B, Chen X, Wu Z. Effect of palliative care for patients with heart failure. Int Heart J. 2018:30;59:503-509. doi:10.1536/ihj.17-289
13. Mazzeffi M, Zivot J, Buchman T, Halkos M. In-hospital mortality after cardiac surgery: patient characteristics, timing, and association with postoperative length of intensive care unit and hospital stay. Ann Thorac Surg. 2014;97:1220-1225. doi:10.1016/j.athoracsur.2013.10.040
1. O’Brien SM, Feng L, He X, et al. The Society of Thoracic Surgeons 2018 Adult Cardiac Surgery Risk Models: Part 2-statistical methods and results. Ann Thorac Surg. 2018;105(5):1419-1428. doi: 10.1016/j.athoracsur.2018.03.003
2. Hurtado Rendón IS, Bittenbender P, Dunn JM, Firstenberg MS. Chapter 8: Diagnostic workup and evaluation: eligibility, risk assessment, FDA guidelines. In: Transcatheter Heart Valve Handbook: A Surgeons’ and Interventional Council Review. Akron City Hospital, Summa Health System, Akron, OH.
3. Herrmann HC, Thourani VH, Kodali SK, et al; PARTNER Investigators. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high-risk and inoperable patients with severe aortic stenosis. Circulation. 2016;134:130-140. doi:10.1161/CIRCULATIONAHA
4. Ho C, Argáez C. Transcatheter Aortic Valve Implantation for Patients with Severe Aortic Stenosis at Various Levels of Surgical Risk: A Review of Clinical Effectiveness. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; March 19, 2018.
5. Rios-Diaz AJ, Lam J, Ramos MS, et al. Global patterns of QALY and DALY use in surgical cost-utility analyses: a systematic review. PLoS One. 2016:10;11:e0148304. doi:10.1371/journal.pone.0148304
6. Prieto L, Sacristán JA. Health, Problems and solutions in calculating quality-adjusted life years (QALYs). Qual Life Outcomes. 2003:19;1:80.
7. Centre for Health Economics. Assessment of Quality of Life. 2014. Accessed May 13, 2022. http://www.aqol.com.au/
8. EuroQol Research Foundation. EQ-5D. Accessed May 13, 2022. https://euroqol.org/
9. 15D Instrument. Accessed May 13, 2022. http://www.15d-instrument.net/15d/
10. Rand Corporation. 36-Item Short Form Survey (SF-36).Accessed May 12, 2022. https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form.html
11. Hui D, Bruera E. The Edmonton Symptom Assessment System 25 years later: past, present, and future developments. J Pain Symptom Manage. 2017:53:630-643. doi:10.1016/j.jpainsymman.2016
12. Xu Z, Chen L, Jin S, Yang B, Chen X, Wu Z. Effect of palliative care for patients with heart failure. Int Heart J. 2018:30;59:503-509. doi:10.1536/ihj.17-289
13. Mazzeffi M, Zivot J, Buchman T, Halkos M. In-hospital mortality after cardiac surgery: patient characteristics, timing, and association with postoperative length of intensive care unit and hospital stay. Ann Thorac Surg. 2014;97:1220-1225. doi:10.1016/j.athoracsur.2013.10.040
Doc accused of killing 14 patients found not guilty
In an unprecedented murder case about end-of-life care, a physician accused of killing 14 critically ill patients with opioid overdoses in a Columbus, Ohio, hospital ICU over a period of 4 years was found not guilty by a jury April 20.
The jury, after a 7-week trial featuring more than 50 witnesses in the Franklin County Court of Common Pleas, declared William Husel, DO, not guilty on 14 counts of murder and attempted murder.
In a news conference after the verdict was announced, lead defense attorney Jose Baez said Dr. Husel, whom he called a “great doctor,” hopes to practice medicine again in the future. “They don’t need to be looking over their shoulders worrying about whether they’ll get charged with crimes,” he said.
The prosecutors in the case declined to comment, other than to say they “accept” the verdict.
Legal experts said it’s highly unlikely that Ohio or any other state would restore Dr. Husel’s suspended medical license. “I doubt he could ever work in medicine again,” said Mark Schumacher, a Columbus medical malpractice defense attorney who retired in 2020 after practicing for 39 years. Mr. Schumacher followed the trial closely.
The trial raised the specific issue of what constitutes a medically justifiable dose of opioid painkillers during the end-of-life procedure known as palliative extubation, in which critically ill patients are withdrawn from the ventilator when they are expected to die. Under medicine’s so-called double-effect principle, physicians must weigh the benefits and risks of ordering potentially lethal doses of painkillers and sedatives to provide comfort care for critically ill patients.
To many observers, however, the case really centered on the largely hidden debate over whether it’s acceptable to hasten the deaths of dying patients who haven’t chosen that path. That’s called euthanasia, which is illegal in the United States. In contrast, 10 states plus the District of Columbia allow physicians to prescribe lethal drugs to terminally ill, mentally competent adults who can self-administer them. That’s called medical aid in dying, or physician-assisted dying or suicide.
“Maybe this is a wake-up call that people believe this is the right thing to do,” said Lewis Nelson, MD, chair of emergency medicine at New Jersey Medical School in Newark. “The medical community has a sense that we often prolong life unnecessarily. But a physician cannot unilaterally decide it’s time for someone to die. It sounds like [Dr. Husel] took that decision into his own hands.”
The case also exposed major gaps in the patient safety culture at Mount Carmel West Hospital in Columbus, which is owned by the Catholic chain Trinity Health. Experts say failures by hospital staff to question physicians’ orders and raise patient safety concerns, as happened at Mount Carmel, occur at many hospitals around the country. Experts say the Husel case offers vital lessons for health care professionals about improving safety procedures.
“This is an extreme example, that everyone should learn from, about what not to do,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “Husel was giving massive overdoses of drugs, people knew it was problematic, and someone didn’t put their foot down. You’ve got to have a process in place to address these situations where there is disagreement over the safety of a medication order.”
Dr. Husel was charged with killing the 14 patients from 2015 through 2018 by ordering single large doses of the painkiller fentanyl – from 500 to 2,000 micrograms – often in combination with other opioids and sedatives, while working as the solo physician on the overnight shift in the ICU at Mount Carmel West Hospital and at Mount Carmel St. Ann’s Hospital in Westerville, Ohio.
Dr. Husel ordered administration of the drugs while his patients were having an endotracheal tube removed as part of palliative extubation. There was conflicting testimony during the trial about whether the patients were showing signs of pain or were even capable of feeling pain.
Prosecutors argued that Dr. Husel, who did a residency and fellowship in critical care medicine at Cleveland Clinic and started working at Mount Carmel in 2013 in his first job as a full-fledged physician, intended to kill the patients or hasten their deaths. They contended that the inexperienced nurses in the ICU went along with his large drug doses because they were “in thrall” to him because of his prestigious background at the Cleveland Clinic and his willingness to take the time to teach them.
“With his training in anesthesiology, he knew what those drugs do,” assistant prosecutor David Zeyen said in closing arguments. “This isn’t negligence. This is on purpose ... Euthanizing animals with the intent to kill is fine in veterinary medicine. It’s not fine in the ICU at Mount Carmel or anywhere.”
The defense team argued that Dr. Husel was a caring and compassionate physician who ordered the drugs to relieve the patients’ pain and discomfort during the extubation process. He did not testify.
“Common sense says Dr Husel had no motive to harm patients,” defense attorney Baez said in his closing. “He dedicated his life to taking care of patients and saving lives, not taking them. ... Why would this man risk his family, career, and 17 years of trying to be a doctor to hasten someone’s death or kill them?”
There were 35 Mount Carmel patients who died in the ICU under Dr. Husel’s care after receiving large fentanyl doses during palliative extubation. The state originally charged him with murder in 25 of those cases, then reduced that to 14.
Many of Dr. Husel’s drug orders were given verbally instead of through the regular process of being entered into the electronic health record. He and the nurses on duty also skipped the standard nonemergency process of getting approval from the pharmacist on duty, instead using the override function on Mount Carmel’s automated Pyxis drug dispensing system.
Dr. Husel’s unusual dosing patterns were first reported to Mount Carmel officials by pharmacists in October 2018, spurring an investigation. The hospital system let him go in December 2018, after concluding that the opioid dosages he used were “significantly excessive and potentially fatal” and “went beyond providing comfort.”
Nearly two dozen RNs and two pharmacists involved in these cases have faced state disciplinary action, mostly license suspension. Federal and state agencies have cited the Mount Carmel system for faults in its patient safety processes and culture that were exposed by the Husel cases.
The Mount Carmel CEO; the chief clinical officer; other physician, nursing, and pharmacy leaders; and dozens of nurses and pharmacists were forced out following the Husel investigation.
In 2019, the Centers for Medicare & Medicaid Services, after threatening to cut off federal reimbursements to Mount Carmel, accepted the hospital system’s correction plan restricting the use of verbal drug orders and prohibiting Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.
Mount Carmel and Trinity have settled a number of civil wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. Gerry Leeseberg, a Columbus medical malpractice plaintiff attorney who is representing 17 of the families, said a number of the cases are set for trial starting in June.
During the trial, family members of many of the 14 patients whom Dr. Husel allegedly murdered testified that Dr. Husel told them their loved ones were dying. Some said they felt rushed into making a decision to extubate the person.
Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved ones gasping for breath. But most medical experts – including the state’s two physician expert witnesses – say the fentanyl doses Dr. Husel ordered were 5-20 times larger than doses normally used in palliative extubation. Such doses, they say, will quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.
Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 micrograms for relieving pain, and its 2018 guidelines reduced that to 25-50 micrograms.
The doses Dr. Husel ordered are lethal, even for most patients with some tolerance to opioids, said Rutgers EM chair Dr. Nelson, who practices medical toxicology and addiction medicine. “Those are doses to provide euthanasia, not to relieve pain.”
At trial, the prosecutors had to overcome two big challenges to win murder convictions against Dr. Husel: They had to prove beyond a reasonable doubt that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.
Late in the trial, at the state’s request, the judge ruled to allow the jury to also consider attempted murder charges, which require proof of intent but not that the defendant’s actions directly caused the deaths.
Another challenge was that physicians have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia. That’s what prosecutors accused Dr. Husel of doing.
“If you hasten a person’s death, even if their death is as sure as the sun is going to rise in the morning ... you have caused their death in the eyes of the law,” assistant prosecutor Mr. Zeyen said in his closing. “You don’t get a pass for killing a dying man ...”
Mr. Leeseberg said it was always going to be extremely hard to convince a jury to convict a physician of murder, with the potential of life in prison, in a case where the physician’s acts occurred openly over 4 years in a hospital setting where no one did anything to stop him. It would have been much easier to convince a jury to convict him of reckless homicide, a lesser offense with a shorter prison term. That would have required proving that he acted in reckless disregard for his patients’ health and safety.
In post-verdict comments to the news media, Judge Michael Holbrook said jurors told him that the procedures for the dispensing of fentanyl and other drugs at Mount Carmel weren’t properly explained to them during the trial, and that they were confused by the large number of prosecution witnesses. He also said they were confused that no one had stated a maximum dosage for fentanyl.
Mr. Schumacher, the retired malpractice defense lawyer who followed the trial, disagreed with defense attorney Baez’s takeaway about the impact of the case on pain-relief practices. In his view, the case likely will heighten rather than reduce the anxiety of physicians and nurses about administering opioids, even when the dosages are clearly needed and appropriate. He doesn’t think Dr. Husel’s dosages can be justified, however.
“Physicians have a naive overreaction to any legal development, and overgeneralize from a particular case to everyday practice,” he said.
There is only one known prior case that’s somewhat comparable of a physician tried for murder or attempted murder for giving a critically ill patient opioids for pain relief. In 1996, a Kansas jury convicted Lloyd Stanley Naramore, DO, of attempted murder in the death of a patient to whom he gave an opioid, and of second-degree murder for removing a patient from a ventilator. After Dr. Naramore served 6 months in prison, an appellate court reversed the convictions for lack of evidence.
In March, RaDonda Vaught, a nurse who worked at Vanderbilt University Medical Center in Nashville, Tenn., was convicted of criminal neglect and negligent homicide for mistakenly administering a fatal dose of the paralyzing drug vecuronium, instead of the prescribed drug Versed (midazolam), to a patient. Providers around the country were alarmed by her criminal prosecution for what was clearly an unintentional error.
But legal and medical experts said Dr. Husel’s case was sharply different from Vaught’s and Dr. Naramore’s because he deliberately and repeatedly ordered large doses of fentanyl and other drugs that he knew or should have known were potentially lethal. “You don’t need 2,000 micrograms of fentanyl plus other drugs for comfort care, and repeat that again and again for patient after patient,” said Mr. Cohen, of the Institute for Safe Medication Practices. “No one gives that to patients. You’ll knock them off.”
During the trial, prosecutors said repeatedly that no one except Dr. Husel knows what he was thinking when he ordered those huge drug dosages for his ICU patients. Judge Holbrook told the jury the state did not have to prove motive, only intent. But many observers still have wondered what his motives were.
Dr. Husel’s own view of his care in these cases soon will become public. Immediately after the April 20 verdict, Mr. Leeseberg filed a notice requesting a May 9 deposition of Dr. Husel, who will no longer be able to claim the Fifth Amendment right against self-incrimination. He predicted the deposition will last about a week, and then the transcript will be publicly available.
A version of this article first appeared on Medscape.com.
In an unprecedented murder case about end-of-life care, a physician accused of killing 14 critically ill patients with opioid overdoses in a Columbus, Ohio, hospital ICU over a period of 4 years was found not guilty by a jury April 20.
The jury, after a 7-week trial featuring more than 50 witnesses in the Franklin County Court of Common Pleas, declared William Husel, DO, not guilty on 14 counts of murder and attempted murder.
In a news conference after the verdict was announced, lead defense attorney Jose Baez said Dr. Husel, whom he called a “great doctor,” hopes to practice medicine again in the future. “They don’t need to be looking over their shoulders worrying about whether they’ll get charged with crimes,” he said.
The prosecutors in the case declined to comment, other than to say they “accept” the verdict.
Legal experts said it’s highly unlikely that Ohio or any other state would restore Dr. Husel’s suspended medical license. “I doubt he could ever work in medicine again,” said Mark Schumacher, a Columbus medical malpractice defense attorney who retired in 2020 after practicing for 39 years. Mr. Schumacher followed the trial closely.
The trial raised the specific issue of what constitutes a medically justifiable dose of opioid painkillers during the end-of-life procedure known as palliative extubation, in which critically ill patients are withdrawn from the ventilator when they are expected to die. Under medicine’s so-called double-effect principle, physicians must weigh the benefits and risks of ordering potentially lethal doses of painkillers and sedatives to provide comfort care for critically ill patients.
To many observers, however, the case really centered on the largely hidden debate over whether it’s acceptable to hasten the deaths of dying patients who haven’t chosen that path. That’s called euthanasia, which is illegal in the United States. In contrast, 10 states plus the District of Columbia allow physicians to prescribe lethal drugs to terminally ill, mentally competent adults who can self-administer them. That’s called medical aid in dying, or physician-assisted dying or suicide.
“Maybe this is a wake-up call that people believe this is the right thing to do,” said Lewis Nelson, MD, chair of emergency medicine at New Jersey Medical School in Newark. “The medical community has a sense that we often prolong life unnecessarily. But a physician cannot unilaterally decide it’s time for someone to die. It sounds like [Dr. Husel] took that decision into his own hands.”
The case also exposed major gaps in the patient safety culture at Mount Carmel West Hospital in Columbus, which is owned by the Catholic chain Trinity Health. Experts say failures by hospital staff to question physicians’ orders and raise patient safety concerns, as happened at Mount Carmel, occur at many hospitals around the country. Experts say the Husel case offers vital lessons for health care professionals about improving safety procedures.
“This is an extreme example, that everyone should learn from, about what not to do,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “Husel was giving massive overdoses of drugs, people knew it was problematic, and someone didn’t put their foot down. You’ve got to have a process in place to address these situations where there is disagreement over the safety of a medication order.”
Dr. Husel was charged with killing the 14 patients from 2015 through 2018 by ordering single large doses of the painkiller fentanyl – from 500 to 2,000 micrograms – often in combination with other opioids and sedatives, while working as the solo physician on the overnight shift in the ICU at Mount Carmel West Hospital and at Mount Carmel St. Ann’s Hospital in Westerville, Ohio.
Dr. Husel ordered administration of the drugs while his patients were having an endotracheal tube removed as part of palliative extubation. There was conflicting testimony during the trial about whether the patients were showing signs of pain or were even capable of feeling pain.
Prosecutors argued that Dr. Husel, who did a residency and fellowship in critical care medicine at Cleveland Clinic and started working at Mount Carmel in 2013 in his first job as a full-fledged physician, intended to kill the patients or hasten their deaths. They contended that the inexperienced nurses in the ICU went along with his large drug doses because they were “in thrall” to him because of his prestigious background at the Cleveland Clinic and his willingness to take the time to teach them.
“With his training in anesthesiology, he knew what those drugs do,” assistant prosecutor David Zeyen said in closing arguments. “This isn’t negligence. This is on purpose ... Euthanizing animals with the intent to kill is fine in veterinary medicine. It’s not fine in the ICU at Mount Carmel or anywhere.”
The defense team argued that Dr. Husel was a caring and compassionate physician who ordered the drugs to relieve the patients’ pain and discomfort during the extubation process. He did not testify.
“Common sense says Dr Husel had no motive to harm patients,” defense attorney Baez said in his closing. “He dedicated his life to taking care of patients and saving lives, not taking them. ... Why would this man risk his family, career, and 17 years of trying to be a doctor to hasten someone’s death or kill them?”
There were 35 Mount Carmel patients who died in the ICU under Dr. Husel’s care after receiving large fentanyl doses during palliative extubation. The state originally charged him with murder in 25 of those cases, then reduced that to 14.
Many of Dr. Husel’s drug orders were given verbally instead of through the regular process of being entered into the electronic health record. He and the nurses on duty also skipped the standard nonemergency process of getting approval from the pharmacist on duty, instead using the override function on Mount Carmel’s automated Pyxis drug dispensing system.
Dr. Husel’s unusual dosing patterns were first reported to Mount Carmel officials by pharmacists in October 2018, spurring an investigation. The hospital system let him go in December 2018, after concluding that the opioid dosages he used were “significantly excessive and potentially fatal” and “went beyond providing comfort.”
Nearly two dozen RNs and two pharmacists involved in these cases have faced state disciplinary action, mostly license suspension. Federal and state agencies have cited the Mount Carmel system for faults in its patient safety processes and culture that were exposed by the Husel cases.
The Mount Carmel CEO; the chief clinical officer; other physician, nursing, and pharmacy leaders; and dozens of nurses and pharmacists were forced out following the Husel investigation.
In 2019, the Centers for Medicare & Medicaid Services, after threatening to cut off federal reimbursements to Mount Carmel, accepted the hospital system’s correction plan restricting the use of verbal drug orders and prohibiting Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.
Mount Carmel and Trinity have settled a number of civil wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. Gerry Leeseberg, a Columbus medical malpractice plaintiff attorney who is representing 17 of the families, said a number of the cases are set for trial starting in June.
During the trial, family members of many of the 14 patients whom Dr. Husel allegedly murdered testified that Dr. Husel told them their loved ones were dying. Some said they felt rushed into making a decision to extubate the person.
Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved ones gasping for breath. But most medical experts – including the state’s two physician expert witnesses – say the fentanyl doses Dr. Husel ordered were 5-20 times larger than doses normally used in palliative extubation. Such doses, they say, will quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.
Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 micrograms for relieving pain, and its 2018 guidelines reduced that to 25-50 micrograms.
The doses Dr. Husel ordered are lethal, even for most patients with some tolerance to opioids, said Rutgers EM chair Dr. Nelson, who practices medical toxicology and addiction medicine. “Those are doses to provide euthanasia, not to relieve pain.”
At trial, the prosecutors had to overcome two big challenges to win murder convictions against Dr. Husel: They had to prove beyond a reasonable doubt that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.
Late in the trial, at the state’s request, the judge ruled to allow the jury to also consider attempted murder charges, which require proof of intent but not that the defendant’s actions directly caused the deaths.
Another challenge was that physicians have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia. That’s what prosecutors accused Dr. Husel of doing.
“If you hasten a person’s death, even if their death is as sure as the sun is going to rise in the morning ... you have caused their death in the eyes of the law,” assistant prosecutor Mr. Zeyen said in his closing. “You don’t get a pass for killing a dying man ...”
Mr. Leeseberg said it was always going to be extremely hard to convince a jury to convict a physician of murder, with the potential of life in prison, in a case where the physician’s acts occurred openly over 4 years in a hospital setting where no one did anything to stop him. It would have been much easier to convince a jury to convict him of reckless homicide, a lesser offense with a shorter prison term. That would have required proving that he acted in reckless disregard for his patients’ health and safety.
In post-verdict comments to the news media, Judge Michael Holbrook said jurors told him that the procedures for the dispensing of fentanyl and other drugs at Mount Carmel weren’t properly explained to them during the trial, and that they were confused by the large number of prosecution witnesses. He also said they were confused that no one had stated a maximum dosage for fentanyl.
Mr. Schumacher, the retired malpractice defense lawyer who followed the trial, disagreed with defense attorney Baez’s takeaway about the impact of the case on pain-relief practices. In his view, the case likely will heighten rather than reduce the anxiety of physicians and nurses about administering opioids, even when the dosages are clearly needed and appropriate. He doesn’t think Dr. Husel’s dosages can be justified, however.
“Physicians have a naive overreaction to any legal development, and overgeneralize from a particular case to everyday practice,” he said.
There is only one known prior case that’s somewhat comparable of a physician tried for murder or attempted murder for giving a critically ill patient opioids for pain relief. In 1996, a Kansas jury convicted Lloyd Stanley Naramore, DO, of attempted murder in the death of a patient to whom he gave an opioid, and of second-degree murder for removing a patient from a ventilator. After Dr. Naramore served 6 months in prison, an appellate court reversed the convictions for lack of evidence.
In March, RaDonda Vaught, a nurse who worked at Vanderbilt University Medical Center in Nashville, Tenn., was convicted of criminal neglect and negligent homicide for mistakenly administering a fatal dose of the paralyzing drug vecuronium, instead of the prescribed drug Versed (midazolam), to a patient. Providers around the country were alarmed by her criminal prosecution for what was clearly an unintentional error.
But legal and medical experts said Dr. Husel’s case was sharply different from Vaught’s and Dr. Naramore’s because he deliberately and repeatedly ordered large doses of fentanyl and other drugs that he knew or should have known were potentially lethal. “You don’t need 2,000 micrograms of fentanyl plus other drugs for comfort care, and repeat that again and again for patient after patient,” said Mr. Cohen, of the Institute for Safe Medication Practices. “No one gives that to patients. You’ll knock them off.”
During the trial, prosecutors said repeatedly that no one except Dr. Husel knows what he was thinking when he ordered those huge drug dosages for his ICU patients. Judge Holbrook told the jury the state did not have to prove motive, only intent. But many observers still have wondered what his motives were.
Dr. Husel’s own view of his care in these cases soon will become public. Immediately after the April 20 verdict, Mr. Leeseberg filed a notice requesting a May 9 deposition of Dr. Husel, who will no longer be able to claim the Fifth Amendment right against self-incrimination. He predicted the deposition will last about a week, and then the transcript will be publicly available.
A version of this article first appeared on Medscape.com.
In an unprecedented murder case about end-of-life care, a physician accused of killing 14 critically ill patients with opioid overdoses in a Columbus, Ohio, hospital ICU over a period of 4 years was found not guilty by a jury April 20.
The jury, after a 7-week trial featuring more than 50 witnesses in the Franklin County Court of Common Pleas, declared William Husel, DO, not guilty on 14 counts of murder and attempted murder.
In a news conference after the verdict was announced, lead defense attorney Jose Baez said Dr. Husel, whom he called a “great doctor,” hopes to practice medicine again in the future. “They don’t need to be looking over their shoulders worrying about whether they’ll get charged with crimes,” he said.
The prosecutors in the case declined to comment, other than to say they “accept” the verdict.
Legal experts said it’s highly unlikely that Ohio or any other state would restore Dr. Husel’s suspended medical license. “I doubt he could ever work in medicine again,” said Mark Schumacher, a Columbus medical malpractice defense attorney who retired in 2020 after practicing for 39 years. Mr. Schumacher followed the trial closely.
The trial raised the specific issue of what constitutes a medically justifiable dose of opioid painkillers during the end-of-life procedure known as palliative extubation, in which critically ill patients are withdrawn from the ventilator when they are expected to die. Under medicine’s so-called double-effect principle, physicians must weigh the benefits and risks of ordering potentially lethal doses of painkillers and sedatives to provide comfort care for critically ill patients.
To many observers, however, the case really centered on the largely hidden debate over whether it’s acceptable to hasten the deaths of dying patients who haven’t chosen that path. That’s called euthanasia, which is illegal in the United States. In contrast, 10 states plus the District of Columbia allow physicians to prescribe lethal drugs to terminally ill, mentally competent adults who can self-administer them. That’s called medical aid in dying, or physician-assisted dying or suicide.
“Maybe this is a wake-up call that people believe this is the right thing to do,” said Lewis Nelson, MD, chair of emergency medicine at New Jersey Medical School in Newark. “The medical community has a sense that we often prolong life unnecessarily. But a physician cannot unilaterally decide it’s time for someone to die. It sounds like [Dr. Husel] took that decision into his own hands.”
The case also exposed major gaps in the patient safety culture at Mount Carmel West Hospital in Columbus, which is owned by the Catholic chain Trinity Health. Experts say failures by hospital staff to question physicians’ orders and raise patient safety concerns, as happened at Mount Carmel, occur at many hospitals around the country. Experts say the Husel case offers vital lessons for health care professionals about improving safety procedures.
“This is an extreme example, that everyone should learn from, about what not to do,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “Husel was giving massive overdoses of drugs, people knew it was problematic, and someone didn’t put their foot down. You’ve got to have a process in place to address these situations where there is disagreement over the safety of a medication order.”
Dr. Husel was charged with killing the 14 patients from 2015 through 2018 by ordering single large doses of the painkiller fentanyl – from 500 to 2,000 micrograms – often in combination with other opioids and sedatives, while working as the solo physician on the overnight shift in the ICU at Mount Carmel West Hospital and at Mount Carmel St. Ann’s Hospital in Westerville, Ohio.
Dr. Husel ordered administration of the drugs while his patients were having an endotracheal tube removed as part of palliative extubation. There was conflicting testimony during the trial about whether the patients were showing signs of pain or were even capable of feeling pain.
Prosecutors argued that Dr. Husel, who did a residency and fellowship in critical care medicine at Cleveland Clinic and started working at Mount Carmel in 2013 in his first job as a full-fledged physician, intended to kill the patients or hasten their deaths. They contended that the inexperienced nurses in the ICU went along with his large drug doses because they were “in thrall” to him because of his prestigious background at the Cleveland Clinic and his willingness to take the time to teach them.
“With his training in anesthesiology, he knew what those drugs do,” assistant prosecutor David Zeyen said in closing arguments. “This isn’t negligence. This is on purpose ... Euthanizing animals with the intent to kill is fine in veterinary medicine. It’s not fine in the ICU at Mount Carmel or anywhere.”
The defense team argued that Dr. Husel was a caring and compassionate physician who ordered the drugs to relieve the patients’ pain and discomfort during the extubation process. He did not testify.
“Common sense says Dr Husel had no motive to harm patients,” defense attorney Baez said in his closing. “He dedicated his life to taking care of patients and saving lives, not taking them. ... Why would this man risk his family, career, and 17 years of trying to be a doctor to hasten someone’s death or kill them?”
There were 35 Mount Carmel patients who died in the ICU under Dr. Husel’s care after receiving large fentanyl doses during palliative extubation. The state originally charged him with murder in 25 of those cases, then reduced that to 14.
Many of Dr. Husel’s drug orders were given verbally instead of through the regular process of being entered into the electronic health record. He and the nurses on duty also skipped the standard nonemergency process of getting approval from the pharmacist on duty, instead using the override function on Mount Carmel’s automated Pyxis drug dispensing system.
Dr. Husel’s unusual dosing patterns were first reported to Mount Carmel officials by pharmacists in October 2018, spurring an investigation. The hospital system let him go in December 2018, after concluding that the opioid dosages he used were “significantly excessive and potentially fatal” and “went beyond providing comfort.”
Nearly two dozen RNs and two pharmacists involved in these cases have faced state disciplinary action, mostly license suspension. Federal and state agencies have cited the Mount Carmel system for faults in its patient safety processes and culture that were exposed by the Husel cases.
The Mount Carmel CEO; the chief clinical officer; other physician, nursing, and pharmacy leaders; and dozens of nurses and pharmacists were forced out following the Husel investigation.
In 2019, the Centers for Medicare & Medicaid Services, after threatening to cut off federal reimbursements to Mount Carmel, accepted the hospital system’s correction plan restricting the use of verbal drug orders and prohibiting Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.
Mount Carmel and Trinity have settled a number of civil wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. Gerry Leeseberg, a Columbus medical malpractice plaintiff attorney who is representing 17 of the families, said a number of the cases are set for trial starting in June.
During the trial, family members of many of the 14 patients whom Dr. Husel allegedly murdered testified that Dr. Husel told them their loved ones were dying. Some said they felt rushed into making a decision to extubate the person.
Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved ones gasping for breath. But most medical experts – including the state’s two physician expert witnesses – say the fentanyl doses Dr. Husel ordered were 5-20 times larger than doses normally used in palliative extubation. Such doses, they say, will quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.
Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 micrograms for relieving pain, and its 2018 guidelines reduced that to 25-50 micrograms.
The doses Dr. Husel ordered are lethal, even for most patients with some tolerance to opioids, said Rutgers EM chair Dr. Nelson, who practices medical toxicology and addiction medicine. “Those are doses to provide euthanasia, not to relieve pain.”
At trial, the prosecutors had to overcome two big challenges to win murder convictions against Dr. Husel: They had to prove beyond a reasonable doubt that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.
Late in the trial, at the state’s request, the judge ruled to allow the jury to also consider attempted murder charges, which require proof of intent but not that the defendant’s actions directly caused the deaths.
Another challenge was that physicians have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia. That’s what prosecutors accused Dr. Husel of doing.
“If you hasten a person’s death, even if their death is as sure as the sun is going to rise in the morning ... you have caused their death in the eyes of the law,” assistant prosecutor Mr. Zeyen said in his closing. “You don’t get a pass for killing a dying man ...”
Mr. Leeseberg said it was always going to be extremely hard to convince a jury to convict a physician of murder, with the potential of life in prison, in a case where the physician’s acts occurred openly over 4 years in a hospital setting where no one did anything to stop him. It would have been much easier to convince a jury to convict him of reckless homicide, a lesser offense with a shorter prison term. That would have required proving that he acted in reckless disregard for his patients’ health and safety.
In post-verdict comments to the news media, Judge Michael Holbrook said jurors told him that the procedures for the dispensing of fentanyl and other drugs at Mount Carmel weren’t properly explained to them during the trial, and that they were confused by the large number of prosecution witnesses. He also said they were confused that no one had stated a maximum dosage for fentanyl.
Mr. Schumacher, the retired malpractice defense lawyer who followed the trial, disagreed with defense attorney Baez’s takeaway about the impact of the case on pain-relief practices. In his view, the case likely will heighten rather than reduce the anxiety of physicians and nurses about administering opioids, even when the dosages are clearly needed and appropriate. He doesn’t think Dr. Husel’s dosages can be justified, however.
“Physicians have a naive overreaction to any legal development, and overgeneralize from a particular case to everyday practice,” he said.
There is only one known prior case that’s somewhat comparable of a physician tried for murder or attempted murder for giving a critically ill patient opioids for pain relief. In 1996, a Kansas jury convicted Lloyd Stanley Naramore, DO, of attempted murder in the death of a patient to whom he gave an opioid, and of second-degree murder for removing a patient from a ventilator. After Dr. Naramore served 6 months in prison, an appellate court reversed the convictions for lack of evidence.
In March, RaDonda Vaught, a nurse who worked at Vanderbilt University Medical Center in Nashville, Tenn., was convicted of criminal neglect and negligent homicide for mistakenly administering a fatal dose of the paralyzing drug vecuronium, instead of the prescribed drug Versed (midazolam), to a patient. Providers around the country were alarmed by her criminal prosecution for what was clearly an unintentional error.
But legal and medical experts said Dr. Husel’s case was sharply different from Vaught’s and Dr. Naramore’s because he deliberately and repeatedly ordered large doses of fentanyl and other drugs that he knew or should have known were potentially lethal. “You don’t need 2,000 micrograms of fentanyl plus other drugs for comfort care, and repeat that again and again for patient after patient,” said Mr. Cohen, of the Institute for Safe Medication Practices. “No one gives that to patients. You’ll knock them off.”
During the trial, prosecutors said repeatedly that no one except Dr. Husel knows what he was thinking when he ordered those huge drug dosages for his ICU patients. Judge Holbrook told the jury the state did not have to prove motive, only intent. But many observers still have wondered what his motives were.
Dr. Husel’s own view of his care in these cases soon will become public. Immediately after the April 20 verdict, Mr. Leeseberg filed a notice requesting a May 9 deposition of Dr. Husel, who will no longer be able to claim the Fifth Amendment right against self-incrimination. He predicted the deposition will last about a week, and then the transcript will be publicly available.
A version of this article first appeared on Medscape.com.
ILD progression, not diagnosis, triggers palliative care
Most health care providers are comfortable recommending palliative care (PC) for their patients with interstitial lung disease (ILD), but most do so at the time of disease progression, rather than diagnosis, as indicated on survey data from 128 clinicians.
ILD is associated with a high mortality rate and profound symptoms that contribute to poor quality of life, Rebecca A. Gersen, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Nevertheless, there is often a lack of preparedness for death by both patients and providers, contributing to increased distress,” they said. Clinician perspectives on the use of PC for ILD patients have not been well studied, although PC is not limited to end-of-life care and is recommended for ILD patients by professional organizations, including the American Thoracic Society. “PC is successful in improving breathlessness in chronic lung disease and can increase survival.”
In a study published in the journal CHEST®, the researchers surveyed health care providers at 68 Pulmonary Fibrosis Foundation centers across the United States. The survey was sent and collected by email and a restricted social media platform. A total of 128 providers from 34 states completed the survey between October 2020 and January 2021. Of these, 61% were physicians, and 67% identified as White.
Overall, 95% of the respondents agreed or strongly agreed that addressing advance directives is important, but only 66% agreed or strongly agreed that they themselves addressed advance directives in the outpatient ILD clinic setting. A greater number (91%) agreed or strongly agreed that they had a high level of comfort in discussing prognosis, while 88% agreed or strongly agreed that they felt comfortable assessing a patient’s readiness for and acceptance of PC. Approximately two-thirds (67%) agreed or strongly agreed that they use PC services for ILD patients. There were no significant differences in responses from clinicians who had more than 10 years of experience and those who had less.
Of the providers who referred patients to PC, 54% did so at objective disease progression, and 80% did so at objective and/or symptomatic progress; 2% referred patients to PC at initial ILD diagnosis.
Lack of resources
Health care providers who reported that they rarely referred patients to palliative care were significantly more likely to cite a lack of local PC options (P < .01). Those who rarely referred patients for PC also were significantly less likely to feel comfortable discussing prognoses or advance directives in the ILD clinic (P = .03 and P = .02, respectively).
Among the 23% of responders who reported that they rarely referred patients, 66% said they did not have PC at their institution.
“In addition to understanding and addressing barriers to care, educational resources may be key to improving PC delivery to the ILD population,” the researchers wrote.
The study findings were limited by several factors, including voluntary participation, lack of a validated questionnaire, and use of self-reports, which may not reflect physicians’ actual practice, the researchers noted. Other limitations include the use of U.S. data only, which may not generalize to countries with different health care models.
However, the results were strengthened by the use of data from providers at a range of institutions across the United States and by the high overall survey response rate, the researchers said.
“While ILD providers reassuringly demonstrate knowledge and interest in PC involvement, no current system exists to facilitate and monitor response to referral,” they noted. “Future research is desperately needed to address barriers to the provision of PC in order to enhance access to a critical service in the management and care of patients with ILD.”
The study was supported by the National Heart, Lung, and Blood Institute. The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Most health care providers are comfortable recommending palliative care (PC) for their patients with interstitial lung disease (ILD), but most do so at the time of disease progression, rather than diagnosis, as indicated on survey data from 128 clinicians.
ILD is associated with a high mortality rate and profound symptoms that contribute to poor quality of life, Rebecca A. Gersen, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Nevertheless, there is often a lack of preparedness for death by both patients and providers, contributing to increased distress,” they said. Clinician perspectives on the use of PC for ILD patients have not been well studied, although PC is not limited to end-of-life care and is recommended for ILD patients by professional organizations, including the American Thoracic Society. “PC is successful in improving breathlessness in chronic lung disease and can increase survival.”
In a study published in the journal CHEST®, the researchers surveyed health care providers at 68 Pulmonary Fibrosis Foundation centers across the United States. The survey was sent and collected by email and a restricted social media platform. A total of 128 providers from 34 states completed the survey between October 2020 and January 2021. Of these, 61% were physicians, and 67% identified as White.
Overall, 95% of the respondents agreed or strongly agreed that addressing advance directives is important, but only 66% agreed or strongly agreed that they themselves addressed advance directives in the outpatient ILD clinic setting. A greater number (91%) agreed or strongly agreed that they had a high level of comfort in discussing prognosis, while 88% agreed or strongly agreed that they felt comfortable assessing a patient’s readiness for and acceptance of PC. Approximately two-thirds (67%) agreed or strongly agreed that they use PC services for ILD patients. There were no significant differences in responses from clinicians who had more than 10 years of experience and those who had less.
Of the providers who referred patients to PC, 54% did so at objective disease progression, and 80% did so at objective and/or symptomatic progress; 2% referred patients to PC at initial ILD diagnosis.
Lack of resources
Health care providers who reported that they rarely referred patients to palliative care were significantly more likely to cite a lack of local PC options (P < .01). Those who rarely referred patients for PC also were significantly less likely to feel comfortable discussing prognoses or advance directives in the ILD clinic (P = .03 and P = .02, respectively).
Among the 23% of responders who reported that they rarely referred patients, 66% said they did not have PC at their institution.
“In addition to understanding and addressing barriers to care, educational resources may be key to improving PC delivery to the ILD population,” the researchers wrote.
The study findings were limited by several factors, including voluntary participation, lack of a validated questionnaire, and use of self-reports, which may not reflect physicians’ actual practice, the researchers noted. Other limitations include the use of U.S. data only, which may not generalize to countries with different health care models.
However, the results were strengthened by the use of data from providers at a range of institutions across the United States and by the high overall survey response rate, the researchers said.
“While ILD providers reassuringly demonstrate knowledge and interest in PC involvement, no current system exists to facilitate and monitor response to referral,” they noted. “Future research is desperately needed to address barriers to the provision of PC in order to enhance access to a critical service in the management and care of patients with ILD.”
The study was supported by the National Heart, Lung, and Blood Institute. The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Most health care providers are comfortable recommending palliative care (PC) for their patients with interstitial lung disease (ILD), but most do so at the time of disease progression, rather than diagnosis, as indicated on survey data from 128 clinicians.
ILD is associated with a high mortality rate and profound symptoms that contribute to poor quality of life, Rebecca A. Gersen, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Nevertheless, there is often a lack of preparedness for death by both patients and providers, contributing to increased distress,” they said. Clinician perspectives on the use of PC for ILD patients have not been well studied, although PC is not limited to end-of-life care and is recommended for ILD patients by professional organizations, including the American Thoracic Society. “PC is successful in improving breathlessness in chronic lung disease and can increase survival.”
In a study published in the journal CHEST®, the researchers surveyed health care providers at 68 Pulmonary Fibrosis Foundation centers across the United States. The survey was sent and collected by email and a restricted social media platform. A total of 128 providers from 34 states completed the survey between October 2020 and January 2021. Of these, 61% were physicians, and 67% identified as White.
Overall, 95% of the respondents agreed or strongly agreed that addressing advance directives is important, but only 66% agreed or strongly agreed that they themselves addressed advance directives in the outpatient ILD clinic setting. A greater number (91%) agreed or strongly agreed that they had a high level of comfort in discussing prognosis, while 88% agreed or strongly agreed that they felt comfortable assessing a patient’s readiness for and acceptance of PC. Approximately two-thirds (67%) agreed or strongly agreed that they use PC services for ILD patients. There were no significant differences in responses from clinicians who had more than 10 years of experience and those who had less.
Of the providers who referred patients to PC, 54% did so at objective disease progression, and 80% did so at objective and/or symptomatic progress; 2% referred patients to PC at initial ILD diagnosis.
Lack of resources
Health care providers who reported that they rarely referred patients to palliative care were significantly more likely to cite a lack of local PC options (P < .01). Those who rarely referred patients for PC also were significantly less likely to feel comfortable discussing prognoses or advance directives in the ILD clinic (P = .03 and P = .02, respectively).
Among the 23% of responders who reported that they rarely referred patients, 66% said they did not have PC at their institution.
“In addition to understanding and addressing barriers to care, educational resources may be key to improving PC delivery to the ILD population,” the researchers wrote.
The study findings were limited by several factors, including voluntary participation, lack of a validated questionnaire, and use of self-reports, which may not reflect physicians’ actual practice, the researchers noted. Other limitations include the use of U.S. data only, which may not generalize to countries with different health care models.
However, the results were strengthened by the use of data from providers at a range of institutions across the United States and by the high overall survey response rate, the researchers said.
“While ILD providers reassuringly demonstrate knowledge and interest in PC involvement, no current system exists to facilitate and monitor response to referral,” they noted. “Future research is desperately needed to address barriers to the provision of PC in order to enhance access to a critical service in the management and care of patients with ILD.”
The study was supported by the National Heart, Lung, and Blood Institute. The researchers disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL CHEST®
Cancer Data Trends 2022
Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.
In this issue:
- Exposure-Related Cancers
- Cancer in Women
- Genitourinary Cancers
- Gastrointestinal Cancers
- Telehealth in Oncology
- Precision Oncology
- Palliative and Hospice Care
- Alcohol and Cancer
- Lung Cancer
- Oropharyngeal Cancer
- Hematologic Cancers
Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:
Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.
Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.
In this issue:
- Exposure-Related Cancers
- Cancer in Women
- Genitourinary Cancers
- Gastrointestinal Cancers
- Telehealth in Oncology
- Precision Oncology
- Palliative and Hospice Care
- Alcohol and Cancer
- Lung Cancer
- Oropharyngeal Cancer
- Hematologic Cancers
Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:
Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.
Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.
In this issue:
- Exposure-Related Cancers
- Cancer in Women
- Genitourinary Cancers
- Gastrointestinal Cancers
- Telehealth in Oncology
- Precision Oncology
- Palliative and Hospice Care
- Alcohol and Cancer
- Lung Cancer
- Oropharyngeal Cancer
- Hematologic Cancers
Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:
Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.
Right place, right time: Facilitating end-of-life conversations
As the geriatric population continues to grow and treatment advances blur the lines between improving the length of life vs improving its quality, end-of-life (EOL) conversations are becoming increasingly important. These discussions are a crucial part of the advance care planning (ACP) process, in which patients discuss their treatment preferences and values with their caregiver/surrogate decision maker and health care provider to ultimately improve EOL decision-making and care. 1,2
EOL conversations are most helpful when incorporated in the outpatient setting as part of the patient’s ongoing health care plan or when initiating treatment for a chronic or life-threatening disease. Because family physicians promote general wellness, understand the patient’s health status and medical history, and have an ongoing—and often longstanding—relationship with patients and their families, we are ideally positioned to engage patients in EOL discussions. However, these conversations can be challenging in the outpatient setting, and often clinicians struggle not only to find ways to raise the subject, but also to find the time to have these supportive, meaningful conversations.3
In this article, we will address the importance of having EOL discussions in the outpatient setting, specifically about advance directives (ADs), and the reasons why patients and physicians might avoid these discussions. The role of palliative care in EOL care, along with its benefits and methods for overcoming patient and physician barriers to its successful use, are reviewed. Finally, we examine specific challenges associated with discussing EOL care with patients with decreased mental capacity, such as those with dementia, and provide strategies to successfully facilitate EOL discussions in these populations.
Moving patients toward completion of advance directives
Although many older patients express a desire to document their wishes before EOL situations arise, they may not fully understand the benefits of an AD or how to complete one. 4 Often the family physician is best equipped to address the patient’s concerns and discuss their goals for EOL care, as well as the potential situations that might arise.
Managing an aging population. Projections suggest that primary care physicians will encounter increasing numbers of geriatric patients in the next 2 decades. Thus it is essential for those in primary care to receive proper training during their residency for the care of this group of patients. According to a group of academic educators and geriatricians from internal medicine and family medicine whose goal was to define a set of minimal and essential competencies in the care of older adults, this includes training on how to discuss and document “advance care planning and goals of care with all patients with chronic or complex illness,” as well as how to differentiate among “types of code status, health care proxies, and advanced directives” within the state in which training occurs. 5
Educate patients and ease fears. Patients often avoid EOL conversations or wait for their family physician to start the conversation. They may not understand how ADs can help guide care or they may believe they are “too healthy” to have these conversations at this time. 4 Simply asking about existing ADs or providing forms to patients during an outpatient visit can open the door to more in-depth discussions. Some examples of opening phrases include:
- Do you have a living will or durable power of attorney for health care?
- Have you ever discussed your health care wishes with your loved ones?
- Who would you want to speak for you regarding your health care if you could not speak for yourself? Have you discussed your health care wishes with that person?
By normalizing the conversation as a routine part of comprehensive, patient-centered care, the family physician can allay patient fears, foster open and honest conversations, and encourage ongoing discussions with loved ones as situations arise.6
Continue to: When ADs are executed...
When ADs are executed, patients often fail to have meaningful conversations with their surrogates about specific treatment wishes or EOL scenarios. As a result, the surrogate may not feel prepared to serve as a proxy decision maker or may find the role extremely stressful.7 Physicians should encourage open conversations between patients and their surrogates about potential EOL scenarios when possible. When possible and appropriate, it is also important to encourage the patient to include the surrogate in future outpatient visits so that the surrogate can understand the patient’s health status and potential decisions they may need to make.
Don’t overlook clinician barriers. Family physicians also might avoid AD discussions because they do not understand laws that govern ADs, which vary from state to state. Various online resources for patients and physicians exist that clarify state-specific regulations and provide state-specific forms (TABLE).
Time constraints present another challenge for family physicians. This can be addressed by establishing workflows that include EOL elements. Also, the Centers for Medicare and Medicaid Services (CMS) has provided separate billing codes for AD discussion based on time spent explaining and discussing how to complete forms.8 CPT codes 99497 and 99498 are time-based codes that cover the first 30 minutes and each additional 30 minutes, respectively, of time spent explaining and discussing how to complete standard forms in a face-to-face setting (TABLE).9 CMS also includes discussion of AD documents as an optional element of the annual Medicare wellness visit.8
Improve quality of life for patients with any serious illness
Unlike hospice, which focuses on providing comfort rather than cure in the final months of a patient’s life, palliative care strives to prevent and relieve the patient’s suffering from a serious illness that is not immediately life-threatening. Palliative care focuses on the early identification, careful assessment, and treatment of the physical, psychosocial, and spiritual symptoms associated with a patient’s condition(s).10,11 It has been well established that palliative care has a positive effect on many clinical outcomes including symptom burden, quality of life, satisfaction with care, and survival.12-14 Patients who receive palliative care consultation also tend to perceive a higher quality of care.15
Conversations lead to better outcomes. Palliative care consultation is being increasingly used in the outpatient setting and can be introduced early in a disease process. Doing so provides an additional opportunity for the family physician to introduce an EOL discussion. A comparison of outcomes between patients who had initial inpatient palliative care consultation vs outpatient palliative care referral found that outpatient referral improved quality EOL care and was associated with significantly fewer emergency department visits (68% vs 48%; P < .001) and hospital admissions (86% vs 52%; P < .001), as well as shorter hospital stays in the last 30 days of life (3-11 vs 5-14 days; P = .01).14 Despite these benefits, 60% to 90% of patients with a serious illness report never having discussed EOL care issues with their clinician.16,17
Continue to: Early EOL discussions...
Early EOL discussions have also been shown to have a positive impact on families. In a US study, family members stated that timely EOL care discussions allowed them to make use of hospice and palliative care services sooner and to make the most of their time with the patient.18
Timing and communication are key
Logistically it can be difficult to gather the right people (patient, family, etc) in the right place and at the right time. For physicians, the most often cited barriers include inadequate time to conduct an EOL discussion, 19 a perceived lack of competence in EOL conversations, 1,20 difficulty navigating patient readiness, 21 and a fear of destroying hope due to prognostic uncertainty. 19,20
A prospective, observational study used the Quality of Communication (QOC) questionnaire to assess life-sustaining treatment preferences, ACP, and the quality of EOL care communication in Dutch outpatients with clinically stable but severe chronic obstructive pulmonary disease (n = 105) or congestive heart failure (n = 80). The QOC questionnaire is a validated instrument that asks patients to rate their physician on several communication skills from 0 (“the very worst” or “My doctor didn’t do this”) to 10 (“the very best”). In this study, quality communication was identified by patients as one of the most important skills for physicians to provide adequate EOL care. 22 While QOC ratings were high for general communication skills (median, 8.0 points), quality EOL care communication was rated very low (median, 0.0 points). Researchers say that this was primarily because most EOL topics were not discussed—especially spirituality, prognosis, and what dying might be like. 22 In a secondary analysis that evaluated quality of EOL care communication during 1-year follow-up of patients with advanced chronic organ failure (n = 265) with the QOC questionnaire, patient ratings improved to moderate to good (medians, 6-8 points) when these topics were addressed. 23
Pick a strategy and prepare. As the older population continues to grow, the demands of palliative care management cannot be met by specialists alone and the responsibility of discussing EOL care with patients and their families will increasingly fall to family physicians as well. 24 Several strategies and approaches have evolved to assist family physicians with acquiring the skills to conduct productive EOL discussions. These include widely referenced resources, such as VitalTalk 25 and the ABCDE Plan. 26 VitalTalk teaches skills to help clinicians navigate difficult conversations, 25 and the “ABCDE” method provides a pneumonic for recommendations for how to deliver bad news ( A dvance preparation; B uild a therapeutic environment/relationship; C ommunicate well; D eal with patient and family reactions; E ncourage and validate emotions). 26
Other strategies include familiarizing oneself with the patient’s medical history and present situation (eg, What are the patient’s symptoms? What do other involved clinicians think and recommend? What therapies have been attempted? What are the relevant social and emotional dynamics?); asking the patient who they want present for the EOL conversation; scheduling the conversation for when you can set aside an appropriate amount of time and in a private place where there will be no interruptions; and going into the meeting with your goal in mind, whether it is to deliver bad news, clarify the prognosis, establish goals of care, or communicate the patient’s goals and wishes for the EOL to those in attendance. 27 It can be very helpful to begin the conversation by clarifying what the patient and their family/surrogate understand about the current diagnosis and prognosis. From there, the family physician can present a “headline” that prepares them for the current conversation (eg, “I have your latest test results, and I need to share some serious news”). This can facilitate a more detailed discussion of the patient’s and surrogate’s goals of care. Using these strategies, family physicians can lead a productive EOL discussion that benefits everyone.
Continue to: How to navigate EOL discussions with patients with dementia
How to navigate EOL discussions with patients with dementia
EOL discussions with patients with dementia become even more complex and warrant specific discussion because one must consider the timing of such discussions, 2,28,29 the trajectory of the disease and how that affects the patient’s capacity for EOL conversations, and the critical importance of engaging caregivers/surrogate decision makers in these discussions. 2 ACP provides an opportunity for the physician, patient, and caregiver/surrogate to jointly explore the patient’s values, beliefs, and preferences for care through the EOL as the disease progresses and the patient’s decisional capacity declines.
Ensure meaningful participation with timing. EOL discussions should occur while the patient has the cognitive capacity to actively participate in the planning process. A National Institutes of Health stage I behavioral intervention development trial evaluated a structured psychoeducational intervention, known as SPIRIT (Sharing Patient’s Illness Representation to Increase Trust), that aimed to promote cognitive and emotional preparation for EOL decisions for patients and their surrogates.28 It was found to be effective in patients, including those with end-stage renal disease and advanced heart failure, and their surrogates.28 Preliminary results from the trial confirmed that people with mild-to-moderate dementia (recent Montreal Cognitive Assessment score ≥ 13) are able to participate meaningfully in EOL discussions and ACP.28
Song et al29 adapted SPIRIT for use with patients with dementia and conducted a feasibility study with 23 patient-surrogate dyads.The mixed-methods study involved an expert panel review of the adapted SPIRIT, followed by a randomized trial with qualitative interviews. All 23 patients with dementia, including 14 with moderate dementia, were able to articulate their values and EOL preferences somewhat or very coherently (91.3% inter-rater reliability).29 In addition, dyad care goal congruence (agreement between patient’s EOL preferences and surrogate’s understanding of those preferences) and surrogate decision-making confidence (comfort in performing as a surrogate) were high and patient decisional conflict (patient difficulty in weighing the benefits and burdens of life-sustaining treatments and decision-making) was low, both at baseline as well as post intervention.29 Although preparedness for EOL decision-making outcome measures did not change, people with dementia and their surrogates perceived SPIRIT to be beneficial, particularly in helping them be on the same page.29
The randomized trial portion of the study (phase 2) continues to recruit 120 patient-surrogate dyads. Patient and surrogate self-reported preparedness for EOL decision-making are the primary outcomes, measured at baseline and 2 to 3 days post intervention. The estimated study completion date is May 31, 2022.30
Evidence-based clinical guidance can improve the process. Following the Belgian Centre for Evidence-Based Medicine’s procedures as a sample methodology, Piers et al2 developed evidence-based clinical recommendations for providers to use in the practical application of ACP in their care of patients with dementia.The researchers searched the literature; developed recommendations based on the evidence obtained, as well as their collective expert opinion; and performed validation using expert and end-user feedback and peer review. The study resulted in 32 recommendations focused on 8 domains that ranged from the beginning of the process (preconditions for optimal implementation of ACP) to later stages (ACP when it is difficult/no longer possible to communicate).2Specific guidance for ACP in dementia care include the following:
- ACP initiation. Begin conversations around the time of diagnosis, continue them throughout ongoing care, and revisit them when changes occur in the patient’s health, financial, or residential status.
- ACP conversations. Use conversations to identify significant others in the patient’s life (potential caregivers and/or surrogate decision makers) and explore the patient’s awareness of the disease and its trajectory. Discuss the patient’s values and beliefs, as well as their fears about, and preferences for, future care and the EOL.
- Role of significant others in the ACP process. Involve a patient’s significant others early in the ACP process, educate them about the surrogate decision-maker role, assess their disease awareness, and inform them about the disease trajectory and anticipated EOL decisions. 2
Continue to: Incorporate and document patients' values and preferences with LEAD
Incorporate and document patients’ values and preferences with LEAD. Dassel et al31 developed the Life-planning in Early Alzheimer’s and Dementia (LEAD) tool, which is a validated dementia-focused EOL planning tool that can be used to promote discussion and document a patient’s care preferences and values within the context of their changing cognitive ability.Dassel et al31 used a 4-phase mixed-method design that included (1) focus groups of patients with early-stage dementia and family caregivers, (2) clinical utility evaluation by content experts, (3) instrument completion sampling to evaluate its psychometric properties, and (4) additional focus groups to inform how the instrument should be used by families and in clinical practice.Six scales with high internal consistency and high test-retest reliability were identified: 3 scales represented patient values (concern about being a burden, the importance of quality [vs length] of life, and the preference for autonomy in decision-making) and 3 scales represented patient preferences (use of life-prolonging measures, controlling the timing of death, and the location of EOL care).31
The LEAD Guide can be used as a self-assessment tool that is completed individually and then shared with the surrogate decision maker and health care provider.32 It also can be used to guide conversations with the surrogate and physician, as well as with trusted family and friends. Using this framework, family physicians can facilitate EOL planning with the patient and their surrogate that is based on the patient’s values and preferences for EOL care prior to, and in anticipation of, the patient’s loss of decisional capacity.31
Facilitate discussions that improve outcomes
Conversations about EOL care are taking on increased importance as the population ages and treatments advance. Understanding the concerns of patients and their surrogate decision makers, as well as the resources available to guide these difficult discussions ( TABLE ), will help family physicians conduct effective conversations that enhance care, reduce the burden on surrogate decision makers, and have a positive impact on many clinical outcomes.
CORRESPONDENCE
Shirley Bodi, MD, 3000 Arlington Avenue, Department of Family Medicine, Dowling Hall, Suite 2200, University of Toledo College of Medicine and Life Sciences, Toledo, OH 43614; [email protected]
1. Bergenholtz Heidi, Timm HU, Missel M. Talking about end of life in general palliative care – what’s going on? A qualitative study on end-of-life conversations in an acute care hospital in Denmark. BMC Palliat Care. 2019;18:62. doi: 10.1186/s12904-019-0448-z
2. Piers R, Albers G, Gilissen J, et al. Advance care planning in dementia: recommendations for healthcare professionals. BMC Palliat Care. 2018;17:88. doi: 10.1186/s12904-018-0332-2
3. Tunzi M, Ventres W. A reflective case study in family medicine advance care planning conversations. J Am Board Fam Med. 2019;32:108-114. doi: 10.3122/jabfm.2019.01.180198
4. Schickedanz AD, Schillinger D, Landefeld CS, et al. A clinical framework for improving the advance care planning process: start with patients’ self-identified barriers. J Am Geriatr Soc. 2009;57:31-39. doi: 10.1111/j.1532-5415.2008.02093.x
5. Williams BC, Warshaw G, Fabiny AR, et al. Medicine in the 21st century: recommended essential geriatrics competencies for internal medicine and family medicine residents. J Grad Med Ed. 2010;2:373-383. doi: 10.4300/JGME-D-10-00065.1
6. Alano G, Pekmezaris R, Tai J, et al. Factors influencing older adults to complete advance directives. Palliat Support Care. 2010;8:267-275. doi: 10.1017/S1478951510000064
7. Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011;154:336-346. doi: 10.7326/0003-4819-154-5-201103010-00008
8. Edelberg C. Advance care planning with and without an annual wellness visit. Ed Management website. June 1, 2016. Accessed November 16, 2021. ww.reliasmedia.com/articles/137829-advanced-care-planning-with-and-without-an-annual-wellness-visit
9. Centers for Medicare and Medicaid Services. Frequently asked questions about billing the physician fee schedule for advance care planning services. July 14, 2016. Accessed December 20, 2021. www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/FAQ-Advance-Care-Planning.pdf
10. World Health Organization. Palliative care fact sheet. August 5, 2020. Accessed November 16, 2021. www.who.int/news-room/fact-sheets/detail/palliative-care
11. National Institute on Aging. What are palliative care and hospice care? Reviewed May 14, 2021. Accessed December 20, 2021. www.nia.nih.gov/health/what-are-palliative-care-and-hospice-care#palliative-vs-hospice
12. Rabow MW, Dibble SL, Pantilat, SZ, et al. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004;164:83-91. doi: 10.1001/archinte.164.1.83
13. Muir JC, Daley F, Davis MS, et al. Integrating palliative care into the outpatient, private practice oncology setting. J Pain Symptom Manage. 2010;40:126-135. doi: 10.1016/j.jpainsymman.2009.12.017
14. Hui D, Kim SH, Roquemore J, et al. Impact of timing and setting of palliative care referral on quality of end-of-life care in cancer patients. Cancer. 2014;120:1743-1749. doi: 10.1002/cncr.28628
15. Leung JM, Udris EM, Uman J, e al. The effect of end-of-life discussions on perceived quality of care and health status among patients with COPD. Chest. 2012;142:128-133. doi: 10.1378/chest.11-2222
16. Davison SN. End-of-life care preferences and needs: perceptions of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010;5:195-204. doi: 10.2215/CJN.05960809
17. Wright AA, Zhang B, Ray A, et al. Associations between end-of-life discussions, patients mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008;300:1665-1673. doi: 10.1001/jama.300.14.1665
18. Park E, Check DK, Yopp JM, et al. An exploratory study of end-of-life prognostic communication needs as reported by widowed fathers due to cancer. Psychooncology. 2015;24:1471-1476. doi: 10.1002/pon.3757
19. Tavares N, Jarrett N, Hunt K, et al. Palliative and end-of-life care conversations in COPD: a systematic literature review. ERJ Open Res. 2017;3:00068-2016. doi: 10.1183/23120541.00068-2016
20. Hancock K, Clayton JM, Parker SM, et al. Truth-telling in discussing prognosis in advanced life-limiting illnesses: a systematic review. Palliat Med. 2007;21:507-517. doi: 10.1177/0269216307080823
21. Parker SM, Clayton JM, Hancock K, et al. A systematic review of prognostic/end-of-life communication with adults in the advanced stages of a life-limiting illness: patient/caregiver preferences for the content, style, and timing of information. J Pain Symptom Manage. 2007;34:81-93. doi: 10.1016/j.jpainsymman.2006.09.035
22. Janssen DJA, Spruit MA, Schols JMGA, et al. A call for high-quality advance care planning in outpatients with severe COPD or chronic heart failure. Chest. 2011;139:1081-1088. doi: 10.1378/chest.10-1753
23. Houben CHM, Spruit MA, Schols JM, et al. Patient-clinician communication about end-of-life care on patients with advanced chronic organ failure during one year. J Pain Symptom Manage. 2015;49:1109-1115. doi: 10.1016/j.jpainsymman.2014.12.008
24. Brighton LJ, Bristowe K. Communication in palliative care: talking about the end of life, before the end of life. Postgrad Med J. 2016;92:466-470. doi: 10.1136/postgradmedj-2015-133368
25. VitalTalk website. Accessed December 20, 2021. vitaltalk.org
26. Rabow MQ, McPhee SJ. Beyond breaking bad news: how to help patients who suffer. Wes J Med. 1999;171:260-263. www.ncbi.nlm.nih.gov/pmc/articles/PMC1305864
27. Pfeifer M, Head B. Which critical communication skills are essential for interdisciplinary end-of-life discussions? AMA J Ethics. 2018;8:E724-E731. doi: 10.1001/amajethics.2018.724
28. Song M-K, Ward SE, Hepburn K, et al. SPIRIT advance care planning intervention in early stage dementias: an NIH stage I behavioral intervention development trial. Contemp Clin Trials. 2018;71:55-62. doi: 10.1016/j.cct.2018.06.005
29. Song M-K, Ward SE, Hepburn K, et al. Can persons with dementia meaningfully participate in advance care planning discussions? A mixed-methods study of SPIRIT. J Palliat Med. 2019;22:1410-1416. doi: 10.1089/jpm.2019.0088
30. Two-phased study of SPIRIT in mild dementia. ClinicalTrials.gov Identifier: NCT03311711. Updated August 23, 2021. Accessed December 20, 2021. clinicaltrials.gov/ct2/show/NCT03311711
31. Dassel K, Utz R, Supiano K, et al. Development of a dementia-focused end-of-life planning tool: the LEAD Guide (Life-planning in Early Alzheimer’s and Dementia). Innov Aging. 2019;3:igz024. doi: 10.1093/geroni/igz024
32. Dassel K, Supiano K, Utz R, et al. The LEAD Guide. Life-planning in Early Alzheimer’s and Dementia. 2019. Accessed December 20, 2021. utahgwep.org/resources/search-all-resources/send/10-dementia/27-the-lead-guide#:~:text=The%20LEAD%20Guide%20(Life%2DPlanning,your%20decisions%20about%20your%20care
As the geriatric population continues to grow and treatment advances blur the lines between improving the length of life vs improving its quality, end-of-life (EOL) conversations are becoming increasingly important. These discussions are a crucial part of the advance care planning (ACP) process, in which patients discuss their treatment preferences and values with their caregiver/surrogate decision maker and health care provider to ultimately improve EOL decision-making and care. 1,2
EOL conversations are most helpful when incorporated in the outpatient setting as part of the patient’s ongoing health care plan or when initiating treatment for a chronic or life-threatening disease. Because family physicians promote general wellness, understand the patient’s health status and medical history, and have an ongoing—and often longstanding—relationship with patients and their families, we are ideally positioned to engage patients in EOL discussions. However, these conversations can be challenging in the outpatient setting, and often clinicians struggle not only to find ways to raise the subject, but also to find the time to have these supportive, meaningful conversations.3
In this article, we will address the importance of having EOL discussions in the outpatient setting, specifically about advance directives (ADs), and the reasons why patients and physicians might avoid these discussions. The role of palliative care in EOL care, along with its benefits and methods for overcoming patient and physician barriers to its successful use, are reviewed. Finally, we examine specific challenges associated with discussing EOL care with patients with decreased mental capacity, such as those with dementia, and provide strategies to successfully facilitate EOL discussions in these populations.
Moving patients toward completion of advance directives
Although many older patients express a desire to document their wishes before EOL situations arise, they may not fully understand the benefits of an AD or how to complete one. 4 Often the family physician is best equipped to address the patient’s concerns and discuss their goals for EOL care, as well as the potential situations that might arise.
Managing an aging population. Projections suggest that primary care physicians will encounter increasing numbers of geriatric patients in the next 2 decades. Thus it is essential for those in primary care to receive proper training during their residency for the care of this group of patients. According to a group of academic educators and geriatricians from internal medicine and family medicine whose goal was to define a set of minimal and essential competencies in the care of older adults, this includes training on how to discuss and document “advance care planning and goals of care with all patients with chronic or complex illness,” as well as how to differentiate among “types of code status, health care proxies, and advanced directives” within the state in which training occurs. 5
Educate patients and ease fears. Patients often avoid EOL conversations or wait for their family physician to start the conversation. They may not understand how ADs can help guide care or they may believe they are “too healthy” to have these conversations at this time. 4 Simply asking about existing ADs or providing forms to patients during an outpatient visit can open the door to more in-depth discussions. Some examples of opening phrases include:
- Do you have a living will or durable power of attorney for health care?
- Have you ever discussed your health care wishes with your loved ones?
- Who would you want to speak for you regarding your health care if you could not speak for yourself? Have you discussed your health care wishes with that person?
By normalizing the conversation as a routine part of comprehensive, patient-centered care, the family physician can allay patient fears, foster open and honest conversations, and encourage ongoing discussions with loved ones as situations arise.6
Continue to: When ADs are executed...
When ADs are executed, patients often fail to have meaningful conversations with their surrogates about specific treatment wishes or EOL scenarios. As a result, the surrogate may not feel prepared to serve as a proxy decision maker or may find the role extremely stressful.7 Physicians should encourage open conversations between patients and their surrogates about potential EOL scenarios when possible. When possible and appropriate, it is also important to encourage the patient to include the surrogate in future outpatient visits so that the surrogate can understand the patient’s health status and potential decisions they may need to make.
Don’t overlook clinician barriers. Family physicians also might avoid AD discussions because they do not understand laws that govern ADs, which vary from state to state. Various online resources for patients and physicians exist that clarify state-specific regulations and provide state-specific forms (TABLE).
Time constraints present another challenge for family physicians. This can be addressed by establishing workflows that include EOL elements. Also, the Centers for Medicare and Medicaid Services (CMS) has provided separate billing codes for AD discussion based on time spent explaining and discussing how to complete forms.8 CPT codes 99497 and 99498 are time-based codes that cover the first 30 minutes and each additional 30 minutes, respectively, of time spent explaining and discussing how to complete standard forms in a face-to-face setting (TABLE).9 CMS also includes discussion of AD documents as an optional element of the annual Medicare wellness visit.8
Improve quality of life for patients with any serious illness
Unlike hospice, which focuses on providing comfort rather than cure in the final months of a patient’s life, palliative care strives to prevent and relieve the patient’s suffering from a serious illness that is not immediately life-threatening. Palliative care focuses on the early identification, careful assessment, and treatment of the physical, psychosocial, and spiritual symptoms associated with a patient’s condition(s).10,11 It has been well established that palliative care has a positive effect on many clinical outcomes including symptom burden, quality of life, satisfaction with care, and survival.12-14 Patients who receive palliative care consultation also tend to perceive a higher quality of care.15
Conversations lead to better outcomes. Palliative care consultation is being increasingly used in the outpatient setting and can be introduced early in a disease process. Doing so provides an additional opportunity for the family physician to introduce an EOL discussion. A comparison of outcomes between patients who had initial inpatient palliative care consultation vs outpatient palliative care referral found that outpatient referral improved quality EOL care and was associated with significantly fewer emergency department visits (68% vs 48%; P < .001) and hospital admissions (86% vs 52%; P < .001), as well as shorter hospital stays in the last 30 days of life (3-11 vs 5-14 days; P = .01).14 Despite these benefits, 60% to 90% of patients with a serious illness report never having discussed EOL care issues with their clinician.16,17
Continue to: Early EOL discussions...
Early EOL discussions have also been shown to have a positive impact on families. In a US study, family members stated that timely EOL care discussions allowed them to make use of hospice and palliative care services sooner and to make the most of their time with the patient.18
Timing and communication are key
Logistically it can be difficult to gather the right people (patient, family, etc) in the right place and at the right time. For physicians, the most often cited barriers include inadequate time to conduct an EOL discussion, 19 a perceived lack of competence in EOL conversations, 1,20 difficulty navigating patient readiness, 21 and a fear of destroying hope due to prognostic uncertainty. 19,20
A prospective, observational study used the Quality of Communication (QOC) questionnaire to assess life-sustaining treatment preferences, ACP, and the quality of EOL care communication in Dutch outpatients with clinically stable but severe chronic obstructive pulmonary disease (n = 105) or congestive heart failure (n = 80). The QOC questionnaire is a validated instrument that asks patients to rate their physician on several communication skills from 0 (“the very worst” or “My doctor didn’t do this”) to 10 (“the very best”). In this study, quality communication was identified by patients as one of the most important skills for physicians to provide adequate EOL care. 22 While QOC ratings were high for general communication skills (median, 8.0 points), quality EOL care communication was rated very low (median, 0.0 points). Researchers say that this was primarily because most EOL topics were not discussed—especially spirituality, prognosis, and what dying might be like. 22 In a secondary analysis that evaluated quality of EOL care communication during 1-year follow-up of patients with advanced chronic organ failure (n = 265) with the QOC questionnaire, patient ratings improved to moderate to good (medians, 6-8 points) when these topics were addressed. 23
Pick a strategy and prepare. As the older population continues to grow, the demands of palliative care management cannot be met by specialists alone and the responsibility of discussing EOL care with patients and their families will increasingly fall to family physicians as well. 24 Several strategies and approaches have evolved to assist family physicians with acquiring the skills to conduct productive EOL discussions. These include widely referenced resources, such as VitalTalk 25 and the ABCDE Plan. 26 VitalTalk teaches skills to help clinicians navigate difficult conversations, 25 and the “ABCDE” method provides a pneumonic for recommendations for how to deliver bad news ( A dvance preparation; B uild a therapeutic environment/relationship; C ommunicate well; D eal with patient and family reactions; E ncourage and validate emotions). 26
Other strategies include familiarizing oneself with the patient’s medical history and present situation (eg, What are the patient’s symptoms? What do other involved clinicians think and recommend? What therapies have been attempted? What are the relevant social and emotional dynamics?); asking the patient who they want present for the EOL conversation; scheduling the conversation for when you can set aside an appropriate amount of time and in a private place where there will be no interruptions; and going into the meeting with your goal in mind, whether it is to deliver bad news, clarify the prognosis, establish goals of care, or communicate the patient’s goals and wishes for the EOL to those in attendance. 27 It can be very helpful to begin the conversation by clarifying what the patient and their family/surrogate understand about the current diagnosis and prognosis. From there, the family physician can present a “headline” that prepares them for the current conversation (eg, “I have your latest test results, and I need to share some serious news”). This can facilitate a more detailed discussion of the patient’s and surrogate’s goals of care. Using these strategies, family physicians can lead a productive EOL discussion that benefits everyone.
Continue to: How to navigate EOL discussions with patients with dementia
How to navigate EOL discussions with patients with dementia
EOL discussions with patients with dementia become even more complex and warrant specific discussion because one must consider the timing of such discussions, 2,28,29 the trajectory of the disease and how that affects the patient’s capacity for EOL conversations, and the critical importance of engaging caregivers/surrogate decision makers in these discussions. 2 ACP provides an opportunity for the physician, patient, and caregiver/surrogate to jointly explore the patient’s values, beliefs, and preferences for care through the EOL as the disease progresses and the patient’s decisional capacity declines.
Ensure meaningful participation with timing. EOL discussions should occur while the patient has the cognitive capacity to actively participate in the planning process. A National Institutes of Health stage I behavioral intervention development trial evaluated a structured psychoeducational intervention, known as SPIRIT (Sharing Patient’s Illness Representation to Increase Trust), that aimed to promote cognitive and emotional preparation for EOL decisions for patients and their surrogates.28 It was found to be effective in patients, including those with end-stage renal disease and advanced heart failure, and their surrogates.28 Preliminary results from the trial confirmed that people with mild-to-moderate dementia (recent Montreal Cognitive Assessment score ≥ 13) are able to participate meaningfully in EOL discussions and ACP.28
Song et al29 adapted SPIRIT for use with patients with dementia and conducted a feasibility study with 23 patient-surrogate dyads.The mixed-methods study involved an expert panel review of the adapted SPIRIT, followed by a randomized trial with qualitative interviews. All 23 patients with dementia, including 14 with moderate dementia, were able to articulate their values and EOL preferences somewhat or very coherently (91.3% inter-rater reliability).29 In addition, dyad care goal congruence (agreement between patient’s EOL preferences and surrogate’s understanding of those preferences) and surrogate decision-making confidence (comfort in performing as a surrogate) were high and patient decisional conflict (patient difficulty in weighing the benefits and burdens of life-sustaining treatments and decision-making) was low, both at baseline as well as post intervention.29 Although preparedness for EOL decision-making outcome measures did not change, people with dementia and their surrogates perceived SPIRIT to be beneficial, particularly in helping them be on the same page.29
The randomized trial portion of the study (phase 2) continues to recruit 120 patient-surrogate dyads. Patient and surrogate self-reported preparedness for EOL decision-making are the primary outcomes, measured at baseline and 2 to 3 days post intervention. The estimated study completion date is May 31, 2022.30
Evidence-based clinical guidance can improve the process. Following the Belgian Centre for Evidence-Based Medicine’s procedures as a sample methodology, Piers et al2 developed evidence-based clinical recommendations for providers to use in the practical application of ACP in their care of patients with dementia.The researchers searched the literature; developed recommendations based on the evidence obtained, as well as their collective expert opinion; and performed validation using expert and end-user feedback and peer review. The study resulted in 32 recommendations focused on 8 domains that ranged from the beginning of the process (preconditions for optimal implementation of ACP) to later stages (ACP when it is difficult/no longer possible to communicate).2Specific guidance for ACP in dementia care include the following:
- ACP initiation. Begin conversations around the time of diagnosis, continue them throughout ongoing care, and revisit them when changes occur in the patient’s health, financial, or residential status.
- ACP conversations. Use conversations to identify significant others in the patient’s life (potential caregivers and/or surrogate decision makers) and explore the patient’s awareness of the disease and its trajectory. Discuss the patient’s values and beliefs, as well as their fears about, and preferences for, future care and the EOL.
- Role of significant others in the ACP process. Involve a patient’s significant others early in the ACP process, educate them about the surrogate decision-maker role, assess their disease awareness, and inform them about the disease trajectory and anticipated EOL decisions. 2
Continue to: Incorporate and document patients' values and preferences with LEAD
Incorporate and document patients’ values and preferences with LEAD. Dassel et al31 developed the Life-planning in Early Alzheimer’s and Dementia (LEAD) tool, which is a validated dementia-focused EOL planning tool that can be used to promote discussion and document a patient’s care preferences and values within the context of their changing cognitive ability.Dassel et al31 used a 4-phase mixed-method design that included (1) focus groups of patients with early-stage dementia and family caregivers, (2) clinical utility evaluation by content experts, (3) instrument completion sampling to evaluate its psychometric properties, and (4) additional focus groups to inform how the instrument should be used by families and in clinical practice.Six scales with high internal consistency and high test-retest reliability were identified: 3 scales represented patient values (concern about being a burden, the importance of quality [vs length] of life, and the preference for autonomy in decision-making) and 3 scales represented patient preferences (use of life-prolonging measures, controlling the timing of death, and the location of EOL care).31
The LEAD Guide can be used as a self-assessment tool that is completed individually and then shared with the surrogate decision maker and health care provider.32 It also can be used to guide conversations with the surrogate and physician, as well as with trusted family and friends. Using this framework, family physicians can facilitate EOL planning with the patient and their surrogate that is based on the patient’s values and preferences for EOL care prior to, and in anticipation of, the patient’s loss of decisional capacity.31
Facilitate discussions that improve outcomes
Conversations about EOL care are taking on increased importance as the population ages and treatments advance. Understanding the concerns of patients and their surrogate decision makers, as well as the resources available to guide these difficult discussions ( TABLE ), will help family physicians conduct effective conversations that enhance care, reduce the burden on surrogate decision makers, and have a positive impact on many clinical outcomes.
CORRESPONDENCE
Shirley Bodi, MD, 3000 Arlington Avenue, Department of Family Medicine, Dowling Hall, Suite 2200, University of Toledo College of Medicine and Life Sciences, Toledo, OH 43614; [email protected]
As the geriatric population continues to grow and treatment advances blur the lines between improving the length of life vs improving its quality, end-of-life (EOL) conversations are becoming increasingly important. These discussions are a crucial part of the advance care planning (ACP) process, in which patients discuss their treatment preferences and values with their caregiver/surrogate decision maker and health care provider to ultimately improve EOL decision-making and care. 1,2
EOL conversations are most helpful when incorporated in the outpatient setting as part of the patient’s ongoing health care plan or when initiating treatment for a chronic or life-threatening disease. Because family physicians promote general wellness, understand the patient’s health status and medical history, and have an ongoing—and often longstanding—relationship with patients and their families, we are ideally positioned to engage patients in EOL discussions. However, these conversations can be challenging in the outpatient setting, and often clinicians struggle not only to find ways to raise the subject, but also to find the time to have these supportive, meaningful conversations.3
In this article, we will address the importance of having EOL discussions in the outpatient setting, specifically about advance directives (ADs), and the reasons why patients and physicians might avoid these discussions. The role of palliative care in EOL care, along with its benefits and methods for overcoming patient and physician barriers to its successful use, are reviewed. Finally, we examine specific challenges associated with discussing EOL care with patients with decreased mental capacity, such as those with dementia, and provide strategies to successfully facilitate EOL discussions in these populations.
Moving patients toward completion of advance directives
Although many older patients express a desire to document their wishes before EOL situations arise, they may not fully understand the benefits of an AD or how to complete one. 4 Often the family physician is best equipped to address the patient’s concerns and discuss their goals for EOL care, as well as the potential situations that might arise.
Managing an aging population. Projections suggest that primary care physicians will encounter increasing numbers of geriatric patients in the next 2 decades. Thus it is essential for those in primary care to receive proper training during their residency for the care of this group of patients. According to a group of academic educators and geriatricians from internal medicine and family medicine whose goal was to define a set of minimal and essential competencies in the care of older adults, this includes training on how to discuss and document “advance care planning and goals of care with all patients with chronic or complex illness,” as well as how to differentiate among “types of code status, health care proxies, and advanced directives” within the state in which training occurs. 5
Educate patients and ease fears. Patients often avoid EOL conversations or wait for their family physician to start the conversation. They may not understand how ADs can help guide care or they may believe they are “too healthy” to have these conversations at this time. 4 Simply asking about existing ADs or providing forms to patients during an outpatient visit can open the door to more in-depth discussions. Some examples of opening phrases include:
- Do you have a living will or durable power of attorney for health care?
- Have you ever discussed your health care wishes with your loved ones?
- Who would you want to speak for you regarding your health care if you could not speak for yourself? Have you discussed your health care wishes with that person?
By normalizing the conversation as a routine part of comprehensive, patient-centered care, the family physician can allay patient fears, foster open and honest conversations, and encourage ongoing discussions with loved ones as situations arise.6
Continue to: When ADs are executed...
When ADs are executed, patients often fail to have meaningful conversations with their surrogates about specific treatment wishes or EOL scenarios. As a result, the surrogate may not feel prepared to serve as a proxy decision maker or may find the role extremely stressful.7 Physicians should encourage open conversations between patients and their surrogates about potential EOL scenarios when possible. When possible and appropriate, it is also important to encourage the patient to include the surrogate in future outpatient visits so that the surrogate can understand the patient’s health status and potential decisions they may need to make.
Don’t overlook clinician barriers. Family physicians also might avoid AD discussions because they do not understand laws that govern ADs, which vary from state to state. Various online resources for patients and physicians exist that clarify state-specific regulations and provide state-specific forms (TABLE).
Time constraints present another challenge for family physicians. This can be addressed by establishing workflows that include EOL elements. Also, the Centers for Medicare and Medicaid Services (CMS) has provided separate billing codes for AD discussion based on time spent explaining and discussing how to complete forms.8 CPT codes 99497 and 99498 are time-based codes that cover the first 30 minutes and each additional 30 minutes, respectively, of time spent explaining and discussing how to complete standard forms in a face-to-face setting (TABLE).9 CMS also includes discussion of AD documents as an optional element of the annual Medicare wellness visit.8
Improve quality of life for patients with any serious illness
Unlike hospice, which focuses on providing comfort rather than cure in the final months of a patient’s life, palliative care strives to prevent and relieve the patient’s suffering from a serious illness that is not immediately life-threatening. Palliative care focuses on the early identification, careful assessment, and treatment of the physical, psychosocial, and spiritual symptoms associated with a patient’s condition(s).10,11 It has been well established that palliative care has a positive effect on many clinical outcomes including symptom burden, quality of life, satisfaction with care, and survival.12-14 Patients who receive palliative care consultation also tend to perceive a higher quality of care.15
Conversations lead to better outcomes. Palliative care consultation is being increasingly used in the outpatient setting and can be introduced early in a disease process. Doing so provides an additional opportunity for the family physician to introduce an EOL discussion. A comparison of outcomes between patients who had initial inpatient palliative care consultation vs outpatient palliative care referral found that outpatient referral improved quality EOL care and was associated with significantly fewer emergency department visits (68% vs 48%; P < .001) and hospital admissions (86% vs 52%; P < .001), as well as shorter hospital stays in the last 30 days of life (3-11 vs 5-14 days; P = .01).14 Despite these benefits, 60% to 90% of patients with a serious illness report never having discussed EOL care issues with their clinician.16,17
Continue to: Early EOL discussions...
Early EOL discussions have also been shown to have a positive impact on families. In a US study, family members stated that timely EOL care discussions allowed them to make use of hospice and palliative care services sooner and to make the most of their time with the patient.18
Timing and communication are key
Logistically it can be difficult to gather the right people (patient, family, etc) in the right place and at the right time. For physicians, the most often cited barriers include inadequate time to conduct an EOL discussion, 19 a perceived lack of competence in EOL conversations, 1,20 difficulty navigating patient readiness, 21 and a fear of destroying hope due to prognostic uncertainty. 19,20
A prospective, observational study used the Quality of Communication (QOC) questionnaire to assess life-sustaining treatment preferences, ACP, and the quality of EOL care communication in Dutch outpatients with clinically stable but severe chronic obstructive pulmonary disease (n = 105) or congestive heart failure (n = 80). The QOC questionnaire is a validated instrument that asks patients to rate their physician on several communication skills from 0 (“the very worst” or “My doctor didn’t do this”) to 10 (“the very best”). In this study, quality communication was identified by patients as one of the most important skills for physicians to provide adequate EOL care. 22 While QOC ratings were high for general communication skills (median, 8.0 points), quality EOL care communication was rated very low (median, 0.0 points). Researchers say that this was primarily because most EOL topics were not discussed—especially spirituality, prognosis, and what dying might be like. 22 In a secondary analysis that evaluated quality of EOL care communication during 1-year follow-up of patients with advanced chronic organ failure (n = 265) with the QOC questionnaire, patient ratings improved to moderate to good (medians, 6-8 points) when these topics were addressed. 23
Pick a strategy and prepare. As the older population continues to grow, the demands of palliative care management cannot be met by specialists alone and the responsibility of discussing EOL care with patients and their families will increasingly fall to family physicians as well. 24 Several strategies and approaches have evolved to assist family physicians with acquiring the skills to conduct productive EOL discussions. These include widely referenced resources, such as VitalTalk 25 and the ABCDE Plan. 26 VitalTalk teaches skills to help clinicians navigate difficult conversations, 25 and the “ABCDE” method provides a pneumonic for recommendations for how to deliver bad news ( A dvance preparation; B uild a therapeutic environment/relationship; C ommunicate well; D eal with patient and family reactions; E ncourage and validate emotions). 26
Other strategies include familiarizing oneself with the patient’s medical history and present situation (eg, What are the patient’s symptoms? What do other involved clinicians think and recommend? What therapies have been attempted? What are the relevant social and emotional dynamics?); asking the patient who they want present for the EOL conversation; scheduling the conversation for when you can set aside an appropriate amount of time and in a private place where there will be no interruptions; and going into the meeting with your goal in mind, whether it is to deliver bad news, clarify the prognosis, establish goals of care, or communicate the patient’s goals and wishes for the EOL to those in attendance. 27 It can be very helpful to begin the conversation by clarifying what the patient and their family/surrogate understand about the current diagnosis and prognosis. From there, the family physician can present a “headline” that prepares them for the current conversation (eg, “I have your latest test results, and I need to share some serious news”). This can facilitate a more detailed discussion of the patient’s and surrogate’s goals of care. Using these strategies, family physicians can lead a productive EOL discussion that benefits everyone.
Continue to: How to navigate EOL discussions with patients with dementia
How to navigate EOL discussions with patients with dementia
EOL discussions with patients with dementia become even more complex and warrant specific discussion because one must consider the timing of such discussions, 2,28,29 the trajectory of the disease and how that affects the patient’s capacity for EOL conversations, and the critical importance of engaging caregivers/surrogate decision makers in these discussions. 2 ACP provides an opportunity for the physician, patient, and caregiver/surrogate to jointly explore the patient’s values, beliefs, and preferences for care through the EOL as the disease progresses and the patient’s decisional capacity declines.
Ensure meaningful participation with timing. EOL discussions should occur while the patient has the cognitive capacity to actively participate in the planning process. A National Institutes of Health stage I behavioral intervention development trial evaluated a structured psychoeducational intervention, known as SPIRIT (Sharing Patient’s Illness Representation to Increase Trust), that aimed to promote cognitive and emotional preparation for EOL decisions for patients and their surrogates.28 It was found to be effective in patients, including those with end-stage renal disease and advanced heart failure, and their surrogates.28 Preliminary results from the trial confirmed that people with mild-to-moderate dementia (recent Montreal Cognitive Assessment score ≥ 13) are able to participate meaningfully in EOL discussions and ACP.28
Song et al29 adapted SPIRIT for use with patients with dementia and conducted a feasibility study with 23 patient-surrogate dyads.The mixed-methods study involved an expert panel review of the adapted SPIRIT, followed by a randomized trial with qualitative interviews. All 23 patients with dementia, including 14 with moderate dementia, were able to articulate their values and EOL preferences somewhat or very coherently (91.3% inter-rater reliability).29 In addition, dyad care goal congruence (agreement between patient’s EOL preferences and surrogate’s understanding of those preferences) and surrogate decision-making confidence (comfort in performing as a surrogate) were high and patient decisional conflict (patient difficulty in weighing the benefits and burdens of life-sustaining treatments and decision-making) was low, both at baseline as well as post intervention.29 Although preparedness for EOL decision-making outcome measures did not change, people with dementia and their surrogates perceived SPIRIT to be beneficial, particularly in helping them be on the same page.29
The randomized trial portion of the study (phase 2) continues to recruit 120 patient-surrogate dyads. Patient and surrogate self-reported preparedness for EOL decision-making are the primary outcomes, measured at baseline and 2 to 3 days post intervention. The estimated study completion date is May 31, 2022.30
Evidence-based clinical guidance can improve the process. Following the Belgian Centre for Evidence-Based Medicine’s procedures as a sample methodology, Piers et al2 developed evidence-based clinical recommendations for providers to use in the practical application of ACP in their care of patients with dementia.The researchers searched the literature; developed recommendations based on the evidence obtained, as well as their collective expert opinion; and performed validation using expert and end-user feedback and peer review. The study resulted in 32 recommendations focused on 8 domains that ranged from the beginning of the process (preconditions for optimal implementation of ACP) to later stages (ACP when it is difficult/no longer possible to communicate).2Specific guidance for ACP in dementia care include the following:
- ACP initiation. Begin conversations around the time of diagnosis, continue them throughout ongoing care, and revisit them when changes occur in the patient’s health, financial, or residential status.
- ACP conversations. Use conversations to identify significant others in the patient’s life (potential caregivers and/or surrogate decision makers) and explore the patient’s awareness of the disease and its trajectory. Discuss the patient’s values and beliefs, as well as their fears about, and preferences for, future care and the EOL.
- Role of significant others in the ACP process. Involve a patient’s significant others early in the ACP process, educate them about the surrogate decision-maker role, assess their disease awareness, and inform them about the disease trajectory and anticipated EOL decisions. 2
Continue to: Incorporate and document patients' values and preferences with LEAD
Incorporate and document patients’ values and preferences with LEAD. Dassel et al31 developed the Life-planning in Early Alzheimer’s and Dementia (LEAD) tool, which is a validated dementia-focused EOL planning tool that can be used to promote discussion and document a patient’s care preferences and values within the context of their changing cognitive ability.Dassel et al31 used a 4-phase mixed-method design that included (1) focus groups of patients with early-stage dementia and family caregivers, (2) clinical utility evaluation by content experts, (3) instrument completion sampling to evaluate its psychometric properties, and (4) additional focus groups to inform how the instrument should be used by families and in clinical practice.Six scales with high internal consistency and high test-retest reliability were identified: 3 scales represented patient values (concern about being a burden, the importance of quality [vs length] of life, and the preference for autonomy in decision-making) and 3 scales represented patient preferences (use of life-prolonging measures, controlling the timing of death, and the location of EOL care).31
The LEAD Guide can be used as a self-assessment tool that is completed individually and then shared with the surrogate decision maker and health care provider.32 It also can be used to guide conversations with the surrogate and physician, as well as with trusted family and friends. Using this framework, family physicians can facilitate EOL planning with the patient and their surrogate that is based on the patient’s values and preferences for EOL care prior to, and in anticipation of, the patient’s loss of decisional capacity.31
Facilitate discussions that improve outcomes
Conversations about EOL care are taking on increased importance as the population ages and treatments advance. Understanding the concerns of patients and their surrogate decision makers, as well as the resources available to guide these difficult discussions ( TABLE ), will help family physicians conduct effective conversations that enhance care, reduce the burden on surrogate decision makers, and have a positive impact on many clinical outcomes.
CORRESPONDENCE
Shirley Bodi, MD, 3000 Arlington Avenue, Department of Family Medicine, Dowling Hall, Suite 2200, University of Toledo College of Medicine and Life Sciences, Toledo, OH 43614; [email protected]
1. Bergenholtz Heidi, Timm HU, Missel M. Talking about end of life in general palliative care – what’s going on? A qualitative study on end-of-life conversations in an acute care hospital in Denmark. BMC Palliat Care. 2019;18:62. doi: 10.1186/s12904-019-0448-z
2. Piers R, Albers G, Gilissen J, et al. Advance care planning in dementia: recommendations for healthcare professionals. BMC Palliat Care. 2018;17:88. doi: 10.1186/s12904-018-0332-2
3. Tunzi M, Ventres W. A reflective case study in family medicine advance care planning conversations. J Am Board Fam Med. 2019;32:108-114. doi: 10.3122/jabfm.2019.01.180198
4. Schickedanz AD, Schillinger D, Landefeld CS, et al. A clinical framework for improving the advance care planning process: start with patients’ self-identified barriers. J Am Geriatr Soc. 2009;57:31-39. doi: 10.1111/j.1532-5415.2008.02093.x
5. Williams BC, Warshaw G, Fabiny AR, et al. Medicine in the 21st century: recommended essential geriatrics competencies for internal medicine and family medicine residents. J Grad Med Ed. 2010;2:373-383. doi: 10.4300/JGME-D-10-00065.1
6. Alano G, Pekmezaris R, Tai J, et al. Factors influencing older adults to complete advance directives. Palliat Support Care. 2010;8:267-275. doi: 10.1017/S1478951510000064
7. Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011;154:336-346. doi: 10.7326/0003-4819-154-5-201103010-00008
8. Edelberg C. Advance care planning with and without an annual wellness visit. Ed Management website. June 1, 2016. Accessed November 16, 2021. ww.reliasmedia.com/articles/137829-advanced-care-planning-with-and-without-an-annual-wellness-visit
9. Centers for Medicare and Medicaid Services. Frequently asked questions about billing the physician fee schedule for advance care planning services. July 14, 2016. Accessed December 20, 2021. www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/FAQ-Advance-Care-Planning.pdf
10. World Health Organization. Palliative care fact sheet. August 5, 2020. Accessed November 16, 2021. www.who.int/news-room/fact-sheets/detail/palliative-care
11. National Institute on Aging. What are palliative care and hospice care? Reviewed May 14, 2021. Accessed December 20, 2021. www.nia.nih.gov/health/what-are-palliative-care-and-hospice-care#palliative-vs-hospice
12. Rabow MW, Dibble SL, Pantilat, SZ, et al. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004;164:83-91. doi: 10.1001/archinte.164.1.83
13. Muir JC, Daley F, Davis MS, et al. Integrating palliative care into the outpatient, private practice oncology setting. J Pain Symptom Manage. 2010;40:126-135. doi: 10.1016/j.jpainsymman.2009.12.017
14. Hui D, Kim SH, Roquemore J, et al. Impact of timing and setting of palliative care referral on quality of end-of-life care in cancer patients. Cancer. 2014;120:1743-1749. doi: 10.1002/cncr.28628
15. Leung JM, Udris EM, Uman J, e al. The effect of end-of-life discussions on perceived quality of care and health status among patients with COPD. Chest. 2012;142:128-133. doi: 10.1378/chest.11-2222
16. Davison SN. End-of-life care preferences and needs: perceptions of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010;5:195-204. doi: 10.2215/CJN.05960809
17. Wright AA, Zhang B, Ray A, et al. Associations between end-of-life discussions, patients mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008;300:1665-1673. doi: 10.1001/jama.300.14.1665
18. Park E, Check DK, Yopp JM, et al. An exploratory study of end-of-life prognostic communication needs as reported by widowed fathers due to cancer. Psychooncology. 2015;24:1471-1476. doi: 10.1002/pon.3757
19. Tavares N, Jarrett N, Hunt K, et al. Palliative and end-of-life care conversations in COPD: a systematic literature review. ERJ Open Res. 2017;3:00068-2016. doi: 10.1183/23120541.00068-2016
20. Hancock K, Clayton JM, Parker SM, et al. Truth-telling in discussing prognosis in advanced life-limiting illnesses: a systematic review. Palliat Med. 2007;21:507-517. doi: 10.1177/0269216307080823
21. Parker SM, Clayton JM, Hancock K, et al. A systematic review of prognostic/end-of-life communication with adults in the advanced stages of a life-limiting illness: patient/caregiver preferences for the content, style, and timing of information. J Pain Symptom Manage. 2007;34:81-93. doi: 10.1016/j.jpainsymman.2006.09.035
22. Janssen DJA, Spruit MA, Schols JMGA, et al. A call for high-quality advance care planning in outpatients with severe COPD or chronic heart failure. Chest. 2011;139:1081-1088. doi: 10.1378/chest.10-1753
23. Houben CHM, Spruit MA, Schols JM, et al. Patient-clinician communication about end-of-life care on patients with advanced chronic organ failure during one year. J Pain Symptom Manage. 2015;49:1109-1115. doi: 10.1016/j.jpainsymman.2014.12.008
24. Brighton LJ, Bristowe K. Communication in palliative care: talking about the end of life, before the end of life. Postgrad Med J. 2016;92:466-470. doi: 10.1136/postgradmedj-2015-133368
25. VitalTalk website. Accessed December 20, 2021. vitaltalk.org
26. Rabow MQ, McPhee SJ. Beyond breaking bad news: how to help patients who suffer. Wes J Med. 1999;171:260-263. www.ncbi.nlm.nih.gov/pmc/articles/PMC1305864
27. Pfeifer M, Head B. Which critical communication skills are essential for interdisciplinary end-of-life discussions? AMA J Ethics. 2018;8:E724-E731. doi: 10.1001/amajethics.2018.724
28. Song M-K, Ward SE, Hepburn K, et al. SPIRIT advance care planning intervention in early stage dementias: an NIH stage I behavioral intervention development trial. Contemp Clin Trials. 2018;71:55-62. doi: 10.1016/j.cct.2018.06.005
29. Song M-K, Ward SE, Hepburn K, et al. Can persons with dementia meaningfully participate in advance care planning discussions? A mixed-methods study of SPIRIT. J Palliat Med. 2019;22:1410-1416. doi: 10.1089/jpm.2019.0088
30. Two-phased study of SPIRIT in mild dementia. ClinicalTrials.gov Identifier: NCT03311711. Updated August 23, 2021. Accessed December 20, 2021. clinicaltrials.gov/ct2/show/NCT03311711
31. Dassel K, Utz R, Supiano K, et al. Development of a dementia-focused end-of-life planning tool: the LEAD Guide (Life-planning in Early Alzheimer’s and Dementia). Innov Aging. 2019;3:igz024. doi: 10.1093/geroni/igz024
32. Dassel K, Supiano K, Utz R, et al. The LEAD Guide. Life-planning in Early Alzheimer’s and Dementia. 2019. Accessed December 20, 2021. utahgwep.org/resources/search-all-resources/send/10-dementia/27-the-lead-guide#:~:text=The%20LEAD%20Guide%20(Life%2DPlanning,your%20decisions%20about%20your%20care
1. Bergenholtz Heidi, Timm HU, Missel M. Talking about end of life in general palliative care – what’s going on? A qualitative study on end-of-life conversations in an acute care hospital in Denmark. BMC Palliat Care. 2019;18:62. doi: 10.1186/s12904-019-0448-z
2. Piers R, Albers G, Gilissen J, et al. Advance care planning in dementia: recommendations for healthcare professionals. BMC Palliat Care. 2018;17:88. doi: 10.1186/s12904-018-0332-2
3. Tunzi M, Ventres W. A reflective case study in family medicine advance care planning conversations. J Am Board Fam Med. 2019;32:108-114. doi: 10.3122/jabfm.2019.01.180198
4. Schickedanz AD, Schillinger D, Landefeld CS, et al. A clinical framework for improving the advance care planning process: start with patients’ self-identified barriers. J Am Geriatr Soc. 2009;57:31-39. doi: 10.1111/j.1532-5415.2008.02093.x
5. Williams BC, Warshaw G, Fabiny AR, et al. Medicine in the 21st century: recommended essential geriatrics competencies for internal medicine and family medicine residents. J Grad Med Ed. 2010;2:373-383. doi: 10.4300/JGME-D-10-00065.1
6. Alano G, Pekmezaris R, Tai J, et al. Factors influencing older adults to complete advance directives. Palliat Support Care. 2010;8:267-275. doi: 10.1017/S1478951510000064
7. Wendler D, Rid A. Systematic review: the effect on surrogates of making treatment decisions for others. Ann Intern Med. 2011;154:336-346. doi: 10.7326/0003-4819-154-5-201103010-00008
8. Edelberg C. Advance care planning with and without an annual wellness visit. Ed Management website. June 1, 2016. Accessed November 16, 2021. ww.reliasmedia.com/articles/137829-advanced-care-planning-with-and-without-an-annual-wellness-visit
9. Centers for Medicare and Medicaid Services. Frequently asked questions about billing the physician fee schedule for advance care planning services. July 14, 2016. Accessed December 20, 2021. www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/FAQ-Advance-Care-Planning.pdf
10. World Health Organization. Palliative care fact sheet. August 5, 2020. Accessed November 16, 2021. www.who.int/news-room/fact-sheets/detail/palliative-care
11. National Institute on Aging. What are palliative care and hospice care? Reviewed May 14, 2021. Accessed December 20, 2021. www.nia.nih.gov/health/what-are-palliative-care-and-hospice-care#palliative-vs-hospice
12. Rabow MW, Dibble SL, Pantilat, SZ, et al. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004;164:83-91. doi: 10.1001/archinte.164.1.83
13. Muir JC, Daley F, Davis MS, et al. Integrating palliative care into the outpatient, private practice oncology setting. J Pain Symptom Manage. 2010;40:126-135. doi: 10.1016/j.jpainsymman.2009.12.017
14. Hui D, Kim SH, Roquemore J, et al. Impact of timing and setting of palliative care referral on quality of end-of-life care in cancer patients. Cancer. 2014;120:1743-1749. doi: 10.1002/cncr.28628
15. Leung JM, Udris EM, Uman J, e al. The effect of end-of-life discussions on perceived quality of care and health status among patients with COPD. Chest. 2012;142:128-133. doi: 10.1378/chest.11-2222
16. Davison SN. End-of-life care preferences and needs: perceptions of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010;5:195-204. doi: 10.2215/CJN.05960809
17. Wright AA, Zhang B, Ray A, et al. Associations between end-of-life discussions, patients mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008;300:1665-1673. doi: 10.1001/jama.300.14.1665
18. Park E, Check DK, Yopp JM, et al. An exploratory study of end-of-life prognostic communication needs as reported by widowed fathers due to cancer. Psychooncology. 2015;24:1471-1476. doi: 10.1002/pon.3757
19. Tavares N, Jarrett N, Hunt K, et al. Palliative and end-of-life care conversations in COPD: a systematic literature review. ERJ Open Res. 2017;3:00068-2016. doi: 10.1183/23120541.00068-2016
20. Hancock K, Clayton JM, Parker SM, et al. Truth-telling in discussing prognosis in advanced life-limiting illnesses: a systematic review. Palliat Med. 2007;21:507-517. doi: 10.1177/0269216307080823
21. Parker SM, Clayton JM, Hancock K, et al. A systematic review of prognostic/end-of-life communication with adults in the advanced stages of a life-limiting illness: patient/caregiver preferences for the content, style, and timing of information. J Pain Symptom Manage. 2007;34:81-93. doi: 10.1016/j.jpainsymman.2006.09.035
22. Janssen DJA, Spruit MA, Schols JMGA, et al. A call for high-quality advance care planning in outpatients with severe COPD or chronic heart failure. Chest. 2011;139:1081-1088. doi: 10.1378/chest.10-1753
23. Houben CHM, Spruit MA, Schols JM, et al. Patient-clinician communication about end-of-life care on patients with advanced chronic organ failure during one year. J Pain Symptom Manage. 2015;49:1109-1115. doi: 10.1016/j.jpainsymman.2014.12.008
24. Brighton LJ, Bristowe K. Communication in palliative care: talking about the end of life, before the end of life. Postgrad Med J. 2016;92:466-470. doi: 10.1136/postgradmedj-2015-133368
25. VitalTalk website. Accessed December 20, 2021. vitaltalk.org
26. Rabow MQ, McPhee SJ. Beyond breaking bad news: how to help patients who suffer. Wes J Med. 1999;171:260-263. www.ncbi.nlm.nih.gov/pmc/articles/PMC1305864
27. Pfeifer M, Head B. Which critical communication skills are essential for interdisciplinary end-of-life discussions? AMA J Ethics. 2018;8:E724-E731. doi: 10.1001/amajethics.2018.724
28. Song M-K, Ward SE, Hepburn K, et al. SPIRIT advance care planning intervention in early stage dementias: an NIH stage I behavioral intervention development trial. Contemp Clin Trials. 2018;71:55-62. doi: 10.1016/j.cct.2018.06.005
29. Song M-K, Ward SE, Hepburn K, et al. Can persons with dementia meaningfully participate in advance care planning discussions? A mixed-methods study of SPIRIT. J Palliat Med. 2019;22:1410-1416. doi: 10.1089/jpm.2019.0088
30. Two-phased study of SPIRIT in mild dementia. ClinicalTrials.gov Identifier: NCT03311711. Updated August 23, 2021. Accessed December 20, 2021. clinicaltrials.gov/ct2/show/NCT03311711
31. Dassel K, Utz R, Supiano K, et al. Development of a dementia-focused end-of-life planning tool: the LEAD Guide (Life-planning in Early Alzheimer’s and Dementia). Innov Aging. 2019;3:igz024. doi: 10.1093/geroni/igz024
32. Dassel K, Supiano K, Utz R, et al. The LEAD Guide. Life-planning in Early Alzheimer’s and Dementia. 2019. Accessed December 20, 2021. utahgwep.org/resources/search-all-resources/send/10-dementia/27-the-lead-guide#:~:text=The%20LEAD%20Guide%20(Life%2DPlanning,your%20decisions%20about%20your%20care
PRACTICE RECOMMENDATIONS
› Improve patients’ quality of life and satisfaction with care through the successful implementation of palliative care. C
› Initiate end-of-life (EOL) discussions with patients with dementia at diagnosis, while the patient is cognizant and able to actively express their values and preferences for EOL care. C
› Engage surrogate decision makers in conversations about dementia, its trajectory, and their role in EOL care early in the process. C
Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series
Doc accused of killing 14 patients in the ICU: Upcoming trial notes patient safety lapses
On Dec. 5, 2017, Danny Mollette, age 74, was brought to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.
Mr. Mollette, who had diabetes, previously had been hospitalized for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, DO, the sole physician on duty in the ICU during the overnight shift.
Around 9:00 p.m., Dr. Husel discussed Mr. Mollette’s “grim prognosis” with family members at the patient’s bedside. He advised them that Mr. Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”
In less than an hour, Mr. Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Ann’s in Westerville, Ohio, from 2014 through 2018 – all under Dr. Husel’s care.
Like Mr. Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl – often combined with a dose of one or more other painkillers or sedatives like hydromorphone – and being withdrawn from the ventilator. These deaths all occurred following a procedure called palliative extubation, the removal of the endotracheal tube in patients who are expected to die.
Mount Carmel fired Dr. Husel in December 2018 following an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal,” and “went beyond providing comfort.” His Ohio medical license was suspended. In February 2022, he is scheduled to go on trial in Columbus on 14 counts of murder.*
Hanging over the murder case against Dr. Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over 4 years, and why numerous registered nurses and hospital pharmacists went along with Dr. Husel’s actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.
“The first time a patient died on a very high dose, someone should have flagged this,” said Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School, Newark. “As soon as I see it the second time or 27th time, it doesn’t seem okay. There was a breakdown in oversight to allow this to continue. The hospital didn’t have guardrails in place.”
The Franklin County (Ohio) Prosecuting Attorney’s Office faces two big challenges in trying Dr. Husel for murder. The prosecutors must prove that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.
Federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that were exposed by the Husel cases. An outside medical expert, Robert Powers, MD, a professor of emergency medicine at the University of Virginia, Charlottesville, testified in one of the dozens of wrongful death lawsuits against Mount Carmel and Dr. Husel that there was no record of anyone supervising Dr. Husel or monitoring his care.
There also are questions about why Mount Carmel administrators and physician leaders did not find out about Dr. Husel’s criminal record as a young man before hiring and credentialing him, even though the Ohio Medical Board had obtained that record. As a college freshman in West Virginia in 1994, Dr. Husel and a friend allegedly stole car stereos, and after a classmate reported their behavior, they built a pipe bomb they planned to plant under the classmate’s car, according to court records.
Dr. Husel pleaded guilty in 1996 to a federal misdemeanor for improperly storing explosive materials, and he received a 6-month sentence followed by supervision. He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, attorneys representing the families of his deceased patients say.
A Mount Carmel spokeswoman said the hospital only checks a physician applicant’s background record for the previous 10 years.
“I think [the credentialing process] should have been more careful and more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You don’t hire bombers and thieves to take care of patients.”
Mount Carmel and Trinity leaders say they knew nothing about Dr. Husel’s palliative extubation practices until a staffer reported Dr. Husel’s high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.
Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.
“What happened is tragic and unacceptable,” the Mount Carmel spokeswoman said in a written statement. “We have made a number of changes designed to prevent this from ever happening again. … Our new hospital leadership team is committed to patient safety and will take immediate action whenever patient safety is at issue.”
In January 2019, Mount Carmel’s then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Mr. Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Dr. Husel’s care could have been treated and survived. Mr. Lamb stepped down in June 2019.
Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Dr. Husel ordered – 500-2,000 mcg – were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.
Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 mcg for relieving pain, and its 2018 guidelines reduced that to 25-50 mcg.
“If I perform a painful procedure, I might give 100 or 150 micrograms of fentanyl, or 500 or 600 for open heart surgery,” said Dr. Nelson of Rutgers, who also practices medical toxicology and addiction medicine. “But you’ll be intubated and monitored carefully. Without having a tube in your airway to help you breathe, those doses will kill you.”**
Mount Carmel West hired Dr. Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. A good-looking and charismatic former high school basketball star, he was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.
In 2014, Dr. Husel was chosen by his hospital colleagues as physician of the year. He was again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Larry Swanner, MD, Mount Carmel’s former vice president of medical affairs, who was fired in 2019.
“Dr. Husel is so knowledgeable that we would try to soak up as much knowledge as we could,” said Jason Schulze, RN, in a July 2020 deposition. Mr. Schulze’s license was suspended, however, that suspension was stayed for a minimum period of two years. This was in connection with his care of one of Dr. Husel’s ICU patients, 44-year-old Troy Allison, who died 3 minutes after Mr. Schulze administered a 1,000-microgram dose of fentanyl ordered by Dr. Husel in July 2018.
Dr. Husel’s winning personality and seeming expertise in the use of pain drugs, combined with his training at the prestigious Cleveland Clinic, may have lulled other hospital staff into going along with his decisions.
“They’re thinking, the guy’s likable and he must know what he’s doing,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “But you can’t get fooled by that. You need a policy in place for what to do if pharmacists or nurses disagree with an order, and you need to have practice simulations so people know how to handle these situations.”
Dr. Husel’s criminal defense attorney, Jose Baez, said Dr. Husel’s treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. “Dr. Husel practiced medicine with compassion, and never wanted to see any of his patients suffer, nor their family,” Mr. Baez said.
Most medical and pharmacy experts sharply disagree. “I’m a pharmacist, and I’ve never seen anything like those kinds of doses,” Mr. Cohen said. “Something strange was going on there.”
Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Dr. Husel’s and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.
“None of the nurses ever thought that Dr. Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney who’s representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”
Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, located in the low-income, inner-city neighborhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.
“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Dr. Husel’s care. “They may have directed less energy, attention, and resources to the inner-city hospital.”
The case of Danny Mollette illustrates the multiple issues with Mount Carmel’s patient safety system.
First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.
After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. Husel told him the pharmacist had said, “It is okay.”
Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. Mr. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mr. Mollette and two subsequent Husel patients.
Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s organs were shutting down and he was brain damaged. In hindsight, we felt kind of rushed to make that decision.”
Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, there’s the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.
Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and that’s illegal in the United States.
“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”
Dr. Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.
Among those violations is that many of Dr. Husel’s drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.
After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospital’s correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.
Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.
“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”
Dr. Husel’s high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely – if ever – questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.
But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Dr. Husel.
Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.
“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s ICU a “dysfunctional” environment. “But,” he noted, “when Mr. Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate. … Clearly, Mr. Deemer trusted Dr. Husel. But Dr. Husel was not to be trusted.”
While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many U.S. hospitals.
“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”
A version of this article first appeared on Medscape.com.
Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice.
This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.
On Dec. 5, 2017, Danny Mollette, age 74, was brought to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.
Mr. Mollette, who had diabetes, previously had been hospitalized for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, DO, the sole physician on duty in the ICU during the overnight shift.
Around 9:00 p.m., Dr. Husel discussed Mr. Mollette’s “grim prognosis” with family members at the patient’s bedside. He advised them that Mr. Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”
In less than an hour, Mr. Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Ann’s in Westerville, Ohio, from 2014 through 2018 – all under Dr. Husel’s care.
Like Mr. Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl – often combined with a dose of one or more other painkillers or sedatives like hydromorphone – and being withdrawn from the ventilator. These deaths all occurred following a procedure called palliative extubation, the removal of the endotracheal tube in patients who are expected to die.
Mount Carmel fired Dr. Husel in December 2018 following an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal,” and “went beyond providing comfort.” His Ohio medical license was suspended. In February 2022, he is scheduled to go on trial in Columbus on 14 counts of murder.*
Hanging over the murder case against Dr. Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over 4 years, and why numerous registered nurses and hospital pharmacists went along with Dr. Husel’s actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.
“The first time a patient died on a very high dose, someone should have flagged this,” said Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School, Newark. “As soon as I see it the second time or 27th time, it doesn’t seem okay. There was a breakdown in oversight to allow this to continue. The hospital didn’t have guardrails in place.”
The Franklin County (Ohio) Prosecuting Attorney’s Office faces two big challenges in trying Dr. Husel for murder. The prosecutors must prove that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.
Federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that were exposed by the Husel cases. An outside medical expert, Robert Powers, MD, a professor of emergency medicine at the University of Virginia, Charlottesville, testified in one of the dozens of wrongful death lawsuits against Mount Carmel and Dr. Husel that there was no record of anyone supervising Dr. Husel or monitoring his care.
There also are questions about why Mount Carmel administrators and physician leaders did not find out about Dr. Husel’s criminal record as a young man before hiring and credentialing him, even though the Ohio Medical Board had obtained that record. As a college freshman in West Virginia in 1994, Dr. Husel and a friend allegedly stole car stereos, and after a classmate reported their behavior, they built a pipe bomb they planned to plant under the classmate’s car, according to court records.
Dr. Husel pleaded guilty in 1996 to a federal misdemeanor for improperly storing explosive materials, and he received a 6-month sentence followed by supervision. He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, attorneys representing the families of his deceased patients say.
A Mount Carmel spokeswoman said the hospital only checks a physician applicant’s background record for the previous 10 years.
“I think [the credentialing process] should have been more careful and more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You don’t hire bombers and thieves to take care of patients.”
Mount Carmel and Trinity leaders say they knew nothing about Dr. Husel’s palliative extubation practices until a staffer reported Dr. Husel’s high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.
Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.
“What happened is tragic and unacceptable,” the Mount Carmel spokeswoman said in a written statement. “We have made a number of changes designed to prevent this from ever happening again. … Our new hospital leadership team is committed to patient safety and will take immediate action whenever patient safety is at issue.”
In January 2019, Mount Carmel’s then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Mr. Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Dr. Husel’s care could have been treated and survived. Mr. Lamb stepped down in June 2019.
Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Dr. Husel ordered – 500-2,000 mcg – were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.
Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 mcg for relieving pain, and its 2018 guidelines reduced that to 25-50 mcg.
“If I perform a painful procedure, I might give 100 or 150 micrograms of fentanyl, or 500 or 600 for open heart surgery,” said Dr. Nelson of Rutgers, who also practices medical toxicology and addiction medicine. “But you’ll be intubated and monitored carefully. Without having a tube in your airway to help you breathe, those doses will kill you.”**
Mount Carmel West hired Dr. Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. A good-looking and charismatic former high school basketball star, he was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.
In 2014, Dr. Husel was chosen by his hospital colleagues as physician of the year. He was again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Larry Swanner, MD, Mount Carmel’s former vice president of medical affairs, who was fired in 2019.
“Dr. Husel is so knowledgeable that we would try to soak up as much knowledge as we could,” said Jason Schulze, RN, in a July 2020 deposition. Mr. Schulze’s license was suspended, however, that suspension was stayed for a minimum period of two years. This was in connection with his care of one of Dr. Husel’s ICU patients, 44-year-old Troy Allison, who died 3 minutes after Mr. Schulze administered a 1,000-microgram dose of fentanyl ordered by Dr. Husel in July 2018.
Dr. Husel’s winning personality and seeming expertise in the use of pain drugs, combined with his training at the prestigious Cleveland Clinic, may have lulled other hospital staff into going along with his decisions.
“They’re thinking, the guy’s likable and he must know what he’s doing,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “But you can’t get fooled by that. You need a policy in place for what to do if pharmacists or nurses disagree with an order, and you need to have practice simulations so people know how to handle these situations.”
Dr. Husel’s criminal defense attorney, Jose Baez, said Dr. Husel’s treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. “Dr. Husel practiced medicine with compassion, and never wanted to see any of his patients suffer, nor their family,” Mr. Baez said.
Most medical and pharmacy experts sharply disagree. “I’m a pharmacist, and I’ve never seen anything like those kinds of doses,” Mr. Cohen said. “Something strange was going on there.”
Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Dr. Husel’s and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.
“None of the nurses ever thought that Dr. Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney who’s representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”
Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, located in the low-income, inner-city neighborhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.
“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Dr. Husel’s care. “They may have directed less energy, attention, and resources to the inner-city hospital.”
The case of Danny Mollette illustrates the multiple issues with Mount Carmel’s patient safety system.
First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.
After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. Husel told him the pharmacist had said, “It is okay.”
Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. Mr. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mr. Mollette and two subsequent Husel patients.
Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s organs were shutting down and he was brain damaged. In hindsight, we felt kind of rushed to make that decision.”
Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, there’s the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.
Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and that’s illegal in the United States.
“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”
Dr. Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.
Among those violations is that many of Dr. Husel’s drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.
After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospital’s correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.
Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.
“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”
Dr. Husel’s high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely – if ever – questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.
But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Dr. Husel.
Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.
“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s ICU a “dysfunctional” environment. “But,” he noted, “when Mr. Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate. … Clearly, Mr. Deemer trusted Dr. Husel. But Dr. Husel was not to be trusted.”
While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many U.S. hospitals.
“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”
A version of this article first appeared on Medscape.com.
Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice.
This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.
On Dec. 5, 2017, Danny Mollette, age 74, was brought to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.
Mr. Mollette, who had diabetes, previously had been hospitalized for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, DO, the sole physician on duty in the ICU during the overnight shift.
Around 9:00 p.m., Dr. Husel discussed Mr. Mollette’s “grim prognosis” with family members at the patient’s bedside. He advised them that Mr. Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”
In less than an hour, Mr. Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Ann’s in Westerville, Ohio, from 2014 through 2018 – all under Dr. Husel’s care.
Like Mr. Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl – often combined with a dose of one or more other painkillers or sedatives like hydromorphone – and being withdrawn from the ventilator. These deaths all occurred following a procedure called palliative extubation, the removal of the endotracheal tube in patients who are expected to die.
Mount Carmel fired Dr. Husel in December 2018 following an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal,” and “went beyond providing comfort.” His Ohio medical license was suspended. In February 2022, he is scheduled to go on trial in Columbus on 14 counts of murder.*
Hanging over the murder case against Dr. Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over 4 years, and why numerous registered nurses and hospital pharmacists went along with Dr. Husel’s actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.
“The first time a patient died on a very high dose, someone should have flagged this,” said Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School, Newark. “As soon as I see it the second time or 27th time, it doesn’t seem okay. There was a breakdown in oversight to allow this to continue. The hospital didn’t have guardrails in place.”
The Franklin County (Ohio) Prosecuting Attorney’s Office faces two big challenges in trying Dr. Husel for murder. The prosecutors must prove that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.
Federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that were exposed by the Husel cases. An outside medical expert, Robert Powers, MD, a professor of emergency medicine at the University of Virginia, Charlottesville, testified in one of the dozens of wrongful death lawsuits against Mount Carmel and Dr. Husel that there was no record of anyone supervising Dr. Husel or monitoring his care.
There also are questions about why Mount Carmel administrators and physician leaders did not find out about Dr. Husel’s criminal record as a young man before hiring and credentialing him, even though the Ohio Medical Board had obtained that record. As a college freshman in West Virginia in 1994, Dr. Husel and a friend allegedly stole car stereos, and after a classmate reported their behavior, they built a pipe bomb they planned to plant under the classmate’s car, according to court records.
Dr. Husel pleaded guilty in 1996 to a federal misdemeanor for improperly storing explosive materials, and he received a 6-month sentence followed by supervision. He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, attorneys representing the families of his deceased patients say.
A Mount Carmel spokeswoman said the hospital only checks a physician applicant’s background record for the previous 10 years.
“I think [the credentialing process] should have been more careful and more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You don’t hire bombers and thieves to take care of patients.”
Mount Carmel and Trinity leaders say they knew nothing about Dr. Husel’s palliative extubation practices until a staffer reported Dr. Husel’s high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.
Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.
“What happened is tragic and unacceptable,” the Mount Carmel spokeswoman said in a written statement. “We have made a number of changes designed to prevent this from ever happening again. … Our new hospital leadership team is committed to patient safety and will take immediate action whenever patient safety is at issue.”
In January 2019, Mount Carmel’s then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Mr. Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Dr. Husel’s care could have been treated and survived. Mr. Lamb stepped down in June 2019.
Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Dr. Husel ordered – 500-2,000 mcg – were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.
Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 mcg for relieving pain, and its 2018 guidelines reduced that to 25-50 mcg.
“If I perform a painful procedure, I might give 100 or 150 micrograms of fentanyl, or 500 or 600 for open heart surgery,” said Dr. Nelson of Rutgers, who also practices medical toxicology and addiction medicine. “But you’ll be intubated and monitored carefully. Without having a tube in your airway to help you breathe, those doses will kill you.”**
Mount Carmel West hired Dr. Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. A good-looking and charismatic former high school basketball star, he was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.
In 2014, Dr. Husel was chosen by his hospital colleagues as physician of the year. He was again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Larry Swanner, MD, Mount Carmel’s former vice president of medical affairs, who was fired in 2019.
“Dr. Husel is so knowledgeable that we would try to soak up as much knowledge as we could,” said Jason Schulze, RN, in a July 2020 deposition. Mr. Schulze’s license was suspended, however, that suspension was stayed for a minimum period of two years. This was in connection with his care of one of Dr. Husel’s ICU patients, 44-year-old Troy Allison, who died 3 minutes after Mr. Schulze administered a 1,000-microgram dose of fentanyl ordered by Dr. Husel in July 2018.
Dr. Husel’s winning personality and seeming expertise in the use of pain drugs, combined with his training at the prestigious Cleveland Clinic, may have lulled other hospital staff into going along with his decisions.
“They’re thinking, the guy’s likable and he must know what he’s doing,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “But you can’t get fooled by that. You need a policy in place for what to do if pharmacists or nurses disagree with an order, and you need to have practice simulations so people know how to handle these situations.”
Dr. Husel’s criminal defense attorney, Jose Baez, said Dr. Husel’s treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. “Dr. Husel practiced medicine with compassion, and never wanted to see any of his patients suffer, nor their family,” Mr. Baez said.
Most medical and pharmacy experts sharply disagree. “I’m a pharmacist, and I’ve never seen anything like those kinds of doses,” Mr. Cohen said. “Something strange was going on there.”
Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Dr. Husel’s and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.
“None of the nurses ever thought that Dr. Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney who’s representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”
Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, located in the low-income, inner-city neighborhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.
“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Dr. Husel’s care. “They may have directed less energy, attention, and resources to the inner-city hospital.”
The case of Danny Mollette illustrates the multiple issues with Mount Carmel’s patient safety system.
First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.
After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. Husel told him the pharmacist had said, “It is okay.”
Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. Mr. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mr. Mollette and two subsequent Husel patients.
Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s organs were shutting down and he was brain damaged. In hindsight, we felt kind of rushed to make that decision.”
Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, there’s the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.
Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and that’s illegal in the United States.
“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”
Dr. Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.
Among those violations is that many of Dr. Husel’s drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.
After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospital’s correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.
Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.
“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”
Dr. Husel’s high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely – if ever – questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.
But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Dr. Husel.
Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.
“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s ICU a “dysfunctional” environment. “But,” he noted, “when Mr. Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate. … Clearly, Mr. Deemer trusted Dr. Husel. But Dr. Husel was not to be trusted.”
While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many U.S. hospitals.
“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”
A version of this article first appeared on Medscape.com.
Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice.
This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.
Easing dementia caregiver burden, addressing interpersonal violence
The number of people with dementia globally is expected to reach 74.7 million by 2030 and 131.5 million by 2050.1 Because dementia is progressive, many patients will exhibit severe symptoms termed behavioral crises. Deteriorating interpersonal conduct and escalating antisocial acts result in an acquired sociopathy.2 Increasing cognitive impairment causes these patients to misunderstand intimate care and perceive it as a threat, often resulting in outbursts of violence against their caregivers.3
Available studies (TABLE4-17) make evident the incidence of interpersonal violence experienced by caregivers secondary to aggressive acts by patients with dementia. This violence ranges from verbal abuse, including racial slurs, to physical abuse—sometimes resulting in significant physical injury. Aggressive behavior by patients with dementia, resulting in violence towards their caregivers or partners, stems from progressive cognitive decline, which can make optimal care difficult. Such episodes may also impair the psychological and physical well-being of caregivers, increasing their risk of depression, anxiety, and even post-traumatic stress disorder (PTSD).18 The extent of the impact is also determined by the interpretation of the abuse by the caregivers themselves. One study suggested that the perception of aggressive or violent behavior as “normal” by a caregiver reduced the overall negative effect of the interactions.7Our review emphasizes the unintended burden that can fall to caregivers of patients with dementia. We also address the role of primary care providers (PCPs) in identifying these instances of violence and intervening appropriately by providing safety strategies, education, resources, and support.
CASE
A 67-year-old man with a medical history of PTSD with depression, type 2 diabetes, alcohol use disorder/dependence, hypertension, and obstructive sleep apnea was brought to his PCP by his wife. She said he had recently been unable to keep appointment times, pay bills, or take his usual medications, venlafaxine and bupropion. She also said his PTSD symptoms had worsened. He was sleeping 12 to 14 hours per day and was increasingly irritable. The patient denied any concerns or changes in his behavior.
The PCP administered a Saint Louis University Mental Status (SLUMS) examination to screen for cognitive impairment.19 The patient scored 14/30 (less than 20 is indicative of dementia). He was unable to complete a simple math problem, recall any items from a list of 5, count in reverse, draw a clock correctly, or recall a full story. Throughout the exam, the patient demonstrated minimal effort and was often only able to complete a task after further prompting by the examiner.
A computed tomography scan of the head revealed no signs of hemorrhage or damage. Thyroid-stimulating hormone levels and vitamin B12 levels were normal. A rapid plasma reagin test result was negative. The patient was given a diagnosis of Alzheimer disease. Donepezil was added to the patient’s medications, starting at 5 mg and then increased to 10 mg. His wife began to assist him with his tasks of daily living. His mood improved, and his wife noted he began to remember his appointments and take his medications with assistance.
However, the patient’s irritability continued to escalate. He grew paranoid and accused his wife of mismanaging their money. This pattern steadily worsened over the course of 6 months. The situation escalated until one day the patient’s wife called a mental health hotline reporting that her husband was holding her hostage and threatening to kill her with a gun. He told her, “I can do something to you, and they won’t even find a fingernail. It doesn’t have to be with a gun either.” She was counseled to try to stay calm to avoid aggravating the situation and to go to a safe place and stay there until help arrived.
His memory had worsened to the point that he could not recall any events from the previous 2 years. He was paranoid about anyone entering his home and would not allow his deteriorating roof to be repaired or his yard to be maintained. He did not shower for weeks at a time. He slept holding a rifle and accused his wife of embezzlement.
Continue to: The patient was evaluated...
The patient was evaluated by another specialist, who assessed his SLUMS score to be 18/30. He increased the patient’s donepezil dose, initiated a bupropion taper, and added sertraline to the regimen. The PCP spoke to the patient’s wife regarding options for her safety including leaving the home, hiding firearms, and calling the police in cases of interpersonal violence. The wife said she did not want to pursue these options. She expressed worry that he might be harmed if he was uncooperative with the police and said there was no one except her to take care of him.
Caregivers struggle to care for their loved ones
Instances of personal violence lead to shock, astonishment, heartbreak, and fear. Anticipation of a recurrence of violence causes many partners and caregivers to feel exhausted, because there is minimal hope for any chance of improvement. There are a few exceptions, however, as our case will show. In addition to emotional exhaustion, there is also a never-ending sense of self-doubt, leading many caregivers to question their ability to handle their family member.20,21 Over time, this leads to caregiver burnout, leaving them unable to understand their family member’s aggression. The sudden loss of caregiver control in dealing with the patient may also result in the family member exhibiting behavioral changes reflecting emotional trauma. For caregivers who do not live with the patient, they may choose to make fewer or shorter visits—or not visit at all—because they fear being abused.7,22
Caregivers of patients with dementia often feel helpless and powerless once abrupt and drastic changes in personality lead to some form of interpersonal violence. Additionally, caregivers with a poor health status are more likely to have lower physical function and experience greater caregiving stress overall.23 Other factors increasing stress are longer years of caregiving and the severity of a patient’s dementia and functional impairment.23
Interventions to reduce caregiver burden
Many studies have assessed the role of different interventions to reduce caregiver burden, such as teaching them problem-solving skills, increasing their knowledge of dementia, recommending social resources, providing emotional support, changing caregiver perceptions of the care situation, introducing coping strategies, relying on strengths and experiences in caregiving, help-seeking, and engaging in activity programs.24-28 For Hispanic caregivers, a structured and self-paced online telenovela format has been effective in improving care and relieving caregiver stress.29 Online positive emotion regulators helped in significantly improving quality of life and physical health in the caregivers.30 In this last intervention, caregivers had 6 online sessions with a facilitator who taught them emotional regulation skills that included: noticing positive events, capitalizing on them, and feeling gratitude; practicing mindfulness; doing a positive reappraisal; acknowledging personal strengths and setting attainable goals; and performing acts of kindness. Empowerment programs have also shown significant improvement in the well-being of caregivers.31
Caregivers may reject support.
Continue to: These practical tips can help
These practical tips can help
Based on our review of the literature, we recommend offering the following supports to caregivers:
- Counsel caregivers early on in a patient’s dementia that behavior changes are likely and may be unpredictable. Explain that dementia can involve changes to personality and behavior as well as memory difficulties.33,34
- Describe resources for support, such as day programs for senior adults, insurance coverage for caregiver respite programs, and the Alzheimer’s Association (www.alz.org/). Encourage caregivers to seek general medical and mental health care for themselves. Caregivers should have opportunities and support to discuss their experiences and to be appropriately trained for the challenge of caring for a family member with dementia.35
- Encourage disclosure about abrupt changes in the patient’s behavior. This invites families to discuss issues with you and may make them more comfortable with such conversations.
- Involve ancillary services (eg, social worker) to plan for a higher level of care well in advance of it becoming necessary.
- Discuss safety strategies for the caregiver, including when it is appropriate to alter a patient’s set routines such as bedtimes and mealtimes.33,34
- Discuss when and how to involve law enforcement, if necessary.33,34 Emphasize the importance of removing firearms from the home as a safety measure. Although federal laws do not explicitly prohibit possession of arms by patients with neurologic damage, a few states mention “organic brain syndrome” or “dementia” as conditions prohibiting use or possession of firearms.36
- Suggest, as feasible, nonpharmacologic aids for the patient such as massage therapy, animal-assisted therapy, personalized interventions, music therapy, and light therapy.37 Prescribe medications to the patient to aid in behavior modification when appropriate.
- Screen caregivers and family members for signs of interpersonal violence. Take notice of changes in caregiver behavior or irregularity in attending follow-up appointments.
CASE
Over the next month, the patient’s symptoms further deteriorated. His PCP recommended hospitalization, but the patient and his wife declined. Magnetic resonance imaging of the patient’s brain revealed severe confluent and patchy regions of white matter and T2 signal hyperintensity, consistent with chronic microvascular ischemic disease. An old, small, left parietal lobe infarct was also noted.
One month later, the patient presented to the emergency department. His symptoms were largely unchanged, but his wife indicated that she could no longer live at home due to burnout. The patient’s medications were adjusted, but he was not admitted for inpatient care. His wife said they needed help at home, but the patient opposed the idea any time that it was mentioned.
A few weeks later, the patient presented for outpatient follow-up. He was delusional, believing that the government was compelling citizens to take sertraline in order to harm their mental health. He had also begun viewing online pornography in front of his wife and attempting to remove all of his money from the bank. He was prescribed aripiprazole 15 mg, and his symptoms began to improve. Soon after, however, he threatened to kill his grandson, then took all his Lasix pills (a 7-day supply) simultaneously. The patient denied that this was a suicide attempt.
Over the course of the next month, the patient began to report hearing voices. A neuropsychological evaluation confirmed a diagnosis of dementia with psychiatric symptoms due to neurologic injury. The patient was referred to a geriatric psychiatrist and continued to be managed medically. He was assigned a multidisciplinary team comprising palliative care, social work, and care management to assist in his care and provide support to the family. His behavior improved.
Continue to: At the time of this publication...
At the time of this publication, the patient’s irritability and paranoia had subsided and he had made no further threats to his family. He has allowed a home health aide into the house and has agreed to have his roof repaired. His wife still lives with him and assists him with activities of daily living.
Interprofessional teams are key
Caregiver burnout increases the risk of patient neglect or abuse, as individuals who have been the targets of aggressive behavior are more likely to leave demented patients unattended.8,16,23 Although tools are available to screen caregivers for depression and burnout, an important step forward would be to develop an interprofessional team to aid in identifying and closely following high-risk patient–caregiver groups. This continual and varied assessment of psychosocial stressors could help prevent the development of violent interactions. These teams would allow integration with the primary health care system by frequent and effective shared communication of knowledge, development of goals, and shared decision-making.38 Setting expectations, providing support, and discussing safety strategies can improve the health and welfare of caregivers and patients with dementia alike.
CORRESPONDENCE
Abu Baker Sheikh, MD, MSC 10-5550, 1 University of New Mexico, Albuquerque, NM 87131; [email protected].
1. Wu YT, Beiser AS, Breteler MMB, et al. The changing prevalence and incidence of dementia over time - current evidence. Nat Rev Neurol. 2017;13:327-339.
2. Cipriani G, Borin G, Vedovello M, et al. Sociopathic behavior and dementia. Acta Neurol Belg. 2013;113:111-115.
3. Cipriani G, Lucetti C, Danti S, et al. Violent and criminal manifestations in dementia patients. Geriatr Gerontol Int. 2016;16:541-549.
4. Skovdahl K, Kihlgren AL, Kihlgren M. Different attitudes when handling aggressive behaviour in dementia—narratives from two caregiver groups. Aging Ment Health. 2003;7:277-286.
5. Kristiansen L, Hellzén O, Asplund K. Swedish assistant nurses’ experiences of job satisfaction when caring for persons suffering from dementia and behavioural disturbances. An interview study. Int J Qualitat Stud Health Well-being. 2006;1:245-256.
6. Wharton TC, Ford BK. What is known about dementia care recipient violence and aggression against caregivers? J Gerontol Soc Work. 2014;57:460-477.
7. Ostaszkiewicz J, Lakhan P, O’Connell B, et al. Ongoing challenges responding to behavioural and psychological symptoms of dementia. Int Nurs Rev. 2015;62:506-516.
8. Kim J, De Bellis AM, Xiao LD. The experience of paid family-care workers of people with dementia in South Korea. Asian Nurs Res (Korean Soc Nurs Sci). 2018;12:34-41.
9. Band-Winterstein T, Avieli H. Women coping with a partner’s dementia-related violence: a qualitative study. J Nurs Scholarsh. 2019; 51:368-379.
10. Munkejord MC, Stefansdottir OA, Sveinbjarnardottir EK. Who cares for the carer? The suffering, struggles and unmet needs of older women caring for husbands living with cognitive decline. Int Pract Devel J. 2020;10:1-11.
11. Seidel D, Thyrian JR. Burden of caring for people with dementia - comparing family caregivers and professional caregivers. A descriptive study. J Multidiscip Healthc. 2019;12:655-663.
12. Tang W, Friedman DB, Kannaley K, et al. Experiences of caregivers by care recipient’s health condition: a study of caregivers for Alzheimer’s disease and related dementias versus other chronic conditions. Geriatr Nurs. 2019;40:181-184.
13. Benbow SM, Bhattacharyya S, Kingston P. Older adults and violence: an analysis of domestic homicide reviews in England involving adults over 60 years of age. Ageing Soc. 2018;39:1097-1121.
14. Herron RV, Wrathall MA. Putting responsive behaviours in place: examining how formal and informal carers understand the actions of people with dementia. Soc Sci Med. 2018;204:9-15.
15. Herron RV, Rosenberg MW. Responding to aggression and reactive behaviours in the home. Dementia (London). 2019;18:1328-1340.
16. Spencer D, Funk LM, Herron RV, et al. Fear, defensive strategies and caring for cognitively impaired family members. J Gerontol Soc Work. 2019;62:67-85.
17. Skovdahl K, Kihlgren AL, Kihlgren M. Dementia and aggressiveness: stimulated recall interviews with caregivers after video-recorded interactions. J Clin Nurs. 2004;13:515-525.
18. Needham I, Abderhalden C, Halfens RJ, et al. Non-somatic effects of patient aggression on nurses: a systematic review. J Adv Nurs. 2005;49:283-296.
19. Tariq SH, Tumosa N, Chibnall JT, et al. The Saint Louis University Mental Status (SLUMS) Examination for detecting mild cognitive impairment and dementia is more sensitive than the Mini-Mental Status Examination (MMSE) - a pilot study. Am J Geriatr Psych. 2006;14:900-910.
20. Janzen S, Zecevic AA, Kloseck M, et al. Managing agitation using nonpharmacological interventions for seniors with dementia. Am J Alzheimers Dis Other Demen. 2013;28:524-532.
21. Zeller A, Dassen T, Kok G, et al. Nursing home caregivers’ explanations for and coping strategies with residents’ aggression: a qualitative study. J Clin Nurs. 2011;20:2469-2478.
22. Alzheimer’s Society. Fix dementia care: homecare. Accessed December 28, 2021. https://www.alzheimers.org.uk/sites/default/files/migrate/downloads/fix_dementia_care_homecare_report.pdf
23. von Känel R, Mausbach BT, Dimsdale JE, et al. Refining caregiver vulnerability for clinical practice: determinants of self-rated health in spousal dementia caregivers. BMC Geriatr. 2019;19:18.
24. Chen HM, Huang MF, Yeh YC, et al. Effectiveness of coping strategies intervention on caregiver burden among caregivers of elderly patients with dementia. Psychogeriatrics. 2015; 15:20-25.
25. Wawrziczny E, Larochette C, Papo D, et al. A customized intervention for dementia caregivers: a quasi-experimental design. J Aging Health. 2019;31:1172-1195.
26. Gitlin LN, Piersol CV, Hodgson N, et al. Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial. Contemp Clin Trials. 2016;49:92-102.
27. de Oliveira AM, Radanovic M, Homem de Mello PC, et al. An intervention to reduce neuropsychiatric symptoms and caregiver burden in dementia: preliminary results from a randomized trial of the tailored activity program-outpatient version. Int J Geriatr Psychiatry. 2019;34:1301-1307.
28. Livingston G, Barber J, Rapaport P, et al. Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial. BMJ. 2013;347:f6276.
29. Kajiyama B, Fernandez G, Carter EA, et al. Helping Hispanic dementia caregivers cope with stress using technology-based resources. Clin Gerontol. 2018;41:209-216.
30. Moskowitz JT, Cheung EO, Snowberg KE, et al. Randomized controlled trial of a facilitated online positive emotion regulation intervention for dementia caregivers. Health Psychol. 2019;38:391-402.
31. Yoon HK, Kim GS. An empowerment program for family caregivers of people with dementia. Public Health Nurs. 2020;37:222-233.
32. Zwingmann I, Dreier-Wolfgramm A, Esser A, et al. Why do family dementia caregivers reject caregiver support services? Analyzing types of rejection and associated health-impairments in a cluster-randomized controlled intervention trial. BMC Health Serv Res. 2020;20:121.
33. Nybakken S, Strandås M, Bondas T. Caregivers’ perceptions of aggressive behaviour in nursing home residents living with dementia: A meta-ethnography. J Adv Nurs. 2018;74:2713-2726.
34. Nakaishi L, Moss H, Weinstein M, et al. Exploring workplace violence among home care workers in a consumer-driven home health care program. Workplace Health Saf. 2013;61:441-450.
35. Medical Advisory Secretariat. Caregiver- and patient-directed interventions for dementia: an evidence-based analysis. Ont Health Technol Assess Ser. 2008;8:1-98.
36. Betz ME, McCourt AD, Vernick JS, et al. Firearms and dementia: clinical considerations. Ann Intern Med. 2018;169:47-49.
37. Leng M, Zhao Y, Wang Z. Comparative efficacy of non-pharmacological interventions on agitation in people with dementia: a systematic review and Bayesian network meta-analysis. Int J Nurs Stud. 2020;102:103489.
38. Morgan S, Pullon S, McKinlay E. Observation of interprofessional collaborative practice in primary care teams: an integrative literature review. Int J Nurs Stud. 2015;52:1217-1230.
The number of people with dementia globally is expected to reach 74.7 million by 2030 and 131.5 million by 2050.1 Because dementia is progressive, many patients will exhibit severe symptoms termed behavioral crises. Deteriorating interpersonal conduct and escalating antisocial acts result in an acquired sociopathy.2 Increasing cognitive impairment causes these patients to misunderstand intimate care and perceive it as a threat, often resulting in outbursts of violence against their caregivers.3
Available studies (TABLE4-17) make evident the incidence of interpersonal violence experienced by caregivers secondary to aggressive acts by patients with dementia. This violence ranges from verbal abuse, including racial slurs, to physical abuse—sometimes resulting in significant physical injury. Aggressive behavior by patients with dementia, resulting in violence towards their caregivers or partners, stems from progressive cognitive decline, which can make optimal care difficult. Such episodes may also impair the psychological and physical well-being of caregivers, increasing their risk of depression, anxiety, and even post-traumatic stress disorder (PTSD).18 The extent of the impact is also determined by the interpretation of the abuse by the caregivers themselves. One study suggested that the perception of aggressive or violent behavior as “normal” by a caregiver reduced the overall negative effect of the interactions.7Our review emphasizes the unintended burden that can fall to caregivers of patients with dementia. We also address the role of primary care providers (PCPs) in identifying these instances of violence and intervening appropriately by providing safety strategies, education, resources, and support.
CASE
A 67-year-old man with a medical history of PTSD with depression, type 2 diabetes, alcohol use disorder/dependence, hypertension, and obstructive sleep apnea was brought to his PCP by his wife. She said he had recently been unable to keep appointment times, pay bills, or take his usual medications, venlafaxine and bupropion. She also said his PTSD symptoms had worsened. He was sleeping 12 to 14 hours per day and was increasingly irritable. The patient denied any concerns or changes in his behavior.
The PCP administered a Saint Louis University Mental Status (SLUMS) examination to screen for cognitive impairment.19 The patient scored 14/30 (less than 20 is indicative of dementia). He was unable to complete a simple math problem, recall any items from a list of 5, count in reverse, draw a clock correctly, or recall a full story. Throughout the exam, the patient demonstrated minimal effort and was often only able to complete a task after further prompting by the examiner.
A computed tomography scan of the head revealed no signs of hemorrhage or damage. Thyroid-stimulating hormone levels and vitamin B12 levels were normal. A rapid plasma reagin test result was negative. The patient was given a diagnosis of Alzheimer disease. Donepezil was added to the patient’s medications, starting at 5 mg and then increased to 10 mg. His wife began to assist him with his tasks of daily living. His mood improved, and his wife noted he began to remember his appointments and take his medications with assistance.
However, the patient’s irritability continued to escalate. He grew paranoid and accused his wife of mismanaging their money. This pattern steadily worsened over the course of 6 months. The situation escalated until one day the patient’s wife called a mental health hotline reporting that her husband was holding her hostage and threatening to kill her with a gun. He told her, “I can do something to you, and they won’t even find a fingernail. It doesn’t have to be with a gun either.” She was counseled to try to stay calm to avoid aggravating the situation and to go to a safe place and stay there until help arrived.
His memory had worsened to the point that he could not recall any events from the previous 2 years. He was paranoid about anyone entering his home and would not allow his deteriorating roof to be repaired or his yard to be maintained. He did not shower for weeks at a time. He slept holding a rifle and accused his wife of embezzlement.
Continue to: The patient was evaluated...
The patient was evaluated by another specialist, who assessed his SLUMS score to be 18/30. He increased the patient’s donepezil dose, initiated a bupropion taper, and added sertraline to the regimen. The PCP spoke to the patient’s wife regarding options for her safety including leaving the home, hiding firearms, and calling the police in cases of interpersonal violence. The wife said she did not want to pursue these options. She expressed worry that he might be harmed if he was uncooperative with the police and said there was no one except her to take care of him.
Caregivers struggle to care for their loved ones
Instances of personal violence lead to shock, astonishment, heartbreak, and fear. Anticipation of a recurrence of violence causes many partners and caregivers to feel exhausted, because there is minimal hope for any chance of improvement. There are a few exceptions, however, as our case will show. In addition to emotional exhaustion, there is also a never-ending sense of self-doubt, leading many caregivers to question their ability to handle their family member.20,21 Over time, this leads to caregiver burnout, leaving them unable to understand their family member’s aggression. The sudden loss of caregiver control in dealing with the patient may also result in the family member exhibiting behavioral changes reflecting emotional trauma. For caregivers who do not live with the patient, they may choose to make fewer or shorter visits—or not visit at all—because they fear being abused.7,22
Caregivers of patients with dementia often feel helpless and powerless once abrupt and drastic changes in personality lead to some form of interpersonal violence. Additionally, caregivers with a poor health status are more likely to have lower physical function and experience greater caregiving stress overall.23 Other factors increasing stress are longer years of caregiving and the severity of a patient’s dementia and functional impairment.23
Interventions to reduce caregiver burden
Many studies have assessed the role of different interventions to reduce caregiver burden, such as teaching them problem-solving skills, increasing their knowledge of dementia, recommending social resources, providing emotional support, changing caregiver perceptions of the care situation, introducing coping strategies, relying on strengths and experiences in caregiving, help-seeking, and engaging in activity programs.24-28 For Hispanic caregivers, a structured and self-paced online telenovela format has been effective in improving care and relieving caregiver stress.29 Online positive emotion regulators helped in significantly improving quality of life and physical health in the caregivers.30 In this last intervention, caregivers had 6 online sessions with a facilitator who taught them emotional regulation skills that included: noticing positive events, capitalizing on them, and feeling gratitude; practicing mindfulness; doing a positive reappraisal; acknowledging personal strengths and setting attainable goals; and performing acts of kindness. Empowerment programs have also shown significant improvement in the well-being of caregivers.31
Caregivers may reject support.
Continue to: These practical tips can help
These practical tips can help
Based on our review of the literature, we recommend offering the following supports to caregivers:
- Counsel caregivers early on in a patient’s dementia that behavior changes are likely and may be unpredictable. Explain that dementia can involve changes to personality and behavior as well as memory difficulties.33,34
- Describe resources for support, such as day programs for senior adults, insurance coverage for caregiver respite programs, and the Alzheimer’s Association (www.alz.org/). Encourage caregivers to seek general medical and mental health care for themselves. Caregivers should have opportunities and support to discuss their experiences and to be appropriately trained for the challenge of caring for a family member with dementia.35
- Encourage disclosure about abrupt changes in the patient’s behavior. This invites families to discuss issues with you and may make them more comfortable with such conversations.
- Involve ancillary services (eg, social worker) to plan for a higher level of care well in advance of it becoming necessary.
- Discuss safety strategies for the caregiver, including when it is appropriate to alter a patient’s set routines such as bedtimes and mealtimes.33,34
- Discuss when and how to involve law enforcement, if necessary.33,34 Emphasize the importance of removing firearms from the home as a safety measure. Although federal laws do not explicitly prohibit possession of arms by patients with neurologic damage, a few states mention “organic brain syndrome” or “dementia” as conditions prohibiting use or possession of firearms.36
- Suggest, as feasible, nonpharmacologic aids for the patient such as massage therapy, animal-assisted therapy, personalized interventions, music therapy, and light therapy.37 Prescribe medications to the patient to aid in behavior modification when appropriate.
- Screen caregivers and family members for signs of interpersonal violence. Take notice of changes in caregiver behavior or irregularity in attending follow-up appointments.
CASE
Over the next month, the patient’s symptoms further deteriorated. His PCP recommended hospitalization, but the patient and his wife declined. Magnetic resonance imaging of the patient’s brain revealed severe confluent and patchy regions of white matter and T2 signal hyperintensity, consistent with chronic microvascular ischemic disease. An old, small, left parietal lobe infarct was also noted.
One month later, the patient presented to the emergency department. His symptoms were largely unchanged, but his wife indicated that she could no longer live at home due to burnout. The patient’s medications were adjusted, but he was not admitted for inpatient care. His wife said they needed help at home, but the patient opposed the idea any time that it was mentioned.
A few weeks later, the patient presented for outpatient follow-up. He was delusional, believing that the government was compelling citizens to take sertraline in order to harm their mental health. He had also begun viewing online pornography in front of his wife and attempting to remove all of his money from the bank. He was prescribed aripiprazole 15 mg, and his symptoms began to improve. Soon after, however, he threatened to kill his grandson, then took all his Lasix pills (a 7-day supply) simultaneously. The patient denied that this was a suicide attempt.
Over the course of the next month, the patient began to report hearing voices. A neuropsychological evaluation confirmed a diagnosis of dementia with psychiatric symptoms due to neurologic injury. The patient was referred to a geriatric psychiatrist and continued to be managed medically. He was assigned a multidisciplinary team comprising palliative care, social work, and care management to assist in his care and provide support to the family. His behavior improved.
Continue to: At the time of this publication...
At the time of this publication, the patient’s irritability and paranoia had subsided and he had made no further threats to his family. He has allowed a home health aide into the house and has agreed to have his roof repaired. His wife still lives with him and assists him with activities of daily living.
Interprofessional teams are key
Caregiver burnout increases the risk of patient neglect or abuse, as individuals who have been the targets of aggressive behavior are more likely to leave demented patients unattended.8,16,23 Although tools are available to screen caregivers for depression and burnout, an important step forward would be to develop an interprofessional team to aid in identifying and closely following high-risk patient–caregiver groups. This continual and varied assessment of psychosocial stressors could help prevent the development of violent interactions. These teams would allow integration with the primary health care system by frequent and effective shared communication of knowledge, development of goals, and shared decision-making.38 Setting expectations, providing support, and discussing safety strategies can improve the health and welfare of caregivers and patients with dementia alike.
CORRESPONDENCE
Abu Baker Sheikh, MD, MSC 10-5550, 1 University of New Mexico, Albuquerque, NM 87131; [email protected].
The number of people with dementia globally is expected to reach 74.7 million by 2030 and 131.5 million by 2050.1 Because dementia is progressive, many patients will exhibit severe symptoms termed behavioral crises. Deteriorating interpersonal conduct and escalating antisocial acts result in an acquired sociopathy.2 Increasing cognitive impairment causes these patients to misunderstand intimate care and perceive it as a threat, often resulting in outbursts of violence against their caregivers.3
Available studies (TABLE4-17) make evident the incidence of interpersonal violence experienced by caregivers secondary to aggressive acts by patients with dementia. This violence ranges from verbal abuse, including racial slurs, to physical abuse—sometimes resulting in significant physical injury. Aggressive behavior by patients with dementia, resulting in violence towards their caregivers or partners, stems from progressive cognitive decline, which can make optimal care difficult. Such episodes may also impair the psychological and physical well-being of caregivers, increasing their risk of depression, anxiety, and even post-traumatic stress disorder (PTSD).18 The extent of the impact is also determined by the interpretation of the abuse by the caregivers themselves. One study suggested that the perception of aggressive or violent behavior as “normal” by a caregiver reduced the overall negative effect of the interactions.7Our review emphasizes the unintended burden that can fall to caregivers of patients with dementia. We also address the role of primary care providers (PCPs) in identifying these instances of violence and intervening appropriately by providing safety strategies, education, resources, and support.
CASE
A 67-year-old man with a medical history of PTSD with depression, type 2 diabetes, alcohol use disorder/dependence, hypertension, and obstructive sleep apnea was brought to his PCP by his wife. She said he had recently been unable to keep appointment times, pay bills, or take his usual medications, venlafaxine and bupropion. She also said his PTSD symptoms had worsened. He was sleeping 12 to 14 hours per day and was increasingly irritable. The patient denied any concerns or changes in his behavior.
The PCP administered a Saint Louis University Mental Status (SLUMS) examination to screen for cognitive impairment.19 The patient scored 14/30 (less than 20 is indicative of dementia). He was unable to complete a simple math problem, recall any items from a list of 5, count in reverse, draw a clock correctly, or recall a full story. Throughout the exam, the patient demonstrated minimal effort and was often only able to complete a task after further prompting by the examiner.
A computed tomography scan of the head revealed no signs of hemorrhage or damage. Thyroid-stimulating hormone levels and vitamin B12 levels were normal. A rapid plasma reagin test result was negative. The patient was given a diagnosis of Alzheimer disease. Donepezil was added to the patient’s medications, starting at 5 mg and then increased to 10 mg. His wife began to assist him with his tasks of daily living. His mood improved, and his wife noted he began to remember his appointments and take his medications with assistance.
However, the patient’s irritability continued to escalate. He grew paranoid and accused his wife of mismanaging their money. This pattern steadily worsened over the course of 6 months. The situation escalated until one day the patient’s wife called a mental health hotline reporting that her husband was holding her hostage and threatening to kill her with a gun. He told her, “I can do something to you, and they won’t even find a fingernail. It doesn’t have to be with a gun either.” She was counseled to try to stay calm to avoid aggravating the situation and to go to a safe place and stay there until help arrived.
His memory had worsened to the point that he could not recall any events from the previous 2 years. He was paranoid about anyone entering his home and would not allow his deteriorating roof to be repaired or his yard to be maintained. He did not shower for weeks at a time. He slept holding a rifle and accused his wife of embezzlement.
Continue to: The patient was evaluated...
The patient was evaluated by another specialist, who assessed his SLUMS score to be 18/30. He increased the patient’s donepezil dose, initiated a bupropion taper, and added sertraline to the regimen. The PCP spoke to the patient’s wife regarding options for her safety including leaving the home, hiding firearms, and calling the police in cases of interpersonal violence. The wife said she did not want to pursue these options. She expressed worry that he might be harmed if he was uncooperative with the police and said there was no one except her to take care of him.
Caregivers struggle to care for their loved ones
Instances of personal violence lead to shock, astonishment, heartbreak, and fear. Anticipation of a recurrence of violence causes many partners and caregivers to feel exhausted, because there is minimal hope for any chance of improvement. There are a few exceptions, however, as our case will show. In addition to emotional exhaustion, there is also a never-ending sense of self-doubt, leading many caregivers to question their ability to handle their family member.20,21 Over time, this leads to caregiver burnout, leaving them unable to understand their family member’s aggression. The sudden loss of caregiver control in dealing with the patient may also result in the family member exhibiting behavioral changes reflecting emotional trauma. For caregivers who do not live with the patient, they may choose to make fewer or shorter visits—or not visit at all—because they fear being abused.7,22
Caregivers of patients with dementia often feel helpless and powerless once abrupt and drastic changes in personality lead to some form of interpersonal violence. Additionally, caregivers with a poor health status are more likely to have lower physical function and experience greater caregiving stress overall.23 Other factors increasing stress are longer years of caregiving and the severity of a patient’s dementia and functional impairment.23
Interventions to reduce caregiver burden
Many studies have assessed the role of different interventions to reduce caregiver burden, such as teaching them problem-solving skills, increasing their knowledge of dementia, recommending social resources, providing emotional support, changing caregiver perceptions of the care situation, introducing coping strategies, relying on strengths and experiences in caregiving, help-seeking, and engaging in activity programs.24-28 For Hispanic caregivers, a structured and self-paced online telenovela format has been effective in improving care and relieving caregiver stress.29 Online positive emotion regulators helped in significantly improving quality of life and physical health in the caregivers.30 In this last intervention, caregivers had 6 online sessions with a facilitator who taught them emotional regulation skills that included: noticing positive events, capitalizing on them, and feeling gratitude; practicing mindfulness; doing a positive reappraisal; acknowledging personal strengths and setting attainable goals; and performing acts of kindness. Empowerment programs have also shown significant improvement in the well-being of caregivers.31
Caregivers may reject support.
Continue to: These practical tips can help
These practical tips can help
Based on our review of the literature, we recommend offering the following supports to caregivers:
- Counsel caregivers early on in a patient’s dementia that behavior changes are likely and may be unpredictable. Explain that dementia can involve changes to personality and behavior as well as memory difficulties.33,34
- Describe resources for support, such as day programs for senior adults, insurance coverage for caregiver respite programs, and the Alzheimer’s Association (www.alz.org/). Encourage caregivers to seek general medical and mental health care for themselves. Caregivers should have opportunities and support to discuss their experiences and to be appropriately trained for the challenge of caring for a family member with dementia.35
- Encourage disclosure about abrupt changes in the patient’s behavior. This invites families to discuss issues with you and may make them more comfortable with such conversations.
- Involve ancillary services (eg, social worker) to plan for a higher level of care well in advance of it becoming necessary.
- Discuss safety strategies for the caregiver, including when it is appropriate to alter a patient’s set routines such as bedtimes and mealtimes.33,34
- Discuss when and how to involve law enforcement, if necessary.33,34 Emphasize the importance of removing firearms from the home as a safety measure. Although federal laws do not explicitly prohibit possession of arms by patients with neurologic damage, a few states mention “organic brain syndrome” or “dementia” as conditions prohibiting use or possession of firearms.36
- Suggest, as feasible, nonpharmacologic aids for the patient such as massage therapy, animal-assisted therapy, personalized interventions, music therapy, and light therapy.37 Prescribe medications to the patient to aid in behavior modification when appropriate.
- Screen caregivers and family members for signs of interpersonal violence. Take notice of changes in caregiver behavior or irregularity in attending follow-up appointments.
CASE
Over the next month, the patient’s symptoms further deteriorated. His PCP recommended hospitalization, but the patient and his wife declined. Magnetic resonance imaging of the patient’s brain revealed severe confluent and patchy regions of white matter and T2 signal hyperintensity, consistent with chronic microvascular ischemic disease. An old, small, left parietal lobe infarct was also noted.
One month later, the patient presented to the emergency department. His symptoms were largely unchanged, but his wife indicated that she could no longer live at home due to burnout. The patient’s medications were adjusted, but he was not admitted for inpatient care. His wife said they needed help at home, but the patient opposed the idea any time that it was mentioned.
A few weeks later, the patient presented for outpatient follow-up. He was delusional, believing that the government was compelling citizens to take sertraline in order to harm their mental health. He had also begun viewing online pornography in front of his wife and attempting to remove all of his money from the bank. He was prescribed aripiprazole 15 mg, and his symptoms began to improve. Soon after, however, he threatened to kill his grandson, then took all his Lasix pills (a 7-day supply) simultaneously. The patient denied that this was a suicide attempt.
Over the course of the next month, the patient began to report hearing voices. A neuropsychological evaluation confirmed a diagnosis of dementia with psychiatric symptoms due to neurologic injury. The patient was referred to a geriatric psychiatrist and continued to be managed medically. He was assigned a multidisciplinary team comprising palliative care, social work, and care management to assist in his care and provide support to the family. His behavior improved.
Continue to: At the time of this publication...
At the time of this publication, the patient’s irritability and paranoia had subsided and he had made no further threats to his family. He has allowed a home health aide into the house and has agreed to have his roof repaired. His wife still lives with him and assists him with activities of daily living.
Interprofessional teams are key
Caregiver burnout increases the risk of patient neglect or abuse, as individuals who have been the targets of aggressive behavior are more likely to leave demented patients unattended.8,16,23 Although tools are available to screen caregivers for depression and burnout, an important step forward would be to develop an interprofessional team to aid in identifying and closely following high-risk patient–caregiver groups. This continual and varied assessment of psychosocial stressors could help prevent the development of violent interactions. These teams would allow integration with the primary health care system by frequent and effective shared communication of knowledge, development of goals, and shared decision-making.38 Setting expectations, providing support, and discussing safety strategies can improve the health and welfare of caregivers and patients with dementia alike.
CORRESPONDENCE
Abu Baker Sheikh, MD, MSC 10-5550, 1 University of New Mexico, Albuquerque, NM 87131; [email protected].
1. Wu YT, Beiser AS, Breteler MMB, et al. The changing prevalence and incidence of dementia over time - current evidence. Nat Rev Neurol. 2017;13:327-339.
2. Cipriani G, Borin G, Vedovello M, et al. Sociopathic behavior and dementia. Acta Neurol Belg. 2013;113:111-115.
3. Cipriani G, Lucetti C, Danti S, et al. Violent and criminal manifestations in dementia patients. Geriatr Gerontol Int. 2016;16:541-549.
4. Skovdahl K, Kihlgren AL, Kihlgren M. Different attitudes when handling aggressive behaviour in dementia—narratives from two caregiver groups. Aging Ment Health. 2003;7:277-286.
5. Kristiansen L, Hellzén O, Asplund K. Swedish assistant nurses’ experiences of job satisfaction when caring for persons suffering from dementia and behavioural disturbances. An interview study. Int J Qualitat Stud Health Well-being. 2006;1:245-256.
6. Wharton TC, Ford BK. What is known about dementia care recipient violence and aggression against caregivers? J Gerontol Soc Work. 2014;57:460-477.
7. Ostaszkiewicz J, Lakhan P, O’Connell B, et al. Ongoing challenges responding to behavioural and psychological symptoms of dementia. Int Nurs Rev. 2015;62:506-516.
8. Kim J, De Bellis AM, Xiao LD. The experience of paid family-care workers of people with dementia in South Korea. Asian Nurs Res (Korean Soc Nurs Sci). 2018;12:34-41.
9. Band-Winterstein T, Avieli H. Women coping with a partner’s dementia-related violence: a qualitative study. J Nurs Scholarsh. 2019; 51:368-379.
10. Munkejord MC, Stefansdottir OA, Sveinbjarnardottir EK. Who cares for the carer? The suffering, struggles and unmet needs of older women caring for husbands living with cognitive decline. Int Pract Devel J. 2020;10:1-11.
11. Seidel D, Thyrian JR. Burden of caring for people with dementia - comparing family caregivers and professional caregivers. A descriptive study. J Multidiscip Healthc. 2019;12:655-663.
12. Tang W, Friedman DB, Kannaley K, et al. Experiences of caregivers by care recipient’s health condition: a study of caregivers for Alzheimer’s disease and related dementias versus other chronic conditions. Geriatr Nurs. 2019;40:181-184.
13. Benbow SM, Bhattacharyya S, Kingston P. Older adults and violence: an analysis of domestic homicide reviews in England involving adults over 60 years of age. Ageing Soc. 2018;39:1097-1121.
14. Herron RV, Wrathall MA. Putting responsive behaviours in place: examining how formal and informal carers understand the actions of people with dementia. Soc Sci Med. 2018;204:9-15.
15. Herron RV, Rosenberg MW. Responding to aggression and reactive behaviours in the home. Dementia (London). 2019;18:1328-1340.
16. Spencer D, Funk LM, Herron RV, et al. Fear, defensive strategies and caring for cognitively impaired family members. J Gerontol Soc Work. 2019;62:67-85.
17. Skovdahl K, Kihlgren AL, Kihlgren M. Dementia and aggressiveness: stimulated recall interviews with caregivers after video-recorded interactions. J Clin Nurs. 2004;13:515-525.
18. Needham I, Abderhalden C, Halfens RJ, et al. Non-somatic effects of patient aggression on nurses: a systematic review. J Adv Nurs. 2005;49:283-296.
19. Tariq SH, Tumosa N, Chibnall JT, et al. The Saint Louis University Mental Status (SLUMS) Examination for detecting mild cognitive impairment and dementia is more sensitive than the Mini-Mental Status Examination (MMSE) - a pilot study. Am J Geriatr Psych. 2006;14:900-910.
20. Janzen S, Zecevic AA, Kloseck M, et al. Managing agitation using nonpharmacological interventions for seniors with dementia. Am J Alzheimers Dis Other Demen. 2013;28:524-532.
21. Zeller A, Dassen T, Kok G, et al. Nursing home caregivers’ explanations for and coping strategies with residents’ aggression: a qualitative study. J Clin Nurs. 2011;20:2469-2478.
22. Alzheimer’s Society. Fix dementia care: homecare. Accessed December 28, 2021. https://www.alzheimers.org.uk/sites/default/files/migrate/downloads/fix_dementia_care_homecare_report.pdf
23. von Känel R, Mausbach BT, Dimsdale JE, et al. Refining caregiver vulnerability for clinical practice: determinants of self-rated health in spousal dementia caregivers. BMC Geriatr. 2019;19:18.
24. Chen HM, Huang MF, Yeh YC, et al. Effectiveness of coping strategies intervention on caregiver burden among caregivers of elderly patients with dementia. Psychogeriatrics. 2015; 15:20-25.
25. Wawrziczny E, Larochette C, Papo D, et al. A customized intervention for dementia caregivers: a quasi-experimental design. J Aging Health. 2019;31:1172-1195.
26. Gitlin LN, Piersol CV, Hodgson N, et al. Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial. Contemp Clin Trials. 2016;49:92-102.
27. de Oliveira AM, Radanovic M, Homem de Mello PC, et al. An intervention to reduce neuropsychiatric symptoms and caregiver burden in dementia: preliminary results from a randomized trial of the tailored activity program-outpatient version. Int J Geriatr Psychiatry. 2019;34:1301-1307.
28. Livingston G, Barber J, Rapaport P, et al. Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial. BMJ. 2013;347:f6276.
29. Kajiyama B, Fernandez G, Carter EA, et al. Helping Hispanic dementia caregivers cope with stress using technology-based resources. Clin Gerontol. 2018;41:209-216.
30. Moskowitz JT, Cheung EO, Snowberg KE, et al. Randomized controlled trial of a facilitated online positive emotion regulation intervention for dementia caregivers. Health Psychol. 2019;38:391-402.
31. Yoon HK, Kim GS. An empowerment program for family caregivers of people with dementia. Public Health Nurs. 2020;37:222-233.
32. Zwingmann I, Dreier-Wolfgramm A, Esser A, et al. Why do family dementia caregivers reject caregiver support services? Analyzing types of rejection and associated health-impairments in a cluster-randomized controlled intervention trial. BMC Health Serv Res. 2020;20:121.
33. Nybakken S, Strandås M, Bondas T. Caregivers’ perceptions of aggressive behaviour in nursing home residents living with dementia: A meta-ethnography. J Adv Nurs. 2018;74:2713-2726.
34. Nakaishi L, Moss H, Weinstein M, et al. Exploring workplace violence among home care workers in a consumer-driven home health care program. Workplace Health Saf. 2013;61:441-450.
35. Medical Advisory Secretariat. Caregiver- and patient-directed interventions for dementia: an evidence-based analysis. Ont Health Technol Assess Ser. 2008;8:1-98.
36. Betz ME, McCourt AD, Vernick JS, et al. Firearms and dementia: clinical considerations. Ann Intern Med. 2018;169:47-49.
37. Leng M, Zhao Y, Wang Z. Comparative efficacy of non-pharmacological interventions on agitation in people with dementia: a systematic review and Bayesian network meta-analysis. Int J Nurs Stud. 2020;102:103489.
38. Morgan S, Pullon S, McKinlay E. Observation of interprofessional collaborative practice in primary care teams: an integrative literature review. Int J Nurs Stud. 2015;52:1217-1230.
1. Wu YT, Beiser AS, Breteler MMB, et al. The changing prevalence and incidence of dementia over time - current evidence. Nat Rev Neurol. 2017;13:327-339.
2. Cipriani G, Borin G, Vedovello M, et al. Sociopathic behavior and dementia. Acta Neurol Belg. 2013;113:111-115.
3. Cipriani G, Lucetti C, Danti S, et al. Violent and criminal manifestations in dementia patients. Geriatr Gerontol Int. 2016;16:541-549.
4. Skovdahl K, Kihlgren AL, Kihlgren M. Different attitudes when handling aggressive behaviour in dementia—narratives from two caregiver groups. Aging Ment Health. 2003;7:277-286.
5. Kristiansen L, Hellzén O, Asplund K. Swedish assistant nurses’ experiences of job satisfaction when caring for persons suffering from dementia and behavioural disturbances. An interview study. Int J Qualitat Stud Health Well-being. 2006;1:245-256.
6. Wharton TC, Ford BK. What is known about dementia care recipient violence and aggression against caregivers? J Gerontol Soc Work. 2014;57:460-477.
7. Ostaszkiewicz J, Lakhan P, O’Connell B, et al. Ongoing challenges responding to behavioural and psychological symptoms of dementia. Int Nurs Rev. 2015;62:506-516.
8. Kim J, De Bellis AM, Xiao LD. The experience of paid family-care workers of people with dementia in South Korea. Asian Nurs Res (Korean Soc Nurs Sci). 2018;12:34-41.
9. Band-Winterstein T, Avieli H. Women coping with a partner’s dementia-related violence: a qualitative study. J Nurs Scholarsh. 2019; 51:368-379.
10. Munkejord MC, Stefansdottir OA, Sveinbjarnardottir EK. Who cares for the carer? The suffering, struggles and unmet needs of older women caring for husbands living with cognitive decline. Int Pract Devel J. 2020;10:1-11.
11. Seidel D, Thyrian JR. Burden of caring for people with dementia - comparing family caregivers and professional caregivers. A descriptive study. J Multidiscip Healthc. 2019;12:655-663.
12. Tang W, Friedman DB, Kannaley K, et al. Experiences of caregivers by care recipient’s health condition: a study of caregivers for Alzheimer’s disease and related dementias versus other chronic conditions. Geriatr Nurs. 2019;40:181-184.
13. Benbow SM, Bhattacharyya S, Kingston P. Older adults and violence: an analysis of domestic homicide reviews in England involving adults over 60 years of age. Ageing Soc. 2018;39:1097-1121.
14. Herron RV, Wrathall MA. Putting responsive behaviours in place: examining how formal and informal carers understand the actions of people with dementia. Soc Sci Med. 2018;204:9-15.
15. Herron RV, Rosenberg MW. Responding to aggression and reactive behaviours in the home. Dementia (London). 2019;18:1328-1340.
16. Spencer D, Funk LM, Herron RV, et al. Fear, defensive strategies and caring for cognitively impaired family members. J Gerontol Soc Work. 2019;62:67-85.
17. Skovdahl K, Kihlgren AL, Kihlgren M. Dementia and aggressiveness: stimulated recall interviews with caregivers after video-recorded interactions. J Clin Nurs. 2004;13:515-525.
18. Needham I, Abderhalden C, Halfens RJ, et al. Non-somatic effects of patient aggression on nurses: a systematic review. J Adv Nurs. 2005;49:283-296.
19. Tariq SH, Tumosa N, Chibnall JT, et al. The Saint Louis University Mental Status (SLUMS) Examination for detecting mild cognitive impairment and dementia is more sensitive than the Mini-Mental Status Examination (MMSE) - a pilot study. Am J Geriatr Psych. 2006;14:900-910.
20. Janzen S, Zecevic AA, Kloseck M, et al. Managing agitation using nonpharmacological interventions for seniors with dementia. Am J Alzheimers Dis Other Demen. 2013;28:524-532.
21. Zeller A, Dassen T, Kok G, et al. Nursing home caregivers’ explanations for and coping strategies with residents’ aggression: a qualitative study. J Clin Nurs. 2011;20:2469-2478.
22. Alzheimer’s Society. Fix dementia care: homecare. Accessed December 28, 2021. https://www.alzheimers.org.uk/sites/default/files/migrate/downloads/fix_dementia_care_homecare_report.pdf
23. von Känel R, Mausbach BT, Dimsdale JE, et al. Refining caregiver vulnerability for clinical practice: determinants of self-rated health in spousal dementia caregivers. BMC Geriatr. 2019;19:18.
24. Chen HM, Huang MF, Yeh YC, et al. Effectiveness of coping strategies intervention on caregiver burden among caregivers of elderly patients with dementia. Psychogeriatrics. 2015; 15:20-25.
25. Wawrziczny E, Larochette C, Papo D, et al. A customized intervention for dementia caregivers: a quasi-experimental design. J Aging Health. 2019;31:1172-1195.
26. Gitlin LN, Piersol CV, Hodgson N, et al. Reducing neuropsychiatric symptoms in persons with dementia and associated burden in family caregivers using tailored activities: Design and methods of a randomized clinical trial. Contemp Clin Trials. 2016;49:92-102.
27. de Oliveira AM, Radanovic M, Homem de Mello PC, et al. An intervention to reduce neuropsychiatric symptoms and caregiver burden in dementia: preliminary results from a randomized trial of the tailored activity program-outpatient version. Int J Geriatr Psychiatry. 2019;34:1301-1307.
28. Livingston G, Barber J, Rapaport P, et al. Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial. BMJ. 2013;347:f6276.
29. Kajiyama B, Fernandez G, Carter EA, et al. Helping Hispanic dementia caregivers cope with stress using technology-based resources. Clin Gerontol. 2018;41:209-216.
30. Moskowitz JT, Cheung EO, Snowberg KE, et al. Randomized controlled trial of a facilitated online positive emotion regulation intervention for dementia caregivers. Health Psychol. 2019;38:391-402.
31. Yoon HK, Kim GS. An empowerment program for family caregivers of people with dementia. Public Health Nurs. 2020;37:222-233.
32. Zwingmann I, Dreier-Wolfgramm A, Esser A, et al. Why do family dementia caregivers reject caregiver support services? Analyzing types of rejection and associated health-impairments in a cluster-randomized controlled intervention trial. BMC Health Serv Res. 2020;20:121.
33. Nybakken S, Strandås M, Bondas T. Caregivers’ perceptions of aggressive behaviour in nursing home residents living with dementia: A meta-ethnography. J Adv Nurs. 2018;74:2713-2726.
34. Nakaishi L, Moss H, Weinstein M, et al. Exploring workplace violence among home care workers in a consumer-driven home health care program. Workplace Health Saf. 2013;61:441-450.
35. Medical Advisory Secretariat. Caregiver- and patient-directed interventions for dementia: an evidence-based analysis. Ont Health Technol Assess Ser. 2008;8:1-98.
36. Betz ME, McCourt AD, Vernick JS, et al. Firearms and dementia: clinical considerations. Ann Intern Med. 2018;169:47-49.
37. Leng M, Zhao Y, Wang Z. Comparative efficacy of non-pharmacological interventions on agitation in people with dementia: a systematic review and Bayesian network meta-analysis. Int J Nurs Stud. 2020;102:103489.
38. Morgan S, Pullon S, McKinlay E. Observation of interprofessional collaborative practice in primary care teams: an integrative literature review. Int J Nurs Stud. 2015;52:1217-1230.
PRACTICE RECOMMENDATIONS
› Screen caregivers and family members of patients with dementia for signs of interpersonal violence. C
› Counsel caregivers early on that behavior changes in patients with dementia are likely and may be unpredictable. C
› Discuss safety strategies for the caregiver, including when it is appropriate to alter routines such as bedtimes and meals. C
Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series
Palliative care specialists seek greater role in lung disease
Mrs. S.’s long-term chronic obstructive pulmonary disease (COPD) prognosis was grim, and she faced a harder time getting through each day. But neither she nor her primary care physician was willing to embrace strategies other than drugs.
“She felt guilty for continuing to smoke, but also expressed a need to smoke to help her deal with her husband’s cancer and eventual death,” recalled Georgia Narsavage, PhD, RN, ANP-BC, professor emerita of nursing at West Virginia University. “Her primary care physician was reluctant to introduce any treatment other than medications because her family was resistant to facing ‘mother dying.’ ”
But things changed when Mrs. S. was referred to a palliative-care clinical nurse specialist following a hospitalization. “The goal of palliative care is to support quality of life by relieving symptoms and decreasing suffering. She was assisted to improve functioning overall, and home support services were provided,” Dr. Narsavage said. “They allowed her to live at home relatively pain free with decreased dyspnea for 3 more years until her transition to hospice care a few months before death.
It wasn’t quite a happy ending. But it was a happier ending, and one that palliative care (PC) advocates hope will become more common in pulmonary care. They’re working to convince colleagues that PC is neither another word for hospice nor a sign that anyone is giving up on a patient.
Underutilized but beneficial
“Palliative care is underutilized in patients with chronic pulmonary disease, and it’s a missed opportunity to potentially alleviate symptoms and improve quality of life,” said Hilary DuBrock, MD, an internist and critical care pulmonologist with the Mayo Clinic in Rochester, Minn. “Chest physicians should know that it’s important to recognize your limitations in addressing all aspects of a chronic disease, and it’s OK to ask for help from a specialty multidisciplinary team of palliative care providers.”
Statistics back up Dr. DuBrock’s perspective about how PC isn’t common in pulmonary care. A 2017 study examined 181,689 U.S. adult patients who had COPD, received oxygen at home, and were hospitalized for exacerbations from 2006-2012. Just 1.7% received PC, although the number grew over the study period.
Another study published in 2017 examined 3,166 patients over the same period with end-stage idiopathic pulmonary fibrosis (IPF) who were on ventilators. The use of PC is group rose from 2.3% in 2006 to 21.6% in 2012.
More recently, a 2020 meta-analysis examined 19 studies and found that patients with lung cancer were much more likely to receive PC than were those with COPD (odds ratio (OR) = 9.59, P < .001, for hospital-based PC and OR = 8.79, P < .001, for home-based PC).
Patients with lung cancer vs. COPD were also less likely to receive invasive ventilation (OR = .26, P < .001), noninvasive ventilation (OR = .63, P = .009) or CPR (OR = .29, P < .001) or die at a nursing home/long-term care facility (OR = .32, P < .001).
Other studies support PC in COPD: Research in Europe has linked PC in COPD to fewer in-hospital deaths and lower end-of-life expenses. A Canadian study also linked PC to fewer in-hospital deaths in COPD.
Dr. DuBrock said she believes there are a couple reasons why PC isn’t more widely accepted in pulmonology. “There has been little evidence in chronic pulmonary disease regarding the role of PC, and there is a lack of standardized guidelines to help clinicians determine appropriate timing and patient selection for referral,” she said. “There is also a reluctance to refer patients to palliative care since some may think that referral implies that they are giving up on their patients.”
In fact, she said, “if appropriately explained and discussed with patients, PC does not necessarily need to imply to patients that you are giving up on them, but rather that you care enough about them to try to find novel ways to improve their quality of life and relieve their symptoms. Additionally, palliative care can be provided alongside ongoing medical care and treatment of their chronic lung disease.”
More than standard care
Another obstacle comes from pulmonologists who claim PC isn’t necessary because they’re handling patient care themselves, said University of Alabama at Birmingham critical care pulmonologist Anand S. Iyer, MD. “They’ll say: ‘I do palliative care, I palliate their breathing. I treat breathlessness and cough, that’s what I do.’ ”
But these symptoms only brush the surface of patient needs, he said. “I don’t think that the average pulmonologist goes beyond that to comprehensive symptom assessment and management of a whole host of symptoms beyond those limited to the lungs – depression, anxiety, fatigue, malnutrition.”
On that latter front, he said, pulmonologists “are really good at having end-of-life conversations at the end of life. We do that every day in the ICU.” Advocates for PC, he said, “want to push that to the clinic a year or two earlier.”
Timing and use of PC
When should pulmonologists call in a PC team? Specialists recommend early consultations, even right after a pulmonary disease is diagnosed. “When a pulmonologist diagnoses a condition as a serious illness – especially chronic pulmonary disease – a consultation with a palliative care physician or advanced practice registered nurse” can help assess the need for care and the best time to introduce palliative care to the patient and family “to provide relief and enhance quality of life,” West Virginia University’s Dr. Narsavage said. “Initial diagnosis is not too early to think about the trajectory.
Dr. Iyer agreed that early PC consultation is key. “We’re talking about comprehensive support for the physical, emotional, and spiritual needs of patients and their families. It can grow as needs of patients become more severe.”
For her part, Dr. DuBrock urged colleagues to focus on patient experiences. “The exact timing of when to refer patients with pulmonary disease is not well established,” she said. “Thus, it’s important to take cues from our patients. If they are experiencing significant symptom burden or impaired quality of life or having difficulty coping with their lung disease, then it may be helpful to call in palliative care to address these issues alongside education and discussion with the patient about the role of palliative care to address their unmet needs.”
As an example, Dr. DuBrock spoke of one of her own patients who has pulmonary hypertension (PH), connective tissue disease, and interstitial lung disease. “Her hypertension was relatively well controlled, but she was still quite symptomatic as well as depressed and having difficulty sleeping. I struggled with wanting to help her feel better but I also recognized that more PH therapy wasn’t necessarily the answer,” Dr. Dubrock said. “After some discussions, I referred her to palliative care, and they were extremely helpful with addressing her symptoms with a combination of pharmacologic and nonpharmacologic therapy and also addressing some of her underlying concerns and fears regarding her prognosis and issues related to advance-care planning. Social work was also helpful with addressing some of her financial concerns. I continue to see her on regular basis and treat her PH, but her overall quality of life, sleep, and mood have improved substantially.”
First steps
According to specialists, the first step in the PC process with patients is to make sure they understand their conditions, their prognoses, and the role of palliative care itself.
Kathleen Oare Lindell, PhD, RN, associate professor of nursing at Medical University of South Carolina, Charleston, who specializes in PC in pulmonary disease, remembers taking the histories of patients with grim prognoses and “their look on their face was like, ‘I just have a common cold.’ ” In other cases, she said, patients may fear they’ll die immediately when they have 3-5 years to live.
Dr. Lindell, who has worked at a specialty center for patients with interstitial lung disease (ILD), emphasized the importance of speaking in layperson terms that patients understand, such as referring to idiopathic pulmonary fibrosis as “unknown lung scarring.” She also said it’s crucial to be up front about their prognoses.
As for patient understanding of PC, she said, “people think it’s hospice that they’re giving. Palliative care is neither. Instead, it helps to address symptom management, I always tell patients, ‘You’ll be scared, you’ll have a cough. There are medicines and nonpharmacological therapies [that can help], and that’s what palliative care does.’ ”
Keith Swetz, MD, an internist and palliative care specialist at the University of Alabama at Birmingham, agreed that a concise discussion of prognosis is vital. “What do they know about their illness, and what do they understand about what will happen when things get worse?” he said.
“With pulmonary disease, they may be looking at months to years punctuated with a lot of ICU admissions, trips to the hospital, symptom burden, and decline in function. Some will want aggressive treatment and say they’re fine being in the hospital, while others will say being comfortable at home is more important.”
Dr. Swetz’s patients commonly have COPD, interstitial lung disease, pulmonary fibrosis, or PH, and some may have concurrent heart failure. While their prognoses may be poor, he said, discussion about their wishes probably aren’t happening outside of the PC setting.
Or if they are happening, he said, they’re lower quality, boiling down complicated care questions to “Do you want us to do everything yes, or no?
“A lot of it has to do with time,” he said. “Clinicians are busy, they might have a full ICU or pulmonary clinic with 15 minutes to see patients. Sitting down and talking about these things isn’t something that’s prioritized or fits into the work stream very well, and often it hasn’t been reimbursed.”
There typically aren’t insurance hassles regarding referrals for PC, Dr. Iyer said, although finding available specialists may be challenging. A 2019 study projected a wave of retirements of older PC physicians over the next few years, and the ratio of patients to PC specialists may not return to 2019 levels for decades. Rural areas are especially shorthanded. But telehealth may improve access, Dr. Iyer said.
What’s next? Specialists are trying to pin down guidelines for when PC consultation is appropriate in pulmonary disease.
Triggers to PC
Dr. Iyer, Dr. Lindell and others authored a 2021 report in the journal CHEST that offers guidance about triggers for PC consultation. The authors cited four “levers” or triggers that are important: worsening lung function, severe symptoms or high burden of care needs, poor prognosis, and frequent severe exacerbations.
“The overall point here is that integrating palliative care into COPD practice isn’t an on-off switch; rather, it should be based upon multiple factors and can evolve over time,” they wrote.
They noted that, “patients with COPD accept palliative care as early as moderate COPD (FEV1 < 80%), so patients may be ready sooner than clinicians think.”
They added that, “if prognosis is such a concern that a clinician is considering referral for lung transplant evaluation, then concurrent referral to specialist palliative care should be routine practice.
Finally, frequent severe exacerbations, i.e. those that require hospitalization or an emergency room visit, carry a high risk for posthospitalization mortality and are ideal inflection points in the illness trajectory of COPD.”
In the big picture, the authors contend, “palliative care should be integrated early and concurrently with COPD-directed therapies, and its intensity should increase over time as symptoms, needs, and exacerbations worsen approaching EOL [end of life].”
None of the interviewees or other authors reported having any relevant conflicts for this story.
Mrs. S.’s long-term chronic obstructive pulmonary disease (COPD) prognosis was grim, and she faced a harder time getting through each day. But neither she nor her primary care physician was willing to embrace strategies other than drugs.
“She felt guilty for continuing to smoke, but also expressed a need to smoke to help her deal with her husband’s cancer and eventual death,” recalled Georgia Narsavage, PhD, RN, ANP-BC, professor emerita of nursing at West Virginia University. “Her primary care physician was reluctant to introduce any treatment other than medications because her family was resistant to facing ‘mother dying.’ ”
But things changed when Mrs. S. was referred to a palliative-care clinical nurse specialist following a hospitalization. “The goal of palliative care is to support quality of life by relieving symptoms and decreasing suffering. She was assisted to improve functioning overall, and home support services were provided,” Dr. Narsavage said. “They allowed her to live at home relatively pain free with decreased dyspnea for 3 more years until her transition to hospice care a few months before death.
It wasn’t quite a happy ending. But it was a happier ending, and one that palliative care (PC) advocates hope will become more common in pulmonary care. They’re working to convince colleagues that PC is neither another word for hospice nor a sign that anyone is giving up on a patient.
Underutilized but beneficial
“Palliative care is underutilized in patients with chronic pulmonary disease, and it’s a missed opportunity to potentially alleviate symptoms and improve quality of life,” said Hilary DuBrock, MD, an internist and critical care pulmonologist with the Mayo Clinic in Rochester, Minn. “Chest physicians should know that it’s important to recognize your limitations in addressing all aspects of a chronic disease, and it’s OK to ask for help from a specialty multidisciplinary team of palliative care providers.”
Statistics back up Dr. DuBrock’s perspective about how PC isn’t common in pulmonary care. A 2017 study examined 181,689 U.S. adult patients who had COPD, received oxygen at home, and were hospitalized for exacerbations from 2006-2012. Just 1.7% received PC, although the number grew over the study period.
Another study published in 2017 examined 3,166 patients over the same period with end-stage idiopathic pulmonary fibrosis (IPF) who were on ventilators. The use of PC is group rose from 2.3% in 2006 to 21.6% in 2012.
More recently, a 2020 meta-analysis examined 19 studies and found that patients with lung cancer were much more likely to receive PC than were those with COPD (odds ratio (OR) = 9.59, P < .001, for hospital-based PC and OR = 8.79, P < .001, for home-based PC).
Patients with lung cancer vs. COPD were also less likely to receive invasive ventilation (OR = .26, P < .001), noninvasive ventilation (OR = .63, P = .009) or CPR (OR = .29, P < .001) or die at a nursing home/long-term care facility (OR = .32, P < .001).
Other studies support PC in COPD: Research in Europe has linked PC in COPD to fewer in-hospital deaths and lower end-of-life expenses. A Canadian study also linked PC to fewer in-hospital deaths in COPD.
Dr. DuBrock said she believes there are a couple reasons why PC isn’t more widely accepted in pulmonology. “There has been little evidence in chronic pulmonary disease regarding the role of PC, and there is a lack of standardized guidelines to help clinicians determine appropriate timing and patient selection for referral,” she said. “There is also a reluctance to refer patients to palliative care since some may think that referral implies that they are giving up on their patients.”
In fact, she said, “if appropriately explained and discussed with patients, PC does not necessarily need to imply to patients that you are giving up on them, but rather that you care enough about them to try to find novel ways to improve their quality of life and relieve their symptoms. Additionally, palliative care can be provided alongside ongoing medical care and treatment of their chronic lung disease.”
More than standard care
Another obstacle comes from pulmonologists who claim PC isn’t necessary because they’re handling patient care themselves, said University of Alabama at Birmingham critical care pulmonologist Anand S. Iyer, MD. “They’ll say: ‘I do palliative care, I palliate their breathing. I treat breathlessness and cough, that’s what I do.’ ”
But these symptoms only brush the surface of patient needs, he said. “I don’t think that the average pulmonologist goes beyond that to comprehensive symptom assessment and management of a whole host of symptoms beyond those limited to the lungs – depression, anxiety, fatigue, malnutrition.”
On that latter front, he said, pulmonologists “are really good at having end-of-life conversations at the end of life. We do that every day in the ICU.” Advocates for PC, he said, “want to push that to the clinic a year or two earlier.”
Timing and use of PC
When should pulmonologists call in a PC team? Specialists recommend early consultations, even right after a pulmonary disease is diagnosed. “When a pulmonologist diagnoses a condition as a serious illness – especially chronic pulmonary disease – a consultation with a palliative care physician or advanced practice registered nurse” can help assess the need for care and the best time to introduce palliative care to the patient and family “to provide relief and enhance quality of life,” West Virginia University’s Dr. Narsavage said. “Initial diagnosis is not too early to think about the trajectory.
Dr. Iyer agreed that early PC consultation is key. “We’re talking about comprehensive support for the physical, emotional, and spiritual needs of patients and their families. It can grow as needs of patients become more severe.”
For her part, Dr. DuBrock urged colleagues to focus on patient experiences. “The exact timing of when to refer patients with pulmonary disease is not well established,” she said. “Thus, it’s important to take cues from our patients. If they are experiencing significant symptom burden or impaired quality of life or having difficulty coping with their lung disease, then it may be helpful to call in palliative care to address these issues alongside education and discussion with the patient about the role of palliative care to address their unmet needs.”
As an example, Dr. DuBrock spoke of one of her own patients who has pulmonary hypertension (PH), connective tissue disease, and interstitial lung disease. “Her hypertension was relatively well controlled, but she was still quite symptomatic as well as depressed and having difficulty sleeping. I struggled with wanting to help her feel better but I also recognized that more PH therapy wasn’t necessarily the answer,” Dr. Dubrock said. “After some discussions, I referred her to palliative care, and they were extremely helpful with addressing her symptoms with a combination of pharmacologic and nonpharmacologic therapy and also addressing some of her underlying concerns and fears regarding her prognosis and issues related to advance-care planning. Social work was also helpful with addressing some of her financial concerns. I continue to see her on regular basis and treat her PH, but her overall quality of life, sleep, and mood have improved substantially.”
First steps
According to specialists, the first step in the PC process with patients is to make sure they understand their conditions, their prognoses, and the role of palliative care itself.
Kathleen Oare Lindell, PhD, RN, associate professor of nursing at Medical University of South Carolina, Charleston, who specializes in PC in pulmonary disease, remembers taking the histories of patients with grim prognoses and “their look on their face was like, ‘I just have a common cold.’ ” In other cases, she said, patients may fear they’ll die immediately when they have 3-5 years to live.
Dr. Lindell, who has worked at a specialty center for patients with interstitial lung disease (ILD), emphasized the importance of speaking in layperson terms that patients understand, such as referring to idiopathic pulmonary fibrosis as “unknown lung scarring.” She also said it’s crucial to be up front about their prognoses.
As for patient understanding of PC, she said, “people think it’s hospice that they’re giving. Palliative care is neither. Instead, it helps to address symptom management, I always tell patients, ‘You’ll be scared, you’ll have a cough. There are medicines and nonpharmacological therapies [that can help], and that’s what palliative care does.’ ”
Keith Swetz, MD, an internist and palliative care specialist at the University of Alabama at Birmingham, agreed that a concise discussion of prognosis is vital. “What do they know about their illness, and what do they understand about what will happen when things get worse?” he said.
“With pulmonary disease, they may be looking at months to years punctuated with a lot of ICU admissions, trips to the hospital, symptom burden, and decline in function. Some will want aggressive treatment and say they’re fine being in the hospital, while others will say being comfortable at home is more important.”
Dr. Swetz’s patients commonly have COPD, interstitial lung disease, pulmonary fibrosis, or PH, and some may have concurrent heart failure. While their prognoses may be poor, he said, discussion about their wishes probably aren’t happening outside of the PC setting.
Or if they are happening, he said, they’re lower quality, boiling down complicated care questions to “Do you want us to do everything yes, or no?
“A lot of it has to do with time,” he said. “Clinicians are busy, they might have a full ICU or pulmonary clinic with 15 minutes to see patients. Sitting down and talking about these things isn’t something that’s prioritized or fits into the work stream very well, and often it hasn’t been reimbursed.”
There typically aren’t insurance hassles regarding referrals for PC, Dr. Iyer said, although finding available specialists may be challenging. A 2019 study projected a wave of retirements of older PC physicians over the next few years, and the ratio of patients to PC specialists may not return to 2019 levels for decades. Rural areas are especially shorthanded. But telehealth may improve access, Dr. Iyer said.
What’s next? Specialists are trying to pin down guidelines for when PC consultation is appropriate in pulmonary disease.
Triggers to PC
Dr. Iyer, Dr. Lindell and others authored a 2021 report in the journal CHEST that offers guidance about triggers for PC consultation. The authors cited four “levers” or triggers that are important: worsening lung function, severe symptoms or high burden of care needs, poor prognosis, and frequent severe exacerbations.
“The overall point here is that integrating palliative care into COPD practice isn’t an on-off switch; rather, it should be based upon multiple factors and can evolve over time,” they wrote.
They noted that, “patients with COPD accept palliative care as early as moderate COPD (FEV1 < 80%), so patients may be ready sooner than clinicians think.”
They added that, “if prognosis is such a concern that a clinician is considering referral for lung transplant evaluation, then concurrent referral to specialist palliative care should be routine practice.
Finally, frequent severe exacerbations, i.e. those that require hospitalization or an emergency room visit, carry a high risk for posthospitalization mortality and are ideal inflection points in the illness trajectory of COPD.”
In the big picture, the authors contend, “palliative care should be integrated early and concurrently with COPD-directed therapies, and its intensity should increase over time as symptoms, needs, and exacerbations worsen approaching EOL [end of life].”
None of the interviewees or other authors reported having any relevant conflicts for this story.
Mrs. S.’s long-term chronic obstructive pulmonary disease (COPD) prognosis was grim, and she faced a harder time getting through each day. But neither she nor her primary care physician was willing to embrace strategies other than drugs.
“She felt guilty for continuing to smoke, but also expressed a need to smoke to help her deal with her husband’s cancer and eventual death,” recalled Georgia Narsavage, PhD, RN, ANP-BC, professor emerita of nursing at West Virginia University. “Her primary care physician was reluctant to introduce any treatment other than medications because her family was resistant to facing ‘mother dying.’ ”
But things changed when Mrs. S. was referred to a palliative-care clinical nurse specialist following a hospitalization. “The goal of palliative care is to support quality of life by relieving symptoms and decreasing suffering. She was assisted to improve functioning overall, and home support services were provided,” Dr. Narsavage said. “They allowed her to live at home relatively pain free with decreased dyspnea for 3 more years until her transition to hospice care a few months before death.
It wasn’t quite a happy ending. But it was a happier ending, and one that palliative care (PC) advocates hope will become more common in pulmonary care. They’re working to convince colleagues that PC is neither another word for hospice nor a sign that anyone is giving up on a patient.
Underutilized but beneficial
“Palliative care is underutilized in patients with chronic pulmonary disease, and it’s a missed opportunity to potentially alleviate symptoms and improve quality of life,” said Hilary DuBrock, MD, an internist and critical care pulmonologist with the Mayo Clinic in Rochester, Minn. “Chest physicians should know that it’s important to recognize your limitations in addressing all aspects of a chronic disease, and it’s OK to ask for help from a specialty multidisciplinary team of palliative care providers.”
Statistics back up Dr. DuBrock’s perspective about how PC isn’t common in pulmonary care. A 2017 study examined 181,689 U.S. adult patients who had COPD, received oxygen at home, and were hospitalized for exacerbations from 2006-2012. Just 1.7% received PC, although the number grew over the study period.
Another study published in 2017 examined 3,166 patients over the same period with end-stage idiopathic pulmonary fibrosis (IPF) who were on ventilators. The use of PC is group rose from 2.3% in 2006 to 21.6% in 2012.
More recently, a 2020 meta-analysis examined 19 studies and found that patients with lung cancer were much more likely to receive PC than were those with COPD (odds ratio (OR) = 9.59, P < .001, for hospital-based PC and OR = 8.79, P < .001, for home-based PC).
Patients with lung cancer vs. COPD were also less likely to receive invasive ventilation (OR = .26, P < .001), noninvasive ventilation (OR = .63, P = .009) or CPR (OR = .29, P < .001) or die at a nursing home/long-term care facility (OR = .32, P < .001).
Other studies support PC in COPD: Research in Europe has linked PC in COPD to fewer in-hospital deaths and lower end-of-life expenses. A Canadian study also linked PC to fewer in-hospital deaths in COPD.
Dr. DuBrock said she believes there are a couple reasons why PC isn’t more widely accepted in pulmonology. “There has been little evidence in chronic pulmonary disease regarding the role of PC, and there is a lack of standardized guidelines to help clinicians determine appropriate timing and patient selection for referral,” she said. “There is also a reluctance to refer patients to palliative care since some may think that referral implies that they are giving up on their patients.”
In fact, she said, “if appropriately explained and discussed with patients, PC does not necessarily need to imply to patients that you are giving up on them, but rather that you care enough about them to try to find novel ways to improve their quality of life and relieve their symptoms. Additionally, palliative care can be provided alongside ongoing medical care and treatment of their chronic lung disease.”
More than standard care
Another obstacle comes from pulmonologists who claim PC isn’t necessary because they’re handling patient care themselves, said University of Alabama at Birmingham critical care pulmonologist Anand S. Iyer, MD. “They’ll say: ‘I do palliative care, I palliate their breathing. I treat breathlessness and cough, that’s what I do.’ ”
But these symptoms only brush the surface of patient needs, he said. “I don’t think that the average pulmonologist goes beyond that to comprehensive symptom assessment and management of a whole host of symptoms beyond those limited to the lungs – depression, anxiety, fatigue, malnutrition.”
On that latter front, he said, pulmonologists “are really good at having end-of-life conversations at the end of life. We do that every day in the ICU.” Advocates for PC, he said, “want to push that to the clinic a year or two earlier.”
Timing and use of PC
When should pulmonologists call in a PC team? Specialists recommend early consultations, even right after a pulmonary disease is diagnosed. “When a pulmonologist diagnoses a condition as a serious illness – especially chronic pulmonary disease – a consultation with a palliative care physician or advanced practice registered nurse” can help assess the need for care and the best time to introduce palliative care to the patient and family “to provide relief and enhance quality of life,” West Virginia University’s Dr. Narsavage said. “Initial diagnosis is not too early to think about the trajectory.
Dr. Iyer agreed that early PC consultation is key. “We’re talking about comprehensive support for the physical, emotional, and spiritual needs of patients and their families. It can grow as needs of patients become more severe.”
For her part, Dr. DuBrock urged colleagues to focus on patient experiences. “The exact timing of when to refer patients with pulmonary disease is not well established,” she said. “Thus, it’s important to take cues from our patients. If they are experiencing significant symptom burden or impaired quality of life or having difficulty coping with their lung disease, then it may be helpful to call in palliative care to address these issues alongside education and discussion with the patient about the role of palliative care to address their unmet needs.”
As an example, Dr. DuBrock spoke of one of her own patients who has pulmonary hypertension (PH), connective tissue disease, and interstitial lung disease. “Her hypertension was relatively well controlled, but she was still quite symptomatic as well as depressed and having difficulty sleeping. I struggled with wanting to help her feel better but I also recognized that more PH therapy wasn’t necessarily the answer,” Dr. Dubrock said. “After some discussions, I referred her to palliative care, and they were extremely helpful with addressing her symptoms with a combination of pharmacologic and nonpharmacologic therapy and also addressing some of her underlying concerns and fears regarding her prognosis and issues related to advance-care planning. Social work was also helpful with addressing some of her financial concerns. I continue to see her on regular basis and treat her PH, but her overall quality of life, sleep, and mood have improved substantially.”
First steps
According to specialists, the first step in the PC process with patients is to make sure they understand their conditions, their prognoses, and the role of palliative care itself.
Kathleen Oare Lindell, PhD, RN, associate professor of nursing at Medical University of South Carolina, Charleston, who specializes in PC in pulmonary disease, remembers taking the histories of patients with grim prognoses and “their look on their face was like, ‘I just have a common cold.’ ” In other cases, she said, patients may fear they’ll die immediately when they have 3-5 years to live.
Dr. Lindell, who has worked at a specialty center for patients with interstitial lung disease (ILD), emphasized the importance of speaking in layperson terms that patients understand, such as referring to idiopathic pulmonary fibrosis as “unknown lung scarring.” She also said it’s crucial to be up front about their prognoses.
As for patient understanding of PC, she said, “people think it’s hospice that they’re giving. Palliative care is neither. Instead, it helps to address symptom management, I always tell patients, ‘You’ll be scared, you’ll have a cough. There are medicines and nonpharmacological therapies [that can help], and that’s what palliative care does.’ ”
Keith Swetz, MD, an internist and palliative care specialist at the University of Alabama at Birmingham, agreed that a concise discussion of prognosis is vital. “What do they know about their illness, and what do they understand about what will happen when things get worse?” he said.
“With pulmonary disease, they may be looking at months to years punctuated with a lot of ICU admissions, trips to the hospital, symptom burden, and decline in function. Some will want aggressive treatment and say they’re fine being in the hospital, while others will say being comfortable at home is more important.”
Dr. Swetz’s patients commonly have COPD, interstitial lung disease, pulmonary fibrosis, or PH, and some may have concurrent heart failure. While their prognoses may be poor, he said, discussion about their wishes probably aren’t happening outside of the PC setting.
Or if they are happening, he said, they’re lower quality, boiling down complicated care questions to “Do you want us to do everything yes, or no?
“A lot of it has to do with time,” he said. “Clinicians are busy, they might have a full ICU or pulmonary clinic with 15 minutes to see patients. Sitting down and talking about these things isn’t something that’s prioritized or fits into the work stream very well, and often it hasn’t been reimbursed.”
There typically aren’t insurance hassles regarding referrals for PC, Dr. Iyer said, although finding available specialists may be challenging. A 2019 study projected a wave of retirements of older PC physicians over the next few years, and the ratio of patients to PC specialists may not return to 2019 levels for decades. Rural areas are especially shorthanded. But telehealth may improve access, Dr. Iyer said.
What’s next? Specialists are trying to pin down guidelines for when PC consultation is appropriate in pulmonary disease.
Triggers to PC
Dr. Iyer, Dr. Lindell and others authored a 2021 report in the journal CHEST that offers guidance about triggers for PC consultation. The authors cited four “levers” or triggers that are important: worsening lung function, severe symptoms or high burden of care needs, poor prognosis, and frequent severe exacerbations.
“The overall point here is that integrating palliative care into COPD practice isn’t an on-off switch; rather, it should be based upon multiple factors and can evolve over time,” they wrote.
They noted that, “patients with COPD accept palliative care as early as moderate COPD (FEV1 < 80%), so patients may be ready sooner than clinicians think.”
They added that, “if prognosis is such a concern that a clinician is considering referral for lung transplant evaluation, then concurrent referral to specialist palliative care should be routine practice.
Finally, frequent severe exacerbations, i.e. those that require hospitalization or an emergency room visit, carry a high risk for posthospitalization mortality and are ideal inflection points in the illness trajectory of COPD.”
In the big picture, the authors contend, “palliative care should be integrated early and concurrently with COPD-directed therapies, and its intensity should increase over time as symptoms, needs, and exacerbations worsen approaching EOL [end of life].”
None of the interviewees or other authors reported having any relevant conflicts for this story.
Black-owned hospice seeks to bring greater ease in dying to Black families
This time, it didn’t take much persuading for Mary Murphy to embrace home hospice. When her mother was dying from Alzheimer’s disease in 2020, she had been reluctant until she saw what a help it was. So when her husband, Willie, neared the end of his life, she embraced hospice again.
The Murphys’ house in a leafy Nashville, Tenn., neighborhood is their happy place – full of their treasures.
“He’s good to me – buys me anything I want,” she said, as she pulled a milky glass vase out of a floor-to-ceiling cabinet with mirrored shelves.
Willie bought Mary the display case to help her to show off the trinkets she picks up at estate sales.
Down the hall, Willie was lying in their bed, now unable to speak. His heart was giving out.
“You gonna wake up for a minute?” she asked, cradling his head. She patted his back while he cleared his throat. “Cough it out.”
Heart and Soul Hospice is owned and operated by people who share the same cultural background as the patients they aim to serve.
In their application to obtain a certificate of need in Tennessee, the hospice owners made it clear they are Black and intend to serve everyone but will focus on African Americans, who are currently underserved. Tennessee data shows that in Nashville just 19% of hospice patients are Black, although they make up 27% of the capital city’s population.
Though the area already had numerous hospice agencies, regulators granted Heart and Soul permission to operate, based primarily on the value of educating an underserved group.
In Ms. Murphy’s first hospice experience, her mother had been living with dementia for decades. Still, Ms. Murphy had concerns about transitioning her mother to hospice. She felt as if she was giving up on her mom.
“My first thought was death,” she said.
National data shows that Black Medicare patients and their families are not making the move to comfort care as often as white patients are. Roughly 41% of Black Medicare beneficiaries who died in 2019 were enrolled in hospice, compared with 54% of White patients, according to data compiled annually by the National Hospice and Palliative Care Organization.
Ms. Murphy’s mother survived nearly 3 years on hospice. The benefit is meant for those in the final 6 months of life, but predicting when the end will come is difficult, especially in cases of dementia. Hospice provides palliative care for the dying and support for caregivers for a long as the process lasts.
Ms. Murphy did most of the caregiving – which can be overwhelming – but hospice helped with a few baths a week, medication in the mail and any medical equipment they needed.
And most important to Ms. Murphy was the emotional support, which came mostly from her hospice nurse.
“Wasn’t no doctor going to come here, hold my hand, stay here until the funeral home came for her,” she said about the day her mother died.
Last year, on the day after Thanksgiving, Willie Murphy died. And the same hospice nurse was at the Murphy home within minutes. She’d already stopped by that morning to check on him and returned as soon as Mary called and told her he wasn’t breathing.
“If you don’t feel like: ‘Oh my God, thank God I have hospice,’ if you can’t say that, then we’re doing something wrong,” said Keisha Mason, Heart and Soul’s director of nursing.
Ms. Mason, like Ms. Murphy, is Black and said that in her view there’s nothing fundamental keeping Black patients from using hospice except learning what the service can offer and that it’s basically free to patients – paid for by Medicare, Medicaid, and most private health plans.
“I say to them, ‘If you see a bill, then call us, because you should not,’” she said.
As Ms. Mason helped launch this new hospice agency, she began using new language, calling hospice more than a Medicare benefit. She describes it as an entitlement.
“Just as you are entitled to unemployment, as you are entitled to Social Security, you are entitled to a hospice benefit,” she said.
The investors in Heart and Soul include David Turner, owner of CNS Hospice in Detroit; Nashville pastor the Rev. Sandy McClain; and André Lee, a former hospital administrator on the campus of Meharry Medical College, a historically Black institution in Nashville.
Mr. Lee and Mr. Turner also started a Black-focused hospice agency in Michigan and have plans to replicate the model in other states.
More families need to consider home hospice as an alternative for end-of-life care, Mr. Lee said. Nursing homes are pricey. And even with Medicare, a hospital bill can be hefty.
“You’ll go in there and they’ll eat you alive,” he said. “I hate to say [something] bad about hospitals, but it’s true.”
Hospice research hasn’t come up with clear reasons to explain the gap between White and Black families’ use of the benefit. Some experts speculate it’s related to spiritual beliefs and widespread mistrust in the medical system because of decades of discrimination.
The hospice industry’s national trade group, the National Hospice and Palliative Care Organization, released a diversity and inclusion toolkit and a guide to reaching more Black patients. It recommends connecting with influential DJs, partnering with Black pastors and simply hiring more Black nurses.
Bridging the gap is not overly complicated, Mr. Lee said.
“A lot of hospices don’t employ enough Black people,” he said. “We all feel comfortable when you see someone over there that looks like you.”
Well-established hospice agencies have attempted to minimize barriers with their own diversity initiatives. Michelle Drayton of Visiting Nurse Service of New York said her large agency has met with ministers who counsel families dealing with failing health.
“Many of them did not fully understand what hospice was,” she said. “They had many of the same sort of misperceptions.”
Every hospice company, whether it’s an upstart or one of the nation’s oldest, can promote end-of-life education and ease care disparities, Ms. Drayton said. “We’re not just handing out a brochure,” she added.
This story is part of a partnership that includes Nashville Public Radio, NPR, and KHN. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
This time, it didn’t take much persuading for Mary Murphy to embrace home hospice. When her mother was dying from Alzheimer’s disease in 2020, she had been reluctant until she saw what a help it was. So when her husband, Willie, neared the end of his life, she embraced hospice again.
The Murphys’ house in a leafy Nashville, Tenn., neighborhood is their happy place – full of their treasures.
“He’s good to me – buys me anything I want,” she said, as she pulled a milky glass vase out of a floor-to-ceiling cabinet with mirrored shelves.
Willie bought Mary the display case to help her to show off the trinkets she picks up at estate sales.
Down the hall, Willie was lying in their bed, now unable to speak. His heart was giving out.
“You gonna wake up for a minute?” she asked, cradling his head. She patted his back while he cleared his throat. “Cough it out.”
Heart and Soul Hospice is owned and operated by people who share the same cultural background as the patients they aim to serve.
In their application to obtain a certificate of need in Tennessee, the hospice owners made it clear they are Black and intend to serve everyone but will focus on African Americans, who are currently underserved. Tennessee data shows that in Nashville just 19% of hospice patients are Black, although they make up 27% of the capital city’s population.
Though the area already had numerous hospice agencies, regulators granted Heart and Soul permission to operate, based primarily on the value of educating an underserved group.
In Ms. Murphy’s first hospice experience, her mother had been living with dementia for decades. Still, Ms. Murphy had concerns about transitioning her mother to hospice. She felt as if she was giving up on her mom.
“My first thought was death,” she said.
National data shows that Black Medicare patients and their families are not making the move to comfort care as often as white patients are. Roughly 41% of Black Medicare beneficiaries who died in 2019 were enrolled in hospice, compared with 54% of White patients, according to data compiled annually by the National Hospice and Palliative Care Organization.
Ms. Murphy’s mother survived nearly 3 years on hospice. The benefit is meant for those in the final 6 months of life, but predicting when the end will come is difficult, especially in cases of dementia. Hospice provides palliative care for the dying and support for caregivers for a long as the process lasts.
Ms. Murphy did most of the caregiving – which can be overwhelming – but hospice helped with a few baths a week, medication in the mail and any medical equipment they needed.
And most important to Ms. Murphy was the emotional support, which came mostly from her hospice nurse.
“Wasn’t no doctor going to come here, hold my hand, stay here until the funeral home came for her,” she said about the day her mother died.
Last year, on the day after Thanksgiving, Willie Murphy died. And the same hospice nurse was at the Murphy home within minutes. She’d already stopped by that morning to check on him and returned as soon as Mary called and told her he wasn’t breathing.
“If you don’t feel like: ‘Oh my God, thank God I have hospice,’ if you can’t say that, then we’re doing something wrong,” said Keisha Mason, Heart and Soul’s director of nursing.
Ms. Mason, like Ms. Murphy, is Black and said that in her view there’s nothing fundamental keeping Black patients from using hospice except learning what the service can offer and that it’s basically free to patients – paid for by Medicare, Medicaid, and most private health plans.
“I say to them, ‘If you see a bill, then call us, because you should not,’” she said.
As Ms. Mason helped launch this new hospice agency, she began using new language, calling hospice more than a Medicare benefit. She describes it as an entitlement.
“Just as you are entitled to unemployment, as you are entitled to Social Security, you are entitled to a hospice benefit,” she said.
The investors in Heart and Soul include David Turner, owner of CNS Hospice in Detroit; Nashville pastor the Rev. Sandy McClain; and André Lee, a former hospital administrator on the campus of Meharry Medical College, a historically Black institution in Nashville.
Mr. Lee and Mr. Turner also started a Black-focused hospice agency in Michigan and have plans to replicate the model in other states.
More families need to consider home hospice as an alternative for end-of-life care, Mr. Lee said. Nursing homes are pricey. And even with Medicare, a hospital bill can be hefty.
“You’ll go in there and they’ll eat you alive,” he said. “I hate to say [something] bad about hospitals, but it’s true.”
Hospice research hasn’t come up with clear reasons to explain the gap between White and Black families’ use of the benefit. Some experts speculate it’s related to spiritual beliefs and widespread mistrust in the medical system because of decades of discrimination.
The hospice industry’s national trade group, the National Hospice and Palliative Care Organization, released a diversity and inclusion toolkit and a guide to reaching more Black patients. It recommends connecting with influential DJs, partnering with Black pastors and simply hiring more Black nurses.
Bridging the gap is not overly complicated, Mr. Lee said.
“A lot of hospices don’t employ enough Black people,” he said. “We all feel comfortable when you see someone over there that looks like you.”
Well-established hospice agencies have attempted to minimize barriers with their own diversity initiatives. Michelle Drayton of Visiting Nurse Service of New York said her large agency has met with ministers who counsel families dealing with failing health.
“Many of them did not fully understand what hospice was,” she said. “They had many of the same sort of misperceptions.”
Every hospice company, whether it’s an upstart or one of the nation’s oldest, can promote end-of-life education and ease care disparities, Ms. Drayton said. “We’re not just handing out a brochure,” she added.
This story is part of a partnership that includes Nashville Public Radio, NPR, and KHN. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
This time, it didn’t take much persuading for Mary Murphy to embrace home hospice. When her mother was dying from Alzheimer’s disease in 2020, she had been reluctant until she saw what a help it was. So when her husband, Willie, neared the end of his life, she embraced hospice again.
The Murphys’ house in a leafy Nashville, Tenn., neighborhood is their happy place – full of their treasures.
“He’s good to me – buys me anything I want,” she said, as she pulled a milky glass vase out of a floor-to-ceiling cabinet with mirrored shelves.
Willie bought Mary the display case to help her to show off the trinkets she picks up at estate sales.
Down the hall, Willie was lying in their bed, now unable to speak. His heart was giving out.
“You gonna wake up for a minute?” she asked, cradling his head. She patted his back while he cleared his throat. “Cough it out.”
Heart and Soul Hospice is owned and operated by people who share the same cultural background as the patients they aim to serve.
In their application to obtain a certificate of need in Tennessee, the hospice owners made it clear they are Black and intend to serve everyone but will focus on African Americans, who are currently underserved. Tennessee data shows that in Nashville just 19% of hospice patients are Black, although they make up 27% of the capital city’s population.
Though the area already had numerous hospice agencies, regulators granted Heart and Soul permission to operate, based primarily on the value of educating an underserved group.
In Ms. Murphy’s first hospice experience, her mother had been living with dementia for decades. Still, Ms. Murphy had concerns about transitioning her mother to hospice. She felt as if she was giving up on her mom.
“My first thought was death,” she said.
National data shows that Black Medicare patients and their families are not making the move to comfort care as often as white patients are. Roughly 41% of Black Medicare beneficiaries who died in 2019 were enrolled in hospice, compared with 54% of White patients, according to data compiled annually by the National Hospice and Palliative Care Organization.
Ms. Murphy’s mother survived nearly 3 years on hospice. The benefit is meant for those in the final 6 months of life, but predicting when the end will come is difficult, especially in cases of dementia. Hospice provides palliative care for the dying and support for caregivers for a long as the process lasts.
Ms. Murphy did most of the caregiving – which can be overwhelming – but hospice helped with a few baths a week, medication in the mail and any medical equipment they needed.
And most important to Ms. Murphy was the emotional support, which came mostly from her hospice nurse.
“Wasn’t no doctor going to come here, hold my hand, stay here until the funeral home came for her,” she said about the day her mother died.
Last year, on the day after Thanksgiving, Willie Murphy died. And the same hospice nurse was at the Murphy home within minutes. She’d already stopped by that morning to check on him and returned as soon as Mary called and told her he wasn’t breathing.
“If you don’t feel like: ‘Oh my God, thank God I have hospice,’ if you can’t say that, then we’re doing something wrong,” said Keisha Mason, Heart and Soul’s director of nursing.
Ms. Mason, like Ms. Murphy, is Black and said that in her view there’s nothing fundamental keeping Black patients from using hospice except learning what the service can offer and that it’s basically free to patients – paid for by Medicare, Medicaid, and most private health plans.
“I say to them, ‘If you see a bill, then call us, because you should not,’” she said.
As Ms. Mason helped launch this new hospice agency, she began using new language, calling hospice more than a Medicare benefit. She describes it as an entitlement.
“Just as you are entitled to unemployment, as you are entitled to Social Security, you are entitled to a hospice benefit,” she said.
The investors in Heart and Soul include David Turner, owner of CNS Hospice in Detroit; Nashville pastor the Rev. Sandy McClain; and André Lee, a former hospital administrator on the campus of Meharry Medical College, a historically Black institution in Nashville.
Mr. Lee and Mr. Turner also started a Black-focused hospice agency in Michigan and have plans to replicate the model in other states.
More families need to consider home hospice as an alternative for end-of-life care, Mr. Lee said. Nursing homes are pricey. And even with Medicare, a hospital bill can be hefty.
“You’ll go in there and they’ll eat you alive,” he said. “I hate to say [something] bad about hospitals, but it’s true.”
Hospice research hasn’t come up with clear reasons to explain the gap between White and Black families’ use of the benefit. Some experts speculate it’s related to spiritual beliefs and widespread mistrust in the medical system because of decades of discrimination.
The hospice industry’s national trade group, the National Hospice and Palliative Care Organization, released a diversity and inclusion toolkit and a guide to reaching more Black patients. It recommends connecting with influential DJs, partnering with Black pastors and simply hiring more Black nurses.
Bridging the gap is not overly complicated, Mr. Lee said.
“A lot of hospices don’t employ enough Black people,” he said. “We all feel comfortable when you see someone over there that looks like you.”
Well-established hospice agencies have attempted to minimize barriers with their own diversity initiatives. Michelle Drayton of Visiting Nurse Service of New York said her large agency has met with ministers who counsel families dealing with failing health.
“Many of them did not fully understand what hospice was,” she said. “They had many of the same sort of misperceptions.”
Every hospice company, whether it’s an upstart or one of the nation’s oldest, can promote end-of-life education and ease care disparities, Ms. Drayton said. “We’re not just handing out a brochure,” she added.
This story is part of a partnership that includes Nashville Public Radio, NPR, and KHN. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
One doctor’s psychedelic journey to confront his cancer
Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.
The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.
Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.
He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.
Dr. Bansal did not arrive at this moment lightly.
“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.
“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”
But Bansal had done his homework on psilocybin and was impressed.
according to studies published in 2011, 2014, and 2016.
One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.
For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.
And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.
He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.
Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
Stuck in a dark place
Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019.
Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).
It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.
“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”
But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.
“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”
As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.
At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.
With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”
He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.
Those things helped, but not enough.
The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.
If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.
As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).
The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
Starting the journey
By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.
The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)
Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.
This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.
Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic.
He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.
“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.
“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”
“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.
For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.
But he did his best to set aside his doubts and embrace the journey he was about to take.
The day of the trip
Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.
This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.
The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.
A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.
“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”
The doctor said: “Don’t worry about it. Just trust and let go.”
And that’s just what he did.
Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.
Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.
Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.
It took about 45 minutes for the medication to kick in.
The investigator
The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.
Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.
He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.
“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”
“But what about the psychological effects?”
They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.
So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.
Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.
To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.
And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.
The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
A trip into the unknown
Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.
“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.
There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.
Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.
“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”
All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.
And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”
“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”
Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”
Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”
His therapist was clear about what to do: Stand firm and walk toward it.
“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
A state of peace
Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.
“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”
After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.
“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”
This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
After the journey
It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:
“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”
And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”
The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.
From his journal:
“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.
“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”
That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.
A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.
“It’s inspiring,” Dr. Richards said.
“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”
And the positive effects can extend deep into the family system, he said.
After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.
Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”
At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
After the experience
Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.
The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.
Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.
The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.
“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”
It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.
In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
Pradeep 2.0
Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.
“And yet it was somehow okay,” he said. “It was only pain.”
“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”
Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”
The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.
“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”
Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”
He even named his new outlook. “I call it Pradeep 2.0.”
A version of this article first appeared on WebMD.com.
Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.
The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.
Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.
He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.
Dr. Bansal did not arrive at this moment lightly.
“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.
“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”
But Bansal had done his homework on psilocybin and was impressed.
according to studies published in 2011, 2014, and 2016.
One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.
For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.
And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.
He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.
Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
Stuck in a dark place
Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019.
Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).
It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.
“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”
But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.
“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”
As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.
At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.
With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”
He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.
Those things helped, but not enough.
The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.
If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.
As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).
The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
Starting the journey
By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.
The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)
Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.
This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.
Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic.
He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.
“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.
“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”
“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.
For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.
But he did his best to set aside his doubts and embrace the journey he was about to take.
The day of the trip
Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.
This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.
The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.
A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.
“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”
The doctor said: “Don’t worry about it. Just trust and let go.”
And that’s just what he did.
Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.
Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.
Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.
It took about 45 minutes for the medication to kick in.
The investigator
The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.
Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.
He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.
“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”
“But what about the psychological effects?”
They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.
So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.
Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.
To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.
And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.
The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
A trip into the unknown
Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.
“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.
There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.
Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.
“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”
All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.
And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”
“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”
Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”
Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”
His therapist was clear about what to do: Stand firm and walk toward it.
“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
A state of peace
Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.
“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”
After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.
“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”
This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
After the journey
It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:
“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”
And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”
The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.
From his journal:
“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.
“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”
That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.
A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.
“It’s inspiring,” Dr. Richards said.
“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”
And the positive effects can extend deep into the family system, he said.
After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.
Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”
At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
After the experience
Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.
The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.
Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.
The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.
“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”
It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.
In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
Pradeep 2.0
Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.
“And yet it was somehow okay,” he said. “It was only pain.”
“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”
Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”
The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.
“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”
Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”
He even named his new outlook. “I call it Pradeep 2.0.”
A version of this article first appeared on WebMD.com.
Pradeep Bansal considered the five capsules he was about to swallow. Together they made up a 25-mg dose of a substance that, in another setting, could have landed him in federal prison.
The substance was psilocybin, the active ingredient in magic mushrooms. To be more exact, it was a synthetic form of psilocybin called COMP360, made to pharmaceutical standards by a company called COMPASS Pathways. He was taking it as part of an Food and Drug Administration–approved clinical study on mental health therapy for people with cancer.
Dr. Bansal, a New York gastroenterologist, was far more comfortable giving medical treatment than receiving it. But he was getting used to it.
He had already been through surgery and a number of other treatments to address the physical aspects of his cancer. The psilocybin was to address the mental aspects – the crushing anxiety and depression that had stuck with him after his diagnosis.
Dr. Bansal did not arrive at this moment lightly.
“I was extremely skeptical going into this process,” said Dr. Bansal, who during a long medical career had looked with distrust and even disdain at alternative therapies.
“I don’t have much patience for holistic medicine, homeopathy, acupuncture, or alternative medicines with claims of spiritual upliftment or altered states of mind.”
But Bansal had done his homework on psilocybin and was impressed.
according to studies published in 2011, 2014, and 2016.
One study from Johns Hopkins University tracked the effects of a single guided dose of psilocybin in terminal cancer patients with anxiety and depression. More than 80% had a “significant decrease” in symptoms – even 6 months after treatment – with more than 60% of the group remaining in the normal mood range.
For the study Dr. Bansal joined, there had been weeks of screening and consultation and preparation in a strictly controlled scientific trial.
And yet, even with all that he had learned, even with his psychiatrist-guide by his side, he was afraid. Afraid of what he might experience under the powerful effects of psilocybin. And afraid that this was all a misguided waste of time – that his mental angst would still be there when it was all over.
He knew that psilocybin, like other psychedelic substances, could take you on a “trip” – could remove you, at least for a time, from normal conscious experience.
Maybe he would feel “funny,” he thought. Maybe he would have some hallucinations. But how would that change the reality of his cancer? How would it lift the black dread and anxiety he felt about his future?
Stuck in a dark place
Dr. Bansal had first noticed blood in his urine – a lot of it – in September 2019.
Two months later, doctors diagnosed cancer in his right kidney. He would need surgery to remove the kidney and surrounding lymph nodes (an operation called radical nephrectomy).
It was a shock, said Dr. Bansal. But the diagnosis and the surgery happened so quickly that he hardly had time to think. And treatment results seemed good. The cancer was only in stage I and the CT scans showed no signs of cancer after surgery.
“We were so relieved. Everyone was so happy,” Dr. Bansal said. “They didn’t even give me chemotherapy after surgery because it seemed so early.”
But a routine scan in June 2020 revealed more cancer in his lung. Within a couple of months, it was in his bladder too.
“It was devastating,” Dr. Bansal said. “I went from thinking I was healthy again to stage IV cancer.”
As doctors scheduled surgery to remove part of his lung, Dr. Bansal started on painful immunotherapy (BCG therapy) for his bladder.
At this point, from a psychological standpoint, Dr. Bansal was reeling. As a doctor, he knew all too well the meaning of stage IV cancer.
With two adult children and a grandchild on the way, Dr. Bansal had been looking forward to retirement with his wife of almost 40 years. “Suddenly, I wasn’t sure I was going to last that long,” Bansal recalled. “I was in a very dark place. I was very anxious, very depressed from lack of sleep.”
He saw a therapist about his cancer diagnosis and maintained his regular meditation practice at home. He hired a personal trainer and tried to focus on any good news that he got about his treatment.
Those things helped, but not enough.
The basic facts were inescapable. His cancer might end everything. He couldn’t stop thinking about it. And then he couldn’t stop thinking about how he couldn’t stop thinking about it.
If the worst happened, he didn’t want to spend his last days in a state of such relentless existential angst. And it wasn’t just for himself. He wanted to be strong and mentally present for his family and his loved ones and his patients.
As he searched for something to ease his mental anguish, Dr. Bansal recalled some psychedelic research on end-of-life anxiety and depression that he’d read about in Michael Pollan’s book on psychedelics, “How to Change Your Mind” (New York, Penguin Press, 2018).
The studies were small and the research was new, but Dr. Bansal was impressed enough with the results to take a chance. He called a lead researcher of one of the studies, a fellow New York doctor, and eventually found himself accepted into a new study.
Starting the journey
By the time Dr. Bansal arrived at the Bill Richards Center for Healing at the Aquilino Cancer Center in Rockville, Md., he had already been through weeks of screening.
The main requirements for the study were a cancer diagnosis and a measurable level of depression. But study participants also had to be physically fit enough to handle the medication, and psychologically free from a personal or family history of psychosis or schizophrenia. (The study also required participants to slowly wean themselves from medications like SSRIs for depression or antianxiety medications under the strict supervision of a qualified doctor.)
Dr. Bansal’s week of treatment began almost immediately on arrival at Aquilino. Everything was carefully choreographed but not rushed. From Monday to Wednesday, doctors followed his physical health with exams, ECGs, and blood work. And most importantly, they began to prepare him for the “dosing session” on Thursday when he would take the psilocybin.
This is the careful crafting of “set and setting” stressed in so many psychedelic therapies. “Set” refers to your mindset going into the drug experience. “Setting” is the space and people around you when the drug sends you into an altered state of consciousness.
Dr. Bansal met several times with at least three therapists in the days leading up to his dosing. He attended 4-plus hours of therapist-led group sessions with other people who would get a dosing on the same day. Together, they talked about what to expect during the experience and what to do in the face of fear or panic.
He connected with a therapist who would be his personal guide. Dr. Bansal’s therapist was a military psychiatrist with over 30 years’ experience.
“He was there with me from day 1, and so we established a relationship,” Dr. Bansal said.
“He asked me a lot of personal background history – you know, my religious convictions, aspirations, all those things.”
“Trust and let go,” was a kind of mantra for the treatment repeated by his guide and other doctors.
For Dr. Bansal, a doctor and scientist accustomed to using hard facts rather than touchy-feely slogans to navigate the care of patients, it was an adjustment, to say the least.
But he did his best to set aside his doubts and embrace the journey he was about to take.
The day of the trip
Thursday morning finally arrived. The setting of the dosing room was warm and welcoming, more like a cozy home study than a hospital room.
This matters more than you might think. First, because it’s important that you feel safe, open, and comfortable enough to let go and enter into a therapeutic process. But also because though rare, it’s possible – especially with psilocybin – for people to lose track of where they are and what they’re doing and put themselves or others in danger.
The dose, 25 mg, had been carefully calibrated to induce a psychedelic experience sufficient for therapy. Much less than that, say 10 mg, isn’t enough for most people to enter this state. A double dose, 50 mg, though not physically unsafe, may leave you too incoherent to have the useful insights key to therapeutic value.
A doctor, the lead investigator of the study, brought the five capsules into the room in an intricately carved crucible with a small ceremonial cup that held the water with which to take it.
“It was very solemn,” Dr. Bansal said. “He sat down with me in a very calming way.”
The doctor said: “Don’t worry about it. Just trust and let go.”
And that’s just what he did.
Dr. Bansal swallowed the capsules and lay down. The doctor quietly left the room so that Dr. Bansal and his psychiatrist guide could begin their session together.
Special eye shades kept him in the pitch dark whether his eyes were open or closed. Headphones streamed a curated musical playlist – much of it Western classical like Strauss, Bach, Mozart, and Beethoven – but also modern electronica and other music from cultures around the globe.
Dr. Bansal would remain here, with his therapist-guide by his side, in largely this same position, for the next 7-and-a-half hours.
It took about 45 minutes for the medication to kick in.
The investigator
The doctor who brought the capsules into the dosing room was Manish Agrawal, MD, codirector of clinical research at the Aquilino Cancer Center and lead investigator of the study.
Dr. Agrawal trained at the National Cancer Institute and practiced for many years as an oncologist before developing an interest in psychedelic therapies. It was his work with cancer patients that drew him to psychedelics in the first place.
He had seen too many of his patients mentally wrecked by a cancer diagnosis, and he often felt helpless to comfort them.
“You take care of the physical aspects of the cancer, right? You talk about side effects and recommend another scan to look for recurrence.”
“But what about the psychological effects?”
They can be very serious and too often go ignored, said Dr. Agrawal. Your plans for the future suddenly become moot. You may be concerned about your ability to work or worried about the pain and suffering and financial strain that might be ahead for both you and your family. And to top it all off, you’re staring into the face of your own mortality.
So it’s no wonder, said Dr. Agrawal, that many people develop clinical levels of anxiety and depression after a cancer diagnosis.
Like Dr. Bansal, Dr. Agrawal had been impressed by early studies on psilocybin-assisted therapies for end-of-life anxiety and depression. He had tried other approaches – support groups, one-on-one therapy, religious counselors, psychiatrist-prescribed medication – but he was never really happy with the results.
To Dr. Agrawal, psilocybin-assisted therapy was the first thing that looked like it could really make a difference.
And so after his psychedelic certification at the California Institute of Integral Studies, Dr. Agrawal was determined to change his approach.
The result was the Bill Richards Center for Healing at Aquilino Cancer Center, built specifically to study psychedelic-assisted therapies for psychological distress in people with cancer. The mission of the center is to help develop safe, FDA-approved psychedelic therapies for the mental health of cancer patients, and, once approved, provide a state-of-the-art facility and staff to administer those treatments.
A trip into the unknown
Back in the dosing room, Dr. Bansal was starting to feel the effects of the medication. As the psilocybin kicked in, spectacular images swirled.
“It was as if a million stained glass windows had suddenly come to life and were dancing in front of my vision,” Dr. Bansal said.
There were moving landscapes and intricate swirling patterns and massive stages in the sky where he saw orchestras playing the music he was hearing.
Dr. Bansal saw himself being crushed by a huge machine and buried, dead, in the Earth. He died and returned to life several times, glided over the top of New York City with the skyscrapers just below him, and took in the vision of the entire universe.
“I saw this expanse of the sky that was limitless. And there was this prehistoric reptile creature that spanned galaxies in the sky ahead of me who was dying. I said: ‘My God, the universe is dying,’ but then after a few moments, the universe came to life again in a burst of stars exploding.”
All the while, Dr. Bansal said, he was well aware that it was simply his mind creating these images, thoughts, and ideas. He knew he was in a safe room wearing eyeshades and headphones.
And yet, he says, it felt true. “The images and feelings are so powerful that you cannot help but believe they are in some way a part of reality.”
“At one point, I saw this giant Ferris wheel coming towards me and it was full of giant crabs, clicking and clacking their pincers. And my brain told me: ‘That’s my cancer!’ ”
Dr. Bansal was terrified. But he and his therapist had arranged a system of signals before the session. “If I was feeling afraid, I would hold his hand and if I had other issues, I would raise my hand. If I was feeling good, I would give him a thumbs up.”
Dr. Bansal reached out to his therapist and grasped his hand. “I said, ‘My cancer is coming at me!’ ”
His therapist was clear about what to do: Stand firm and walk toward it.
“That’s what they tell you: If you see anything frightening, you face it. And that’s the whole point of this exercise. And so, I stood and walked forward, and it just blew off in a puff of smoke.”
A state of peace
Around 3 hours into the experience, Dr. Bansal started to feel an immense sense of peace, happiness, and even comfort.
“I felt like I was watching a movie or a multidimensional slideshow. I was also a part of the movie. I felt like I could tell my mind what I wanted to see, and it would show it to me. It’s almost like you can mold your own visions. It was mystical.”
After about 8 hours, as the effects of the drug wore off, Dr. Bansal removed his eyeshades and headphones. He was completely drained.
“Even though I was lying down on my back for 7 hours, I felt like I had been run over by a truck. I was exhausted beyond belief physically and mentally.”
This was partly because of the fact that he hadn’t eaten much during the session. But mostly, said Dr. Bansal, it was because of the searing emotional intensity of the experience.
After the journey
It’s hard to put into words, said Dr. Bansal, what this treatment has done for his life. He feels as if he has stumbled onto something very precious that had been right in front of him all along. He wrote of his change in perspective almost obsessively in his journal in the days and weeks after treatment. One passage reads:
“It seems that, as time is passing on, I’m becoming more relaxed and hopeful, more calm, and at peace. Family has become even more important to me now. Money, politics, material gains, alcohol, seem less important.”
And yet there was nothing “easy” about the experience. In fact, in some ways the experience demanded more from him. “I feel I need to be more compassionate and considerate – less irritable and angry, more understanding of others’ needs. I feel I need to be a better human being, a better patient, a better father, and a better doctor for my patients.”
The experience, he said, gave him something far more important than mere ease. It gave him a sense of meaning.
From his journal:
“I died, and I was reborn. If I survived this, then I can face anything and anybody in the cosmic scheme. I can become part of it.
“How many sorrows in the universe? My cancer is nothing. Life does not end with the end of life. What was will be again. Eternally.”
That’s not an unusual response, according to the namesake of the Bill Richards Center for Healing. Bill Richards, PhD, has worked in the world of psychedelic-assisted psychotherapy since 1963.
A psychologist with decades of experience, Dr. Richards and colleagues figure that, with few possible exceptions, he has helped treat more people with psychedelic therapies than anyone alive in Western medicine today. At Aquilino, he works directly with patients and oversees the therapy protocol that goes along with the psilocybin dosing sessions.
“It’s inspiring,” Dr. Richards said.
“You meet someone who’s very depressed and scared and isolating from family and having all kinds of physical complaints. And a few days later, you talk to the same person and they have a whole new lease on life.”
And the positive effects can extend deep into the family system, he said.
After psilocybin treatment, said Dr. Richards, the person with cancer can become a kind of social worker for the family. They’re often far better able to talk about death and loss and even money and family issues than their loved ones. It’s not uncommon after treatment to see the resolution of years-old resentments or grievances that have dogged a family for many years.
Plus, said Dr. Richards, the cancer patient often ends up as a kind model to other family members for how to approach death. “They can demonstrate how to live fully – right to the last breath – which is a real gift because those relatives and loved ones have to die someday too, you know.”
At 80 years old, Dr. Richards is still in active practice and hopes to spend the rest of his days working with people in end-of-life care.
After the experience
Psychedelic-assisted therapy does not end with the dosing session. Integration sessions, where you discuss what happened during the dosing session, are a key part of most treatments.
The goal is to help participants absorb and “integrate” their experience. It typically happens over two or more sessions of 60-90 minutes with a therapist. In some cases, the therapist may invite a significant other to join in the integration process.
Dr. Agrawal’s trial at the Bill Richards center added something new: group therapy. Not only did Dr. Bansal meet with his therapist, he also met with a group of three other people in the trial who had their dosing the same day.
The point, said Dr. Agrawal, is to try and determine the effect of the group on the therapy. After their private dosing sessions, they come back together to discuss their experiences.
“After the psilocybin, they feel like they’ve been to war together,” Dr. Agrawal said. “There is this profound openness and connection. They feel able to share things with each other that they wouldn’t with other people.”
It will take some time to figure out how the group affects the overall outcome, but Dr. Bansal thinks it was integral to the success of his treatment.
In fact, he continues to meet regularly with his therapy group, even though it’s long since past the requirements of the study.
Pradeep 2.0
Dr. Bansal still has tough days with his cancer. Recently, immunotherapy treatment for his bladder caused side effects – pain, bleeding, fever, and chills – for most of the night. He felt like he was “passing razor blades” when he peed.
“And yet it was somehow okay,” he said. “It was only pain.”
“It’s as if there is a part of me that is watching myself objectively, going through the painful process of treatments saying: ‘It’s all right. I will be with you through this journey, through this experience. Don’t worry.’”
Months after taking that one dose, Dr. Bansal still calls it as “the single most powerful experience of my life.”
The change in his mental outlook, Dr. Bansal said, was profound, particularly in regard to his cancer.
“I understood that I still had cancer and that it could kill me in a few weeks, or months, or years. But my perspective had shifted.”
Dr. Bansal was as surprised as anyone. “Had somebody told me going into this that I would come out a transformed being or a person with a completely different perspective on life, I would never have believed it.”
He even named his new outlook. “I call it Pradeep 2.0.”
A version of this article first appeared on WebMD.com.