Low Concordance for Site of Death

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Where do you want to spend your last days of life? Low concordance between preferred and actual site of death among hospitalized adults

At the turn of the 20th century, most deaths in the United States occurred at home. By the 1960s, over 70% of deaths occurred in an institutional setting, reflecting an evolution of medical technology.[1, 2, 3] With the birth of the hospice movement in the 1970s, dying patients had the opportunity to have both death at home and aggressive symptom control at the end of life. Although there has been a slow decline in the proportion of deaths that occur in the hospital over the past 2 decades,[3] the overwhelming majority of persons state that they would prefer to die at home. However, recent findings suggest that most people will die in an institutional setting.[3, 4, 5, 6]

Although good data exist describing population preferences for location of death, and we know, based on death records, where deaths occur in the United States, there are few studies that examine concordance between preferred and actual site of death at the individual patient level. Furthermore, although factors have been identified that predict death at home, factors predicting concordance between preferred and actual site of death are not well described.[3, 6, 7, 8, 9, 10, 11, 12, 13]

Regardless of where death ultimately occurs, most adults will experience multiple hospitalizations within the last years of their life. Understanding the preferences and subsequent experiences of this population is of particular relevance to hospitalist physicians who are in a unique position to elicit goals from seriously ill patients and help match patient preferences with their medical care. In this observational study, we sought to determine preferences for site of death in a cohort of adult patients admitted to the hospital for medical illness, and then follow those patients to determine where death occurred for those who died. We also sought to explore factors that may predict concordance between preferred and actual site of death. We hypothesized that ethnic diversity and lower socioeconomic status would be associated with a lower likelihood of concordance between preferred and actual site of death. We also hypothesized that advanced care planning would be associated with a higher likelihood of concordance. The Colorado Multi‐Institutional Review Board approved this study.

METHODS

Participants were recruited from 3 hospitals affiliated with the University of Colorado School of Medicine Internal Medicine Residency program, including the Denver Veterans' Administration Center (DVAMC), Denver Health Medical Center (DHMC), and University of Colorado Hospital (UCH). The DVAMC is a large urban Veterans Administration hospital, serving veterans from the Denver metro area, and is a tertiary referral center for veterans in rural Colorado, Wyoming, and parts of Montana. DHMC, the safety‐net hospital for the Denver area, serves over 25% of the residents in the city and county of Denver, including such special populations as the indigent, chronically mentally ill, and persons with polysubstance dependence. UCH had 350 licensed beds at the time of our study and serves as the Rocky Mountain region's only academic tertiary, specialty care, and referral center. At the time of this study, there was limited inpatient palliative care services at the DVAMC and UH, and no palliative care services at DHMC. Participants were screened on the first day following admission to the adult general medical service. Participants were recruited on 96 postadmission days between February 2004 and June 2006. Recruitment days varied from Monday through Friday, to include admissions from the weekend and throughout the year to reduce potential bias due to seasonal trends of diseases such as influenza. Patients were excluded if they died or were discharged within the first 24 hours of admission, were pregnant, jailed, or unable to give informed consent. All other patients were approached and invited to participate in a brief survey.

After informed consent was obtained, participants completed a bedside interview that included self‐identified ethnicity and the Berkman‐Syme Social Network Index,[14] a brief questionnaire quantifying social support from spouse or domestic partner, family, friends, and other religious or secular organizations. Baseline socioeconomic measures (eg, income, employment, home ownership, car ownership) and questions related to the last days of life were also included. Participants were asked the following question, If you were very sick, with an illness that could not be cured, and in bed most of the time, where would you spend the last days of your life if you could chose?

For each participant, we performed a detailed chart review to determine demographic data, presence of advance directives, and CARING criteria (Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines), a set of prognostic criteria identifying patients at an index hospitalization who have a high burden of illness and are at risk for death in the following year.[15] We then followed patients for 5 years. If participants died within the follow‐up period, we collected the date and location of death using medical records, death certificates, or in a few cases when official death records were unavailable, direct contact with the family. Participants were considered alive if they had a clinic visit or MD/RN phone contact within 3 months prior to the final collection point date.

Analysis

SAS 9.1 (SAS Institute Inc., Cary, NC) was used for all analyses. Simple frequencies and means statistics were used to determine rates of descriptive characteristics of the sample as well as rates of the measured outcomes, preferred place to spend last days of life, and actual site of death. Agreement or concordance between preferred and actual site of death was calculated. For the purposes of the analysis, we assumed all persons who stated they had no preference died in a place concordant with their wishes. To calculate agreement by preferred and actual site, participants who expressed a preference and died (n=111) in hospital, nursing home, home, or hospice setting were included in the analysis, and participants (n=4) who died in an unknown or other locations were excluded (eg, motel room).

Logistic Regression Modeling

2 tests were performed for all categorical variables to determine a significant association with outcome variables. Preferred place of death and concordance between preferred and actual site of death were modeled using predictive variables selected if univariable association demonstrated a P0.25. This standard cutoff was selected to broadly identify candidate variables for logistic regression modeling.[16] A stepwise algorithm was used to select significant predictors that would remain in the model.

In lieu of fitting a multinomial logit model for preferred site of death of home vs hospital vs nursing home or hospice facility as preferred site of death, 3 logit models (although only 2 may be sufficient to estimate the underlying multinomial logit model[17]) were considered with outcome categories: home vs nursing home or hospice facility, and hospital vs nursing home or hospice facility and home vs hospital.

For the logistic regression modeling of concordance, we included the full sample of patients who died during the follow‐up period (n=123). We classified participants as dying in a place concordant with their wishes or not concordant.

RESULTS

Study Population

Subjects were recruited on 96 post‐admission days totaling 842 admissions. Three hundred thirty‐one patients (39%) were ineligible for study participation (n=175 discharged within 24 hours, n=76 unable to consent, n=78 ineligible for other reasons [eg, prisoner, pregnant, under 18 years old], n=2 died within 24 hours of admission). Only 53 of the remaining 511 (10%) patients refused; 458 patients (90%) gave informed consent to participate. Characteristics of the study population are depicted in Table 1. There were very few missing cases (<3%), that is persons without a recent clinic follow‐up date, contact, or a confirmed date of death. These persons were considered alive. Overall, the sample population was ethnically diverse, slightly older than middle age, mostly male (due to the inclusion of the Veterans Administration hospital), and of low socioeconomic status.

Baseline Characteristics (n=458)
Mean age (SD), y57.9 (14.8)
  • NOTE: Abbreviations: CARING, Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines; DHMC, Denver Health Medical Center, DVAMC, Denver Veterans Affairs Medical Center; SD, standard deviation; UCH, University of Colorado Hospital.

  • Unstable living situation defined as either homeless, living in shelters, or with friends.

  • Low social support defined as Identifying 2 forms of social support (spouse/significant other, relatives, friends, church or other group) present in their life. Data are presented as % (n) unless otherwise noted.

Mean time to death (SD), d339.5 (348.4)
Ethnicity 
African American19% (88)
Caucasian52% (239)
Latino22% (102)
Other6% (29)
Spanish language only6% (27)
Female gender35% (159)
Admitted to DVAMC41% (188)
Admitted to DHMC38% (174)
Admitted to UCH21% (96)
CARING criteria 
Cancer diagnosis11% (51)
Admitted to hospital 2 times in the past year for chronic illness40% (181)
Resident in a nursing home2% (9)
Noncancer hospice guidelines (meeting 2)13% (59)
Income <$30,000/year84% (377)
No greater than high school education55% (248)
Home owner26% (120)
Rents home39% (177)
Unstable living situationa34% (156)
Low social supportb36% (165)
Uninsured18% (81)
Regular primary care provider73% (330)

Preferred Site of Death

When asked where they preferred to spend the last days of their life, 75% of patients (n=343) stated they would like to be at home. In the hospital was the preferred location for 10% of patients, whereas 6% stated a nursing home and 4% a hospice inpatient facility. Two percent stated they had no preference, and 3% refused to answer (Figure 1)

Figure 1
Preferred (n=458) and actual (n=121) site of death.

We found that in the univariable analysis the following factors were associated with preference for site of death at a significance level of P<0.25: unstable housing, hospital setting, income level, ethnicity, CARING criteria, presence of an advance directive, education level, married, primary care provider, and presence of public insurance. Results of the logit models (home vs nursing home or hospice facility, and hospital vs nursing home or hospice facility and home vs hospital) are presented in Table 2.

Logistic Regression Modeling of Preference for Death at Home or Hospital
 Adjusted Odds Ratio (95% Confidence Interval)
 Home vs Nursing Home/Hospice FacilityHospital vs Nursing Home/Hospice FacilityHome vs Hospital
  • NOTE: Abbreviations: CARING, Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines.

Low income2.71 (1.305.67)3.05 (1.019.24)0.99 (0.422.37)
Married2.44 (1.145.21)2.40 (0.876.62)0.82 (0.421.57)
CARING criteria0.58 (0.301.14)0.44 (0.181.09)0.89 (0.471.66)

Patients with income <$30,000/year were more likely to prefer home (or hospital) over a nursing home or hospice facility. Being married was predictive of preferring home over nursing home or hospice facility. Patients meeting 1 of the CARING criteria trended toward being less likely (P=0.11 for home and P=0.08 for hospital) to prefer home (or hospital) vs nursing home or hospice facility. However, there were no significant predictors for a preference for home or hospital when directly comparing the 2 locations, as expected from observing similar effects of variables in the other 2 logit models.

Actual Site of Death

One hundred twenty‐three patients died during the follow‐up period (26% of the total sample). Of those who died, the mean age was 64 years (standard deviation 13), 82% had annual incomes <$30,000, 73% were men, and 77% met at least 1 of the CARING criteria suggesting advanced medical illness. The distribution of ethnicities of the deceased subsample was similar to that of the overall cohort. Complete death records were obtained for 121 patients. Only 31% (n=38) died at home, whereas 35% (n=42) died in a hospital, 20% (n=24) died in a nursing home, and 12% (n=14) died in an inpatient hospice facility (Figure 1).

In univariable analysis, there were no associations at a 25% significance level between actual site of death and ethnicity, gender, age, severity of illness, high vs low social support, high or low socioeconomic status, stable vs unstable housing, or presence of a completed advance directive in the medical record.

Concordance Between Preferred and Actual Site of Death

Overall, 37% of the patients died where they stated they would prefer to die, including the 2 with no preference. Concordance rates for each site of death are presented in Table 3. We examined sociodemographic variables, disease severity, advance‐care planning, primary care provider, health insurance, and hospital site to look for associations with concordance. We found that female gender was positively associated with concordance (odds ratio [OR], 3.30; 95% confidence interval [CI], 1.25‐8.72). CARING criteria (P=0.06) and Latino ethnicity (vs all other ethnicity categories, P=0.12) also showed trends for association. Restricting to those who preferred home, the associations became stronger (OR, 4.62; 95% CI, 1.44‐14.79 for female; OR, 7.72; 95% CI, 1.67‐35.71 for CARING criteria), and the trend for the negative association between Latino ethnicity and concordance remained (P=0.12). Results of the model are shown in Table 4.

Concordance by Site of Preferred and Actual Site of Death With a Preferred Site (n=111)
 Actual Site of Death, n (Row %)Row Total, % Out of 111
 HospitalNursing HomeHomeHospice Facility
Preferred hospital5 (42%)3 (25%)2 (17%)2 (17%)12 (11%)
Preferred nursing home1 (13%)5 (63%)2 (25%)08 (7%)
Preferred home30 (34%)15 (17%)31 (35%)12 (14%)88 (79%)
Preferred hospice facility3 (100%)0003 (3%)
Predictors of Concordance Between Preferred and Actual Site of Death
 Adjusted Odds Ratio (95% Confidence Interval)
 AllHome (Using Same Variables)Home (Using Only Significant Variables)
  • NOTE: Abbreviations: CARING, Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines.

Female gender3.30 (1.258.72)4.62 (1.4414.79)3.57 (1.2410.34)
CARING criteria3.09 (0.979.81)7.72 (1.6735.71)5.93 (1.4124.91)
Latino vs African American/Caucasian/other0.43 (0.151.24)0.35 (0.091.30) 

DISCUSSION

We found, similarly to previous reports in the literature, the majority of patients preferred to die at home. We did not find a significant difference in preferences or location of death by ethnicity or illness severity. Lower‐income patients and married patients were more likely to prefer to be at home over a nursing home or a hospice facility in the last days of life. We found that the minority of patients died at their stated preferred site of death, and female gender was the only predictive variable we found to distinguish those patients who died in a place concordant with their wishes compared to those who did not.

In the literature, previous studies have reported concordance rates between preferred and actual site of death that range from 30% to 90%.[12, 13, 18, 19, 20, 21, 22, 23, 24] We found a concordance rate at the lowest end of this spectrum. In trying to understand our findings and place them in context, it is helpful to examine other studies. Many of these studies focused solely on cancer patients.[13, 18, 19, 20, 21, 22, 23] Cancer follows a more predictable trajectory of decline compared to other common life‐threatening illnesses, such as cardiac disease, emphysema, or liver failure, that often involve periods of acute deteriorations and plateaus throughout illness progression. The more predictable trajectory may explain the overall higher concordance rates found in the studies involving cancer patients.

The majority of studies in the literature examining concordance between preferred and actual site of death recruited the study sample from home health or home palliative care programs that were providing support and care to participants.[10, 12, 13, 18, 22, 25, 26, 27] The high concordance rates reported may be the result of the patients in the sample receiving services at home aimed at eliciting preferences and providing support at home. Our observational study is unique in that we elicited patient preferences from a diverse group of hospitalized adults. Patients had a broad range of medical illness and were at various stages in their disease trajectory. This allowed our findings to be more generalizable, a major strength of our study.

The only variable associated with concordance that we identified to predict concordance between preferred and actual site of death was female gender. Women have been shown to be more active in medical decision making, which may explain our findings.[28] Female gender and illness severity (as measured by the CARING criteria) were found to be associated with concordance when the preference is for death at home. For persons with more advanced medical illness, they may have had more opportunity to consider their preferences and talk about these preferences. It is even possible that our interview prompted some participants to have discussions with their families or providers.

Variables with high face validity, such as high social support, higher education, and completing an advance directive, did not demonstrate any effect on the outcome of concordance. Other studies have shown that low functional status, Caucasian ethnicity, home care, higher education, and social support have been associated with a greater likelihood for a home death.[3, 6, 9] However, although studies specifically examining concordance between preferred and actual site of death have looked at predictors for home death, we were unable to find predictors for concordance across all preferences in the literature. We can conclude from our findings that the factors that influence concordance of preferences for site of death are extremely complex and difficult to capture and measure. This is extremely unsatisfying in the face of the low concordance rate of 30% we identified.

Latino ethnicity showed a trend toward having a negative association with concordance between preferred and actual site of death. This trend persisted whether it was concordance overall or for concordance with those who preferred a death at home. In the literature, Latinos have been found to be less likely to complete advance directives, use hospice services at the end of life, and are more likely to experience a hospital death.[29, 30, 31, 32, 33] As care at the end of life continues to improve, careful attention should be paid to ensure that these kinds of gaps do not widen any further.

We interviewed patients at an index hospitalization. Patients had an acute medical illness or an exacerbation of a chronic medical illness and required at least 24 hours of hospitalization to be eligible for inclusion. Our bedside interview made use of an opportune time to question patients, a time when it may have been easier for patients to visualize severe illness at the end of life, rather than asking this question during a time of wellness. Although participants overwhelmingly stated they preferred to be at home, for those who died, decisions were made in their care that did not allow for this preference.

Our follow‐up after the initial bedside interview only included death records of where and when participants died. We do not have the details and narrative of the conversations that may have taken place that led to the care decisions that determined participants' actual place of death. We do not know if preferences were elicited or discussed, and care decisions then negotiated, to best meet the goals and preferences expressed at that time. We also do not know if the conversations did not occur and the default of medical intervention and cure‐focused care dictated how participants spent the last days of their life. There is evidence that when conversations about goals and preferences do occur, concordance between preferences and care received are high.[12, 21]

We were unable to identify any predictors beyond gender in this cohort of adults hospitalized with a broad spectrum of severe medical illness to predict concordance with stated preferences and actual site of death. We can conclude then, based on our findings and supported by the literature, that the default trends toward institutional end‐of‐life experiences. To shift to a more patient‐centered approach, away from the default, healthcare providers need to embrace a palliative approach and incorporate preferences and goals into the discussions about next steps of care to facilitate the peaceful death that the majority of patients imagine for themselves. Hospitalist physicians have a unique opportunity at an index hospitalization to start the conversation about preferences for care including where patients would want to spend the last days of their life.

Our study does have some limitations. We elicited preferences at a single point in time, at an index hospitalization. It is possible that participants' preferences changed over the course of their illness. However, in Agar et al.'s study of longitudinal patient preferences for site of death and place of care, most preferences remained stable over time.[18] We also did not have data that included palliative care involvement, homecare or hospice utilization, or cause of death. All of these variables may be important predictors of concordance. Issues of symptom management and lack of caregiver may also dictate place of death, even when goals and care are aligned. We do not have data to address these components of end‐of‐life decision making.

CONCLUSION

Patients continue to express a preference for death at home. However, the majority of patients experienced an institutional death. Furthermore, few participants achieved concordance with where they preferred to die and where they actually died. Female gender was the sole factor associated with concordance between preferred and actual site of death. Incorporating a palliative approach that elicits goals and helps match goals to care, may offer the best opportunity to help people die where they chose.

Disclosures: This research was supported by the Brookdale National Fellowship Award and the NIA/Beeson grant 5K23AG028957. All authors have seen and agree with the contents of the article. This submission was not under review by any other publication. The authors have no financial interest or other potential conflicts of interest.

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References
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At the turn of the 20th century, most deaths in the United States occurred at home. By the 1960s, over 70% of deaths occurred in an institutional setting, reflecting an evolution of medical technology.[1, 2, 3] With the birth of the hospice movement in the 1970s, dying patients had the opportunity to have both death at home and aggressive symptom control at the end of life. Although there has been a slow decline in the proportion of deaths that occur in the hospital over the past 2 decades,[3] the overwhelming majority of persons state that they would prefer to die at home. However, recent findings suggest that most people will die in an institutional setting.[3, 4, 5, 6]

Although good data exist describing population preferences for location of death, and we know, based on death records, where deaths occur in the United States, there are few studies that examine concordance between preferred and actual site of death at the individual patient level. Furthermore, although factors have been identified that predict death at home, factors predicting concordance between preferred and actual site of death are not well described.[3, 6, 7, 8, 9, 10, 11, 12, 13]

Regardless of where death ultimately occurs, most adults will experience multiple hospitalizations within the last years of their life. Understanding the preferences and subsequent experiences of this population is of particular relevance to hospitalist physicians who are in a unique position to elicit goals from seriously ill patients and help match patient preferences with their medical care. In this observational study, we sought to determine preferences for site of death in a cohort of adult patients admitted to the hospital for medical illness, and then follow those patients to determine where death occurred for those who died. We also sought to explore factors that may predict concordance between preferred and actual site of death. We hypothesized that ethnic diversity and lower socioeconomic status would be associated with a lower likelihood of concordance between preferred and actual site of death. We also hypothesized that advanced care planning would be associated with a higher likelihood of concordance. The Colorado Multi‐Institutional Review Board approved this study.

METHODS

Participants were recruited from 3 hospitals affiliated with the University of Colorado School of Medicine Internal Medicine Residency program, including the Denver Veterans' Administration Center (DVAMC), Denver Health Medical Center (DHMC), and University of Colorado Hospital (UCH). The DVAMC is a large urban Veterans Administration hospital, serving veterans from the Denver metro area, and is a tertiary referral center for veterans in rural Colorado, Wyoming, and parts of Montana. DHMC, the safety‐net hospital for the Denver area, serves over 25% of the residents in the city and county of Denver, including such special populations as the indigent, chronically mentally ill, and persons with polysubstance dependence. UCH had 350 licensed beds at the time of our study and serves as the Rocky Mountain region's only academic tertiary, specialty care, and referral center. At the time of this study, there was limited inpatient palliative care services at the DVAMC and UH, and no palliative care services at DHMC. Participants were screened on the first day following admission to the adult general medical service. Participants were recruited on 96 postadmission days between February 2004 and June 2006. Recruitment days varied from Monday through Friday, to include admissions from the weekend and throughout the year to reduce potential bias due to seasonal trends of diseases such as influenza. Patients were excluded if they died or were discharged within the first 24 hours of admission, were pregnant, jailed, or unable to give informed consent. All other patients were approached and invited to participate in a brief survey.

After informed consent was obtained, participants completed a bedside interview that included self‐identified ethnicity and the Berkman‐Syme Social Network Index,[14] a brief questionnaire quantifying social support from spouse or domestic partner, family, friends, and other religious or secular organizations. Baseline socioeconomic measures (eg, income, employment, home ownership, car ownership) and questions related to the last days of life were also included. Participants were asked the following question, If you were very sick, with an illness that could not be cured, and in bed most of the time, where would you spend the last days of your life if you could chose?

For each participant, we performed a detailed chart review to determine demographic data, presence of advance directives, and CARING criteria (Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines), a set of prognostic criteria identifying patients at an index hospitalization who have a high burden of illness and are at risk for death in the following year.[15] We then followed patients for 5 years. If participants died within the follow‐up period, we collected the date and location of death using medical records, death certificates, or in a few cases when official death records were unavailable, direct contact with the family. Participants were considered alive if they had a clinic visit or MD/RN phone contact within 3 months prior to the final collection point date.

Analysis

SAS 9.1 (SAS Institute Inc., Cary, NC) was used for all analyses. Simple frequencies and means statistics were used to determine rates of descriptive characteristics of the sample as well as rates of the measured outcomes, preferred place to spend last days of life, and actual site of death. Agreement or concordance between preferred and actual site of death was calculated. For the purposes of the analysis, we assumed all persons who stated they had no preference died in a place concordant with their wishes. To calculate agreement by preferred and actual site, participants who expressed a preference and died (n=111) in hospital, nursing home, home, or hospice setting were included in the analysis, and participants (n=4) who died in an unknown or other locations were excluded (eg, motel room).

Logistic Regression Modeling

2 tests were performed for all categorical variables to determine a significant association with outcome variables. Preferred place of death and concordance between preferred and actual site of death were modeled using predictive variables selected if univariable association demonstrated a P0.25. This standard cutoff was selected to broadly identify candidate variables for logistic regression modeling.[16] A stepwise algorithm was used to select significant predictors that would remain in the model.

In lieu of fitting a multinomial logit model for preferred site of death of home vs hospital vs nursing home or hospice facility as preferred site of death, 3 logit models (although only 2 may be sufficient to estimate the underlying multinomial logit model[17]) were considered with outcome categories: home vs nursing home or hospice facility, and hospital vs nursing home or hospice facility and home vs hospital.

For the logistic regression modeling of concordance, we included the full sample of patients who died during the follow‐up period (n=123). We classified participants as dying in a place concordant with their wishes or not concordant.

RESULTS

Study Population

Subjects were recruited on 96 post‐admission days totaling 842 admissions. Three hundred thirty‐one patients (39%) were ineligible for study participation (n=175 discharged within 24 hours, n=76 unable to consent, n=78 ineligible for other reasons [eg, prisoner, pregnant, under 18 years old], n=2 died within 24 hours of admission). Only 53 of the remaining 511 (10%) patients refused; 458 patients (90%) gave informed consent to participate. Characteristics of the study population are depicted in Table 1. There were very few missing cases (<3%), that is persons without a recent clinic follow‐up date, contact, or a confirmed date of death. These persons were considered alive. Overall, the sample population was ethnically diverse, slightly older than middle age, mostly male (due to the inclusion of the Veterans Administration hospital), and of low socioeconomic status.

Baseline Characteristics (n=458)
Mean age (SD), y57.9 (14.8)
  • NOTE: Abbreviations: CARING, Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines; DHMC, Denver Health Medical Center, DVAMC, Denver Veterans Affairs Medical Center; SD, standard deviation; UCH, University of Colorado Hospital.

  • Unstable living situation defined as either homeless, living in shelters, or with friends.

  • Low social support defined as Identifying 2 forms of social support (spouse/significant other, relatives, friends, church or other group) present in their life. Data are presented as % (n) unless otherwise noted.

Mean time to death (SD), d339.5 (348.4)
Ethnicity 
African American19% (88)
Caucasian52% (239)
Latino22% (102)
Other6% (29)
Spanish language only6% (27)
Female gender35% (159)
Admitted to DVAMC41% (188)
Admitted to DHMC38% (174)
Admitted to UCH21% (96)
CARING criteria 
Cancer diagnosis11% (51)
Admitted to hospital 2 times in the past year for chronic illness40% (181)
Resident in a nursing home2% (9)
Noncancer hospice guidelines (meeting 2)13% (59)
Income <$30,000/year84% (377)
No greater than high school education55% (248)
Home owner26% (120)
Rents home39% (177)
Unstable living situationa34% (156)
Low social supportb36% (165)
Uninsured18% (81)
Regular primary care provider73% (330)

Preferred Site of Death

When asked where they preferred to spend the last days of their life, 75% of patients (n=343) stated they would like to be at home. In the hospital was the preferred location for 10% of patients, whereas 6% stated a nursing home and 4% a hospice inpatient facility. Two percent stated they had no preference, and 3% refused to answer (Figure 1)

Figure 1
Preferred (n=458) and actual (n=121) site of death.

We found that in the univariable analysis the following factors were associated with preference for site of death at a significance level of P<0.25: unstable housing, hospital setting, income level, ethnicity, CARING criteria, presence of an advance directive, education level, married, primary care provider, and presence of public insurance. Results of the logit models (home vs nursing home or hospice facility, and hospital vs nursing home or hospice facility and home vs hospital) are presented in Table 2.

Logistic Regression Modeling of Preference for Death at Home or Hospital
 Adjusted Odds Ratio (95% Confidence Interval)
 Home vs Nursing Home/Hospice FacilityHospital vs Nursing Home/Hospice FacilityHome vs Hospital
  • NOTE: Abbreviations: CARING, Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines.

Low income2.71 (1.305.67)3.05 (1.019.24)0.99 (0.422.37)
Married2.44 (1.145.21)2.40 (0.876.62)0.82 (0.421.57)
CARING criteria0.58 (0.301.14)0.44 (0.181.09)0.89 (0.471.66)

Patients with income <$30,000/year were more likely to prefer home (or hospital) over a nursing home or hospice facility. Being married was predictive of preferring home over nursing home or hospice facility. Patients meeting 1 of the CARING criteria trended toward being less likely (P=0.11 for home and P=0.08 for hospital) to prefer home (or hospital) vs nursing home or hospice facility. However, there were no significant predictors for a preference for home or hospital when directly comparing the 2 locations, as expected from observing similar effects of variables in the other 2 logit models.

Actual Site of Death

One hundred twenty‐three patients died during the follow‐up period (26% of the total sample). Of those who died, the mean age was 64 years (standard deviation 13), 82% had annual incomes <$30,000, 73% were men, and 77% met at least 1 of the CARING criteria suggesting advanced medical illness. The distribution of ethnicities of the deceased subsample was similar to that of the overall cohort. Complete death records were obtained for 121 patients. Only 31% (n=38) died at home, whereas 35% (n=42) died in a hospital, 20% (n=24) died in a nursing home, and 12% (n=14) died in an inpatient hospice facility (Figure 1).

In univariable analysis, there were no associations at a 25% significance level between actual site of death and ethnicity, gender, age, severity of illness, high vs low social support, high or low socioeconomic status, stable vs unstable housing, or presence of a completed advance directive in the medical record.

Concordance Between Preferred and Actual Site of Death

Overall, 37% of the patients died where they stated they would prefer to die, including the 2 with no preference. Concordance rates for each site of death are presented in Table 3. We examined sociodemographic variables, disease severity, advance‐care planning, primary care provider, health insurance, and hospital site to look for associations with concordance. We found that female gender was positively associated with concordance (odds ratio [OR], 3.30; 95% confidence interval [CI], 1.25‐8.72). CARING criteria (P=0.06) and Latino ethnicity (vs all other ethnicity categories, P=0.12) also showed trends for association. Restricting to those who preferred home, the associations became stronger (OR, 4.62; 95% CI, 1.44‐14.79 for female; OR, 7.72; 95% CI, 1.67‐35.71 for CARING criteria), and the trend for the negative association between Latino ethnicity and concordance remained (P=0.12). Results of the model are shown in Table 4.

Concordance by Site of Preferred and Actual Site of Death With a Preferred Site (n=111)
 Actual Site of Death, n (Row %)Row Total, % Out of 111
 HospitalNursing HomeHomeHospice Facility
Preferred hospital5 (42%)3 (25%)2 (17%)2 (17%)12 (11%)
Preferred nursing home1 (13%)5 (63%)2 (25%)08 (7%)
Preferred home30 (34%)15 (17%)31 (35%)12 (14%)88 (79%)
Preferred hospice facility3 (100%)0003 (3%)
Predictors of Concordance Between Preferred and Actual Site of Death
 Adjusted Odds Ratio (95% Confidence Interval)
 AllHome (Using Same Variables)Home (Using Only Significant Variables)
  • NOTE: Abbreviations: CARING, Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines.

Female gender3.30 (1.258.72)4.62 (1.4414.79)3.57 (1.2410.34)
CARING criteria3.09 (0.979.81)7.72 (1.6735.71)5.93 (1.4124.91)
Latino vs African American/Caucasian/other0.43 (0.151.24)0.35 (0.091.30) 

DISCUSSION

We found, similarly to previous reports in the literature, the majority of patients preferred to die at home. We did not find a significant difference in preferences or location of death by ethnicity or illness severity. Lower‐income patients and married patients were more likely to prefer to be at home over a nursing home or a hospice facility in the last days of life. We found that the minority of patients died at their stated preferred site of death, and female gender was the only predictive variable we found to distinguish those patients who died in a place concordant with their wishes compared to those who did not.

In the literature, previous studies have reported concordance rates between preferred and actual site of death that range from 30% to 90%.[12, 13, 18, 19, 20, 21, 22, 23, 24] We found a concordance rate at the lowest end of this spectrum. In trying to understand our findings and place them in context, it is helpful to examine other studies. Many of these studies focused solely on cancer patients.[13, 18, 19, 20, 21, 22, 23] Cancer follows a more predictable trajectory of decline compared to other common life‐threatening illnesses, such as cardiac disease, emphysema, or liver failure, that often involve periods of acute deteriorations and plateaus throughout illness progression. The more predictable trajectory may explain the overall higher concordance rates found in the studies involving cancer patients.

The majority of studies in the literature examining concordance between preferred and actual site of death recruited the study sample from home health or home palliative care programs that were providing support and care to participants.[10, 12, 13, 18, 22, 25, 26, 27] The high concordance rates reported may be the result of the patients in the sample receiving services at home aimed at eliciting preferences and providing support at home. Our observational study is unique in that we elicited patient preferences from a diverse group of hospitalized adults. Patients had a broad range of medical illness and were at various stages in their disease trajectory. This allowed our findings to be more generalizable, a major strength of our study.

The only variable associated with concordance that we identified to predict concordance between preferred and actual site of death was female gender. Women have been shown to be more active in medical decision making, which may explain our findings.[28] Female gender and illness severity (as measured by the CARING criteria) were found to be associated with concordance when the preference is for death at home. For persons with more advanced medical illness, they may have had more opportunity to consider their preferences and talk about these preferences. It is even possible that our interview prompted some participants to have discussions with their families or providers.

Variables with high face validity, such as high social support, higher education, and completing an advance directive, did not demonstrate any effect on the outcome of concordance. Other studies have shown that low functional status, Caucasian ethnicity, home care, higher education, and social support have been associated with a greater likelihood for a home death.[3, 6, 9] However, although studies specifically examining concordance between preferred and actual site of death have looked at predictors for home death, we were unable to find predictors for concordance across all preferences in the literature. We can conclude from our findings that the factors that influence concordance of preferences for site of death are extremely complex and difficult to capture and measure. This is extremely unsatisfying in the face of the low concordance rate of 30% we identified.

Latino ethnicity showed a trend toward having a negative association with concordance between preferred and actual site of death. This trend persisted whether it was concordance overall or for concordance with those who preferred a death at home. In the literature, Latinos have been found to be less likely to complete advance directives, use hospice services at the end of life, and are more likely to experience a hospital death.[29, 30, 31, 32, 33] As care at the end of life continues to improve, careful attention should be paid to ensure that these kinds of gaps do not widen any further.

We interviewed patients at an index hospitalization. Patients had an acute medical illness or an exacerbation of a chronic medical illness and required at least 24 hours of hospitalization to be eligible for inclusion. Our bedside interview made use of an opportune time to question patients, a time when it may have been easier for patients to visualize severe illness at the end of life, rather than asking this question during a time of wellness. Although participants overwhelmingly stated they preferred to be at home, for those who died, decisions were made in their care that did not allow for this preference.

Our follow‐up after the initial bedside interview only included death records of where and when participants died. We do not have the details and narrative of the conversations that may have taken place that led to the care decisions that determined participants' actual place of death. We do not know if preferences were elicited or discussed, and care decisions then negotiated, to best meet the goals and preferences expressed at that time. We also do not know if the conversations did not occur and the default of medical intervention and cure‐focused care dictated how participants spent the last days of their life. There is evidence that when conversations about goals and preferences do occur, concordance between preferences and care received are high.[12, 21]

We were unable to identify any predictors beyond gender in this cohort of adults hospitalized with a broad spectrum of severe medical illness to predict concordance with stated preferences and actual site of death. We can conclude then, based on our findings and supported by the literature, that the default trends toward institutional end‐of‐life experiences. To shift to a more patient‐centered approach, away from the default, healthcare providers need to embrace a palliative approach and incorporate preferences and goals into the discussions about next steps of care to facilitate the peaceful death that the majority of patients imagine for themselves. Hospitalist physicians have a unique opportunity at an index hospitalization to start the conversation about preferences for care including where patients would want to spend the last days of their life.

Our study does have some limitations. We elicited preferences at a single point in time, at an index hospitalization. It is possible that participants' preferences changed over the course of their illness. However, in Agar et al.'s study of longitudinal patient preferences for site of death and place of care, most preferences remained stable over time.[18] We also did not have data that included palliative care involvement, homecare or hospice utilization, or cause of death. All of these variables may be important predictors of concordance. Issues of symptom management and lack of caregiver may also dictate place of death, even when goals and care are aligned. We do not have data to address these components of end‐of‐life decision making.

CONCLUSION

Patients continue to express a preference for death at home. However, the majority of patients experienced an institutional death. Furthermore, few participants achieved concordance with where they preferred to die and where they actually died. Female gender was the sole factor associated with concordance between preferred and actual site of death. Incorporating a palliative approach that elicits goals and helps match goals to care, may offer the best opportunity to help people die where they chose.

Disclosures: This research was supported by the Brookdale National Fellowship Award and the NIA/Beeson grant 5K23AG028957. All authors have seen and agree with the contents of the article. This submission was not under review by any other publication. The authors have no financial interest or other potential conflicts of interest.

At the turn of the 20th century, most deaths in the United States occurred at home. By the 1960s, over 70% of deaths occurred in an institutional setting, reflecting an evolution of medical technology.[1, 2, 3] With the birth of the hospice movement in the 1970s, dying patients had the opportunity to have both death at home and aggressive symptom control at the end of life. Although there has been a slow decline in the proportion of deaths that occur in the hospital over the past 2 decades,[3] the overwhelming majority of persons state that they would prefer to die at home. However, recent findings suggest that most people will die in an institutional setting.[3, 4, 5, 6]

Although good data exist describing population preferences for location of death, and we know, based on death records, where deaths occur in the United States, there are few studies that examine concordance between preferred and actual site of death at the individual patient level. Furthermore, although factors have been identified that predict death at home, factors predicting concordance between preferred and actual site of death are not well described.[3, 6, 7, 8, 9, 10, 11, 12, 13]

Regardless of where death ultimately occurs, most adults will experience multiple hospitalizations within the last years of their life. Understanding the preferences and subsequent experiences of this population is of particular relevance to hospitalist physicians who are in a unique position to elicit goals from seriously ill patients and help match patient preferences with their medical care. In this observational study, we sought to determine preferences for site of death in a cohort of adult patients admitted to the hospital for medical illness, and then follow those patients to determine where death occurred for those who died. We also sought to explore factors that may predict concordance between preferred and actual site of death. We hypothesized that ethnic diversity and lower socioeconomic status would be associated with a lower likelihood of concordance between preferred and actual site of death. We also hypothesized that advanced care planning would be associated with a higher likelihood of concordance. The Colorado Multi‐Institutional Review Board approved this study.

METHODS

Participants were recruited from 3 hospitals affiliated with the University of Colorado School of Medicine Internal Medicine Residency program, including the Denver Veterans' Administration Center (DVAMC), Denver Health Medical Center (DHMC), and University of Colorado Hospital (UCH). The DVAMC is a large urban Veterans Administration hospital, serving veterans from the Denver metro area, and is a tertiary referral center for veterans in rural Colorado, Wyoming, and parts of Montana. DHMC, the safety‐net hospital for the Denver area, serves over 25% of the residents in the city and county of Denver, including such special populations as the indigent, chronically mentally ill, and persons with polysubstance dependence. UCH had 350 licensed beds at the time of our study and serves as the Rocky Mountain region's only academic tertiary, specialty care, and referral center. At the time of this study, there was limited inpatient palliative care services at the DVAMC and UH, and no palliative care services at DHMC. Participants were screened on the first day following admission to the adult general medical service. Participants were recruited on 96 postadmission days between February 2004 and June 2006. Recruitment days varied from Monday through Friday, to include admissions from the weekend and throughout the year to reduce potential bias due to seasonal trends of diseases such as influenza. Patients were excluded if they died or were discharged within the first 24 hours of admission, were pregnant, jailed, or unable to give informed consent. All other patients were approached and invited to participate in a brief survey.

After informed consent was obtained, participants completed a bedside interview that included self‐identified ethnicity and the Berkman‐Syme Social Network Index,[14] a brief questionnaire quantifying social support from spouse or domestic partner, family, friends, and other religious or secular organizations. Baseline socioeconomic measures (eg, income, employment, home ownership, car ownership) and questions related to the last days of life were also included. Participants were asked the following question, If you were very sick, with an illness that could not be cured, and in bed most of the time, where would you spend the last days of your life if you could chose?

For each participant, we performed a detailed chart review to determine demographic data, presence of advance directives, and CARING criteria (Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines), a set of prognostic criteria identifying patients at an index hospitalization who have a high burden of illness and are at risk for death in the following year.[15] We then followed patients for 5 years. If participants died within the follow‐up period, we collected the date and location of death using medical records, death certificates, or in a few cases when official death records were unavailable, direct contact with the family. Participants were considered alive if they had a clinic visit or MD/RN phone contact within 3 months prior to the final collection point date.

Analysis

SAS 9.1 (SAS Institute Inc., Cary, NC) was used for all analyses. Simple frequencies and means statistics were used to determine rates of descriptive characteristics of the sample as well as rates of the measured outcomes, preferred place to spend last days of life, and actual site of death. Agreement or concordance between preferred and actual site of death was calculated. For the purposes of the analysis, we assumed all persons who stated they had no preference died in a place concordant with their wishes. To calculate agreement by preferred and actual site, participants who expressed a preference and died (n=111) in hospital, nursing home, home, or hospice setting were included in the analysis, and participants (n=4) who died in an unknown or other locations were excluded (eg, motel room).

Logistic Regression Modeling

2 tests were performed for all categorical variables to determine a significant association with outcome variables. Preferred place of death and concordance between preferred and actual site of death were modeled using predictive variables selected if univariable association demonstrated a P0.25. This standard cutoff was selected to broadly identify candidate variables for logistic regression modeling.[16] A stepwise algorithm was used to select significant predictors that would remain in the model.

In lieu of fitting a multinomial logit model for preferred site of death of home vs hospital vs nursing home or hospice facility as preferred site of death, 3 logit models (although only 2 may be sufficient to estimate the underlying multinomial logit model[17]) were considered with outcome categories: home vs nursing home or hospice facility, and hospital vs nursing home or hospice facility and home vs hospital.

For the logistic regression modeling of concordance, we included the full sample of patients who died during the follow‐up period (n=123). We classified participants as dying in a place concordant with their wishes or not concordant.

RESULTS

Study Population

Subjects were recruited on 96 post‐admission days totaling 842 admissions. Three hundred thirty‐one patients (39%) were ineligible for study participation (n=175 discharged within 24 hours, n=76 unable to consent, n=78 ineligible for other reasons [eg, prisoner, pregnant, under 18 years old], n=2 died within 24 hours of admission). Only 53 of the remaining 511 (10%) patients refused; 458 patients (90%) gave informed consent to participate. Characteristics of the study population are depicted in Table 1. There were very few missing cases (<3%), that is persons without a recent clinic follow‐up date, contact, or a confirmed date of death. These persons were considered alive. Overall, the sample population was ethnically diverse, slightly older than middle age, mostly male (due to the inclusion of the Veterans Administration hospital), and of low socioeconomic status.

Baseline Characteristics (n=458)
Mean age (SD), y57.9 (14.8)
  • NOTE: Abbreviations: CARING, Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines; DHMC, Denver Health Medical Center, DVAMC, Denver Veterans Affairs Medical Center; SD, standard deviation; UCH, University of Colorado Hospital.

  • Unstable living situation defined as either homeless, living in shelters, or with friends.

  • Low social support defined as Identifying 2 forms of social support (spouse/significant other, relatives, friends, church or other group) present in their life. Data are presented as % (n) unless otherwise noted.

Mean time to death (SD), d339.5 (348.4)
Ethnicity 
African American19% (88)
Caucasian52% (239)
Latino22% (102)
Other6% (29)
Spanish language only6% (27)
Female gender35% (159)
Admitted to DVAMC41% (188)
Admitted to DHMC38% (174)
Admitted to UCH21% (96)
CARING criteria 
Cancer diagnosis11% (51)
Admitted to hospital 2 times in the past year for chronic illness40% (181)
Resident in a nursing home2% (9)
Noncancer hospice guidelines (meeting 2)13% (59)
Income <$30,000/year84% (377)
No greater than high school education55% (248)
Home owner26% (120)
Rents home39% (177)
Unstable living situationa34% (156)
Low social supportb36% (165)
Uninsured18% (81)
Regular primary care provider73% (330)

Preferred Site of Death

When asked where they preferred to spend the last days of their life, 75% of patients (n=343) stated they would like to be at home. In the hospital was the preferred location for 10% of patients, whereas 6% stated a nursing home and 4% a hospice inpatient facility. Two percent stated they had no preference, and 3% refused to answer (Figure 1)

Figure 1
Preferred (n=458) and actual (n=121) site of death.

We found that in the univariable analysis the following factors were associated with preference for site of death at a significance level of P<0.25: unstable housing, hospital setting, income level, ethnicity, CARING criteria, presence of an advance directive, education level, married, primary care provider, and presence of public insurance. Results of the logit models (home vs nursing home or hospice facility, and hospital vs nursing home or hospice facility and home vs hospital) are presented in Table 2.

Logistic Regression Modeling of Preference for Death at Home or Hospital
 Adjusted Odds Ratio (95% Confidence Interval)
 Home vs Nursing Home/Hospice FacilityHospital vs Nursing Home/Hospice FacilityHome vs Hospital
  • NOTE: Abbreviations: CARING, Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines.

Low income2.71 (1.305.67)3.05 (1.019.24)0.99 (0.422.37)
Married2.44 (1.145.21)2.40 (0.876.62)0.82 (0.421.57)
CARING criteria0.58 (0.301.14)0.44 (0.181.09)0.89 (0.471.66)

Patients with income <$30,000/year were more likely to prefer home (or hospital) over a nursing home or hospice facility. Being married was predictive of preferring home over nursing home or hospice facility. Patients meeting 1 of the CARING criteria trended toward being less likely (P=0.11 for home and P=0.08 for hospital) to prefer home (or hospital) vs nursing home or hospice facility. However, there were no significant predictors for a preference for home or hospital when directly comparing the 2 locations, as expected from observing similar effects of variables in the other 2 logit models.

Actual Site of Death

One hundred twenty‐three patients died during the follow‐up period (26% of the total sample). Of those who died, the mean age was 64 years (standard deviation 13), 82% had annual incomes <$30,000, 73% were men, and 77% met at least 1 of the CARING criteria suggesting advanced medical illness. The distribution of ethnicities of the deceased subsample was similar to that of the overall cohort. Complete death records were obtained for 121 patients. Only 31% (n=38) died at home, whereas 35% (n=42) died in a hospital, 20% (n=24) died in a nursing home, and 12% (n=14) died in an inpatient hospice facility (Figure 1).

In univariable analysis, there were no associations at a 25% significance level between actual site of death and ethnicity, gender, age, severity of illness, high vs low social support, high or low socioeconomic status, stable vs unstable housing, or presence of a completed advance directive in the medical record.

Concordance Between Preferred and Actual Site of Death

Overall, 37% of the patients died where they stated they would prefer to die, including the 2 with no preference. Concordance rates for each site of death are presented in Table 3. We examined sociodemographic variables, disease severity, advance‐care planning, primary care provider, health insurance, and hospital site to look for associations with concordance. We found that female gender was positively associated with concordance (odds ratio [OR], 3.30; 95% confidence interval [CI], 1.25‐8.72). CARING criteria (P=0.06) and Latino ethnicity (vs all other ethnicity categories, P=0.12) also showed trends for association. Restricting to those who preferred home, the associations became stronger (OR, 4.62; 95% CI, 1.44‐14.79 for female; OR, 7.72; 95% CI, 1.67‐35.71 for CARING criteria), and the trend for the negative association between Latino ethnicity and concordance remained (P=0.12). Results of the model are shown in Table 4.

Concordance by Site of Preferred and Actual Site of Death With a Preferred Site (n=111)
 Actual Site of Death, n (Row %)Row Total, % Out of 111
 HospitalNursing HomeHomeHospice Facility
Preferred hospital5 (42%)3 (25%)2 (17%)2 (17%)12 (11%)
Preferred nursing home1 (13%)5 (63%)2 (25%)08 (7%)
Preferred home30 (34%)15 (17%)31 (35%)12 (14%)88 (79%)
Preferred hospice facility3 (100%)0003 (3%)
Predictors of Concordance Between Preferred and Actual Site of Death
 Adjusted Odds Ratio (95% Confidence Interval)
 AllHome (Using Same Variables)Home (Using Only Significant Variables)
  • NOTE: Abbreviations: CARING, Cancer, Admissions 2, Residence in a nursing home, Intensive care unit admit with multiorgan failure, 2 Noncancer hospice Guidelines.

Female gender3.30 (1.258.72)4.62 (1.4414.79)3.57 (1.2410.34)
CARING criteria3.09 (0.979.81)7.72 (1.6735.71)5.93 (1.4124.91)
Latino vs African American/Caucasian/other0.43 (0.151.24)0.35 (0.091.30) 

DISCUSSION

We found, similarly to previous reports in the literature, the majority of patients preferred to die at home. We did not find a significant difference in preferences or location of death by ethnicity or illness severity. Lower‐income patients and married patients were more likely to prefer to be at home over a nursing home or a hospice facility in the last days of life. We found that the minority of patients died at their stated preferred site of death, and female gender was the only predictive variable we found to distinguish those patients who died in a place concordant with their wishes compared to those who did not.

In the literature, previous studies have reported concordance rates between preferred and actual site of death that range from 30% to 90%.[12, 13, 18, 19, 20, 21, 22, 23, 24] We found a concordance rate at the lowest end of this spectrum. In trying to understand our findings and place them in context, it is helpful to examine other studies. Many of these studies focused solely on cancer patients.[13, 18, 19, 20, 21, 22, 23] Cancer follows a more predictable trajectory of decline compared to other common life‐threatening illnesses, such as cardiac disease, emphysema, or liver failure, that often involve periods of acute deteriorations and plateaus throughout illness progression. The more predictable trajectory may explain the overall higher concordance rates found in the studies involving cancer patients.

The majority of studies in the literature examining concordance between preferred and actual site of death recruited the study sample from home health or home palliative care programs that were providing support and care to participants.[10, 12, 13, 18, 22, 25, 26, 27] The high concordance rates reported may be the result of the patients in the sample receiving services at home aimed at eliciting preferences and providing support at home. Our observational study is unique in that we elicited patient preferences from a diverse group of hospitalized adults. Patients had a broad range of medical illness and were at various stages in their disease trajectory. This allowed our findings to be more generalizable, a major strength of our study.

The only variable associated with concordance that we identified to predict concordance between preferred and actual site of death was female gender. Women have been shown to be more active in medical decision making, which may explain our findings.[28] Female gender and illness severity (as measured by the CARING criteria) were found to be associated with concordance when the preference is for death at home. For persons with more advanced medical illness, they may have had more opportunity to consider their preferences and talk about these preferences. It is even possible that our interview prompted some participants to have discussions with their families or providers.

Variables with high face validity, such as high social support, higher education, and completing an advance directive, did not demonstrate any effect on the outcome of concordance. Other studies have shown that low functional status, Caucasian ethnicity, home care, higher education, and social support have been associated with a greater likelihood for a home death.[3, 6, 9] However, although studies specifically examining concordance between preferred and actual site of death have looked at predictors for home death, we were unable to find predictors for concordance across all preferences in the literature. We can conclude from our findings that the factors that influence concordance of preferences for site of death are extremely complex and difficult to capture and measure. This is extremely unsatisfying in the face of the low concordance rate of 30% we identified.

Latino ethnicity showed a trend toward having a negative association with concordance between preferred and actual site of death. This trend persisted whether it was concordance overall or for concordance with those who preferred a death at home. In the literature, Latinos have been found to be less likely to complete advance directives, use hospice services at the end of life, and are more likely to experience a hospital death.[29, 30, 31, 32, 33] As care at the end of life continues to improve, careful attention should be paid to ensure that these kinds of gaps do not widen any further.

We interviewed patients at an index hospitalization. Patients had an acute medical illness or an exacerbation of a chronic medical illness and required at least 24 hours of hospitalization to be eligible for inclusion. Our bedside interview made use of an opportune time to question patients, a time when it may have been easier for patients to visualize severe illness at the end of life, rather than asking this question during a time of wellness. Although participants overwhelmingly stated they preferred to be at home, for those who died, decisions were made in their care that did not allow for this preference.

Our follow‐up after the initial bedside interview only included death records of where and when participants died. We do not have the details and narrative of the conversations that may have taken place that led to the care decisions that determined participants' actual place of death. We do not know if preferences were elicited or discussed, and care decisions then negotiated, to best meet the goals and preferences expressed at that time. We also do not know if the conversations did not occur and the default of medical intervention and cure‐focused care dictated how participants spent the last days of their life. There is evidence that when conversations about goals and preferences do occur, concordance between preferences and care received are high.[12, 21]

We were unable to identify any predictors beyond gender in this cohort of adults hospitalized with a broad spectrum of severe medical illness to predict concordance with stated preferences and actual site of death. We can conclude then, based on our findings and supported by the literature, that the default trends toward institutional end‐of‐life experiences. To shift to a more patient‐centered approach, away from the default, healthcare providers need to embrace a palliative approach and incorporate preferences and goals into the discussions about next steps of care to facilitate the peaceful death that the majority of patients imagine for themselves. Hospitalist physicians have a unique opportunity at an index hospitalization to start the conversation about preferences for care including where patients would want to spend the last days of their life.

Our study does have some limitations. We elicited preferences at a single point in time, at an index hospitalization. It is possible that participants' preferences changed over the course of their illness. However, in Agar et al.'s study of longitudinal patient preferences for site of death and place of care, most preferences remained stable over time.[18] We also did not have data that included palliative care involvement, homecare or hospice utilization, or cause of death. All of these variables may be important predictors of concordance. Issues of symptom management and lack of caregiver may also dictate place of death, even when goals and care are aligned. We do not have data to address these components of end‐of‐life decision making.

CONCLUSION

Patients continue to express a preference for death at home. However, the majority of patients experienced an institutional death. Furthermore, few participants achieved concordance with where they preferred to die and where they actually died. Female gender was the sole factor associated with concordance between preferred and actual site of death. Incorporating a palliative approach that elicits goals and helps match goals to care, may offer the best opportunity to help people die where they chose.

Disclosures: This research was supported by the Brookdale National Fellowship Award and the NIA/Beeson grant 5K23AG028957. All authors have seen and agree with the contents of the article. This submission was not under review by any other publication. The authors have no financial interest or other potential conflicts of interest.

References
  1. Field MJ, Cassel CK, eds. Committee on Care at the End of Life. Approaching Death: Improving Care at the End of Life. Washington DC: National Academy Press; 1997.
  2. Brock DB, Foley DJ. Demography and epidemiology of dying in the U.S. with emphasis on deaths of older persons. Hosp J. 1998;13:4960.
  3. Weitzen S, Teno JM, Fennell M, Mor V. Factors associated with site of death: a national study of where people die. Med Care. 2003;41:323335.
  4. Townsend J, Fermont D, Dyer S, Karran O, Walgrove A, Piper M. Terminal cancer care and patient's preferences for place of death: a prospective study. BMJ. 1990;301:415417.
  5. Pritchard RS, Fisher ES, Teno JM, et al. Influence of patient preferences and local health system characteristics on the place of death. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Risks and Outcomes of Treatment. J Am Geriatr Soc. 1998;46:12421250.
  6. Gruneir A, Mor V, Weitzen S, Truchil R, Teno J, Roy J. Where people die: a multilevel approach to understanding influences on site of death in America. Med Care Res Rev. 2007;64:351378.
  7. Cohen J, Bilsen J, Hooft P, Deboosere P, Wal G, Deliens L. Dying at home or in an institution using death certificates to explore the factors associated with place of death. Health Policy. 2006;78:319329.
  8. Karlsen S, Addington‐Hall J. How do cancer patients who die at home differ from those who die elsewhere? Palliat Med. 1998;12:279286.
  9. Gomes B, Higginson IJ. Factors influencing death at home in terminally ill patients with cancer: systematic review [published correction appears in BMJ. 2006;332:1012]. BMJ 2006;332:515521.
  10. Gyllenhammar E, Thoren‐Todoulos E, Strang P, Strom G, Eriksson E, Kinch M. Predictive factors for home deaths among cancer patients in Swedish palliative home care. Support Care Cancer. 2003;11:560567.
  11. Gyllenhammar E, Nordfors LO. Systemic adenosine infusions alleviated neuropathic pain. Pain. 2001;94:121122.
  12. Leff B, Kaffenbarger KP, Remsburg R. Prevalence, effectiveness, and predictors of planning their place of death among older persons followed in community‐based long term care. J Am Geriatr Soc. 2000;48:943948.
  13. Brazil K, Howell D, Bedard M, Krueger P, Heidebrecht C. Preferences for place of care and place of death among informal caregivers of the terminally ill. Palliat Med. 2005;19:492499.
  14. Berkman LF, Syme SL. Social networks, host resistance, and mortality: a nine‐year follow‐up study of Alameda County residents. Am J Epidemiol. 1979;109:186204.
  15. Fischer SM, Gozansky WS, Sauaia A, Min SJ, Kutner JS, Kramer A. A practical tool to identify patients who may benefit from a palliative approach: the CARING criteria. J Pain Symptom Manage. 2006;31:285292.
  16. Hosmer DW, Lemeshow S. Applied Logistic Regression. 2nd ed. New York, NY: Wiley‐Interscience; 2000.
  17. Begg CB, Gray R. Calculation of polychotmous logistic regression parameters using individualized regressions. Biometrika. 1984;71:1118.
  18. Agar M, Currow DC, Shelby‐James TM, Plummer J, Sanderson C, Abernethy AP. Preference for place of care and place of death in palliative care: are these different questions? Palliat Med. 2008;22(7):787795.
  19. Thomas C, Morris SM, Clark D. Place of death: preferences among cancer patients and their carers. Soc Sci Med. 2004;58:24312444.
  20. Tang ST, McCorkle R. Determinants of congruence between the preferred and actual place of death for terminally ill cancer patients. J Palliat Care. 2003;19:230237.
  21. McWhinney IR, Bass MJ, Orr V. Factors associated with location of death (home or hospital) of patients referred to a palliative care team. CMAJ. 1995;152:361367.
  22. Bakitas M, Ahles TA, Skalla K, et al. Proxy perspectives regarding end‐of‐life care for persons with cancer. Cancer. 2008;112:18541861.
  23. Beccaro M, Costantini M, Giorgi Rossi P, Miccinesi G, Grimaldi M, Bruzzi P. Actual and preferred place of death of cancer patients. Results from the Italian survey of the dying of cancer (ISDOC). J Epidemiol Community Health. 2006;60:412416.
  24. Tolle SW, Tilden VP, Rosenfeld AG, Hickman SE. Family reports of barriers to optimal care of the dying. Nurs Res. 2000;49:310317.
  25. Thomas C, Morris SM, Clark D. Place of death: preferences among cancer patients and their carers. Soc Sci Med. 2004;58(12):24312444.
  26. Groth‐Juncker A, McCusker J. Where do elderly patients prefer to die? Place of death and patient characteristics of 100 elderly patients under the care of a home health care team. J Am Geriatr Soc. 1983;31:457461.
  27. Cantwell P, Turco S, Brenneis C, Hanson J, Neumann CM, Bruera E. Predictors of home death in palliative care cancer patients. J Palliat Care. 2000;16:2328.
  28. Arora NK, McHorney CA. Patient preferences for medical decision making: who really wants to participate? Med Care. 2000;38:335341.
  29. Smith AK, McCarthy EP, Paulk E, et al. Racial and ethnic differences in advance care planning among patients with cancer: impact of terminal illness acknowledgment, religiousness, and treatment preferences. J Clin Oncol. 2008;26:41314137.
  30. Romero LJ, Lindeman RD, Koehler KM, Allen A. Influence of ethnicity on advance directives and end‐of‐life decisions. JAMA. 1997;277:298299.
  31. McKinley ED, Garrett JM, Evans AT, Danis M. Differences in end‐of‐life decision making among black and white ambulatory cancer patients. J Gen Intern Med. 1996;11:651656.
  32. Greiner KA, Perera S, Ahluwalia JS. Hospice usage by minorities in the last year of life: results from the National Mortality Feedback Survey. J Am Geriatr Soc. 2003;51:970978.
  33. Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers' mental health. J Clin Oncol. 2010;28:44574464.
References
  1. Field MJ, Cassel CK, eds. Committee on Care at the End of Life. Approaching Death: Improving Care at the End of Life. Washington DC: National Academy Press; 1997.
  2. Brock DB, Foley DJ. Demography and epidemiology of dying in the U.S. with emphasis on deaths of older persons. Hosp J. 1998;13:4960.
  3. Weitzen S, Teno JM, Fennell M, Mor V. Factors associated with site of death: a national study of where people die. Med Care. 2003;41:323335.
  4. Townsend J, Fermont D, Dyer S, Karran O, Walgrove A, Piper M. Terminal cancer care and patient's preferences for place of death: a prospective study. BMJ. 1990;301:415417.
  5. Pritchard RS, Fisher ES, Teno JM, et al. Influence of patient preferences and local health system characteristics on the place of death. SUPPORT Investigators. Study to Understand Prognoses and Preferences for Risks and Outcomes of Treatment. J Am Geriatr Soc. 1998;46:12421250.
  6. Gruneir A, Mor V, Weitzen S, Truchil R, Teno J, Roy J. Where people die: a multilevel approach to understanding influences on site of death in America. Med Care Res Rev. 2007;64:351378.
  7. Cohen J, Bilsen J, Hooft P, Deboosere P, Wal G, Deliens L. Dying at home or in an institution using death certificates to explore the factors associated with place of death. Health Policy. 2006;78:319329.
  8. Karlsen S, Addington‐Hall J. How do cancer patients who die at home differ from those who die elsewhere? Palliat Med. 1998;12:279286.
  9. Gomes B, Higginson IJ. Factors influencing death at home in terminally ill patients with cancer: systematic review [published correction appears in BMJ. 2006;332:1012]. BMJ 2006;332:515521.
  10. Gyllenhammar E, Thoren‐Todoulos E, Strang P, Strom G, Eriksson E, Kinch M. Predictive factors for home deaths among cancer patients in Swedish palliative home care. Support Care Cancer. 2003;11:560567.
  11. Gyllenhammar E, Nordfors LO. Systemic adenosine infusions alleviated neuropathic pain. Pain. 2001;94:121122.
  12. Leff B, Kaffenbarger KP, Remsburg R. Prevalence, effectiveness, and predictors of planning their place of death among older persons followed in community‐based long term care. J Am Geriatr Soc. 2000;48:943948.
  13. Brazil K, Howell D, Bedard M, Krueger P, Heidebrecht C. Preferences for place of care and place of death among informal caregivers of the terminally ill. Palliat Med. 2005;19:492499.
  14. Berkman LF, Syme SL. Social networks, host resistance, and mortality: a nine‐year follow‐up study of Alameda County residents. Am J Epidemiol. 1979;109:186204.
  15. Fischer SM, Gozansky WS, Sauaia A, Min SJ, Kutner JS, Kramer A. A practical tool to identify patients who may benefit from a palliative approach: the CARING criteria. J Pain Symptom Manage. 2006;31:285292.
  16. Hosmer DW, Lemeshow S. Applied Logistic Regression. 2nd ed. New York, NY: Wiley‐Interscience; 2000.
  17. Begg CB, Gray R. Calculation of polychotmous logistic regression parameters using individualized regressions. Biometrika. 1984;71:1118.
  18. Agar M, Currow DC, Shelby‐James TM, Plummer J, Sanderson C, Abernethy AP. Preference for place of care and place of death in palliative care: are these different questions? Palliat Med. 2008;22(7):787795.
  19. Thomas C, Morris SM, Clark D. Place of death: preferences among cancer patients and their carers. Soc Sci Med. 2004;58:24312444.
  20. Tang ST, McCorkle R. Determinants of congruence between the preferred and actual place of death for terminally ill cancer patients. J Palliat Care. 2003;19:230237.
  21. McWhinney IR, Bass MJ, Orr V. Factors associated with location of death (home or hospital) of patients referred to a palliative care team. CMAJ. 1995;152:361367.
  22. Bakitas M, Ahles TA, Skalla K, et al. Proxy perspectives regarding end‐of‐life care for persons with cancer. Cancer. 2008;112:18541861.
  23. Beccaro M, Costantini M, Giorgi Rossi P, Miccinesi G, Grimaldi M, Bruzzi P. Actual and preferred place of death of cancer patients. Results from the Italian survey of the dying of cancer (ISDOC). J Epidemiol Community Health. 2006;60:412416.
  24. Tolle SW, Tilden VP, Rosenfeld AG, Hickman SE. Family reports of barriers to optimal care of the dying. Nurs Res. 2000;49:310317.
  25. Thomas C, Morris SM, Clark D. Place of death: preferences among cancer patients and their carers. Soc Sci Med. 2004;58(12):24312444.
  26. Groth‐Juncker A, McCusker J. Where do elderly patients prefer to die? Place of death and patient characteristics of 100 elderly patients under the care of a home health care team. J Am Geriatr Soc. 1983;31:457461.
  27. Cantwell P, Turco S, Brenneis C, Hanson J, Neumann CM, Bruera E. Predictors of home death in palliative care cancer patients. J Palliat Care. 2000;16:2328.
  28. Arora NK, McHorney CA. Patient preferences for medical decision making: who really wants to participate? Med Care. 2000;38:335341.
  29. Smith AK, McCarthy EP, Paulk E, et al. Racial and ethnic differences in advance care planning among patients with cancer: impact of terminal illness acknowledgment, religiousness, and treatment preferences. J Clin Oncol. 2008;26:41314137.
  30. Romero LJ, Lindeman RD, Koehler KM, Allen A. Influence of ethnicity on advance directives and end‐of‐life decisions. JAMA. 1997;277:298299.
  31. McKinley ED, Garrett JM, Evans AT, Danis M. Differences in end‐of‐life decision making among black and white ambulatory cancer patients. J Gen Intern Med. 1996;11:651656.
  32. Greiner KA, Perera S, Ahluwalia JS. Hospice usage by minorities in the last year of life: results from the National Mortality Feedback Survey. J Am Geriatr Soc. 2003;51:970978.
  33. Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers' mental health. J Clin Oncol. 2010;28:44574464.
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Where do you want to spend your last days of life? Low concordance between preferred and actual site of death among hospitalized adults
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Address for correspondence and reprint requests: Stacy Fischer, MD, Division of General Internal Medicine, Academic Office 1, General Internal Medicine, 8th Floor, 12631 East 17th Ave., Aurora, CO 80045; Telephone: 303‐724‐2406; E‐mail: [email protected]
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Deterioration Alerts on Medical Wards

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A trial of a real‐time Alert for clinical deterioration in Patients hospitalized on general medical wards

Timely interventions are essential in the management of complex medical conditions such as new‐onset sepsis in order to prevent rapid progression to severe sepsis and septic shock.[1, 2, 3, 4, 5] Similarly, rapid identification and appropriate treatment of other medical and surgical conditions have been associated with improved outcomes.[6, 7, 8] We previously developed a real‐time, computerized prediction tool (PT) using recursive partitioning regression tree analysis for the identification of impending sepsis for use on general hospital wards.[9] We also showed that implementation of a real‐time computerized sepsis alert on hospital wards based on the PT resulted in increased use of early interventions, including antibiotic escalation, intravenous fluids, oxygen therapy, and diagnostics in patients identified as at risk.[10]

The first goal of this study was to develop an updated PT for use on hospital wards that could be used to predict subsequent global clinical deterioration and the need for a higher level of care. The second goal was to determine whether simply providing a real‐time alert to nursing staff based on the updated PT resulted in any demonstrable changes in patient outcomes.

METHODS

Study Location

The study was conducted at Barnes‐Jewish Hospital, a 1250‐bed academic medical center in St. Louis, Missouri. Eight adult medicine wards were assessed from July 2007 through December 2011. The medicine wards are closed areas with patient care delivered by dedicated house staff physicians under the supervision of a board‐certified attending physician. The study was approved by the Washington University School of Medicine Human Studies Committee.

Study Period

The period from July 2007 through January 2010 was used to train and retrospectively test the prediction model. The period from January 2011 through December 2011 was used to prospectively validate the model during a randomized trial using alerts generated from the prediction model.

Patients

Electronically captured clinical data were housed in a centralized clinical data repository. This repository cataloged 28,927 hospital visits from 19,116 distinct patients between July 2007 and January 2010. It contained a rich set of demographic and medical data for each of the visits, such as patient age, manually collected vital‐sign data, pharmacy data, laboratory data, and intensive care unit (ICU) transfer. This study served as a proof of concept for our vision of using machine learning to identify at‐risk patients and ultimately to perform real‐time event detection and interventions.

Algorithm Overview

Details regarding the predictive model development have been previously described.[11] To predict ICU transfer for patients housed on general medical wards, we used logistic regression, employing a novel framework to analyze the data stream from each patient, assigning scores to reflect the probability of ICU transfer to each patient.

Before building the model, several preprocessing steps were applied to eliminate outliers and find an appropriate representation of patients' states. For each of 36 input variables we specified acceptable ranges based on the domain knowledge of the medical experts on our team. For any value that was outside of the medically conceivable range, we replaced it by the mean value for that patient, if available. Values for every continuous parameter were scaled so that all measurements lay in the interval [0, 1] and were normalized by the minimum and maximum of the parameter. To capture the temporal effects in our data, we retained a sliding window of all the collected data points within the last 24 hours. We then subdivided these data into a series of 6 sequential buckets of 4 hours each.

To capture variations within a bucket, we computed 3 values for each feature in the bucket: the minimum, maximum, and mean data points. Each of the resulting 3n values was input to the logistic regression equation as separate variables. To deal with missing data points within the buckets, we used the patients' most recent reading from any time earlier in the hospital stay, if available. If no prior values existed, we used mean values calculated over the entire historical dataset. Bucket 6 max/min/mean represents the most recent 4‐hour window from the preceding 24‐hour time period for the maximum, minimum, and mean values, respectively. By itself, logistic regression does not operate on time‐series data. That is, each variable input to the logistic equation corresponds to exactly 1 data point (eg, a blood‐pressure variable would consist of a single blood‐pressure reading). In a clinical application, however, it is important to capture unusual changes in vital‐sign data over time. Such changes may precede clinical deterioration by hours, providing a chance to intervene if detected early enough. In addition, not all readings in time‐series data should be treated equally; the value of some kinds of data may change depending on their age. For example, a patient's condition may be better reflected by a blood‐oxygenation reading collected 1 hour ago than a reading collected 12 hours ago. This is the rationale for our use of a sliding window of all collected data points within the last 24 hours performed in a real‐time basis.

The algorithm was first implemented in MATLAB (Natick, MA). For the purposes of training, we used a single 24‐hour window of data from each patient. For patients admitted to ICU, this window was 26 hours to 2 hours prior to ICU admission; for all other patients, this window consisted of the first 24 hours of their hospital stay. The dataset's 36 input variables were divided into buckets and min/mean/max features wherever applicable, resulting in 398 variables. The first half of the dataset was used to train the model. We then used the second half of the dataset as the validation dataset. We generated a predicted outcome for each case in the validation data, using the model parameter coefficients derived from the training data. We also employed bootstrap aggregation to improve classification accuracy and to address overfitting. We then applied various threshold cut‐points to convert these predictions into binary values and compared the results against the ICU transfer outcome. A threshold of 0.9760 for specificity was chosen to achieve a sensitivity of approximately 40%. These operating characteristics were chosen in turn to generate a manageable number of alerts per hospital nursing unit per day (estimated at 12 per nursing unit per day). At this cut‐point the C‐statistic was 0.8834, with an overall accuracy of 0.9292.

In order to train the logistic model, we used a single 24‐hour window of data for each patient. However, in a system that predicts patients' outcomes in real time, scores are recomputed each time new data are entered into the database. Hence, patients have a series of scores over the length of their hospital stay, and an alert is triggered when any one of these scores is above the chosen threshold.

Once the model was developed, we implemented it in an internally developed, Java‐based clinical decision support rules engine, which identified when new data relevant to the model were available in a real‐time central data repository. The rules engine queried the data repository to acquire all data needed to evaluate the model. The score was calculated with each relevant new data point, and an alert was generated when the score exceeded the cut‐point threshold. We then prospectively validated these alerts on patients on 8 general medical wards at Barnes Jewish Hospital. Details regarding the architecture of our clinical decision support system have been previously published.[12] The sensitivity and positive predictive values for ICU transfer for these alerts were tracked during an intervention trial that ran from January 24, 2011, through December 31, 2011. Four general medical wards were randomized to the intervention group and 4 wards were randomized to the control group. The 8 general medical wards were ordered according to their alert rates based upon the historical data from July 2007 through January 2010, creating 4 pairs of wards in ascending order of alert rate. Within each of the 4 pairs, 1 member of the pair was randomized to the intervention group and the other to the control group using a random number generator.

Real‐time automated alerts generated 24 hours per day, 7 days per week from the predictive algorithm were sent to the charge‐nurse pager on the intervention units. Alerts were also generated and stored in the database on the control units, but these alerts were not sent to the charge nurse on those units. The alerts were sent to the charge nurses on the respective wards, as these individuals were thought to be in the best position to perform the initial assessment of the alerted patients, especially during evening hours when physician staffing was reduced. The charge nurses assessed the intervention‐group patients and were instructed to contact the responsible physician (hospitalist or internal medicine house officer) to inform them of the alert, or to call the rapid response team (RRT) if the patient's condition already appeared to be significantly deteriorating.

Descriptive statistics for algorithm sensitivity and positive predictive value and for patient outcomes were performed. Associations between alerts and the primary outcome, ICU transfer, were determined, as well as the impact of alerts in the intervention group compared with the control group, using [2] tests. The same analyses were performed for patient death. Differences in length of stay (LOS) were assessed using the Wilcoxon rank sum test.

RESULTS

Predictive Model

The variables with the greatest coefficients contributing to the PT model included respiratory rate, oxygen saturation, shock index, systolic blood pressure, anticoagulation use, heart rate, and diastolic blood pressure. A complete list of variables is provided in the Appendix (see Supporting Information in the online version of this article). All but 1 are routinely collected vital‐sign measures, and all but 1 occur in the 4‐hour period immediately prior to the alert (bucket 6).

Prospective Trial

Patient characteristics are presented in Table 1. Patients were well matched for race, sex, age, and underlying diagnoses. All alerts reported to the charge nurses were to be associated with a call from the charge nurse to the responsible physician caring for the alerted patient. The mean number of alerts per alerted patient was 1.8 (standard deviation=1.7). Patients meeting the alert threshold were at nearly 5.3‐fold greater risk of ICU transfer (95% confidence interval [CI]: 4.6‐6.0) than those not satisfying the alert threshold (358 of 2353 [15.2%; 95% CI: 13.8%‐16.7%] vs 512 of 17678 [2.9%; 95% CI: 2.7%‐3.2%], respectively; P<0.0001). Patients with alerts were at 8.9‐fold greater risk of death (95% CI: 7.4‐10.7) than those without alerts (244 of 2353 [10.4%; 95% CI: 9.2%‐11.7%] vs 206 of 17678 [1.2%; 95% CI: 1.0%‐1.3%], respectively; P<0.0001). Operating characteristics of the PT from the prospective trial are shown in Table 2. Alerts occurred a median of 25.5 hours prior to ICU transfer (interquartile range, 7.00‐81.75) and 8 hours prior to death (interquartile range, 4.09‐15.66).

Demographics by Study Group
 Study Group
 Control (N=10,120)Intervention (N=9911)
  • NOTE: No significant differences between study groups. Abbreviations: F, female; ICD‐9, International Classification of Diseases, 9th Revision; IQR, interquartile range; M, male.

RaceN%N%
White5,062504,93450
Black4,864484,79048
Other19421872
Sex    
F5,355535,30854
M4,765474,60346
Age at discharge, median (IQR), y57 (4469)57 (4470)
Top 10 ICD‐9 descriptions and counts, n (%)   
1Diseases of the digestive system1,774 (17.5)Diseases of the digestive system1,664 (16.7)
2Diseases of the circulatory system1,252 (12.4)Diseases of the circulatory system1,253 (12.6)
3Diseases of the respiratory system1,236 (12.2)Diseases of the respiratory system1,210 (12.2)
4Injury and poisoning864 (8.5)Injury and poisoning849 (8.6)
5Endocrine, nutritional, and metabolic diseases, and immunity disorders797 (7.9)Diseases of the genitourinary system795 (8.0)
6Diseases of the genitourinary system762 (7.5)Endocrine, nutritional, and metabolic diseases, and immunity disorders780 (7.9)
7Infectious and parasitic diseases555 (5.5)Infectious and parasitic diseases549 (5.5)
8Neoplasms547 (5.4)Neoplasms465 (4.7)
9Diseases of the blood and blood‐forming organs426 (4.2)Diseases of the blood and blood‐forming organs429 (4.3)
10Symptoms, signs, and ill‐defined conditions and factors influencing health status410 (4.1)Diseases of the musculoskeletal system and connective tissue399 (4.0)
Prediction ToolGenerated Alerts and Outcomes
 Sensitivity, %Specificity, %PPV, %NPV, %Positive Likelihood RatioNegative Likelihood Ratio
  • NOTE: Abbreviations: CI, confidence interval; ICU, intensive care unit; NPV, negitive predictive value; PPV, positive predictive value.

ICU TransferYes (N=870)No (N=19,161)      
Alert3581,99541.1 (95% CI: 37.944.5)89.6 (95% CI: 89.290.0)15.2 (95% CI: 13.816.7)97.1 (95% CI: 96.897.3)3.95 (95% CI: 3.614.30)0.66 (95% CI: 0.620.70)
No Alert51217,166      
DeathYes (N=450)No (N=19,581)      
Alert244210954.2 (95% CI: 49.658.8)89.2 (95% CI: 88.889.7)10.4 (95% CI: 9.211.7)98.8 (95% CI: 98.799.0)5.03 (95% CI: 4.585.53)0.51 (95% CI: 0.460.57)
No Alert20617,472      

Among patients identified by the PT, there were no differences in the proportion of patients who were transferred to the ICU or who died in the intervention group as compared with the control group (Table 3). In addition, although there was no difference in LOS in the intervention group compared with the control group, identification by the PT was associated with a significantly longer median LOS (7.01 days vs 2.94 days, P<0.001). The largest numbers of patients who were transferred to the ICU or died did so in the first hospital day, and 60% of patients who were transferred to the ICU did so in the first 4 days, whereas deaths were more evenly distributed across the hospital stay.

Outcomes (ICU Transfer, Mortality, and LOS) by Study Group and Alert
 Outcomes by Alert Statusa
Alert Study GroupNo‐Alert Study Group
Intervention, N=1194Control, N=1159Intervention, N=8717Control, N=8961
N%N%N%N%
  • NOTE: No significant differences between study groups. Abbreviations: ICU, intensive care unit; IQR, interquartile range; LOS, length of stay

  • LOS significantly differed by alert status (P<0.01).

ICU Transfer        
Yes192161661425232603
No10028499386846597870197
Death        
Yes12711117109611101
No106789104290862199885199
LOS from admit to discharge, median (IQR), da7.07 (3.9912.15)6.92 (3.8212.67)2.97 (1.775.33)2.91 (1.745.19)

DISCUSSION

We have demonstrated that a relatively simple hospital‐specific method for generating a PT derived from routine laboratory and hemodynamic values is capable of predicting clinical deterioration and the need for ICU transfer, as well as hospital mortality, in non‐ICU patients admitted to general hospital wards. We also found that the PT identified a sicker patient population as manifest by longer hospital LOS. The methods used in generating this real‐time PT are relatively simple and easily executed with the use of an electronic medical record (EMR) system. However, our data also showed that simply providing an alert to nursing units based on the PT did not result in any demonstrable improvement in patient outcomes. Moreover, our PT and intervention in their current form have substantial limitations, including low sensitivity and positive predictive value, high possibility of alert fatigue, and no clear clinical impact. These limitations suggest that this approach has limited applicability in its current form.

Unplanned ICU transfers occurring as early as within 8 hours of hospitalization are relatively common and associated with increased mortality.[13] Bapoje et al evaluated a total of 152 patients over 1 year who had unplanned ICU transfers.[14] The most common reason was worsening of the problem for which the patient was admitted (48%). Other investigators have also attempted to identify predictors for clinical deterioration resulting in unplanned ICU transfer that could be employed in a PT or early warning system (EWS). Keller et al evaluated 50 consecutive general medical patients with unplanned ICU transfers between 2003 and 2004.[15] Using a case‐control methodology, these investigators found shock index values>0.85 to be the best predictor for subsequent unplanned ICU transfer (P<0.02; odds ratio: 3.0).

Organizations such as the Institute for Healthcare Improvement have called for the development and implementation of EWSs in order to direct the activities of RRTs and improve outcomes.[16] Escobar et al carried out a retrospective case‐control study using as the unit of analysis 12‐hour patient shifts on hospital wards.[17] Using logistic regression and split validation, they developed a PT for ICU transfer from clinical variables available in their EMR. The EMR derived PT had a C‐statistic of 0.845 in the derivation dataset and 0.775 in the validation dataset, concluding that EMR‐based detection of impending deterioration outside the ICU is feasible in integrated healthcare delivery systems.

We found that simply providing an alert to nursing units did not result in any demonstrable improvements in the outcomes of high‐risk patients identified by our PT. This may have been due to simply relying on the alerted nursing staff to make phone calls to physicians and not linking a specific and effective patient‐directed intervention to the PT. Other investigators have similarly observed that the use of an EWS or PT may not result in outcome improvements.[18] Gao et al performed an analysis of 31 studies describing hospital track and trigger EWSs.[19] They found little evidence of reliability, validity, and utility of these systems. Peebles et al showed that even when high‐risk non‐ICU patients are identified, delays in providing appropriate therapies occur, which may explain the lack of efficacy of EWSs and RRTs.[20] These observations suggest that there is currently a paucity of validated interventions available to improve outcome in deteriorating patients, despite our ability to identify patients who are at risk for such deterioration.

As a result of mandates from quality‐improvement organizations, most US hospitals currently employ RRTs for emergent mobilization of resources when a clinically deteriorating patient is identified on a hospital ward.[21] However, as noted above, there is limited evidence to suggest that RRTs contribute to improved patient outcomes.[22, 23, 24, 25, 26, 27] The potential importance of this is reflected in a recent report suggesting that 2900 US hospitals now have rapid‐response systems in place without clear demonstration of their overall efficacy.[28] Linking rapid‐response interventions with a validated real‐time alert may represent a way of improving the effectiveness of such interventions.[29, 30, 31, 32, 33, 34] Our data showed that hospital LOS was statistically longer among alerted patients compared with nonalerted patients. This supports the conclusion that the alerts helped identify a sicker group of patients, but the nursing alerts did not appear to change outcomes. This finding also seems to refute the hypothesis that simply linking an intervention to a PT will improve outcomes, albeit the intervention we employed may not have been robust enough to influence patient outcomes.

The development of accurate real‐time EWSs holds the potential to identify patients at risk for clinical deterioration at an earlier point in time when rescue interventions can be implemented in a potentially more effective manner in both adults and children.[35] Unfortunately, the ideal intervention to be applied in this situation is unknown. Our experience suggests that successful interventions will require a more integrated approach than simply providing an alert with general management principles. As a result of our experience, we are undertaking a randomized clinical trial in 2013 to determine whether linking a patient‐specific intervention to a PT will result in improved outcomes. The intervention we will be testing is to have the RRT immediately notified about alerted patients so as to formally evaluate them and to determine the need for therapeutic interventions, and to administer such interventions as needed and/or transfer the alerted patients to a higher level of care as deemed necessary. Additionally, we are updating our PT with more temporal data to determine if this will improve its accuracy. One of these updates will include linking the PT to wirelessly obtained continuous oximetry and heart‐rate data, using minimally intrusive sensors, to establish a 2‐tiered EWS.[11]

Our study has several important limitations. First, the PT was developed using local data, and thus the results may not be applicable to other settings. However, our model shares many of the characteristics identified in other clinical‐deterioration PTs.[15, 17] Second, the positive prediction value of 15.2% for ICU transfer may not be clinically useful due to the large number of false‐positive results. Moreover, the large number of false positives could result in alert fatigue, causing alerts to be ignored. Third, although the charge nurses were supposed to call the responsible physicians for the alerted patients, we did not determine whether all these calls occurred or whether they resulted in any meaningful changes in monitoring or patient treatment. This is important because lack of an effective intervention or treatment would make the intervention group much more like our control group. Future studies are needed to assess the impact of an integrated intervention (eg, notification of experienced RRT members with adequate resource access) to determine if patient outcomes can be impacted by the use of an EWS. Finally, we did not compare the performance of our PT to other models such as the modified early warning score (MEWS).

An additional limitation to consider is that our PT offered no new information to the nurse manager, or the PT did not change the opinions of the charge nurses. This is supported by a recent study of 63 serious adverse outcomes in a Belgian teaching hospital where death was the final outcome.[36] Survey results revealed that nurses were often unaware that their patients were deteriorating before the crisis. Nurses also reported threshold levels for concern for abnormal vital signs that suggested they would call for assistance relatively late in clinical crises. The limited ability of nursing staff to identify deteriorating patients is also supported by a recent simulation study demonstrating that nurses did identify that patients were deteriorating, but as each patient deteriorated staff performance declined, with a reduction in all observational records and actions.[37]

In summary, we have demonstrated that a relatively simple hospital‐specific PT could accurately identify patients on general medicine wards who subsequently developed clinical deterioration and the need for ICU transfer, as well as hospital mortality. However, no improvements in patient outcomes were found from reporting this information to nursing wards on a real‐time basis. The low positive predictive value of the alerts, local development of the EWS, and absence of improved outcomes substantially limits the broader application of this system in its current form. Continued efforts are needed to identify and implement systems that will not only accurately identify high‐risk patients on general wards but also intervene to improve their outcomes.

Acknowledgments

Disclosures: This study was funded in part by the Barnes‐Jewish Hospital Foundation and by Grant No. UL1 RR024992 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and the NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH. ClinicalTrials.gov Identifier: NCT01280942. The authors report no conflicts of interest.

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References
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Timely interventions are essential in the management of complex medical conditions such as new‐onset sepsis in order to prevent rapid progression to severe sepsis and septic shock.[1, 2, 3, 4, 5] Similarly, rapid identification and appropriate treatment of other medical and surgical conditions have been associated with improved outcomes.[6, 7, 8] We previously developed a real‐time, computerized prediction tool (PT) using recursive partitioning regression tree analysis for the identification of impending sepsis for use on general hospital wards.[9] We also showed that implementation of a real‐time computerized sepsis alert on hospital wards based on the PT resulted in increased use of early interventions, including antibiotic escalation, intravenous fluids, oxygen therapy, and diagnostics in patients identified as at risk.[10]

The first goal of this study was to develop an updated PT for use on hospital wards that could be used to predict subsequent global clinical deterioration and the need for a higher level of care. The second goal was to determine whether simply providing a real‐time alert to nursing staff based on the updated PT resulted in any demonstrable changes in patient outcomes.

METHODS

Study Location

The study was conducted at Barnes‐Jewish Hospital, a 1250‐bed academic medical center in St. Louis, Missouri. Eight adult medicine wards were assessed from July 2007 through December 2011. The medicine wards are closed areas with patient care delivered by dedicated house staff physicians under the supervision of a board‐certified attending physician. The study was approved by the Washington University School of Medicine Human Studies Committee.

Study Period

The period from July 2007 through January 2010 was used to train and retrospectively test the prediction model. The period from January 2011 through December 2011 was used to prospectively validate the model during a randomized trial using alerts generated from the prediction model.

Patients

Electronically captured clinical data were housed in a centralized clinical data repository. This repository cataloged 28,927 hospital visits from 19,116 distinct patients between July 2007 and January 2010. It contained a rich set of demographic and medical data for each of the visits, such as patient age, manually collected vital‐sign data, pharmacy data, laboratory data, and intensive care unit (ICU) transfer. This study served as a proof of concept for our vision of using machine learning to identify at‐risk patients and ultimately to perform real‐time event detection and interventions.

Algorithm Overview

Details regarding the predictive model development have been previously described.[11] To predict ICU transfer for patients housed on general medical wards, we used logistic regression, employing a novel framework to analyze the data stream from each patient, assigning scores to reflect the probability of ICU transfer to each patient.

Before building the model, several preprocessing steps were applied to eliminate outliers and find an appropriate representation of patients' states. For each of 36 input variables we specified acceptable ranges based on the domain knowledge of the medical experts on our team. For any value that was outside of the medically conceivable range, we replaced it by the mean value for that patient, if available. Values for every continuous parameter were scaled so that all measurements lay in the interval [0, 1] and were normalized by the minimum and maximum of the parameter. To capture the temporal effects in our data, we retained a sliding window of all the collected data points within the last 24 hours. We then subdivided these data into a series of 6 sequential buckets of 4 hours each.

To capture variations within a bucket, we computed 3 values for each feature in the bucket: the minimum, maximum, and mean data points. Each of the resulting 3n values was input to the logistic regression equation as separate variables. To deal with missing data points within the buckets, we used the patients' most recent reading from any time earlier in the hospital stay, if available. If no prior values existed, we used mean values calculated over the entire historical dataset. Bucket 6 max/min/mean represents the most recent 4‐hour window from the preceding 24‐hour time period for the maximum, minimum, and mean values, respectively. By itself, logistic regression does not operate on time‐series data. That is, each variable input to the logistic equation corresponds to exactly 1 data point (eg, a blood‐pressure variable would consist of a single blood‐pressure reading). In a clinical application, however, it is important to capture unusual changes in vital‐sign data over time. Such changes may precede clinical deterioration by hours, providing a chance to intervene if detected early enough. In addition, not all readings in time‐series data should be treated equally; the value of some kinds of data may change depending on their age. For example, a patient's condition may be better reflected by a blood‐oxygenation reading collected 1 hour ago than a reading collected 12 hours ago. This is the rationale for our use of a sliding window of all collected data points within the last 24 hours performed in a real‐time basis.

The algorithm was first implemented in MATLAB (Natick, MA). For the purposes of training, we used a single 24‐hour window of data from each patient. For patients admitted to ICU, this window was 26 hours to 2 hours prior to ICU admission; for all other patients, this window consisted of the first 24 hours of their hospital stay. The dataset's 36 input variables were divided into buckets and min/mean/max features wherever applicable, resulting in 398 variables. The first half of the dataset was used to train the model. We then used the second half of the dataset as the validation dataset. We generated a predicted outcome for each case in the validation data, using the model parameter coefficients derived from the training data. We also employed bootstrap aggregation to improve classification accuracy and to address overfitting. We then applied various threshold cut‐points to convert these predictions into binary values and compared the results against the ICU transfer outcome. A threshold of 0.9760 for specificity was chosen to achieve a sensitivity of approximately 40%. These operating characteristics were chosen in turn to generate a manageable number of alerts per hospital nursing unit per day (estimated at 12 per nursing unit per day). At this cut‐point the C‐statistic was 0.8834, with an overall accuracy of 0.9292.

In order to train the logistic model, we used a single 24‐hour window of data for each patient. However, in a system that predicts patients' outcomes in real time, scores are recomputed each time new data are entered into the database. Hence, patients have a series of scores over the length of their hospital stay, and an alert is triggered when any one of these scores is above the chosen threshold.

Once the model was developed, we implemented it in an internally developed, Java‐based clinical decision support rules engine, which identified when new data relevant to the model were available in a real‐time central data repository. The rules engine queried the data repository to acquire all data needed to evaluate the model. The score was calculated with each relevant new data point, and an alert was generated when the score exceeded the cut‐point threshold. We then prospectively validated these alerts on patients on 8 general medical wards at Barnes Jewish Hospital. Details regarding the architecture of our clinical decision support system have been previously published.[12] The sensitivity and positive predictive values for ICU transfer for these alerts were tracked during an intervention trial that ran from January 24, 2011, through December 31, 2011. Four general medical wards were randomized to the intervention group and 4 wards were randomized to the control group. The 8 general medical wards were ordered according to their alert rates based upon the historical data from July 2007 through January 2010, creating 4 pairs of wards in ascending order of alert rate. Within each of the 4 pairs, 1 member of the pair was randomized to the intervention group and the other to the control group using a random number generator.

Real‐time automated alerts generated 24 hours per day, 7 days per week from the predictive algorithm were sent to the charge‐nurse pager on the intervention units. Alerts were also generated and stored in the database on the control units, but these alerts were not sent to the charge nurse on those units. The alerts were sent to the charge nurses on the respective wards, as these individuals were thought to be in the best position to perform the initial assessment of the alerted patients, especially during evening hours when physician staffing was reduced. The charge nurses assessed the intervention‐group patients and were instructed to contact the responsible physician (hospitalist or internal medicine house officer) to inform them of the alert, or to call the rapid response team (RRT) if the patient's condition already appeared to be significantly deteriorating.

Descriptive statistics for algorithm sensitivity and positive predictive value and for patient outcomes were performed. Associations between alerts and the primary outcome, ICU transfer, were determined, as well as the impact of alerts in the intervention group compared with the control group, using [2] tests. The same analyses were performed for patient death. Differences in length of stay (LOS) were assessed using the Wilcoxon rank sum test.

RESULTS

Predictive Model

The variables with the greatest coefficients contributing to the PT model included respiratory rate, oxygen saturation, shock index, systolic blood pressure, anticoagulation use, heart rate, and diastolic blood pressure. A complete list of variables is provided in the Appendix (see Supporting Information in the online version of this article). All but 1 are routinely collected vital‐sign measures, and all but 1 occur in the 4‐hour period immediately prior to the alert (bucket 6).

Prospective Trial

Patient characteristics are presented in Table 1. Patients were well matched for race, sex, age, and underlying diagnoses. All alerts reported to the charge nurses were to be associated with a call from the charge nurse to the responsible physician caring for the alerted patient. The mean number of alerts per alerted patient was 1.8 (standard deviation=1.7). Patients meeting the alert threshold were at nearly 5.3‐fold greater risk of ICU transfer (95% confidence interval [CI]: 4.6‐6.0) than those not satisfying the alert threshold (358 of 2353 [15.2%; 95% CI: 13.8%‐16.7%] vs 512 of 17678 [2.9%; 95% CI: 2.7%‐3.2%], respectively; P<0.0001). Patients with alerts were at 8.9‐fold greater risk of death (95% CI: 7.4‐10.7) than those without alerts (244 of 2353 [10.4%; 95% CI: 9.2%‐11.7%] vs 206 of 17678 [1.2%; 95% CI: 1.0%‐1.3%], respectively; P<0.0001). Operating characteristics of the PT from the prospective trial are shown in Table 2. Alerts occurred a median of 25.5 hours prior to ICU transfer (interquartile range, 7.00‐81.75) and 8 hours prior to death (interquartile range, 4.09‐15.66).

Demographics by Study Group
 Study Group
 Control (N=10,120)Intervention (N=9911)
  • NOTE: No significant differences between study groups. Abbreviations: F, female; ICD‐9, International Classification of Diseases, 9th Revision; IQR, interquartile range; M, male.

RaceN%N%
White5,062504,93450
Black4,864484,79048
Other19421872
Sex    
F5,355535,30854
M4,765474,60346
Age at discharge, median (IQR), y57 (4469)57 (4470)
Top 10 ICD‐9 descriptions and counts, n (%)   
1Diseases of the digestive system1,774 (17.5)Diseases of the digestive system1,664 (16.7)
2Diseases of the circulatory system1,252 (12.4)Diseases of the circulatory system1,253 (12.6)
3Diseases of the respiratory system1,236 (12.2)Diseases of the respiratory system1,210 (12.2)
4Injury and poisoning864 (8.5)Injury and poisoning849 (8.6)
5Endocrine, nutritional, and metabolic diseases, and immunity disorders797 (7.9)Diseases of the genitourinary system795 (8.0)
6Diseases of the genitourinary system762 (7.5)Endocrine, nutritional, and metabolic diseases, and immunity disorders780 (7.9)
7Infectious and parasitic diseases555 (5.5)Infectious and parasitic diseases549 (5.5)
8Neoplasms547 (5.4)Neoplasms465 (4.7)
9Diseases of the blood and blood‐forming organs426 (4.2)Diseases of the blood and blood‐forming organs429 (4.3)
10Symptoms, signs, and ill‐defined conditions and factors influencing health status410 (4.1)Diseases of the musculoskeletal system and connective tissue399 (4.0)
Prediction ToolGenerated Alerts and Outcomes
 Sensitivity, %Specificity, %PPV, %NPV, %Positive Likelihood RatioNegative Likelihood Ratio
  • NOTE: Abbreviations: CI, confidence interval; ICU, intensive care unit; NPV, negitive predictive value; PPV, positive predictive value.

ICU TransferYes (N=870)No (N=19,161)      
Alert3581,99541.1 (95% CI: 37.944.5)89.6 (95% CI: 89.290.0)15.2 (95% CI: 13.816.7)97.1 (95% CI: 96.897.3)3.95 (95% CI: 3.614.30)0.66 (95% CI: 0.620.70)
No Alert51217,166      
DeathYes (N=450)No (N=19,581)      
Alert244210954.2 (95% CI: 49.658.8)89.2 (95% CI: 88.889.7)10.4 (95% CI: 9.211.7)98.8 (95% CI: 98.799.0)5.03 (95% CI: 4.585.53)0.51 (95% CI: 0.460.57)
No Alert20617,472      

Among patients identified by the PT, there were no differences in the proportion of patients who were transferred to the ICU or who died in the intervention group as compared with the control group (Table 3). In addition, although there was no difference in LOS in the intervention group compared with the control group, identification by the PT was associated with a significantly longer median LOS (7.01 days vs 2.94 days, P<0.001). The largest numbers of patients who were transferred to the ICU or died did so in the first hospital day, and 60% of patients who were transferred to the ICU did so in the first 4 days, whereas deaths were more evenly distributed across the hospital stay.

Outcomes (ICU Transfer, Mortality, and LOS) by Study Group and Alert
 Outcomes by Alert Statusa
Alert Study GroupNo‐Alert Study Group
Intervention, N=1194Control, N=1159Intervention, N=8717Control, N=8961
N%N%N%N%
  • NOTE: No significant differences between study groups. Abbreviations: ICU, intensive care unit; IQR, interquartile range; LOS, length of stay

  • LOS significantly differed by alert status (P<0.01).

ICU Transfer        
Yes192161661425232603
No10028499386846597870197
Death        
Yes12711117109611101
No106789104290862199885199
LOS from admit to discharge, median (IQR), da7.07 (3.9912.15)6.92 (3.8212.67)2.97 (1.775.33)2.91 (1.745.19)

DISCUSSION

We have demonstrated that a relatively simple hospital‐specific method for generating a PT derived from routine laboratory and hemodynamic values is capable of predicting clinical deterioration and the need for ICU transfer, as well as hospital mortality, in non‐ICU patients admitted to general hospital wards. We also found that the PT identified a sicker patient population as manifest by longer hospital LOS. The methods used in generating this real‐time PT are relatively simple and easily executed with the use of an electronic medical record (EMR) system. However, our data also showed that simply providing an alert to nursing units based on the PT did not result in any demonstrable improvement in patient outcomes. Moreover, our PT and intervention in their current form have substantial limitations, including low sensitivity and positive predictive value, high possibility of alert fatigue, and no clear clinical impact. These limitations suggest that this approach has limited applicability in its current form.

Unplanned ICU transfers occurring as early as within 8 hours of hospitalization are relatively common and associated with increased mortality.[13] Bapoje et al evaluated a total of 152 patients over 1 year who had unplanned ICU transfers.[14] The most common reason was worsening of the problem for which the patient was admitted (48%). Other investigators have also attempted to identify predictors for clinical deterioration resulting in unplanned ICU transfer that could be employed in a PT or early warning system (EWS). Keller et al evaluated 50 consecutive general medical patients with unplanned ICU transfers between 2003 and 2004.[15] Using a case‐control methodology, these investigators found shock index values>0.85 to be the best predictor for subsequent unplanned ICU transfer (P<0.02; odds ratio: 3.0).

Organizations such as the Institute for Healthcare Improvement have called for the development and implementation of EWSs in order to direct the activities of RRTs and improve outcomes.[16] Escobar et al carried out a retrospective case‐control study using as the unit of analysis 12‐hour patient shifts on hospital wards.[17] Using logistic regression and split validation, they developed a PT for ICU transfer from clinical variables available in their EMR. The EMR derived PT had a C‐statistic of 0.845 in the derivation dataset and 0.775 in the validation dataset, concluding that EMR‐based detection of impending deterioration outside the ICU is feasible in integrated healthcare delivery systems.

We found that simply providing an alert to nursing units did not result in any demonstrable improvements in the outcomes of high‐risk patients identified by our PT. This may have been due to simply relying on the alerted nursing staff to make phone calls to physicians and not linking a specific and effective patient‐directed intervention to the PT. Other investigators have similarly observed that the use of an EWS or PT may not result in outcome improvements.[18] Gao et al performed an analysis of 31 studies describing hospital track and trigger EWSs.[19] They found little evidence of reliability, validity, and utility of these systems. Peebles et al showed that even when high‐risk non‐ICU patients are identified, delays in providing appropriate therapies occur, which may explain the lack of efficacy of EWSs and RRTs.[20] These observations suggest that there is currently a paucity of validated interventions available to improve outcome in deteriorating patients, despite our ability to identify patients who are at risk for such deterioration.

As a result of mandates from quality‐improvement organizations, most US hospitals currently employ RRTs for emergent mobilization of resources when a clinically deteriorating patient is identified on a hospital ward.[21] However, as noted above, there is limited evidence to suggest that RRTs contribute to improved patient outcomes.[22, 23, 24, 25, 26, 27] The potential importance of this is reflected in a recent report suggesting that 2900 US hospitals now have rapid‐response systems in place without clear demonstration of their overall efficacy.[28] Linking rapid‐response interventions with a validated real‐time alert may represent a way of improving the effectiveness of such interventions.[29, 30, 31, 32, 33, 34] Our data showed that hospital LOS was statistically longer among alerted patients compared with nonalerted patients. This supports the conclusion that the alerts helped identify a sicker group of patients, but the nursing alerts did not appear to change outcomes. This finding also seems to refute the hypothesis that simply linking an intervention to a PT will improve outcomes, albeit the intervention we employed may not have been robust enough to influence patient outcomes.

The development of accurate real‐time EWSs holds the potential to identify patients at risk for clinical deterioration at an earlier point in time when rescue interventions can be implemented in a potentially more effective manner in both adults and children.[35] Unfortunately, the ideal intervention to be applied in this situation is unknown. Our experience suggests that successful interventions will require a more integrated approach than simply providing an alert with general management principles. As a result of our experience, we are undertaking a randomized clinical trial in 2013 to determine whether linking a patient‐specific intervention to a PT will result in improved outcomes. The intervention we will be testing is to have the RRT immediately notified about alerted patients so as to formally evaluate them and to determine the need for therapeutic interventions, and to administer such interventions as needed and/or transfer the alerted patients to a higher level of care as deemed necessary. Additionally, we are updating our PT with more temporal data to determine if this will improve its accuracy. One of these updates will include linking the PT to wirelessly obtained continuous oximetry and heart‐rate data, using minimally intrusive sensors, to establish a 2‐tiered EWS.[11]

Our study has several important limitations. First, the PT was developed using local data, and thus the results may not be applicable to other settings. However, our model shares many of the characteristics identified in other clinical‐deterioration PTs.[15, 17] Second, the positive prediction value of 15.2% for ICU transfer may not be clinically useful due to the large number of false‐positive results. Moreover, the large number of false positives could result in alert fatigue, causing alerts to be ignored. Third, although the charge nurses were supposed to call the responsible physicians for the alerted patients, we did not determine whether all these calls occurred or whether they resulted in any meaningful changes in monitoring or patient treatment. This is important because lack of an effective intervention or treatment would make the intervention group much more like our control group. Future studies are needed to assess the impact of an integrated intervention (eg, notification of experienced RRT members with adequate resource access) to determine if patient outcomes can be impacted by the use of an EWS. Finally, we did not compare the performance of our PT to other models such as the modified early warning score (MEWS).

An additional limitation to consider is that our PT offered no new information to the nurse manager, or the PT did not change the opinions of the charge nurses. This is supported by a recent study of 63 serious adverse outcomes in a Belgian teaching hospital where death was the final outcome.[36] Survey results revealed that nurses were often unaware that their patients were deteriorating before the crisis. Nurses also reported threshold levels for concern for abnormal vital signs that suggested they would call for assistance relatively late in clinical crises. The limited ability of nursing staff to identify deteriorating patients is also supported by a recent simulation study demonstrating that nurses did identify that patients were deteriorating, but as each patient deteriorated staff performance declined, with a reduction in all observational records and actions.[37]

In summary, we have demonstrated that a relatively simple hospital‐specific PT could accurately identify patients on general medicine wards who subsequently developed clinical deterioration and the need for ICU transfer, as well as hospital mortality. However, no improvements in patient outcomes were found from reporting this information to nursing wards on a real‐time basis. The low positive predictive value of the alerts, local development of the EWS, and absence of improved outcomes substantially limits the broader application of this system in its current form. Continued efforts are needed to identify and implement systems that will not only accurately identify high‐risk patients on general wards but also intervene to improve their outcomes.

Acknowledgments

Disclosures: This study was funded in part by the Barnes‐Jewish Hospital Foundation and by Grant No. UL1 RR024992 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and the NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH. ClinicalTrials.gov Identifier: NCT01280942. The authors report no conflicts of interest.

Timely interventions are essential in the management of complex medical conditions such as new‐onset sepsis in order to prevent rapid progression to severe sepsis and septic shock.[1, 2, 3, 4, 5] Similarly, rapid identification and appropriate treatment of other medical and surgical conditions have been associated with improved outcomes.[6, 7, 8] We previously developed a real‐time, computerized prediction tool (PT) using recursive partitioning regression tree analysis for the identification of impending sepsis for use on general hospital wards.[9] We also showed that implementation of a real‐time computerized sepsis alert on hospital wards based on the PT resulted in increased use of early interventions, including antibiotic escalation, intravenous fluids, oxygen therapy, and diagnostics in patients identified as at risk.[10]

The first goal of this study was to develop an updated PT for use on hospital wards that could be used to predict subsequent global clinical deterioration and the need for a higher level of care. The second goal was to determine whether simply providing a real‐time alert to nursing staff based on the updated PT resulted in any demonstrable changes in patient outcomes.

METHODS

Study Location

The study was conducted at Barnes‐Jewish Hospital, a 1250‐bed academic medical center in St. Louis, Missouri. Eight adult medicine wards were assessed from July 2007 through December 2011. The medicine wards are closed areas with patient care delivered by dedicated house staff physicians under the supervision of a board‐certified attending physician. The study was approved by the Washington University School of Medicine Human Studies Committee.

Study Period

The period from July 2007 through January 2010 was used to train and retrospectively test the prediction model. The period from January 2011 through December 2011 was used to prospectively validate the model during a randomized trial using alerts generated from the prediction model.

Patients

Electronically captured clinical data were housed in a centralized clinical data repository. This repository cataloged 28,927 hospital visits from 19,116 distinct patients between July 2007 and January 2010. It contained a rich set of demographic and medical data for each of the visits, such as patient age, manually collected vital‐sign data, pharmacy data, laboratory data, and intensive care unit (ICU) transfer. This study served as a proof of concept for our vision of using machine learning to identify at‐risk patients and ultimately to perform real‐time event detection and interventions.

Algorithm Overview

Details regarding the predictive model development have been previously described.[11] To predict ICU transfer for patients housed on general medical wards, we used logistic regression, employing a novel framework to analyze the data stream from each patient, assigning scores to reflect the probability of ICU transfer to each patient.

Before building the model, several preprocessing steps were applied to eliminate outliers and find an appropriate representation of patients' states. For each of 36 input variables we specified acceptable ranges based on the domain knowledge of the medical experts on our team. For any value that was outside of the medically conceivable range, we replaced it by the mean value for that patient, if available. Values for every continuous parameter were scaled so that all measurements lay in the interval [0, 1] and were normalized by the minimum and maximum of the parameter. To capture the temporal effects in our data, we retained a sliding window of all the collected data points within the last 24 hours. We then subdivided these data into a series of 6 sequential buckets of 4 hours each.

To capture variations within a bucket, we computed 3 values for each feature in the bucket: the minimum, maximum, and mean data points. Each of the resulting 3n values was input to the logistic regression equation as separate variables. To deal with missing data points within the buckets, we used the patients' most recent reading from any time earlier in the hospital stay, if available. If no prior values existed, we used mean values calculated over the entire historical dataset. Bucket 6 max/min/mean represents the most recent 4‐hour window from the preceding 24‐hour time period for the maximum, minimum, and mean values, respectively. By itself, logistic regression does not operate on time‐series data. That is, each variable input to the logistic equation corresponds to exactly 1 data point (eg, a blood‐pressure variable would consist of a single blood‐pressure reading). In a clinical application, however, it is important to capture unusual changes in vital‐sign data over time. Such changes may precede clinical deterioration by hours, providing a chance to intervene if detected early enough. In addition, not all readings in time‐series data should be treated equally; the value of some kinds of data may change depending on their age. For example, a patient's condition may be better reflected by a blood‐oxygenation reading collected 1 hour ago than a reading collected 12 hours ago. This is the rationale for our use of a sliding window of all collected data points within the last 24 hours performed in a real‐time basis.

The algorithm was first implemented in MATLAB (Natick, MA). For the purposes of training, we used a single 24‐hour window of data from each patient. For patients admitted to ICU, this window was 26 hours to 2 hours prior to ICU admission; for all other patients, this window consisted of the first 24 hours of their hospital stay. The dataset's 36 input variables were divided into buckets and min/mean/max features wherever applicable, resulting in 398 variables. The first half of the dataset was used to train the model. We then used the second half of the dataset as the validation dataset. We generated a predicted outcome for each case in the validation data, using the model parameter coefficients derived from the training data. We also employed bootstrap aggregation to improve classification accuracy and to address overfitting. We then applied various threshold cut‐points to convert these predictions into binary values and compared the results against the ICU transfer outcome. A threshold of 0.9760 for specificity was chosen to achieve a sensitivity of approximately 40%. These operating characteristics were chosen in turn to generate a manageable number of alerts per hospital nursing unit per day (estimated at 12 per nursing unit per day). At this cut‐point the C‐statistic was 0.8834, with an overall accuracy of 0.9292.

In order to train the logistic model, we used a single 24‐hour window of data for each patient. However, in a system that predicts patients' outcomes in real time, scores are recomputed each time new data are entered into the database. Hence, patients have a series of scores over the length of their hospital stay, and an alert is triggered when any one of these scores is above the chosen threshold.

Once the model was developed, we implemented it in an internally developed, Java‐based clinical decision support rules engine, which identified when new data relevant to the model were available in a real‐time central data repository. The rules engine queried the data repository to acquire all data needed to evaluate the model. The score was calculated with each relevant new data point, and an alert was generated when the score exceeded the cut‐point threshold. We then prospectively validated these alerts on patients on 8 general medical wards at Barnes Jewish Hospital. Details regarding the architecture of our clinical decision support system have been previously published.[12] The sensitivity and positive predictive values for ICU transfer for these alerts were tracked during an intervention trial that ran from January 24, 2011, through December 31, 2011. Four general medical wards were randomized to the intervention group and 4 wards were randomized to the control group. The 8 general medical wards were ordered according to their alert rates based upon the historical data from July 2007 through January 2010, creating 4 pairs of wards in ascending order of alert rate. Within each of the 4 pairs, 1 member of the pair was randomized to the intervention group and the other to the control group using a random number generator.

Real‐time automated alerts generated 24 hours per day, 7 days per week from the predictive algorithm were sent to the charge‐nurse pager on the intervention units. Alerts were also generated and stored in the database on the control units, but these alerts were not sent to the charge nurse on those units. The alerts were sent to the charge nurses on the respective wards, as these individuals were thought to be in the best position to perform the initial assessment of the alerted patients, especially during evening hours when physician staffing was reduced. The charge nurses assessed the intervention‐group patients and were instructed to contact the responsible physician (hospitalist or internal medicine house officer) to inform them of the alert, or to call the rapid response team (RRT) if the patient's condition already appeared to be significantly deteriorating.

Descriptive statistics for algorithm sensitivity and positive predictive value and for patient outcomes were performed. Associations between alerts and the primary outcome, ICU transfer, were determined, as well as the impact of alerts in the intervention group compared with the control group, using [2] tests. The same analyses were performed for patient death. Differences in length of stay (LOS) were assessed using the Wilcoxon rank sum test.

RESULTS

Predictive Model

The variables with the greatest coefficients contributing to the PT model included respiratory rate, oxygen saturation, shock index, systolic blood pressure, anticoagulation use, heart rate, and diastolic blood pressure. A complete list of variables is provided in the Appendix (see Supporting Information in the online version of this article). All but 1 are routinely collected vital‐sign measures, and all but 1 occur in the 4‐hour period immediately prior to the alert (bucket 6).

Prospective Trial

Patient characteristics are presented in Table 1. Patients were well matched for race, sex, age, and underlying diagnoses. All alerts reported to the charge nurses were to be associated with a call from the charge nurse to the responsible physician caring for the alerted patient. The mean number of alerts per alerted patient was 1.8 (standard deviation=1.7). Patients meeting the alert threshold were at nearly 5.3‐fold greater risk of ICU transfer (95% confidence interval [CI]: 4.6‐6.0) than those not satisfying the alert threshold (358 of 2353 [15.2%; 95% CI: 13.8%‐16.7%] vs 512 of 17678 [2.9%; 95% CI: 2.7%‐3.2%], respectively; P<0.0001). Patients with alerts were at 8.9‐fold greater risk of death (95% CI: 7.4‐10.7) than those without alerts (244 of 2353 [10.4%; 95% CI: 9.2%‐11.7%] vs 206 of 17678 [1.2%; 95% CI: 1.0%‐1.3%], respectively; P<0.0001). Operating characteristics of the PT from the prospective trial are shown in Table 2. Alerts occurred a median of 25.5 hours prior to ICU transfer (interquartile range, 7.00‐81.75) and 8 hours prior to death (interquartile range, 4.09‐15.66).

Demographics by Study Group
 Study Group
 Control (N=10,120)Intervention (N=9911)
  • NOTE: No significant differences between study groups. Abbreviations: F, female; ICD‐9, International Classification of Diseases, 9th Revision; IQR, interquartile range; M, male.

RaceN%N%
White5,062504,93450
Black4,864484,79048
Other19421872
Sex    
F5,355535,30854
M4,765474,60346
Age at discharge, median (IQR), y57 (4469)57 (4470)
Top 10 ICD‐9 descriptions and counts, n (%)   
1Diseases of the digestive system1,774 (17.5)Diseases of the digestive system1,664 (16.7)
2Diseases of the circulatory system1,252 (12.4)Diseases of the circulatory system1,253 (12.6)
3Diseases of the respiratory system1,236 (12.2)Diseases of the respiratory system1,210 (12.2)
4Injury and poisoning864 (8.5)Injury and poisoning849 (8.6)
5Endocrine, nutritional, and metabolic diseases, and immunity disorders797 (7.9)Diseases of the genitourinary system795 (8.0)
6Diseases of the genitourinary system762 (7.5)Endocrine, nutritional, and metabolic diseases, and immunity disorders780 (7.9)
7Infectious and parasitic diseases555 (5.5)Infectious and parasitic diseases549 (5.5)
8Neoplasms547 (5.4)Neoplasms465 (4.7)
9Diseases of the blood and blood‐forming organs426 (4.2)Diseases of the blood and blood‐forming organs429 (4.3)
10Symptoms, signs, and ill‐defined conditions and factors influencing health status410 (4.1)Diseases of the musculoskeletal system and connective tissue399 (4.0)
Prediction ToolGenerated Alerts and Outcomes
 Sensitivity, %Specificity, %PPV, %NPV, %Positive Likelihood RatioNegative Likelihood Ratio
  • NOTE: Abbreviations: CI, confidence interval; ICU, intensive care unit; NPV, negitive predictive value; PPV, positive predictive value.

ICU TransferYes (N=870)No (N=19,161)      
Alert3581,99541.1 (95% CI: 37.944.5)89.6 (95% CI: 89.290.0)15.2 (95% CI: 13.816.7)97.1 (95% CI: 96.897.3)3.95 (95% CI: 3.614.30)0.66 (95% CI: 0.620.70)
No Alert51217,166      
DeathYes (N=450)No (N=19,581)      
Alert244210954.2 (95% CI: 49.658.8)89.2 (95% CI: 88.889.7)10.4 (95% CI: 9.211.7)98.8 (95% CI: 98.799.0)5.03 (95% CI: 4.585.53)0.51 (95% CI: 0.460.57)
No Alert20617,472      

Among patients identified by the PT, there were no differences in the proportion of patients who were transferred to the ICU or who died in the intervention group as compared with the control group (Table 3). In addition, although there was no difference in LOS in the intervention group compared with the control group, identification by the PT was associated with a significantly longer median LOS (7.01 days vs 2.94 days, P<0.001). The largest numbers of patients who were transferred to the ICU or died did so in the first hospital day, and 60% of patients who were transferred to the ICU did so in the first 4 days, whereas deaths were more evenly distributed across the hospital stay.

Outcomes (ICU Transfer, Mortality, and LOS) by Study Group and Alert
 Outcomes by Alert Statusa
Alert Study GroupNo‐Alert Study Group
Intervention, N=1194Control, N=1159Intervention, N=8717Control, N=8961
N%N%N%N%
  • NOTE: No significant differences between study groups. Abbreviations: ICU, intensive care unit; IQR, interquartile range; LOS, length of stay

  • LOS significantly differed by alert status (P<0.01).

ICU Transfer        
Yes192161661425232603
No10028499386846597870197
Death        
Yes12711117109611101
No106789104290862199885199
LOS from admit to discharge, median (IQR), da7.07 (3.9912.15)6.92 (3.8212.67)2.97 (1.775.33)2.91 (1.745.19)

DISCUSSION

We have demonstrated that a relatively simple hospital‐specific method for generating a PT derived from routine laboratory and hemodynamic values is capable of predicting clinical deterioration and the need for ICU transfer, as well as hospital mortality, in non‐ICU patients admitted to general hospital wards. We also found that the PT identified a sicker patient population as manifest by longer hospital LOS. The methods used in generating this real‐time PT are relatively simple and easily executed with the use of an electronic medical record (EMR) system. However, our data also showed that simply providing an alert to nursing units based on the PT did not result in any demonstrable improvement in patient outcomes. Moreover, our PT and intervention in their current form have substantial limitations, including low sensitivity and positive predictive value, high possibility of alert fatigue, and no clear clinical impact. These limitations suggest that this approach has limited applicability in its current form.

Unplanned ICU transfers occurring as early as within 8 hours of hospitalization are relatively common and associated with increased mortality.[13] Bapoje et al evaluated a total of 152 patients over 1 year who had unplanned ICU transfers.[14] The most common reason was worsening of the problem for which the patient was admitted (48%). Other investigators have also attempted to identify predictors for clinical deterioration resulting in unplanned ICU transfer that could be employed in a PT or early warning system (EWS). Keller et al evaluated 50 consecutive general medical patients with unplanned ICU transfers between 2003 and 2004.[15] Using a case‐control methodology, these investigators found shock index values>0.85 to be the best predictor for subsequent unplanned ICU transfer (P<0.02; odds ratio: 3.0).

Organizations such as the Institute for Healthcare Improvement have called for the development and implementation of EWSs in order to direct the activities of RRTs and improve outcomes.[16] Escobar et al carried out a retrospective case‐control study using as the unit of analysis 12‐hour patient shifts on hospital wards.[17] Using logistic regression and split validation, they developed a PT for ICU transfer from clinical variables available in their EMR. The EMR derived PT had a C‐statistic of 0.845 in the derivation dataset and 0.775 in the validation dataset, concluding that EMR‐based detection of impending deterioration outside the ICU is feasible in integrated healthcare delivery systems.

We found that simply providing an alert to nursing units did not result in any demonstrable improvements in the outcomes of high‐risk patients identified by our PT. This may have been due to simply relying on the alerted nursing staff to make phone calls to physicians and not linking a specific and effective patient‐directed intervention to the PT. Other investigators have similarly observed that the use of an EWS or PT may not result in outcome improvements.[18] Gao et al performed an analysis of 31 studies describing hospital track and trigger EWSs.[19] They found little evidence of reliability, validity, and utility of these systems. Peebles et al showed that even when high‐risk non‐ICU patients are identified, delays in providing appropriate therapies occur, which may explain the lack of efficacy of EWSs and RRTs.[20] These observations suggest that there is currently a paucity of validated interventions available to improve outcome in deteriorating patients, despite our ability to identify patients who are at risk for such deterioration.

As a result of mandates from quality‐improvement organizations, most US hospitals currently employ RRTs for emergent mobilization of resources when a clinically deteriorating patient is identified on a hospital ward.[21] However, as noted above, there is limited evidence to suggest that RRTs contribute to improved patient outcomes.[22, 23, 24, 25, 26, 27] The potential importance of this is reflected in a recent report suggesting that 2900 US hospitals now have rapid‐response systems in place without clear demonstration of their overall efficacy.[28] Linking rapid‐response interventions with a validated real‐time alert may represent a way of improving the effectiveness of such interventions.[29, 30, 31, 32, 33, 34] Our data showed that hospital LOS was statistically longer among alerted patients compared with nonalerted patients. This supports the conclusion that the alerts helped identify a sicker group of patients, but the nursing alerts did not appear to change outcomes. This finding also seems to refute the hypothesis that simply linking an intervention to a PT will improve outcomes, albeit the intervention we employed may not have been robust enough to influence patient outcomes.

The development of accurate real‐time EWSs holds the potential to identify patients at risk for clinical deterioration at an earlier point in time when rescue interventions can be implemented in a potentially more effective manner in both adults and children.[35] Unfortunately, the ideal intervention to be applied in this situation is unknown. Our experience suggests that successful interventions will require a more integrated approach than simply providing an alert with general management principles. As a result of our experience, we are undertaking a randomized clinical trial in 2013 to determine whether linking a patient‐specific intervention to a PT will result in improved outcomes. The intervention we will be testing is to have the RRT immediately notified about alerted patients so as to formally evaluate them and to determine the need for therapeutic interventions, and to administer such interventions as needed and/or transfer the alerted patients to a higher level of care as deemed necessary. Additionally, we are updating our PT with more temporal data to determine if this will improve its accuracy. One of these updates will include linking the PT to wirelessly obtained continuous oximetry and heart‐rate data, using minimally intrusive sensors, to establish a 2‐tiered EWS.[11]

Our study has several important limitations. First, the PT was developed using local data, and thus the results may not be applicable to other settings. However, our model shares many of the characteristics identified in other clinical‐deterioration PTs.[15, 17] Second, the positive prediction value of 15.2% for ICU transfer may not be clinically useful due to the large number of false‐positive results. Moreover, the large number of false positives could result in alert fatigue, causing alerts to be ignored. Third, although the charge nurses were supposed to call the responsible physicians for the alerted patients, we did not determine whether all these calls occurred or whether they resulted in any meaningful changes in monitoring or patient treatment. This is important because lack of an effective intervention or treatment would make the intervention group much more like our control group. Future studies are needed to assess the impact of an integrated intervention (eg, notification of experienced RRT members with adequate resource access) to determine if patient outcomes can be impacted by the use of an EWS. Finally, we did not compare the performance of our PT to other models such as the modified early warning score (MEWS).

An additional limitation to consider is that our PT offered no new information to the nurse manager, or the PT did not change the opinions of the charge nurses. This is supported by a recent study of 63 serious adverse outcomes in a Belgian teaching hospital where death was the final outcome.[36] Survey results revealed that nurses were often unaware that their patients were deteriorating before the crisis. Nurses also reported threshold levels for concern for abnormal vital signs that suggested they would call for assistance relatively late in clinical crises. The limited ability of nursing staff to identify deteriorating patients is also supported by a recent simulation study demonstrating that nurses did identify that patients were deteriorating, but as each patient deteriorated staff performance declined, with a reduction in all observational records and actions.[37]

In summary, we have demonstrated that a relatively simple hospital‐specific PT could accurately identify patients on general medicine wards who subsequently developed clinical deterioration and the need for ICU transfer, as well as hospital mortality. However, no improvements in patient outcomes were found from reporting this information to nursing wards on a real‐time basis. The low positive predictive value of the alerts, local development of the EWS, and absence of improved outcomes substantially limits the broader application of this system in its current form. Continued efforts are needed to identify and implement systems that will not only accurately identify high‐risk patients on general wards but also intervene to improve their outcomes.

Acknowledgments

Disclosures: This study was funded in part by the Barnes‐Jewish Hospital Foundation and by Grant No. UL1 RR024992 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and the NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH. ClinicalTrials.gov Identifier: NCT01280942. The authors report no conflicts of interest.

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  25. Hatlem T, Jones C, Woodard EK. Reducing mortality and avoiding preventable ICU utilization: analysis of a successful rapid response program using APR DRGs [published online ahead of print March 10, 2010]. J Healthc Qual. doi: 10.1111/j.1945‐1474.2010.00084.x.
  26. Hillman K, Chen J, Cretikos M, et al. Introduction of the medical emergency team (MET) system: a cluster‐randomised control trial. Lancet. 2005;365:20912097.
  27. Gao H, Harrison DA, Parry GJ, Daly K, Subbe CP, Rowan K. The impact of the introduction of critical care outreach services in England: a multicentre interrupted time‐series analysis. Crit Care. 2007;11:R113.
  28. Schneider ME. Rapid response systems now established at 2,900 hospitals. Hospitalist News. March 2010;3:1.
  29. Chan PS, Jain R, Nallmothu BK, Berg RA, Sasson C. Rapid response teams: a systematic review and meta‐analysis. Arch Intern Med. 2010;170:1826.
  30. McGauhey J, Alerice F, Fowler R, et al. Outreach and early warning systems (EWS) for the prevention of intensive care admission and death of critically ill adult patients on general hospital wards. Cochrane Database Syst Rev. 2007;3:CD005529.
  31. Jones DA, DeVita MA, Bellomo R. Rapid‐response teams. N Engl J Med. 2011;365:139146.
  32. Georgaka D, Mparmparousi M, Vitos M. Early warning systems. Hosp Chron. 2012;7(suppl 1):3743.
  33. Sittig DF, Wright A, Osheroff JA, et al. Grand challenges in clinical decision support. J Biomed Inform. 2008;41(2):387392.
  34. A Kho, Rotz D, Alrahi K, et al. Utility of commonly captured data from an EHR to identify hospitalized patients at risk for clinical deterioration. AMIA Annu Symp Proc. 2007;404408.
  35. Akre M, Finkelstein M, Erickson M, Liu M, Vanderbilt L, Billman G. Sensitivity of the pediatric early warning score to identify patient deterioration. Pediatrics. 2010;125(4)e763e769.
  36. Meester K, Bogaert P, Clarke SP, Bossaert L. In‐hospital mortality after serious adverse events on medical and surgical nursing units: a mixed methods study [published online ahead of print July 24, 2012]. J Clin Nurs. doi: 10.1111/j.1365‐2702.2012.04154.x.
  37. Cooper S, McConnell‐Henry T, Cant R, et al. Managing deteriorating patients: registered nurses' performance in a simulated setting. Open Nurs J. 2011;5:120126.
References
  1. Ferrer R, Artigas A, Levy MM, et al. Improvement in process of care and outcome after a multicenter severe sepsis educational program in Spain. JAMA. 2008;299:22942303.
  2. Rivers E, Nguyen B, Havstad S, et al. Early goal‐directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001;345:13681377.
  3. Micek ST, Roubinian N, Heuring T, et al. Before‐after study of a standardized hospital order set for the management of septic shock. Crit Care Med. 2007;34:27072713.
  4. Dellinger RP, Levy MM, Carley JM. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008;36:296327.
  5. Lundberg JS, Perl TM, Wiblin T, et al. Septic shock: an analysis of outcomes for patients with onset on hospital wards versus intensive care units. Crit Care Med. 1998;26:10201024.
  6. Young MP, Gooder VJ, McBride K, James B, Fisher E. Inpatient transfers to the intensive care unit: delays are associated with increased mortality and morbidity. J Gen Intern Med. 2003;18:7783.
  7. Vidán MT, Sánchez E, Gracia Y, Marañón E, Vaquero J, Serra JA. Causes and effects of surgical delay in patients with hip fracture: a cohort study. Ann Intern Med. 2011;155:226233.
  8. McKinney JS, Deng Y, Kasner SE, Kostis JB. Comprehensive stroke centers overcome the weekend versus weekday gap in stroke treatment and mortality. Stroke. 2011;42:24032409.
  9. Thiel SW, Asghar M, Micek ST, Reichley RM, Doherty J, Kollef MH. Hospital‐wide impact of a standardized order set for the management of bacteremic severe sepsis. Crit Care Med. 2009;37:819824.
  10. Sawyer AM, Deal EN, Labelle AJ, et al. Implementation of a real‐time computerized sepsis alert in non–intensive care unit patients. Crit Care Med. 2011;39:469473.
  11. Hackmann G, Chen M, Chipara O, et al. Toward a two‐tier clinical warning system for hospitalized patients. AMIA Annu Symp Proc. 2011;2011:511519.
  12. Huang Y, Noirot LA, Heard KM, Reichley RM, Dunagan WC, Bailey TC. Migrating toward a next‐generation clinical decision support application: the BJC HealthCare experience. AMIA Annu Symp Proc. 2007;344348.
  13. Liu V, Kipnis P, Rizk NW, Escobar GJ. Adverse outcomes associated with delayed intensive care unit transfers in an integrated healthcare system. J Hosp Med. 2011;7:224230.
  14. Bapoje SR, Gaudiani JL, Narayanan V, Albert RK. Unplanned transfers to a medical intensive care unit: causes and relationship to preventable errors in care. J Hosp Med. 2011;6:6872.
  15. Keller AS, Kirkland LL, Rajasekaran SY, Cha S, Rady MY, Huddleston JM. Unplanned transfers to the intensive care unit: the role of the shock index. J Hosp Med. 2010;5:460465.
  16. Institute for Healthcare Improvement. Early warning systems: the next level of rapid response. Available at: http://www.ihi.org/IHI/Programs/AudioAndWebPrograms/ExpeditionEarlyWarningSystemsTheNextLevelofRapidResponse.htmplayerwmp. Accessed April 6, 2011.
  17. Escobar GJ, Laguardia JC, Turk BJ, Ragins A, Kipnis P, Draper D. Early detection of impending physiologic deterioration among patients who are not in intensive care: development of predictive models using data from an automated electronic medical record. J Hosp Med. 2012;7:388395.
  18. Duncan KD, McMullan C, Mills BM. Early warning systems: the next level of rapid response. Nursing. 2012;42:3844.
  19. Gao H, McDonnell A, Harrison DA, et al. Systematic review and evaluation of physiological track and trigger warning systems for identifying at‐risk patients on the ward. Intensive Care Med. 2007;33:667679.
  20. Peebles E, Subbe CP, Hughes P, Gemmell L. Timing and teamwork—an observational pilot study of patients referred to a Rapid Response Team with the aim of identifying factors amenable to re‐design of a Rapid Response System. Resuscitation. 2012;83:782787.
  21. Prado R, Albert RK, Mehler PS, Chu ES. Rapid response: a quality improvement conundrum. J Hosp Med. 2009;4:255257.
  22. Priestley G, Watson W, Rashidian A, et al. Introducing critical care outreach: a ward‐randomised trial of phased introduction in a general hospital. Intensive Care Med. 2004;30:13981404.
  23. Pittard AJ. Out of our reach? Assessing the impact of introducing critical care outreach service. Anaesthesiology. 2003;58:882885.
  24. Ball C, Kirkby M, Williams S. Effect of the critical care outreach team on patient survival to discharge from hospital and readmission to critical care: non‐randomised population based study. BMJ. 2003;327:10141016.
  25. Hatlem T, Jones C, Woodard EK. Reducing mortality and avoiding preventable ICU utilization: analysis of a successful rapid response program using APR DRGs [published online ahead of print March 10, 2010]. J Healthc Qual. doi: 10.1111/j.1945‐1474.2010.00084.x.
  26. Hillman K, Chen J, Cretikos M, et al. Introduction of the medical emergency team (MET) system: a cluster‐randomised control trial. Lancet. 2005;365:20912097.
  27. Gao H, Harrison DA, Parry GJ, Daly K, Subbe CP, Rowan K. The impact of the introduction of critical care outreach services in England: a multicentre interrupted time‐series analysis. Crit Care. 2007;11:R113.
  28. Schneider ME. Rapid response systems now established at 2,900 hospitals. Hospitalist News. March 2010;3:1.
  29. Chan PS, Jain R, Nallmothu BK, Berg RA, Sasson C. Rapid response teams: a systematic review and meta‐analysis. Arch Intern Med. 2010;170:1826.
  30. McGauhey J, Alerice F, Fowler R, et al. Outreach and early warning systems (EWS) for the prevention of intensive care admission and death of critically ill adult patients on general hospital wards. Cochrane Database Syst Rev. 2007;3:CD005529.
  31. Jones DA, DeVita MA, Bellomo R. Rapid‐response teams. N Engl J Med. 2011;365:139146.
  32. Georgaka D, Mparmparousi M, Vitos M. Early warning systems. Hosp Chron. 2012;7(suppl 1):3743.
  33. Sittig DF, Wright A, Osheroff JA, et al. Grand challenges in clinical decision support. J Biomed Inform. 2008;41(2):387392.
  34. A Kho, Rotz D, Alrahi K, et al. Utility of commonly captured data from an EHR to identify hospitalized patients at risk for clinical deterioration. AMIA Annu Symp Proc. 2007;404408.
  35. Akre M, Finkelstein M, Erickson M, Liu M, Vanderbilt L, Billman G. Sensitivity of the pediatric early warning score to identify patient deterioration. Pediatrics. 2010;125(4)e763e769.
  36. Meester K, Bogaert P, Clarke SP, Bossaert L. In‐hospital mortality after serious adverse events on medical and surgical nursing units: a mixed methods study [published online ahead of print July 24, 2012]. J Clin Nurs. doi: 10.1111/j.1365‐2702.2012.04154.x.
  37. Cooper S, McConnell‐Henry T, Cant R, et al. Managing deteriorating patients: registered nurses' performance in a simulated setting. Open Nurs J. 2011;5:120126.
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Address for correspondence and reprint requests: Thomas Bailey, MD, Division of Infectious Diseases, Washington University School of Medicine, 660 S. Euclid Ave., Campus Box 8051, St. Louis, MO 63110; Telephone: 314‐454‐8293; Fax: 314‐454‐5392; E‐mail: [email protected]
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Subspecialties Working Together in Multidisciplinary Cosmetic Centers

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Dr. Feldman discusses a multidisciplinary approach to cosmetic medicine and reviews the findings from his survey of physicians from different specialties. For more information, read Dr. Feldman's article in the July 2012 issue, "Academic Physicians' Attitudes Toward Implementation of Multidisciplinary Cosmetic Centers and the Challenges of Subspecialties Working Together."

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From Dermatology, Pathology, and Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina.

Dr. Feldman discusses a multidisciplinary approach to cosmetic medicine and reviews the findings from his survey of physicians from different specialties. For more information, read Dr. Feldman's article in the July 2012 issue, "Academic Physicians' Attitudes Toward Implementation of Multidisciplinary Cosmetic Centers and the Challenges of Subspecialties Working Together."

Dr. Feldman discusses a multidisciplinary approach to cosmetic medicine and reviews the findings from his survey of physicians from different specialties. For more information, read Dr. Feldman's article in the July 2012 issue, "Academic Physicians' Attitudes Toward Implementation of Multidisciplinary Cosmetic Centers and the Challenges of Subspecialties Working Together."

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'I never know when to call palliative care'

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This morbidity and mortality conference was like any other: First, we reviewed the case of a patient with a complication from anticoagulation and then another with an anastomotic leak. Finally, we discussed an elderly patient who had a major emergent procedure to treat complications from an underlying life-limiting condition, only to die in hospital weeks later after developing insurmountable medical, surgical, and infectious complications.

Dr. Zara Cooper

This elderly patient was a man in his mid-70s recently diagnosed with recurrent melanoma. He came to our emergency department with peritonitis and hypotension. His wife of 52 years sat beside him. She was tearful and afraid. "We want everything done," she said. Eight weeks ago, he was working full time and playing golf. But, 6 weeks ago he became confused. A CT scan revealed brain metastasis. He spent 5 of the last 6 weeks in the ICU and in a step-down unit, or a nursing home after a series of complications from his brain biopsy. Now he was back in the hospital with a bowel perforation.

Before our surgical team even saw him, he was told he needed surgery, or he would die. We discussed the surgical risks including the likelihood of a protracted ICU stay, and the high risk he would never go home. Still, he and his wife were unprepared for death and so we went to the operating room.

The following weeks were fraught with complications. His symptoms – including delirium, tumor headaches, and pain – were all difficult to manage on his cocktail of steroids, opiates, and antipsychotics. Occasionally, he would mumble something about dying but we couldn’t determine if he was lucid. His symptoms and "talk about death" were distressing for his family. All in all, our team spent almost an hour each day answering their questions and tending to their anxiety and suffering. It took a high emotional toll on our entire team, as we each worried to ourselves that we were doing more harm than good.

One organ system failed after the other. And finally, after two operations, 10 different consultants, and 3 weeks in the hospital, we stopped talking about organ systems and told the family that this man was dying. That day we consulted palliative care to help us with "goals of care." The next day, he became oliguric, and we shifted our focus to comfort. He died within hours surrounded by his loving extended family.

When we discussed this case at M&M, there were no objections to the decision to operate or how we managed his laundry list of complications. His death was deemed "nonpreventable." But, at then end of the discussion, a colleague asked, with some exasperation, "I never know when to call palliative care. How do you decide when the patient is dying?"

In retrospect, it is clear that this patient was dying when we met him in the emergency department. He was malnourished and disabled from his cancer and treatment. His bowel perforation was caused by the steroids prescribed to treat his underlying terminal disease. The best outcome we could hope for was a good quality of life in his last days, a peaceful and dignified death, and an uncomplicated bereavement for his survivors. Our emergency, life-saving surgery was, in fact, palliative. Death was near, but we just didn’t want him to die this way.

According to the American College of Surgeons code of professional conduct, surgeons play a pivotal role in facilitating the transition from curative to palliative treatment for the patients and the entire health care team. Furthermore, "effective palliation obligates sensitive discussion with patients and their families." These conversations can be particularly onerous for surgeons because we take on tremendous sense of personal responsibility for postoperative outcomes. Once we commit to operating on a patient, their death, especially if it follows complications, can be equated with personal defeat. We may benefit from consulting specialists who can help us set the stage, and smooth the transition for our patients and their families. Surgeons may also personally benefit from the support of other providers to help us cope with these emotionally difficult cases.

Palliative care is a multidisciplinary model of care to address the physical, intellectual, emotional, social, and spiritual needs of patients and families facing serious illness. The goal of palliative care is to support the best possible quality of life for patients at all stages of serious illness, through providing aggressive symptom management, psychosocial and spiritual care, and grief and bereavement counseling before and after death. Palliative care seeks to be life affirming and is based on the understanding of death as a normal life process. It can and should be delivered along with life-prolonging treatment.

 

 

In this case, palliative care should have been offered in the emergency department as soon as this patient was admitted to our service. The patient, and his family, would have benefited from a team of physicians, nurses, pharmacists, social workers, and chaplains with the time and expertise to manage distressing symptoms from his cancer, and attend to the grief and suffering that characterized his final weeks. Earlier palliative care may have also steered us away from the slog of high-burden treatments that ultimately offered him little benefit. For the surgeons, palliative care would have provided additional resources to take the best possible care of our patient who, whether or not he made it home, was near the end of his life from an advanced illness.

Dr. Zara Cooper is an ACS Fellow, and assistant professor of surgery, Harvard Medical School, and department of surgery, division of trauma, burns and critical care at Brigham and Women’s Hospital, Boston. Dr. Cooper has no disclosures relevant to this editorial.

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This morbidity and mortality conference was like any other: First, we reviewed the case of a patient with a complication from anticoagulation and then another with an anastomotic leak. Finally, we discussed an elderly patient who had a major emergent procedure to treat complications from an underlying life-limiting condition, only to die in hospital weeks later after developing insurmountable medical, surgical, and infectious complications.

Dr. Zara Cooper

This elderly patient was a man in his mid-70s recently diagnosed with recurrent melanoma. He came to our emergency department with peritonitis and hypotension. His wife of 52 years sat beside him. She was tearful and afraid. "We want everything done," she said. Eight weeks ago, he was working full time and playing golf. But, 6 weeks ago he became confused. A CT scan revealed brain metastasis. He spent 5 of the last 6 weeks in the ICU and in a step-down unit, or a nursing home after a series of complications from his brain biopsy. Now he was back in the hospital with a bowel perforation.

Before our surgical team even saw him, he was told he needed surgery, or he would die. We discussed the surgical risks including the likelihood of a protracted ICU stay, and the high risk he would never go home. Still, he and his wife were unprepared for death and so we went to the operating room.

The following weeks were fraught with complications. His symptoms – including delirium, tumor headaches, and pain – were all difficult to manage on his cocktail of steroids, opiates, and antipsychotics. Occasionally, he would mumble something about dying but we couldn’t determine if he was lucid. His symptoms and "talk about death" were distressing for his family. All in all, our team spent almost an hour each day answering their questions and tending to their anxiety and suffering. It took a high emotional toll on our entire team, as we each worried to ourselves that we were doing more harm than good.

One organ system failed after the other. And finally, after two operations, 10 different consultants, and 3 weeks in the hospital, we stopped talking about organ systems and told the family that this man was dying. That day we consulted palliative care to help us with "goals of care." The next day, he became oliguric, and we shifted our focus to comfort. He died within hours surrounded by his loving extended family.

When we discussed this case at M&M, there were no objections to the decision to operate or how we managed his laundry list of complications. His death was deemed "nonpreventable." But, at then end of the discussion, a colleague asked, with some exasperation, "I never know when to call palliative care. How do you decide when the patient is dying?"

In retrospect, it is clear that this patient was dying when we met him in the emergency department. He was malnourished and disabled from his cancer and treatment. His bowel perforation was caused by the steroids prescribed to treat his underlying terminal disease. The best outcome we could hope for was a good quality of life in his last days, a peaceful and dignified death, and an uncomplicated bereavement for his survivors. Our emergency, life-saving surgery was, in fact, palliative. Death was near, but we just didn’t want him to die this way.

According to the American College of Surgeons code of professional conduct, surgeons play a pivotal role in facilitating the transition from curative to palliative treatment for the patients and the entire health care team. Furthermore, "effective palliation obligates sensitive discussion with patients and their families." These conversations can be particularly onerous for surgeons because we take on tremendous sense of personal responsibility for postoperative outcomes. Once we commit to operating on a patient, their death, especially if it follows complications, can be equated with personal defeat. We may benefit from consulting specialists who can help us set the stage, and smooth the transition for our patients and their families. Surgeons may also personally benefit from the support of other providers to help us cope with these emotionally difficult cases.

Palliative care is a multidisciplinary model of care to address the physical, intellectual, emotional, social, and spiritual needs of patients and families facing serious illness. The goal of palliative care is to support the best possible quality of life for patients at all stages of serious illness, through providing aggressive symptom management, psychosocial and spiritual care, and grief and bereavement counseling before and after death. Palliative care seeks to be life affirming and is based on the understanding of death as a normal life process. It can and should be delivered along with life-prolonging treatment.

 

 

In this case, palliative care should have been offered in the emergency department as soon as this patient was admitted to our service. The patient, and his family, would have benefited from a team of physicians, nurses, pharmacists, social workers, and chaplains with the time and expertise to manage distressing symptoms from his cancer, and attend to the grief and suffering that characterized his final weeks. Earlier palliative care may have also steered us away from the slog of high-burden treatments that ultimately offered him little benefit. For the surgeons, palliative care would have provided additional resources to take the best possible care of our patient who, whether or not he made it home, was near the end of his life from an advanced illness.

Dr. Zara Cooper is an ACS Fellow, and assistant professor of surgery, Harvard Medical School, and department of surgery, division of trauma, burns and critical care at Brigham and Women’s Hospital, Boston. Dr. Cooper has no disclosures relevant to this editorial.

This morbidity and mortality conference was like any other: First, we reviewed the case of a patient with a complication from anticoagulation and then another with an anastomotic leak. Finally, we discussed an elderly patient who had a major emergent procedure to treat complications from an underlying life-limiting condition, only to die in hospital weeks later after developing insurmountable medical, surgical, and infectious complications.

Dr. Zara Cooper

This elderly patient was a man in his mid-70s recently diagnosed with recurrent melanoma. He came to our emergency department with peritonitis and hypotension. His wife of 52 years sat beside him. She was tearful and afraid. "We want everything done," she said. Eight weeks ago, he was working full time and playing golf. But, 6 weeks ago he became confused. A CT scan revealed brain metastasis. He spent 5 of the last 6 weeks in the ICU and in a step-down unit, or a nursing home after a series of complications from his brain biopsy. Now he was back in the hospital with a bowel perforation.

Before our surgical team even saw him, he was told he needed surgery, or he would die. We discussed the surgical risks including the likelihood of a protracted ICU stay, and the high risk he would never go home. Still, he and his wife were unprepared for death and so we went to the operating room.

The following weeks were fraught with complications. His symptoms – including delirium, tumor headaches, and pain – were all difficult to manage on his cocktail of steroids, opiates, and antipsychotics. Occasionally, he would mumble something about dying but we couldn’t determine if he was lucid. His symptoms and "talk about death" were distressing for his family. All in all, our team spent almost an hour each day answering their questions and tending to their anxiety and suffering. It took a high emotional toll on our entire team, as we each worried to ourselves that we were doing more harm than good.

One organ system failed after the other. And finally, after two operations, 10 different consultants, and 3 weeks in the hospital, we stopped talking about organ systems and told the family that this man was dying. That day we consulted palliative care to help us with "goals of care." The next day, he became oliguric, and we shifted our focus to comfort. He died within hours surrounded by his loving extended family.

When we discussed this case at M&M, there were no objections to the decision to operate or how we managed his laundry list of complications. His death was deemed "nonpreventable." But, at then end of the discussion, a colleague asked, with some exasperation, "I never know when to call palliative care. How do you decide when the patient is dying?"

In retrospect, it is clear that this patient was dying when we met him in the emergency department. He was malnourished and disabled from his cancer and treatment. His bowel perforation was caused by the steroids prescribed to treat his underlying terminal disease. The best outcome we could hope for was a good quality of life in his last days, a peaceful and dignified death, and an uncomplicated bereavement for his survivors. Our emergency, life-saving surgery was, in fact, palliative. Death was near, but we just didn’t want him to die this way.

According to the American College of Surgeons code of professional conduct, surgeons play a pivotal role in facilitating the transition from curative to palliative treatment for the patients and the entire health care team. Furthermore, "effective palliation obligates sensitive discussion with patients and their families." These conversations can be particularly onerous for surgeons because we take on tremendous sense of personal responsibility for postoperative outcomes. Once we commit to operating on a patient, their death, especially if it follows complications, can be equated with personal defeat. We may benefit from consulting specialists who can help us set the stage, and smooth the transition for our patients and their families. Surgeons may also personally benefit from the support of other providers to help us cope with these emotionally difficult cases.

Palliative care is a multidisciplinary model of care to address the physical, intellectual, emotional, social, and spiritual needs of patients and families facing serious illness. The goal of palliative care is to support the best possible quality of life for patients at all stages of serious illness, through providing aggressive symptom management, psychosocial and spiritual care, and grief and bereavement counseling before and after death. Palliative care seeks to be life affirming and is based on the understanding of death as a normal life process. It can and should be delivered along with life-prolonging treatment.

 

 

In this case, palliative care should have been offered in the emergency department as soon as this patient was admitted to our service. The patient, and his family, would have benefited from a team of physicians, nurses, pharmacists, social workers, and chaplains with the time and expertise to manage distressing symptoms from his cancer, and attend to the grief and suffering that characterized his final weeks. Earlier palliative care may have also steered us away from the slog of high-burden treatments that ultimately offered him little benefit. For the surgeons, palliative care would have provided additional resources to take the best possible care of our patient who, whether or not he made it home, was near the end of his life from an advanced illness.

Dr. Zara Cooper is an ACS Fellow, and assistant professor of surgery, Harvard Medical School, and department of surgery, division of trauma, burns and critical care at Brigham and Women’s Hospital, Boston. Dr. Cooper has no disclosures relevant to this editorial.

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Dabigatran noninferior to warfarin for preventing recurrent VTE

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New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin presents a significantly higher risk of bleeding.

These results are from the RE-MEDY study, which compared the 2 drugs as long-term prophylaxis in patients who had received at least 3 months of VTE treatment.

The data appear in an NEJM article alongside results of the RE-SONATE study, which compared dabigatran and placebo in a similar patient population.

Both of these randomized, double-blind studies were sponsored by the makers of dabigatran, Boehringer Ingelheim.

In the RE-MEDY trial, 2856 patients were randomized in a 1:1 ratio to receive dabigatran or warfarin for up to 36 months. Patients either received active dabigatran at 150 mg twice daily and a warfarin-like placebo or active warfarin and a dabigatran-like placebo. The warfarin dose was adjusted to maintain an INR of 2.0 to 3.0.

In the RE-SONATE trial, 1343 patients were randomized to receive treatment for 6 months. They were assigned in a 1:1 ratio to receive dabigatran at 150 mg twice daily or a matching placebo.

Extended follow-up to evaluate the long-term risk of VTE recurrence took place 12 months after the completion of study treatment.

In RE-MEDY, recurrent VTE occurred in 1.8% of patients in the dabigatran arm and 1.3% of patients in the warfarin arm (P=0.01 for noninferiority).

In RE-SONATE, recurrent VTE occurred in 0.4% of patients in the dabigatran arm and 5.6% of patients in the placebo arm (P<0.001 for superiority).

The rate of clinically relevant or major bleeding was lower with dabigatran than with warfarin—at 5.6% and 10.2%, respectively (P<0.001).

But the rate of clinically relevant or major bleeding was higher with dabigatran than with placebo, at 5.3% and 1.8%, respectively (P=0.001).

“[These results] suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said lead study author Sam Schulman, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.

“They reinforce the efficacy and favorable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.”

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Credit: Andre E.X. Brown

New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin presents a significantly higher risk of bleeding.

These results are from the RE-MEDY study, which compared the 2 drugs as long-term prophylaxis in patients who had received at least 3 months of VTE treatment.

The data appear in an NEJM article alongside results of the RE-SONATE study, which compared dabigatran and placebo in a similar patient population.

Both of these randomized, double-blind studies were sponsored by the makers of dabigatran, Boehringer Ingelheim.

In the RE-MEDY trial, 2856 patients were randomized in a 1:1 ratio to receive dabigatran or warfarin for up to 36 months. Patients either received active dabigatran at 150 mg twice daily and a warfarin-like placebo or active warfarin and a dabigatran-like placebo. The warfarin dose was adjusted to maintain an INR of 2.0 to 3.0.

In the RE-SONATE trial, 1343 patients were randomized to receive treatment for 6 months. They were assigned in a 1:1 ratio to receive dabigatran at 150 mg twice daily or a matching placebo.

Extended follow-up to evaluate the long-term risk of VTE recurrence took place 12 months after the completion of study treatment.

In RE-MEDY, recurrent VTE occurred in 1.8% of patients in the dabigatran arm and 1.3% of patients in the warfarin arm (P=0.01 for noninferiority).

In RE-SONATE, recurrent VTE occurred in 0.4% of patients in the dabigatran arm and 5.6% of patients in the placebo arm (P<0.001 for superiority).

The rate of clinically relevant or major bleeding was lower with dabigatran than with warfarin—at 5.6% and 10.2%, respectively (P<0.001).

But the rate of clinically relevant or major bleeding was higher with dabigatran than with placebo, at 5.3% and 1.8%, respectively (P=0.001).

“[These results] suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said lead study author Sam Schulman, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.

“They reinforce the efficacy and favorable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.”

Thrombus
Credit: Andre E.X. Brown

New research suggests dabigatran is noninferior to warfarin as extended prophylaxis for recurrent venous thromboembolism (VTE), and warfarin presents a significantly higher risk of bleeding.

These results are from the RE-MEDY study, which compared the 2 drugs as long-term prophylaxis in patients who had received at least 3 months of VTE treatment.

The data appear in an NEJM article alongside results of the RE-SONATE study, which compared dabigatran and placebo in a similar patient population.

Both of these randomized, double-blind studies were sponsored by the makers of dabigatran, Boehringer Ingelheim.

In the RE-MEDY trial, 2856 patients were randomized in a 1:1 ratio to receive dabigatran or warfarin for up to 36 months. Patients either received active dabigatran at 150 mg twice daily and a warfarin-like placebo or active warfarin and a dabigatran-like placebo. The warfarin dose was adjusted to maintain an INR of 2.0 to 3.0.

In the RE-SONATE trial, 1343 patients were randomized to receive treatment for 6 months. They were assigned in a 1:1 ratio to receive dabigatran at 150 mg twice daily or a matching placebo.

Extended follow-up to evaluate the long-term risk of VTE recurrence took place 12 months after the completion of study treatment.

In RE-MEDY, recurrent VTE occurred in 1.8% of patients in the dabigatran arm and 1.3% of patients in the warfarin arm (P=0.01 for noninferiority).

In RE-SONATE, recurrent VTE occurred in 0.4% of patients in the dabigatran arm and 5.6% of patients in the placebo arm (P<0.001 for superiority).

The rate of clinically relevant or major bleeding was lower with dabigatran than with warfarin—at 5.6% and 10.2%, respectively (P<0.001).

But the rate of clinically relevant or major bleeding was higher with dabigatran than with placebo, at 5.3% and 1.8%, respectively (P=0.001).

“[These results] suggest dabigatran is a good option to prevent deep vein thrombosis and pulmonary embolism from happening again after an initial event,” said lead study author Sam Schulman, MD, PhD, of McMaster University in Hamilton, Ontario, Canada.

“They reinforce the efficacy and favorable safety profile of dabigatran seen in the RE-COVER trials, where dabigatran showed similar efficacy and a significant reduction in clinically relevant bleeding versus warfarin in the treatment of acute venous thromboembolism.”

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The Society of Hospital Medicine’s "Choosing Wisely" Recommendations for Hospitalists

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SHM has joined the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign, a multiyear effort to spark national dialogue about waste in the healthcare system and the kinds of common treatments that doctors and patients should think twice about before deciding to pursue. Ad hoc subcommittees of SHM’s Hospital Quality and Patient Safety Committee created lists of five adult and five pediatric treatments that hospitalists and their patients should question (see below). Those lists were shared alongside 15 other medical specialty societies at a Feb. 21 news conference in Washington, D.C.

Adult Hospitalist "Avoid List"

1. Do not place, or leave in place, urinary catheters for incontinence or convenience or monitoring of output for non-critically ill patients (acceptable indications: critical illness, obstruction, hospice, perioperatively for <2 days for urologic procedures; use weights instead to monitor diuresis).

2. Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless at high risk for GI complications.

3. Avoid transfusions of red blood cells for arbitrary hemoglobin or hematocrit thresholds and in the absence of symptoms or active coronary disease, heart failure or stroke.

4. Do not order continuous telemetry monitoring outside of the ICU without using a protocol that governs continuation.

5. Do not perform repetitive CBC and chemistry testing in the face of clinical and lab stability.

Pediatric HospitalIST "Avoid List"

1. Don’t order chest radiographs in children with uncomplicated asthma or bronchiolitis.

2. Don’t routinely use bronchodilators in children with bronchiolitis.

3. Don’t use systemic corticosteroids in children under 2 years of age with an uncomplicated lower respiratory tract infection.

4. Don’t treat gastroesophageal reflux in infants routinely with acid suppression therapy.

5. Don’t use continuous pulse oximetry routinely in children with acute respiratory illness unless they are on supplemental oxygen.

       For complete recommendations and references, visit SHM's website.

 

 

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SHM has joined the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign, a multiyear effort to spark national dialogue about waste in the healthcare system and the kinds of common treatments that doctors and patients should think twice about before deciding to pursue. Ad hoc subcommittees of SHM’s Hospital Quality and Patient Safety Committee created lists of five adult and five pediatric treatments that hospitalists and their patients should question (see below). Those lists were shared alongside 15 other medical specialty societies at a Feb. 21 news conference in Washington, D.C.

Adult Hospitalist "Avoid List"

1. Do not place, or leave in place, urinary catheters for incontinence or convenience or monitoring of output for non-critically ill patients (acceptable indications: critical illness, obstruction, hospice, perioperatively for <2 days for urologic procedures; use weights instead to monitor diuresis).

2. Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless at high risk for GI complications.

3. Avoid transfusions of red blood cells for arbitrary hemoglobin or hematocrit thresholds and in the absence of symptoms or active coronary disease, heart failure or stroke.

4. Do not order continuous telemetry monitoring outside of the ICU without using a protocol that governs continuation.

5. Do not perform repetitive CBC and chemistry testing in the face of clinical and lab stability.

Pediatric HospitalIST "Avoid List"

1. Don’t order chest radiographs in children with uncomplicated asthma or bronchiolitis.

2. Don’t routinely use bronchodilators in children with bronchiolitis.

3. Don’t use systemic corticosteroids in children under 2 years of age with an uncomplicated lower respiratory tract infection.

4. Don’t treat gastroesophageal reflux in infants routinely with acid suppression therapy.

5. Don’t use continuous pulse oximetry routinely in children with acute respiratory illness unless they are on supplemental oxygen.

       For complete recommendations and references, visit SHM's website.

 

 

SHM has joined the American Board of Internal Medicine (ABIM) Foundation’s Choosing Wisely campaign, a multiyear effort to spark national dialogue about waste in the healthcare system and the kinds of common treatments that doctors and patients should think twice about before deciding to pursue. Ad hoc subcommittees of SHM’s Hospital Quality and Patient Safety Committee created lists of five adult and five pediatric treatments that hospitalists and their patients should question (see below). Those lists were shared alongside 15 other medical specialty societies at a Feb. 21 news conference in Washington, D.C.

Adult Hospitalist "Avoid List"

1. Do not place, or leave in place, urinary catheters for incontinence or convenience or monitoring of output for non-critically ill patients (acceptable indications: critical illness, obstruction, hospice, perioperatively for <2 days for urologic procedures; use weights instead to monitor diuresis).

2. Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless at high risk for GI complications.

3. Avoid transfusions of red blood cells for arbitrary hemoglobin or hematocrit thresholds and in the absence of symptoms or active coronary disease, heart failure or stroke.

4. Do not order continuous telemetry monitoring outside of the ICU without using a protocol that governs continuation.

5. Do not perform repetitive CBC and chemistry testing in the face of clinical and lab stability.

Pediatric HospitalIST "Avoid List"

1. Don’t order chest radiographs in children with uncomplicated asthma or bronchiolitis.

2. Don’t routinely use bronchodilators in children with bronchiolitis.

3. Don’t use systemic corticosteroids in children under 2 years of age with an uncomplicated lower respiratory tract infection.

4. Don’t treat gastroesophageal reflux in infants routinely with acid suppression therapy.

5. Don’t use continuous pulse oximetry routinely in children with acute respiratory illness unless they are on supplemental oxygen.

       For complete recommendations and references, visit SHM's website.

 

 

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Better Choices, Better Healthcare

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WASHINGTON, D.C.—SHM joined hands today with 15 other U.S. medical specialty societies in the fight to eliminate wasteful medical tests, drugs, and treatments.

The 10,000-member SHM, which represents more than 40,000 hospitalists, released two lists of common tests and procedures that clinicians and patients should seriously question as part of the ABIM Foundation’s Choosing Wisely campaign. The campaign debuted in April 2012 with nine medical societies providing input on medical decisions that lack evidence, waste finite healthcare resources, or potentially harm patients.

“We acknowledge that there is waste in our system,” says Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation. “We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.”

SHM’s Hospital Quality and Patient Safety Committee created two lists of five recommendations: one for adult hospitalists and inpatients, and one for pediatric hospitalists and patients. Examples include:

  • Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless they are at high risk for gastrointestinal complications;
  • Do not order continuous telemetry monitoring outside the ICU without using a protocol that governs its continuation; and
  • Do not order chest radiography in children who have uncomplicated asthma or bronchiolitis.

The “avoid” lists were chosen by SHM because they potentially represent significant, needless waste of healthcare resources, according to John Bulger, DO, MBA, SFHM, chief quality officer at Geisinger Medical Center in Danville, Pa. Dr. Bulger, who chaired SHM’s Choosing Wisely committee, encourages hospitalists to stop and take a long look at the list and think about ways to improve their own practice. He encourages hospitalists to take the recommendations to their hospitals’ quality-improvement (QI) committee and start collecting baseline data, he says. “We should be able to come back a year from now and show that we’ve been able to change practice using these lists,” he says.

We acknowledge that there is waste in our system. We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.


—Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation

HM pioneer Robert Wachter, MD, MHM, who heads the division of hospital medicine at the University of California at San Francisco, chairs the American Board of Internal Medicine, and sits on the board of the ABIM Foundation, agrees.

“I think you’ll be hearing similar kinds of drumbeats about waste from every national organization involved in healthcare,” says Dr. Wachter, author of the Wachter’s World blog. “I think hospitalists should be active and enthusiastic partners in the Choosing Wisely campaign and leaders in American healthcare’s efforts to figure out how to purge waste from the system and decrease unnecessary expense.”

Click here to listen to more of Dr. Wachter’s interview on the Choosing Wisely campaign.

A similar kind of focus on efficiency and cost-effectiveness was part of the initial motivation for developing hospital medicine, Dr. Wachter says. He compares the current national obsession about healthcare waste with the medical quality and patient safety movements of the past decade.

“It’s the right time, the right message, and the right messenger,” he says. “But now we’re a little scared about raised expectations. Delivering on them is going to be more difficult, even, than patient safety was because, ultimately, it will require curtailing some income streams. You can’t reach the final outcome of cutting costs in healthcare without someone making less money.” TH

 

 

Larry Beresford is a freelance writer in Oakland, Calif. 

CHoosing Wisely

Who: Sponsored by the ABIM Foundation, the campaign includes 25 medical specialty societies.

What: A national quality campaign to educate physicians and patients about wasteful medical tests, procedures, and treatments.

When: Launched April 4, 2012.

Why: Treatments that are commonly ordered but not supported by medical research are not only potentially wasteful of finite healthcare resources, but they also could harm patients.

More: Check out the complete adult and pediatric HM "avoid" lists.

 

 

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WASHINGTON, D.C.—SHM joined hands today with 15 other U.S. medical specialty societies in the fight to eliminate wasteful medical tests, drugs, and treatments.

The 10,000-member SHM, which represents more than 40,000 hospitalists, released two lists of common tests and procedures that clinicians and patients should seriously question as part of the ABIM Foundation’s Choosing Wisely campaign. The campaign debuted in April 2012 with nine medical societies providing input on medical decisions that lack evidence, waste finite healthcare resources, or potentially harm patients.

“We acknowledge that there is waste in our system,” says Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation. “We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.”

SHM’s Hospital Quality and Patient Safety Committee created two lists of five recommendations: one for adult hospitalists and inpatients, and one for pediatric hospitalists and patients. Examples include:

  • Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless they are at high risk for gastrointestinal complications;
  • Do not order continuous telemetry monitoring outside the ICU without using a protocol that governs its continuation; and
  • Do not order chest radiography in children who have uncomplicated asthma or bronchiolitis.

The “avoid” lists were chosen by SHM because they potentially represent significant, needless waste of healthcare resources, according to John Bulger, DO, MBA, SFHM, chief quality officer at Geisinger Medical Center in Danville, Pa. Dr. Bulger, who chaired SHM’s Choosing Wisely committee, encourages hospitalists to stop and take a long look at the list and think about ways to improve their own practice. He encourages hospitalists to take the recommendations to their hospitals’ quality-improvement (QI) committee and start collecting baseline data, he says. “We should be able to come back a year from now and show that we’ve been able to change practice using these lists,” he says.

We acknowledge that there is waste in our system. We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.


—Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation

HM pioneer Robert Wachter, MD, MHM, who heads the division of hospital medicine at the University of California at San Francisco, chairs the American Board of Internal Medicine, and sits on the board of the ABIM Foundation, agrees.

“I think you’ll be hearing similar kinds of drumbeats about waste from every national organization involved in healthcare,” says Dr. Wachter, author of the Wachter’s World blog. “I think hospitalists should be active and enthusiastic partners in the Choosing Wisely campaign and leaders in American healthcare’s efforts to figure out how to purge waste from the system and decrease unnecessary expense.”

Click here to listen to more of Dr. Wachter’s interview on the Choosing Wisely campaign.

A similar kind of focus on efficiency and cost-effectiveness was part of the initial motivation for developing hospital medicine, Dr. Wachter says. He compares the current national obsession about healthcare waste with the medical quality and patient safety movements of the past decade.

“It’s the right time, the right message, and the right messenger,” he says. “But now we’re a little scared about raised expectations. Delivering on them is going to be more difficult, even, than patient safety was because, ultimately, it will require curtailing some income streams. You can’t reach the final outcome of cutting costs in healthcare without someone making less money.” TH

 

 

Larry Beresford is a freelance writer in Oakland, Calif. 

CHoosing Wisely

Who: Sponsored by the ABIM Foundation, the campaign includes 25 medical specialty societies.

What: A national quality campaign to educate physicians and patients about wasteful medical tests, procedures, and treatments.

When: Launched April 4, 2012.

Why: Treatments that are commonly ordered but not supported by medical research are not only potentially wasteful of finite healthcare resources, but they also could harm patients.

More: Check out the complete adult and pediatric HM "avoid" lists.

 

 

WASHINGTON, D.C.—SHM joined hands today with 15 other U.S. medical specialty societies in the fight to eliminate wasteful medical tests, drugs, and treatments.

The 10,000-member SHM, which represents more than 40,000 hospitalists, released two lists of common tests and procedures that clinicians and patients should seriously question as part of the ABIM Foundation’s Choosing Wisely campaign. The campaign debuted in April 2012 with nine medical societies providing input on medical decisions that lack evidence, waste finite healthcare resources, or potentially harm patients.

“We acknowledge that there is waste in our system,” says Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation. “We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.”

SHM’s Hospital Quality and Patient Safety Committee created two lists of five recommendations: one for adult hospitalists and inpatients, and one for pediatric hospitalists and patients. Examples include:

  • Do not prescribe medications for stress ulcer prophylaxis to medical inpatients unless they are at high risk for gastrointestinal complications;
  • Do not order continuous telemetry monitoring outside the ICU without using a protocol that governs its continuation; and
  • Do not order chest radiography in children who have uncomplicated asthma or bronchiolitis.

The “avoid” lists were chosen by SHM because they potentially represent significant, needless waste of healthcare resources, according to John Bulger, DO, MBA, SFHM, chief quality officer at Geisinger Medical Center in Danville, Pa. Dr. Bulger, who chaired SHM’s Choosing Wisely committee, encourages hospitalists to stop and take a long look at the list and think about ways to improve their own practice. He encourages hospitalists to take the recommendations to their hospitals’ quality-improvement (QI) committee and start collecting baseline data, he says. “We should be able to come back a year from now and show that we’ve been able to change practice using these lists,” he says.

We acknowledge that there is waste in our system. We also believe that if you have an engaged, empowered patient, together you will make better choices, have less waste, and probably also reduce costs.


—Gregory Maynard, MD, MSc, SFHM, senior vice president of SHM’s Center for Healthcare Improvement and Innovation

HM pioneer Robert Wachter, MD, MHM, who heads the division of hospital medicine at the University of California at San Francisco, chairs the American Board of Internal Medicine, and sits on the board of the ABIM Foundation, agrees.

“I think you’ll be hearing similar kinds of drumbeats about waste from every national organization involved in healthcare,” says Dr. Wachter, author of the Wachter’s World blog. “I think hospitalists should be active and enthusiastic partners in the Choosing Wisely campaign and leaders in American healthcare’s efforts to figure out how to purge waste from the system and decrease unnecessary expense.”

Click here to listen to more of Dr. Wachter’s interview on the Choosing Wisely campaign.

A similar kind of focus on efficiency and cost-effectiveness was part of the initial motivation for developing hospital medicine, Dr. Wachter says. He compares the current national obsession about healthcare waste with the medical quality and patient safety movements of the past decade.

“It’s the right time, the right message, and the right messenger,” he says. “But now we’re a little scared about raised expectations. Delivering on them is going to be more difficult, even, than patient safety was because, ultimately, it will require curtailing some income streams. You can’t reach the final outcome of cutting costs in healthcare without someone making less money.” TH

 

 

Larry Beresford is a freelance writer in Oakland, Calif. 

CHoosing Wisely

Who: Sponsored by the ABIM Foundation, the campaign includes 25 medical specialty societies.

What: A national quality campaign to educate physicians and patients about wasteful medical tests, procedures, and treatments.

When: Launched April 4, 2012.

Why: Treatments that are commonly ordered but not supported by medical research are not only potentially wasteful of finite healthcare resources, but they also could harm patients.

More: Check out the complete adult and pediatric HM "avoid" lists.

 

 

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Hospitalists Earn High Marks in Patient Care Survey

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The lead author of a new report that says hospitalized Medicare patients are happier in facilities using a greater number of hospitalists didn't expect that would be the case.

The study, "Hospitalist Staffing and Patient Satisfaction in the National Medicare Population," which was recently published in the Journal of Hospital Medicine, sprung from the theory that hospitals using a large number of hospitalists generally would rank lower in patient satisfaction than others. In part, the expectation was tied to the belief that patients might prefer to be seen by their primary-care physician (PCP) rather than a hospitalist.

"What we'd like people to take away is that in our study—and it's only one study—hospitals with higher levels of hospitalist care had modestly higher patient satisfaction scores, especially in the areas of discharge planning and overall satisfaction," says Lena Chen, MD, MS, clinical lecturer in the division of general medicine at the University of Michigan in Ann Arbor. "It suggests that there doesn't need to be a tradeoff between greater use of hospitalist services and patient satisfaction."

The retrospective cohort study looked at 2,843 acute-care hospitals and split them into groups ranked by the percentage of patients cared for by hospitalists. Those categorized as "nonhospitalist" hospitals had a median of 0% of general medicine patients cared for by hospitalists; a "mixed" hospital had a median of 39.5% of general medicine patients cared for by hospitalists; and a "hospitalist" hospital had a median of 76.5% cared for by hospitalists, according to the report. "Hospitalist" hospitals scored better (65.6%) on global measures of satisfaction than "mixed" (63.9%) or "nonhospitalist" (63.9%) hospitals (P<0.001), the study found. Hospitalist care was not associated with patient satisfaction in the areas of room cleanliness or communication with a physician.

Dr. Chen says she would like to see the research prompt more investigation into why hospitalist care is associated with patient satisfaction.

"We all want to have satisfied patients," she adds. "It would be important to have research that explores what the factors are that lead to greater patient satisfaction. This is a first step, but it's definitely not the end of the road."

Visit our website for more information about patient satisfaction.

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The lead author of a new report that says hospitalized Medicare patients are happier in facilities using a greater number of hospitalists didn't expect that would be the case.

The study, "Hospitalist Staffing and Patient Satisfaction in the National Medicare Population," which was recently published in the Journal of Hospital Medicine, sprung from the theory that hospitals using a large number of hospitalists generally would rank lower in patient satisfaction than others. In part, the expectation was tied to the belief that patients might prefer to be seen by their primary-care physician (PCP) rather than a hospitalist.

"What we'd like people to take away is that in our study—and it's only one study—hospitals with higher levels of hospitalist care had modestly higher patient satisfaction scores, especially in the areas of discharge planning and overall satisfaction," says Lena Chen, MD, MS, clinical lecturer in the division of general medicine at the University of Michigan in Ann Arbor. "It suggests that there doesn't need to be a tradeoff between greater use of hospitalist services and patient satisfaction."

The retrospective cohort study looked at 2,843 acute-care hospitals and split them into groups ranked by the percentage of patients cared for by hospitalists. Those categorized as "nonhospitalist" hospitals had a median of 0% of general medicine patients cared for by hospitalists; a "mixed" hospital had a median of 39.5% of general medicine patients cared for by hospitalists; and a "hospitalist" hospital had a median of 76.5% cared for by hospitalists, according to the report. "Hospitalist" hospitals scored better (65.6%) on global measures of satisfaction than "mixed" (63.9%) or "nonhospitalist" (63.9%) hospitals (P<0.001), the study found. Hospitalist care was not associated with patient satisfaction in the areas of room cleanliness or communication with a physician.

Dr. Chen says she would like to see the research prompt more investigation into why hospitalist care is associated with patient satisfaction.

"We all want to have satisfied patients," she adds. "It would be important to have research that explores what the factors are that lead to greater patient satisfaction. This is a first step, but it's definitely not the end of the road."

Visit our website for more information about patient satisfaction.

The lead author of a new report that says hospitalized Medicare patients are happier in facilities using a greater number of hospitalists didn't expect that would be the case.

The study, "Hospitalist Staffing and Patient Satisfaction in the National Medicare Population," which was recently published in the Journal of Hospital Medicine, sprung from the theory that hospitals using a large number of hospitalists generally would rank lower in patient satisfaction than others. In part, the expectation was tied to the belief that patients might prefer to be seen by their primary-care physician (PCP) rather than a hospitalist.

"What we'd like people to take away is that in our study—and it's only one study—hospitals with higher levels of hospitalist care had modestly higher patient satisfaction scores, especially in the areas of discharge planning and overall satisfaction," says Lena Chen, MD, MS, clinical lecturer in the division of general medicine at the University of Michigan in Ann Arbor. "It suggests that there doesn't need to be a tradeoff between greater use of hospitalist services and patient satisfaction."

The retrospective cohort study looked at 2,843 acute-care hospitals and split them into groups ranked by the percentage of patients cared for by hospitalists. Those categorized as "nonhospitalist" hospitals had a median of 0% of general medicine patients cared for by hospitalists; a "mixed" hospital had a median of 39.5% of general medicine patients cared for by hospitalists; and a "hospitalist" hospital had a median of 76.5% cared for by hospitalists, according to the report. "Hospitalist" hospitals scored better (65.6%) on global measures of satisfaction than "mixed" (63.9%) or "nonhospitalist" (63.9%) hospitals (P<0.001), the study found. Hospitalist care was not associated with patient satisfaction in the areas of room cleanliness or communication with a physician.

Dr. Chen says she would like to see the research prompt more investigation into why hospitalist care is associated with patient satisfaction.

"We all want to have satisfied patients," she adds. "It would be important to have research that explores what the factors are that lead to greater patient satisfaction. This is a first step, but it's definitely not the end of the road."

Visit our website for more information about patient satisfaction.

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Drugs, Pregnancy, and Lactation: New Weight Loss Drugs

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The need for effective weight management medications as an adjunct to diet and exercise has escalated in the United States as obesity has reached epidemic proportions.

However, in recent years, several Food and Drug Administration–approved medications for weight loss have been plagued with safety concerns and many have been removed from the market, leaving clinicians with limited choices for treatment of overweight or obese patients.

In 2012, two new weight loss medications were approved by the FDA – the first new medications approved for this indication in over a decade (N. Engl. J. Med. 2012;367:1577-9).

As of February 2013, one of the two products, a combination product containing the anorexant phentermine and the anticonvulsant topiramate in an extended-release form, is currently available by prescription in the United States. Marketed as Qysmia, the product is intended to be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese).

The medication is also indicated for adults with a BMI of 27 or greater (overweight) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The recommended starting daily dose contains 3.75 mg of phentermine and 23 mg of topiramate; the maximum dose contains 15 mg of phentermine and 92 mg of topiramate.

In part, due to concerns about the teratogenicity of topiramate, Qysmia has been designated a category X drug, and specific pregnancy prevention measures in the form of a Risk Evaluation and Mitigation Strategy (REMS) have been put in place. The medication can be obtained only by prescription obtained directly from a health care provider, and providers receive training on the risks of birth defects. A prescription for Qysmia can only be filled by specially certified mail order pharmacies in the United States.

Educational materials indicate that the drug should not be prescribed to women who are pregnant or who are planning on becoming pregnant. Women who are not planning pregnancy but have the potential to become pregnant should have a negative pregnancy test before starting the drug and again every month while taking the drug, and they should use an effective method or combination of methods of contraception. The manufacturer has also initiated a pregnancy surveillance system.

Given the likelihood that many women of reproductive age will use this medication, even with a REMS in place, the potential for unintentional exposure in pregnancy exists. In the inevitable event of an exposed pregnancy, what are the specific risks and their magnitude? The concern about birth defects with this medication stems from previously published data suggesting that topiramate used in monotherapy for other indications, most commonly epilepsy, is associated with an increased risk for oral clefts (cleft lip with or without cleft palate). Although numbers are still small, a few studies have suggested the risk for oral clefts, with the most recent a large pooled case-control analysis from two data sources in the United States (Am. J. Obstet. Gynecol. 2012;207:405e1-7). The pooled estimate of the risk of oral clefts was 5.36 with very wide confidence intervals (1.49-20.07), based on seven exposed children with cleft lip with or without cleft palate. To the extent that this estimate is correct, this translates to an absolute risk of about 5 in 1,000 first-trimester topiramate-exposed pregnancies, compared with a baseline risk of about 1 in 1,000 in unexposed pregnancies.

Published studies of topiramate and oral clefts have not involved sufficient numbers of exposed and affected children to allow examination of a dose threshold; however, the range of recommended doses for seizure prevention in adults treated with topiramate monotherapy (50-400 mg/day) overlaps with the dosing range of topiramate contained in Qysmia. It is important to note that based on the published reports suggesting an increased risk for oral clefts, the pregnancy category for topiramate alone was recently changed from a C to a D, while the pregnancy category for Qysmia is an X. The rationale behind the category D is likely that the benefits of topiramate might outweigh the risks in a pregnant woman with a seizure disorder for whom topiramate is the only effective medication. However, topiramate use for weight loss would typically never be indicated in pregnancy.

The second drug, lorcaserin (Belviq), is a single-ingredient serotonergic medication – a selective agonist of the 5-HT2C receptor. Lorcaserin was approved by the FDA in 2012, but as of February 2013, it is not yet available in the United States. This medication also received a pregnancy category X designation; however, in this situation, it was presumably for the sole reason that intentional weight loss in pregnancy is not recommended. Preclinical data for lorcaserin did not suggest teratogenicity, but maternal exposure in rats late in gestation resulted in lower pup body weight that persisted into adulthood.

 

 

To the extent that these new medications are effective in reducing and maintaining BMI within a healthier range in women who are currently overweight or obese, they may lead to improvement in subsequent pregnancy outcomes. However, avoiding exposure to these medications during early pregnancy will be a challenge, even with pregnancy prevention guidance and restricted distribution programs. Postmarketing surveillance for outcomes of inadvertently exposed pregnancies will be essential.

Dr. Chambers is associate professor of pediatrics and family and preventive medicine at the University of California, San Diego. She is director of the California Teratogen Information Service and Clinical Research Program. Dr. Chambers is a past president of the Organization of Teratology Information Specialists and past president of the Teratology Society. She said she had no relevant financial disclosures. To comment, e-mail her at [email protected].

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The need for effective weight management medications as an adjunct to diet and exercise has escalated in the United States as obesity has reached epidemic proportions.

However, in recent years, several Food and Drug Administration–approved medications for weight loss have been plagued with safety concerns and many have been removed from the market, leaving clinicians with limited choices for treatment of overweight or obese patients.

In 2012, two new weight loss medications were approved by the FDA – the first new medications approved for this indication in over a decade (N. Engl. J. Med. 2012;367:1577-9).

As of February 2013, one of the two products, a combination product containing the anorexant phentermine and the anticonvulsant topiramate in an extended-release form, is currently available by prescription in the United States. Marketed as Qysmia, the product is intended to be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese).

The medication is also indicated for adults with a BMI of 27 or greater (overweight) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The recommended starting daily dose contains 3.75 mg of phentermine and 23 mg of topiramate; the maximum dose contains 15 mg of phentermine and 92 mg of topiramate.

In part, due to concerns about the teratogenicity of topiramate, Qysmia has been designated a category X drug, and specific pregnancy prevention measures in the form of a Risk Evaluation and Mitigation Strategy (REMS) have been put in place. The medication can be obtained only by prescription obtained directly from a health care provider, and providers receive training on the risks of birth defects. A prescription for Qysmia can only be filled by specially certified mail order pharmacies in the United States.

Educational materials indicate that the drug should not be prescribed to women who are pregnant or who are planning on becoming pregnant. Women who are not planning pregnancy but have the potential to become pregnant should have a negative pregnancy test before starting the drug and again every month while taking the drug, and they should use an effective method or combination of methods of contraception. The manufacturer has also initiated a pregnancy surveillance system.

Given the likelihood that many women of reproductive age will use this medication, even with a REMS in place, the potential for unintentional exposure in pregnancy exists. In the inevitable event of an exposed pregnancy, what are the specific risks and their magnitude? The concern about birth defects with this medication stems from previously published data suggesting that topiramate used in monotherapy for other indications, most commonly epilepsy, is associated with an increased risk for oral clefts (cleft lip with or without cleft palate). Although numbers are still small, a few studies have suggested the risk for oral clefts, with the most recent a large pooled case-control analysis from two data sources in the United States (Am. J. Obstet. Gynecol. 2012;207:405e1-7). The pooled estimate of the risk of oral clefts was 5.36 with very wide confidence intervals (1.49-20.07), based on seven exposed children with cleft lip with or without cleft palate. To the extent that this estimate is correct, this translates to an absolute risk of about 5 in 1,000 first-trimester topiramate-exposed pregnancies, compared with a baseline risk of about 1 in 1,000 in unexposed pregnancies.

Published studies of topiramate and oral clefts have not involved sufficient numbers of exposed and affected children to allow examination of a dose threshold; however, the range of recommended doses for seizure prevention in adults treated with topiramate monotherapy (50-400 mg/day) overlaps with the dosing range of topiramate contained in Qysmia. It is important to note that based on the published reports suggesting an increased risk for oral clefts, the pregnancy category for topiramate alone was recently changed from a C to a D, while the pregnancy category for Qysmia is an X. The rationale behind the category D is likely that the benefits of topiramate might outweigh the risks in a pregnant woman with a seizure disorder for whom topiramate is the only effective medication. However, topiramate use for weight loss would typically never be indicated in pregnancy.

The second drug, lorcaserin (Belviq), is a single-ingredient serotonergic medication – a selective agonist of the 5-HT2C receptor. Lorcaserin was approved by the FDA in 2012, but as of February 2013, it is not yet available in the United States. This medication also received a pregnancy category X designation; however, in this situation, it was presumably for the sole reason that intentional weight loss in pregnancy is not recommended. Preclinical data for lorcaserin did not suggest teratogenicity, but maternal exposure in rats late in gestation resulted in lower pup body weight that persisted into adulthood.

 

 

To the extent that these new medications are effective in reducing and maintaining BMI within a healthier range in women who are currently overweight or obese, they may lead to improvement in subsequent pregnancy outcomes. However, avoiding exposure to these medications during early pregnancy will be a challenge, even with pregnancy prevention guidance and restricted distribution programs. Postmarketing surveillance for outcomes of inadvertently exposed pregnancies will be essential.

Dr. Chambers is associate professor of pediatrics and family and preventive medicine at the University of California, San Diego. She is director of the California Teratogen Information Service and Clinical Research Program. Dr. Chambers is a past president of the Organization of Teratology Information Specialists and past president of the Teratology Society. She said she had no relevant financial disclosures. To comment, e-mail her at [email protected].

The need for effective weight management medications as an adjunct to diet and exercise has escalated in the United States as obesity has reached epidemic proportions.

However, in recent years, several Food and Drug Administration–approved medications for weight loss have been plagued with safety concerns and many have been removed from the market, leaving clinicians with limited choices for treatment of overweight or obese patients.

In 2012, two new weight loss medications were approved by the FDA – the first new medications approved for this indication in over a decade (N. Engl. J. Med. 2012;367:1577-9).

As of February 2013, one of the two products, a combination product containing the anorexant phentermine and the anticonvulsant topiramate in an extended-release form, is currently available by prescription in the United States. Marketed as Qysmia, the product is intended to be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater (obese).

The medication is also indicated for adults with a BMI of 27 or greater (overweight) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. The recommended starting daily dose contains 3.75 mg of phentermine and 23 mg of topiramate; the maximum dose contains 15 mg of phentermine and 92 mg of topiramate.

In part, due to concerns about the teratogenicity of topiramate, Qysmia has been designated a category X drug, and specific pregnancy prevention measures in the form of a Risk Evaluation and Mitigation Strategy (REMS) have been put in place. The medication can be obtained only by prescription obtained directly from a health care provider, and providers receive training on the risks of birth defects. A prescription for Qysmia can only be filled by specially certified mail order pharmacies in the United States.

Educational materials indicate that the drug should not be prescribed to women who are pregnant or who are planning on becoming pregnant. Women who are not planning pregnancy but have the potential to become pregnant should have a negative pregnancy test before starting the drug and again every month while taking the drug, and they should use an effective method or combination of methods of contraception. The manufacturer has also initiated a pregnancy surveillance system.

Given the likelihood that many women of reproductive age will use this medication, even with a REMS in place, the potential for unintentional exposure in pregnancy exists. In the inevitable event of an exposed pregnancy, what are the specific risks and their magnitude? The concern about birth defects with this medication stems from previously published data suggesting that topiramate used in monotherapy for other indications, most commonly epilepsy, is associated with an increased risk for oral clefts (cleft lip with or without cleft palate). Although numbers are still small, a few studies have suggested the risk for oral clefts, with the most recent a large pooled case-control analysis from two data sources in the United States (Am. J. Obstet. Gynecol. 2012;207:405e1-7). The pooled estimate of the risk of oral clefts was 5.36 with very wide confidence intervals (1.49-20.07), based on seven exposed children with cleft lip with or without cleft palate. To the extent that this estimate is correct, this translates to an absolute risk of about 5 in 1,000 first-trimester topiramate-exposed pregnancies, compared with a baseline risk of about 1 in 1,000 in unexposed pregnancies.

Published studies of topiramate and oral clefts have not involved sufficient numbers of exposed and affected children to allow examination of a dose threshold; however, the range of recommended doses for seizure prevention in adults treated with topiramate monotherapy (50-400 mg/day) overlaps with the dosing range of topiramate contained in Qysmia. It is important to note that based on the published reports suggesting an increased risk for oral clefts, the pregnancy category for topiramate alone was recently changed from a C to a D, while the pregnancy category for Qysmia is an X. The rationale behind the category D is likely that the benefits of topiramate might outweigh the risks in a pregnant woman with a seizure disorder for whom topiramate is the only effective medication. However, topiramate use for weight loss would typically never be indicated in pregnancy.

The second drug, lorcaserin (Belviq), is a single-ingredient serotonergic medication – a selective agonist of the 5-HT2C receptor. Lorcaserin was approved by the FDA in 2012, but as of February 2013, it is not yet available in the United States. This medication also received a pregnancy category X designation; however, in this situation, it was presumably for the sole reason that intentional weight loss in pregnancy is not recommended. Preclinical data for lorcaserin did not suggest teratogenicity, but maternal exposure in rats late in gestation resulted in lower pup body weight that persisted into adulthood.

 

 

To the extent that these new medications are effective in reducing and maintaining BMI within a healthier range in women who are currently overweight or obese, they may lead to improvement in subsequent pregnancy outcomes. However, avoiding exposure to these medications during early pregnancy will be a challenge, even with pregnancy prevention guidance and restricted distribution programs. Postmarketing surveillance for outcomes of inadvertently exposed pregnancies will be essential.

Dr. Chambers is associate professor of pediatrics and family and preventive medicine at the University of California, San Diego. She is director of the California Teratogen Information Service and Clinical Research Program. Dr. Chambers is a past president of the Organization of Teratology Information Specialists and past president of the Teratology Society. She said she had no relevant financial disclosures. To comment, e-mail her at [email protected].

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Preparing drugs for a trial

Credit: Esther Dyson

After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended enrollment in 5 trials and stopped dose-escalation of the drug.

The patients died of tumor lysis syndrome, a complication that likely stems from the drug’s potency, according to Tracy Sorrentino, a spokeswoman for the company, AbbVie.

Research has suggested the risk of tumor lysis syndrome might be eliminated by altering the dose of ABT-199, Sorrentino said.

But until that is confirmed, AbbVie has stopped dose-escalation in patients receiving ABT-199 and voluntarily suspended enrollment in phase 1 trials of the drug.

The trials are testing ABT-199, both alone and in combination, as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma, and small lymphocytic lymphoma.

Though enrollment has stopped for these trials, dosing of active patients in ABT-199 trials will continue. In addition, a study testing ABT-199 in women with systemic lupus erythematosus is still enrolling patients.

Sorrentino said AbbVie has “every expectation” the suspended enrollment is temporary, and refining the dose of ABT-199 may eliminate the problem. In fact, the company is still planning to begin phase 3 trials of the drug later this year.

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Preparing drugs for a trial

Credit: Esther Dyson

After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended enrollment in 5 trials and stopped dose-escalation of the drug.

The patients died of tumor lysis syndrome, a complication that likely stems from the drug’s potency, according to Tracy Sorrentino, a spokeswoman for the company, AbbVie.

Research has suggested the risk of tumor lysis syndrome might be eliminated by altering the dose of ABT-199, Sorrentino said.

But until that is confirmed, AbbVie has stopped dose-escalation in patients receiving ABT-199 and voluntarily suspended enrollment in phase 1 trials of the drug.

The trials are testing ABT-199, both alone and in combination, as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma, and small lymphocytic lymphoma.

Though enrollment has stopped for these trials, dosing of active patients in ABT-199 trials will continue. In addition, a study testing ABT-199 in women with systemic lupus erythematosus is still enrolling patients.

Sorrentino said AbbVie has “every expectation” the suspended enrollment is temporary, and refining the dose of ABT-199 may eliminate the problem. In fact, the company is still planning to begin phase 3 trials of the drug later this year.

Preparing drugs for a trial

Credit: Esther Dyson

After 2 deaths among patients receiving the BCL-2 inhibitor ABT-199, the company developing the drug has suspended enrollment in 5 trials and stopped dose-escalation of the drug.

The patients died of tumor lysis syndrome, a complication that likely stems from the drug’s potency, according to Tracy Sorrentino, a spokeswoman for the company, AbbVie.

Research has suggested the risk of tumor lysis syndrome might be eliminated by altering the dose of ABT-199, Sorrentino said.

But until that is confirmed, AbbVie has stopped dose-escalation in patients receiving ABT-199 and voluntarily suspended enrollment in phase 1 trials of the drug.

The trials are testing ABT-199, both alone and in combination, as a treatment for chronic lymphocytic leukemia, non-Hodgkin lymphoma, and small lymphocytic lymphoma.

Though enrollment has stopped for these trials, dosing of active patients in ABT-199 trials will continue. In addition, a study testing ABT-199 in women with systemic lupus erythematosus is still enrolling patients.

Sorrentino said AbbVie has “every expectation” the suspended enrollment is temporary, and refining the dose of ABT-199 may eliminate the problem. In fact, the company is still planning to begin phase 3 trials of the drug later this year.

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