Hospice & Palliative Medicine

The woods are lovely, dark and deep,
But I have promises to keep,
And miles to go before I sleep,
And miles to go before I sleep.

—Robert Frost, “Stopping by Woods on a Snowy Evening”¹

Frost's words are simple yet elegant. They can be interpreted many ways. I see the allegory of life as a journey in this poem. The passage, like the woods, is beautiful, but there is a long, long way to go.

See related article

And so it is with the treatment of heart failure. There is beauty in our understanding of the syndrome’s physiologic complexities and natural history, and of effective treatments uncovered. Still, we’ve a monstrous climb ahead to get to the summit of this clinical challenge in order to start a real descent.

THE PAST, PRESENT, AND FUTURE OF HEART FAILURE THERAPY

Okwuosa et al,² in this issue of the Journal, have capably summarized the ABCs of treating heart failure with reduced ejection fraction (also called systolic heart failure), approaching the subject from a perspective on past, present, and future therapies. They summarize heart failure interventions with a guideline-based philosophy, pointing out that these care paths are supposed to be evidence-based. They observe that in the 1960s the standard of care was digitalis, diuretics (furosemide first became available in 1967), and rest. That was about all we had for this problem.

There are now many drugs, devices, and operations that help patients with heart failure. But they never really cure the disease or, more aptly, the syndrome—and therapies are supposed to cure. This limitation of present therapies is important, given the disturbing epidemiology of heart failure, its economic cost, and the suffering of patients. That burden is well detailed.

In addition to curing, the overarching goals of treatment generally are to ameliorate distressing symptoms and to prevent comorbidities. In heart failure with reduced ejection fraction, we want to prevent premature death, stroke, myocardial infarction, congestive states, hospitalization, renal insufficiency, renal failure, cachexia, inanition, feebleness, and respiratory distress, among others.

The ABC mnemonic of Okwuosa et al will help caregivers remember the basics. It is important, however, to put algorithms into proper perspective and to look toward the future.

PROBLEMS WITH EVIDENCE-BASED MEDICINE

Several problems with our current heart failure treatments are rooted in how we perform clinical trials, arguably the premier method of determining truth in clinical practice and the foundation of evidence-based medicine.^3,4

Do the trials represent real-world practice?

Were the clinical trials that led to regulatory approval and professional society endorsement of the therapies that we prescribe in our offices done in the same sorts of patients as those in our waiting rooms asking for help? Perhaps, for the most part, they have been. And thus, Okwuosa et al have crafted a work relevant to all of us and every patient.

But I believe there are major gaps in the types of participants enrolled in trials, eg, underrepresentation of certain racial and ethnic groups, not to mention the relative paucity of women. The very elderly (a rapidly growing population) have largely been ignored as well, and participants with significant renal insufficiency, anemia, and diabetes mellitus seem far fewer than what we deal with in a busy clinic.

In addition, Okwuosa et al focus only on patients with reduced left ventricular ejection fraction, a group that makes up only about half of the heart failure crowd.

What about quality of life and other important outcomes?

Clinical trials in heart failure with reduced ejection fraction have generally focused on major clinical end points (primarily, but not exclusively, mortality), to the exclusion of quality of life. Though sometimes included in trials, quality-of-life metrics generally get relegated to second-class seats or ‘tween-deck steerage. Perhaps that is because measuring quality of life can be time-consuming and difficult.

Yet, in the words of sociologist William Bruce Cameron, not everything that counts can be counted, and not everything that can be counted counts. That goes for quality of life.

Lies, damned lies, and P values

Quandaries in data management and analysis include what to do about trial dropouts, study power, precision of statistical analysis, intention-to-treat principles, and choice of the P value that defines significance (or not) for any end point observation. Of course, there are myriad sophisticated mathematical and statistical reasons to justify why we don’t simply count on-treatment participants or allow imputation of results when patients or results drop out, forcing us to worship at the altar of P < .05.

A review of the P value concept⁵ recently appeared with an accompanying editorial by Kyriacou⁶ that concluded that “the automatic application of dichotomized hypothesis testing based on prearranged levels of statistical significance should be substituted with a more complex process using effect estimates, confidence intervals, and even P values, thereby permitting scientists, statisticians, and clinicians to use their own inferential capabilities to assign scientific significance.”⁶

How many great treatments have we tossed out because of rigid reliance on old-fashioned approaches to determining therapeutic evidence? Many treatments studied have had great results in a minority of patients in clinical trials but did not have a major positive (or negative) impact on the overall cohort (with lack of primary end point statistical significance). And what to do when the primary end point is a neutral or negative one but secondary end points are positive? Why not focus more attention on those patients benefiting from an intervention despite the overall results of any trial?

Dilemmas of trials

Other issues are that clinical trials cost too much, and that recruitment and follow-up take too long. Intercurrent therapies (and guidelines) can emerge that jeopardize the trial itself or make observations untimely. The dilemma of stacking therapies one on top of another, often making patient compliance impossible, is another problem with clinical trials. Yet this is how we get to the ABCs.

A NEW WAY TO DO TRIALS

The information provided by Okwuosa et al is useful and encouraging, but too many gaps exist in our heart failure therapies to permit us to celebrate with exuberance. Too many patients still suffer, too many die too young, and the costs are still too great.

Perhaps the future of therapeutic development should embrace different and better ways to demonstrate real value (relying on the equation of value equals outcomes meaningful to patients, divided by cost) of therapies, including the old, the new, the trashed and the underdeveloped. More creative data analysis to reexamine the current tools on the shelf and the ones tried but discarded is essential.

A position paper from the Cardiovascular Round Table of the European Society of Cardiology concluded that “a coordinated effort involving academia, regulators, industry and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier availability of innovative therapies and better management of cardiovascular diseases.”⁷

Lauer and D’Agostino,⁸ also in an editorial, argued for innovative methods of doing clinical trials and discovering truth about therapies that are applicable to the future of developing treatments for heart failure with reduced ejection fraction. They noted that “the randomized registry trial represents a disruptive technology” and wondered if it will be “given serious consideration as a way to resolve the recognized limitations of current clinical-trial design.”⁸

Indeed, conducting megatrials with existing megadatabases using a registry format could help. Registries emerging from early adaptive trial design efforts, particularly when Bayesian analysis theory is applied, might help inform clinical experience faster and more efficiently. Bayesian analysis is a statistical approach that attempts to estimate parameters of an underlying distribution of events in an ongoing fashion based on the observed distribution. A clinical trial of stem cell therapies could, at the end of the trial, be turned into a multicenter registry that would continue to inform us about the more real-world application of newer treatment approaches.

Though the therapeutic cupboard for heart failure is certainly not bare, as Okwuosa et al point out, it is wanting. Let’s look for new therapeutic ABCs differently. We should be attacking the real challenge—curing the disease processes that cause the syndrome. Yes, there are miles to go before we sleep.

The woods are lovely, dark and deep,
But I have promises to keep,
And miles to go before I sleep,
And miles to go before I sleep.

—Robert Frost, “Stopping by Woods on a Snowy Evening”¹

Frost's words are simple yet elegant. They can be interpreted many ways. I see the allegory of life as a journey in this poem. The passage, like the woods, is beautiful, but there is a long, long way to go.

See related article

And so it is with the treatment of heart failure. There is beauty in our understanding of the syndrome’s physiologic complexities and natural history, and of effective treatments uncovered. Still, we’ve a monstrous climb ahead to get to the summit of this clinical challenge in order to start a real descent.

THE PAST, PRESENT, AND FUTURE OF HEART FAILURE THERAPY

Okwuosa et al,² in this issue of the Journal, have capably summarized the ABCs of treating heart failure with reduced ejection fraction (also called systolic heart failure), approaching the subject from a perspective on past, present, and future therapies. They summarize heart failure interventions with a guideline-based philosophy, pointing out that these care paths are supposed to be evidence-based. They observe that in the 1960s the standard of care was digitalis, diuretics (furosemide first became available in 1967), and rest. That was about all we had for this problem.

There are now many drugs, devices, and operations that help patients with heart failure. But they never really cure the disease or, more aptly, the syndrome—and therapies are supposed to cure. This limitation of present therapies is important, given the disturbing epidemiology of heart failure, its economic cost, and the suffering of patients. That burden is well detailed.

In addition to curing, the overarching goals of treatment generally are to ameliorate distressing symptoms and to prevent comorbidities. In heart failure with reduced ejection fraction, we want to prevent premature death, stroke, myocardial infarction, congestive states, hospitalization, renal insufficiency, renal failure, cachexia, inanition, feebleness, and respiratory distress, among others.

The ABC mnemonic of Okwuosa et al will help caregivers remember the basics. It is important, however, to put algorithms into proper perspective and to look toward the future.

PROBLEMS WITH EVIDENCE-BASED MEDICINE

Several problems with our current heart failure treatments are rooted in how we perform clinical trials, arguably the premier method of determining truth in clinical practice and the foundation of evidence-based medicine.^3,4

Do the trials represent real-world practice?

Were the clinical trials that led to regulatory approval and professional society endorsement of the therapies that we prescribe in our offices done in the same sorts of patients as those in our waiting rooms asking for help? Perhaps, for the most part, they have been. And thus, Okwuosa et al have crafted a work relevant to all of us and every patient.

But I believe there are major gaps in the types of participants enrolled in trials, eg, underrepresentation of certain racial and ethnic groups, not to mention the relative paucity of women. The very elderly (a rapidly growing population) have largely been ignored as well, and participants with significant renal insufficiency, anemia, and diabetes mellitus seem far fewer than what we deal with in a busy clinic.

In addition, Okwuosa et al focus only on patients with reduced left ventricular ejection fraction, a group that makes up only about half of the heart failure crowd.

What about quality of life and other important outcomes?

Clinical trials in heart failure with reduced ejection fraction have generally focused on major clinical end points (primarily, but not exclusively, mortality), to the exclusion of quality of life. Though sometimes included in trials, quality-of-life metrics generally get relegated to second-class seats or ‘tween-deck steerage. Perhaps that is because measuring quality of life can be time-consuming and difficult.

Yet, in the words of sociologist William Bruce Cameron, not everything that counts can be counted, and not everything that can be counted counts. That goes for quality of life.

Lies, damned lies, and P values

Quandaries in data management and analysis include what to do about trial dropouts, study power, precision of statistical analysis, intention-to-treat principles, and choice of the P value that defines significance (or not) for any end point observation. Of course, there are myriad sophisticated mathematical and statistical reasons to justify why we don’t simply count on-treatment participants or allow imputation of results when patients or results drop out, forcing us to worship at the altar of P < .05.

A review of the P value concept⁵ recently appeared with an accompanying editorial by Kyriacou⁶ that concluded that “the automatic application of dichotomized hypothesis testing based on prearranged levels of statistical significance should be substituted with a more complex process using effect estimates, confidence intervals, and even P values, thereby permitting scientists, statisticians, and clinicians to use their own inferential capabilities to assign scientific significance.”⁶

How many great treatments have we tossed out because of rigid reliance on old-fashioned approaches to determining therapeutic evidence? Many treatments studied have had great results in a minority of patients in clinical trials but did not have a major positive (or negative) impact on the overall cohort (with lack of primary end point statistical significance). And what to do when the primary end point is a neutral or negative one but secondary end points are positive? Why not focus more attention on those patients benefiting from an intervention despite the overall results of any trial?

Dilemmas of trials

Other issues are that clinical trials cost too much, and that recruitment and follow-up take too long. Intercurrent therapies (and guidelines) can emerge that jeopardize the trial itself or make observations untimely. The dilemma of stacking therapies one on top of another, often making patient compliance impossible, is another problem with clinical trials. Yet this is how we get to the ABCs.

A NEW WAY TO DO TRIALS

The information provided by Okwuosa et al is useful and encouraging, but too many gaps exist in our heart failure therapies to permit us to celebrate with exuberance. Too many patients still suffer, too many die too young, and the costs are still too great.

Perhaps the future of therapeutic development should embrace different and better ways to demonstrate real value (relying on the equation of value equals outcomes meaningful to patients, divided by cost) of therapies, including the old, the new, the trashed and the underdeveloped. More creative data analysis to reexamine the current tools on the shelf and the ones tried but discarded is essential.

A position paper from the Cardiovascular Round Table of the European Society of Cardiology concluded that “a coordinated effort involving academia, regulators, industry and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier availability of innovative therapies and better management of cardiovascular diseases.”⁷

Lauer and D’Agostino,⁸ also in an editorial, argued for innovative methods of doing clinical trials and discovering truth about therapies that are applicable to the future of developing treatments for heart failure with reduced ejection fraction. They noted that “the randomized registry trial represents a disruptive technology” and wondered if it will be “given serious consideration as a way to resolve the recognized limitations of current clinical-trial design.”⁸

Indeed, conducting megatrials with existing megadatabases using a registry format could help. Registries emerging from early adaptive trial design efforts, particularly when Bayesian analysis theory is applied, might help inform clinical experience faster and more efficiently. Bayesian analysis is a statistical approach that attempts to estimate parameters of an underlying distribution of events in an ongoing fashion based on the observed distribution. A clinical trial of stem cell therapies could, at the end of the trial, be turned into a multicenter registry that would continue to inform us about the more real-world application of newer treatment approaches.

Though the therapeutic cupboard for heart failure is certainly not bare, as Okwuosa et al point out, it is wanting. Let’s look for new therapeutic ABCs differently. We should be attacking the real challenge—curing the disease processes that cause the syndrome. Yes, there are miles to go before we sleep.

The woods are lovely, dark and deep,
But I have promises to keep,
And miles to go before I sleep,
And miles to go before I sleep.

—Robert Frost, “Stopping by Woods on a Snowy Evening”¹

Frost's words are simple yet elegant. They can be interpreted many ways. I see the allegory of life as a journey in this poem. The passage, like the woods, is beautiful, but there is a long, long way to go.

See related article

And so it is with the treatment of heart failure. There is beauty in our understanding of the syndrome’s physiologic complexities and natural history, and of effective treatments uncovered. Still, we’ve a monstrous climb ahead to get to the summit of this clinical challenge in order to start a real descent.

THE PAST, PRESENT, AND FUTURE OF HEART FAILURE THERAPY

Okwuosa et al,² in this issue of the Journal, have capably summarized the ABCs of treating heart failure with reduced ejection fraction (also called systolic heart failure), approaching the subject from a perspective on past, present, and future therapies. They summarize heart failure interventions with a guideline-based philosophy, pointing out that these care paths are supposed to be evidence-based. They observe that in the 1960s the standard of care was digitalis, diuretics (furosemide first became available in 1967), and rest. That was about all we had for this problem.

There are now many drugs, devices, and operations that help patients with heart failure. But they never really cure the disease or, more aptly, the syndrome—and therapies are supposed to cure. This limitation of present therapies is important, given the disturbing epidemiology of heart failure, its economic cost, and the suffering of patients. That burden is well detailed.

In addition to curing, the overarching goals of treatment generally are to ameliorate distressing symptoms and to prevent comorbidities. In heart failure with reduced ejection fraction, we want to prevent premature death, stroke, myocardial infarction, congestive states, hospitalization, renal insufficiency, renal failure, cachexia, inanition, feebleness, and respiratory distress, among others.

The ABC mnemonic of Okwuosa et al will help caregivers remember the basics. It is important, however, to put algorithms into proper perspective and to look toward the future.

PROBLEMS WITH EVIDENCE-BASED MEDICINE

Several problems with our current heart failure treatments are rooted in how we perform clinical trials, arguably the premier method of determining truth in clinical practice and the foundation of evidence-based medicine.^3,4

Do the trials represent real-world practice?

Were the clinical trials that led to regulatory approval and professional society endorsement of the therapies that we prescribe in our offices done in the same sorts of patients as those in our waiting rooms asking for help? Perhaps, for the most part, they have been. And thus, Okwuosa et al have crafted a work relevant to all of us and every patient.

But I believe there are major gaps in the types of participants enrolled in trials, eg, underrepresentation of certain racial and ethnic groups, not to mention the relative paucity of women. The very elderly (a rapidly growing population) have largely been ignored as well, and participants with significant renal insufficiency, anemia, and diabetes mellitus seem far fewer than what we deal with in a busy clinic.

In addition, Okwuosa et al focus only on patients with reduced left ventricular ejection fraction, a group that makes up only about half of the heart failure crowd.

What about quality of life and other important outcomes?

Clinical trials in heart failure with reduced ejection fraction have generally focused on major clinical end points (primarily, but not exclusively, mortality), to the exclusion of quality of life. Though sometimes included in trials, quality-of-life metrics generally get relegated to second-class seats or ‘tween-deck steerage. Perhaps that is because measuring quality of life can be time-consuming and difficult.

Yet, in the words of sociologist William Bruce Cameron, not everything that counts can be counted, and not everything that can be counted counts. That goes for quality of life.

Lies, damned lies, and P values

Quandaries in data management and analysis include what to do about trial dropouts, study power, precision of statistical analysis, intention-to-treat principles, and choice of the P value that defines significance (or not) for any end point observation. Of course, there are myriad sophisticated mathematical and statistical reasons to justify why we don’t simply count on-treatment participants or allow imputation of results when patients or results drop out, forcing us to worship at the altar of P < .05.

A review of the P value concept⁵ recently appeared with an accompanying editorial by Kyriacou⁶ that concluded that “the automatic application of dichotomized hypothesis testing based on prearranged levels of statistical significance should be substituted with a more complex process using effect estimates, confidence intervals, and even P values, thereby permitting scientists, statisticians, and clinicians to use their own inferential capabilities to assign scientific significance.”⁶

How many great treatments have we tossed out because of rigid reliance on old-fashioned approaches to determining therapeutic evidence? Many treatments studied have had great results in a minority of patients in clinical trials but did not have a major positive (or negative) impact on the overall cohort (with lack of primary end point statistical significance). And what to do when the primary end point is a neutral or negative one but secondary end points are positive? Why not focus more attention on those patients benefiting from an intervention despite the overall results of any trial?

Dilemmas of trials

Other issues are that clinical trials cost too much, and that recruitment and follow-up take too long. Intercurrent therapies (and guidelines) can emerge that jeopardize the trial itself or make observations untimely. The dilemma of stacking therapies one on top of another, often making patient compliance impossible, is another problem with clinical trials. Yet this is how we get to the ABCs.

A NEW WAY TO DO TRIALS

The information provided by Okwuosa et al is useful and encouraging, but too many gaps exist in our heart failure therapies to permit us to celebrate with exuberance. Too many patients still suffer, too many die too young, and the costs are still too great.

Perhaps the future of therapeutic development should embrace different and better ways to demonstrate real value (relying on the equation of value equals outcomes meaningful to patients, divided by cost) of therapies, including the old, the new, the trashed and the underdeveloped. More creative data analysis to reexamine the current tools on the shelf and the ones tried but discarded is essential.

A position paper from the Cardiovascular Round Table of the European Society of Cardiology concluded that “a coordinated effort involving academia, regulators, industry and payors will help to foster better and more effective conduct of clinical cardiovascular trials, supporting earlier availability of innovative therapies and better management of cardiovascular diseases.”⁷

Lauer and D’Agostino,⁸ also in an editorial, argued for innovative methods of doing clinical trials and discovering truth about therapies that are applicable to the future of developing treatments for heart failure with reduced ejection fraction. They noted that “the randomized registry trial represents a disruptive technology” and wondered if it will be “given serious consideration as a way to resolve the recognized limitations of current clinical-trial design.”⁸

Indeed, conducting megatrials with existing megadatabases using a registry format could help. Registries emerging from early adaptive trial design efforts, particularly when Bayesian analysis theory is applied, might help inform clinical experience faster and more efficiently. Bayesian analysis is a statistical approach that attempts to estimate parameters of an underlying distribution of events in an ongoing fashion based on the observed distribution. A clinical trial of stem cell therapies could, at the end of the trial, be turned into a multicenter registry that would continue to inform us about the more real-world application of newer treatment approaches.

Though the therapeutic cupboard for heart failure is certainly not bare, as Okwuosa et al point out, it is wanting. Let’s look for new therapeutic ABCs differently. We should be attacking the real challenge—curing the disease processes that cause the syndrome. Yes, there are miles to go before we sleep.

WAIKOLOA, HAWAII – The FRAIL scale questionnaire predicts functional status and mortality at 1 year among geriatric trauma patients and is a useful tool for bedside screening by clinicians, results from a single-center study demonstrated.

“Over the past 2 years, the implications of frailty among the geriatric trauma population have gained much attention in the trauma community,” Cathy A. Maxwell, PhD, RN, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “This work highlights the clinical utility of the FRAIL scale for screening injured older patients who are admitted to trauma centers and other acute care hospitals. Hopefully, it will encourage trauma care providers to use the instrument to identify older patients’ pre-injury/baseline status and to obtain a frailty risk adjustment measure for quality improvement efforts.”

Developed by the International Association of Nutrition and Aging, the validated five-item FRAIL scale requires answers to questions about fatigue, resistance, ambulation, illnesses, and loss of weight (J Nutr Health Aging. 2012;16[7]:601-8). In an effort to examine the influence of pre-injury physical frailty (as measured by FRAIL) on 1-year outcomes, Dr. Maxwell, of the Vanderbilt University, Nashville, Tenn., and her associates evaluated injured patients aged 65 and older who were admitted through the ED between October 2013 and March 2014 and who participated in a prior study (J Trauma Acute Care Surg. 2016;80[2]:195-203). The researchers identified the five items of the FRAIL instrument from that study and created a pre-injury FRAIL score for each patient.

Dr. Maxwell reported results from 188 patients with a median age of 77, a median Injury Severity Score of 10, and a median comorbidity index of 3. Upon admission to the ED, 63 patients (34%) screened as frail (defined as a FRAIL score of 3 or greater), 71 (38%) screened as pre-frail (defined as a FRAIL score of 1-2), and 54 (29%) screened as non-frail (defined as a FRAIL score of zero). Frequencies for components of the FRAIL score were as follows: fatigue (65%), resistance (32%), ambulation (40%), illnesses (27%), and loss of weight (6%).

After the researchers controlled for age, comorbidities, injury severity, and cognitive status via the Ascertain Dementia 8-item Informant Questionnaire (AD8), they found that pre-injury FRAIL scores explained about 13% of the variability in physical function as measured by the Barthel Index (P less than .001). A total of 47 patients (26%) died within 1 year of admission. Logistic regression analysis revealed that after adjustment for these same variables, the higher the pre-injury FRAIL score, the greater the likelihood of mortality within 1 year (odds ratio, 1.74; P = .001).

“The FRAIL scale predicts functional decline and mortality in geriatric trauma patients and is a useful tool for clinicians,” Dr. Maxwell concluded. “Bedside nurses in our trauma unit at Vanderbilt University Medical Center are currently using this instrument to screen our older patients. We have seen an increase in earlier geriatric palliative care consultations as a result of our screening efforts.”

She acknowledged certain limitations of the study, including the fact that it was a secondary analysis. “We created FRAIL scale scores for 188 patients from six different data sources, thus, the created scores may not accurately represent actual prospectively collected FRAIL scores,” Dr. Maxwell said. “That being said, we compared the frailty frequencies from this study with actual FRAIL scale scores (from current bedside FRAIL screens) and we are seeing similar percentages of patients in non-frail, pre-frail and frail categories. This strengthens the findings of this study.”

She reported having no financial disclosures.

[email protected]

WAIKOLOA, HAWAII – The FRAIL scale questionnaire predicts functional status and mortality at 1 year among geriatric trauma patients and is a useful tool for bedside screening by clinicians, results from a single-center study demonstrated.

“Over the past 2 years, the implications of frailty among the geriatric trauma population have gained much attention in the trauma community,” Cathy A. Maxwell, PhD, RN, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “This work highlights the clinical utility of the FRAIL scale for screening injured older patients who are admitted to trauma centers and other acute care hospitals. Hopefully, it will encourage trauma care providers to use the instrument to identify older patients’ pre-injury/baseline status and to obtain a frailty risk adjustment measure for quality improvement efforts.”

Developed by the International Association of Nutrition and Aging, the validated five-item FRAIL scale requires answers to questions about fatigue, resistance, ambulation, illnesses, and loss of weight (J Nutr Health Aging. 2012;16[7]:601-8). In an effort to examine the influence of pre-injury physical frailty (as measured by FRAIL) on 1-year outcomes, Dr. Maxwell, of the Vanderbilt University, Nashville, Tenn., and her associates evaluated injured patients aged 65 and older who were admitted through the ED between October 2013 and March 2014 and who participated in a prior study (J Trauma Acute Care Surg. 2016;80[2]:195-203). The researchers identified the five items of the FRAIL instrument from that study and created a pre-injury FRAIL score for each patient.

Dr. Maxwell reported results from 188 patients with a median age of 77, a median Injury Severity Score of 10, and a median comorbidity index of 3. Upon admission to the ED, 63 patients (34%) screened as frail (defined as a FRAIL score of 3 or greater), 71 (38%) screened as pre-frail (defined as a FRAIL score of 1-2), and 54 (29%) screened as non-frail (defined as a FRAIL score of zero). Frequencies for components of the FRAIL score were as follows: fatigue (65%), resistance (32%), ambulation (40%), illnesses (27%), and loss of weight (6%).

After the researchers controlled for age, comorbidities, injury severity, and cognitive status via the Ascertain Dementia 8-item Informant Questionnaire (AD8), they found that pre-injury FRAIL scores explained about 13% of the variability in physical function as measured by the Barthel Index (P less than .001). A total of 47 patients (26%) died within 1 year of admission. Logistic regression analysis revealed that after adjustment for these same variables, the higher the pre-injury FRAIL score, the greater the likelihood of mortality within 1 year (odds ratio, 1.74; P = .001).

“The FRAIL scale predicts functional decline and mortality in geriatric trauma patients and is a useful tool for clinicians,” Dr. Maxwell concluded. “Bedside nurses in our trauma unit at Vanderbilt University Medical Center are currently using this instrument to screen our older patients. We have seen an increase in earlier geriatric palliative care consultations as a result of our screening efforts.”

She acknowledged certain limitations of the study, including the fact that it was a secondary analysis. “We created FRAIL scale scores for 188 patients from six different data sources, thus, the created scores may not accurately represent actual prospectively collected FRAIL scores,” Dr. Maxwell said. “That being said, we compared the frailty frequencies from this study with actual FRAIL scale scores (from current bedside FRAIL screens) and we are seeing similar percentages of patients in non-frail, pre-frail and frail categories. This strengthens the findings of this study.”

She reported having no financial disclosures.

[email protected]

WAIKOLOA, HAWAII – The FRAIL scale questionnaire predicts functional status and mortality at 1 year among geriatric trauma patients and is a useful tool for bedside screening by clinicians, results from a single-center study demonstrated.

“Over the past 2 years, the implications of frailty among the geriatric trauma population have gained much attention in the trauma community,” Cathy A. Maxwell, PhD, RN, said in an interview in advance of the annual meeting of the American Association for the Surgery of Trauma. “This work highlights the clinical utility of the FRAIL scale for screening injured older patients who are admitted to trauma centers and other acute care hospitals. Hopefully, it will encourage trauma care providers to use the instrument to identify older patients’ pre-injury/baseline status and to obtain a frailty risk adjustment measure for quality improvement efforts.”

Developed by the International Association of Nutrition and Aging, the validated five-item FRAIL scale requires answers to questions about fatigue, resistance, ambulation, illnesses, and loss of weight (J Nutr Health Aging. 2012;16[7]:601-8). In an effort to examine the influence of pre-injury physical frailty (as measured by FRAIL) on 1-year outcomes, Dr. Maxwell, of the Vanderbilt University, Nashville, Tenn., and her associates evaluated injured patients aged 65 and older who were admitted through the ED between October 2013 and March 2014 and who participated in a prior study (J Trauma Acute Care Surg. 2016;80[2]:195-203). The researchers identified the five items of the FRAIL instrument from that study and created a pre-injury FRAIL score for each patient.

Dr. Maxwell reported results from 188 patients with a median age of 77, a median Injury Severity Score of 10, and a median comorbidity index of 3. Upon admission to the ED, 63 patients (34%) screened as frail (defined as a FRAIL score of 3 or greater), 71 (38%) screened as pre-frail (defined as a FRAIL score of 1-2), and 54 (29%) screened as non-frail (defined as a FRAIL score of zero). Frequencies for components of the FRAIL score were as follows: fatigue (65%), resistance (32%), ambulation (40%), illnesses (27%), and loss of weight (6%).

After the researchers controlled for age, comorbidities, injury severity, and cognitive status via the Ascertain Dementia 8-item Informant Questionnaire (AD8), they found that pre-injury FRAIL scores explained about 13% of the variability in physical function as measured by the Barthel Index (P less than .001). A total of 47 patients (26%) died within 1 year of admission. Logistic regression analysis revealed that after adjustment for these same variables, the higher the pre-injury FRAIL score, the greater the likelihood of mortality within 1 year (odds ratio, 1.74; P = .001).

“The FRAIL scale predicts functional decline and mortality in geriatric trauma patients and is a useful tool for clinicians,” Dr. Maxwell concluded. “Bedside nurses in our trauma unit at Vanderbilt University Medical Center are currently using this instrument to screen our older patients. We have seen an increase in earlier geriatric palliative care consultations as a result of our screening efforts.”

She acknowledged certain limitations of the study, including the fact that it was a secondary analysis. “We created FRAIL scale scores for 188 patients from six different data sources, thus, the created scores may not accurately represent actual prospectively collected FRAIL scores,” Dr. Maxwell said. “That being said, we compared the frailty frequencies from this study with actual FRAIL scale scores (from current bedside FRAIL screens) and we are seeing similar percentages of patients in non-frail, pre-frail and frail categories. This strengthens the findings of this study.”

She reported having no financial disclosures.

[email protected]

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

There is increased anxiety and depression among family caregivers who do not take care of themselves, according to a study to be presented at the 2016 ASCO Palliative Care in Oncology Symposium.

Nearly a quarter of 294 caregivers of Medicare patients with advanced cancer reported high depression scores (23%) and 34% reported borderline or high anxiety scores. Worse caregiver anxiety, depression, and mental health–related quality of life scores were significantly associated with lower scores in every self-care measure (P less than .05 for all). Lower self-care behavior scores were associated with longer durations, higher hours, and more days/week of caregiving and with fair or poor patient health.

The cross-sectional survey was conducted in community settings of eight cancer centers in Alabama, Florida, and Tennessee. The family caregivers of Medicare beneficiaries diagnosed with pancreatic, lung, brain, ovarian, head & neck, hematologic, or stage IV cancer completed measures of self-care behaviors, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, stress management, and sleep. Caregivers averaged 66 years and were mostly female (72.8%), white (91.2%), Protestant (76.2%), retired (54.4%), and patients’ spouse/partner (60.2%). Approximately half were rural dwellers (46.9%) and had incomes less than $50,000 (53.8%). The majority provided support 6-7 days per week (71%) for greater than 1 year (68%).

“This research serves as an important call to action for the oncology community to implement support networks and services that care for the caregiver,” ASCO representative Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center, New York, said in a written statement ahead of the symposium.

“We hope our research rallies the oncology palliative care communities to develop assessment tools and services that support caregivers,” lead author James Nicholas Dionne-Odom, PhD, RN, of the University of Alabama at Birmingham, said in the statement.

[email protected]

On Twitter @jessnicolecraig

Nearly one-third of hospital newborn nurseries and neonatal ICUs do not have an antibiotic stewardship program, according to a survey of 146 hospital nursery centers across all 50 states.

Researchers randomly selected a level III NICU in each state using the 2014 American Hospital Association annual survey, then selected a level I and level II nursery in the same city. They collected data on the hospital, nursery, and antibiotic stewardship program characteristics and interviewed staff pharmacists and infectious diseases physicians (J Pediatric Infect Dis Soc. 2016 Jul 15. doi: 10.1093/jpids/piw040).

©luchschen/Thinkstock

A total of 104 (71%) of responding hospitals had an antibiotic stewardship program in place for their nurseries. Hospitals with a nursery-based antibiotic stewardship programs tended to be larger, have more full-time equivalent staff dedicated to the antibiotic stewardship program, have higher level nurses, and be affiliated with a university, according to Joseph B. Cantey, MD, and his colleagues from the Texas A&M Health Science Center in Temple.

Geographic region and core stewardship strategies did not influence the likelihood of a nursery-based antibiotic stewardship program in place.

From the interviews, the researchers identified several barriers to implementation of antibiotic stewardship programs, and themes such as unwanted coverage, unnecessary coverage, and need for communication.

“Many [antibiotic stewardship program] and nursery representatives stated that nursery [antibiotic stewardship program] coverage was not important, either because antibiotic consumption was perceived as low (theme 1), narrow-spectrum (theme 2), or both,” the authors wrote.

Some nursery providers also argued that participating in stewardship programs was time consuming and not valuable, which the authors said was often related to a lack of pediatric expertise in the program providers. Some of those interviewed also spoke of issues relating to jurisdiction and responsibility for the programs, and there was also a common perception that antibiotic stewardship programs were more concerned with cost savings than patient care.

“Barriers to effective nursery stewardship are exacerbated by lack of communication between stewardship providers and their nursery counterparts,” the authors reported.

No conflicts of interest were declared.

Nearly one-third of hospital newborn nurseries and neonatal ICUs do not have an antibiotic stewardship program, according to a survey of 146 hospital nursery centers across all 50 states.

Researchers randomly selected a level III NICU in each state using the 2014 American Hospital Association annual survey, then selected a level I and level II nursery in the same city. They collected data on the hospital, nursery, and antibiotic stewardship program characteristics and interviewed staff pharmacists and infectious diseases physicians (J Pediatric Infect Dis Soc. 2016 Jul 15. doi: 10.1093/jpids/piw040).

©luchschen/Thinkstock

A total of 104 (71%) of responding hospitals had an antibiotic stewardship program in place for their nurseries. Hospitals with a nursery-based antibiotic stewardship programs tended to be larger, have more full-time equivalent staff dedicated to the antibiotic stewardship program, have higher level nurses, and be affiliated with a university, according to Joseph B. Cantey, MD, and his colleagues from the Texas A&M Health Science Center in Temple.

Geographic region and core stewardship strategies did not influence the likelihood of a nursery-based antibiotic stewardship program in place.

From the interviews, the researchers identified several barriers to implementation of antibiotic stewardship programs, and themes such as unwanted coverage, unnecessary coverage, and need for communication.

“Many [antibiotic stewardship program] and nursery representatives stated that nursery [antibiotic stewardship program] coverage was not important, either because antibiotic consumption was perceived as low (theme 1), narrow-spectrum (theme 2), or both,” the authors wrote.

Some nursery providers also argued that participating in stewardship programs was time consuming and not valuable, which the authors said was often related to a lack of pediatric expertise in the program providers. Some of those interviewed also spoke of issues relating to jurisdiction and responsibility for the programs, and there was also a common perception that antibiotic stewardship programs were more concerned with cost savings than patient care.

“Barriers to effective nursery stewardship are exacerbated by lack of communication between stewardship providers and their nursery counterparts,” the authors reported.

No conflicts of interest were declared.

Nearly one-third of hospital newborn nurseries and neonatal ICUs do not have an antibiotic stewardship program, according to a survey of 146 hospital nursery centers across all 50 states.

Researchers randomly selected a level III NICU in each state using the 2014 American Hospital Association annual survey, then selected a level I and level II nursery in the same city. They collected data on the hospital, nursery, and antibiotic stewardship program characteristics and interviewed staff pharmacists and infectious diseases physicians (J Pediatric Infect Dis Soc. 2016 Jul 15. doi: 10.1093/jpids/piw040).

©luchschen/Thinkstock

A total of 104 (71%) of responding hospitals had an antibiotic stewardship program in place for their nurseries. Hospitals with a nursery-based antibiotic stewardship programs tended to be larger, have more full-time equivalent staff dedicated to the antibiotic stewardship program, have higher level nurses, and be affiliated with a university, according to Joseph B. Cantey, MD, and his colleagues from the Texas A&M Health Science Center in Temple.

Geographic region and core stewardship strategies did not influence the likelihood of a nursery-based antibiotic stewardship program in place.

From the interviews, the researchers identified several barriers to implementation of antibiotic stewardship programs, and themes such as unwanted coverage, unnecessary coverage, and need for communication.

“Many [antibiotic stewardship program] and nursery representatives stated that nursery [antibiotic stewardship program] coverage was not important, either because antibiotic consumption was perceived as low (theme 1), narrow-spectrum (theme 2), or both,” the authors wrote.

Some nursery providers also argued that participating in stewardship programs was time consuming and not valuable, which the authors said was often related to a lack of pediatric expertise in the program providers. Some of those interviewed also spoke of issues relating to jurisdiction and responsibility for the programs, and there was also a common perception that antibiotic stewardship programs were more concerned with cost savings than patient care.

“Barriers to effective nursery stewardship are exacerbated by lack of communication between stewardship providers and their nursery counterparts,” the authors reported.

No conflicts of interest were declared.

Purpose: This literature review was performed to better understand how to facilitate the integration of palliative care and oncology care at the onset of treatment for patients at a VAMC facility.

Background: Palliative care is defined by the World Health Organization (WHO) as an approach to care aimed at improving the quality of life of patients and their families who are facing obstacles associated with a serious or terminal illness (WHO). The intention of palliative care is not curative; it does however address the prevention, early identification and treatment of pain, and problems which may be physical, psychosocial and spiritual. Palliative care should be integrated early in the course of the disease and in conjunction with life-saving treatments (Greer et al, 2013).

Methods: A search of databases included Google Scholar, PubMed, Ovid, and CINAHL identified randomized clinical trials, systematic reviews and expert reviews regarding the integration of palliative care at the initial diagnosis and when cancer treatment begins.

Results: Several interventions for integration of palliative care with standard cancer were identified as well as increase patient outcomes. The National Comprehensive Care Network,(NCCN), the American Society of Clinical Oncology, (ASCO), and the Institute of Medicine (IOM), all advocate for the initiation of palliative care at the onset of treatment. Guidelines for screening, assessments, and interventions are available to begin the process of integration. There are several barriers, however, affecting the integration of palliative care with comprehensive oncology care. These barriers include inadequate staffing, inadequate training, standardized assessment and screening tools. The process also requires the cooperation and support of facility leadership and administration.

Implications: There is strong evidence for the integration of palliative and oncology care for Veterans receiving cancer care at VAMC facilities. Oncology would continue to focus on the treatment of disease with the primary assessment of pain, other symptom management, and goals of care. Palliative care would be able to assist the patient with the more complicated symptomatology, psychosocial support, advance care planning and easier transitions into hospice care. Each discipline has a role in the improved outcomes and improved quality of life for patients.

Purpose: This literature review was performed to better understand how to facilitate the integration of palliative care and oncology care at the onset of treatment for patients at a VAMC facility.

Background: Palliative care is defined by the World Health Organization (WHO) as an approach to care aimed at improving the quality of life of patients and their families who are facing obstacles associated with a serious or terminal illness (WHO). The intention of palliative care is not curative; it does however address the prevention, early identification and treatment of pain, and problems which may be physical, psychosocial and spiritual. Palliative care should be integrated early in the course of the disease and in conjunction with life-saving treatments (Greer et al, 2013).

Methods: A search of databases included Google Scholar, PubMed, Ovid, and CINAHL identified randomized clinical trials, systematic reviews and expert reviews regarding the integration of palliative care at the initial diagnosis and when cancer treatment begins.

Results: Several interventions for integration of palliative care with standard cancer were identified as well as increase patient outcomes. The National Comprehensive Care Network,(NCCN), the American Society of Clinical Oncology, (ASCO), and the Institute of Medicine (IOM), all advocate for the initiation of palliative care at the onset of treatment. Guidelines for screening, assessments, and interventions are available to begin the process of integration. There are several barriers, however, affecting the integration of palliative care with comprehensive oncology care. These barriers include inadequate staffing, inadequate training, standardized assessment and screening tools. The process also requires the cooperation and support of facility leadership and administration.

Implications: There is strong evidence for the integration of palliative and oncology care for Veterans receiving cancer care at VAMC facilities. Oncology would continue to focus on the treatment of disease with the primary assessment of pain, other symptom management, and goals of care. Palliative care would be able to assist the patient with the more complicated symptomatology, psychosocial support, advance care planning and easier transitions into hospice care. Each discipline has a role in the improved outcomes and improved quality of life for patients.

Purpose: This literature review was performed to better understand how to facilitate the integration of palliative care and oncology care at the onset of treatment for patients at a VAMC facility.

Background: Palliative care is defined by the World Health Organization (WHO) as an approach to care aimed at improving the quality of life of patients and their families who are facing obstacles associated with a serious or terminal illness (WHO). The intention of palliative care is not curative; it does however address the prevention, early identification and treatment of pain, and problems which may be physical, psychosocial and spiritual. Palliative care should be integrated early in the course of the disease and in conjunction with life-saving treatments (Greer et al, 2013).

Methods: A search of databases included Google Scholar, PubMed, Ovid, and CINAHL identified randomized clinical trials, systematic reviews and expert reviews regarding the integration of palliative care at the initial diagnosis and when cancer treatment begins.

Results: Several interventions for integration of palliative care with standard cancer were identified as well as increase patient outcomes. The National Comprehensive Care Network,(NCCN), the American Society of Clinical Oncology, (ASCO), and the Institute of Medicine (IOM), all advocate for the initiation of palliative care at the onset of treatment. Guidelines for screening, assessments, and interventions are available to begin the process of integration. There are several barriers, however, affecting the integration of palliative care with comprehensive oncology care. These barriers include inadequate staffing, inadequate training, standardized assessment and screening tools. The process also requires the cooperation and support of facility leadership and administration.

Implications: There is strong evidence for the integration of palliative and oncology care for Veterans receiving cancer care at VAMC facilities. Oncology would continue to focus on the treatment of disease with the primary assessment of pain, other symptom management, and goals of care. Palliative care would be able to assist the patient with the more complicated symptomatology, psychosocial support, advance care planning and easier transitions into hospice care. Each discipline has a role in the improved outcomes and improved quality of life for patients.

Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.

The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.

Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.

In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.

As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.

“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.

Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.

The current action is just “one part of a larger effort to address this epidemic.

“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”

Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”

“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.

“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.

[email protected]

Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.

The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.

Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.

In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.

As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.

“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.

Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.

The current action is just “one part of a larger effort to address this epidemic.

“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”

Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”

“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.

“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.

[email protected]

Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.

The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.

Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.

In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.

As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.

“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.

Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.

The current action is just “one part of a larger effort to address this epidemic.

“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”

Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”

“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.

“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.

[email protected]

Clinicians outside of the surgical specialties may consider surgeons primarily providers of technical services, but those of us who provide surgical care fully appreciate that communicating with patients and families is a large component of routine surgical practice. Typical communications in surgical practice include obtaining a history of present illness, which is a key element in the ultimate decision to offer a surgical intervention, or not; discussing the risks, benefits, and alternatives of any operation being considered; and the numerous discussions held following any surgical procedure. What many surgeons may not fully appreciate, however, is how these routine communication events can fall under the general category of advance care planning (ACP).

ACP is defined as a process in which physicians (and other health care providers) discuss a patient’s goals, values, and beliefs and determine how these inform a patient’s desire for current or future medical care. Hickman et al. (Hastings Center Report Special Report 35, no. 6 (2005):S26-S30) note that ACP should focus on defining “good” care for each patient. Furthermore, changes in a patient’s medical condition represent an opportune time to revisit a patient’s hopes and goals. Consideration of surgical intervention often represents a major change in a patient’s medical condition and therefore is an excellent opportunity to engage a patient in an ACP discussion.

Given that ACP discussions are likely occurring in surgical practices on a regular basis, surgeons need to be aware of a recent change in the Physician Fee Schedule that took effect Jan. 1, 2016. Effective this date, Current Procedural Terminology (CPT) codes 99497 and 99498 now allow for billing for ACP services. CPT code 99497 includes ACP “including the explanation and discussion of advance directives such as standard forms (with the completion of such forms, when performed), by the physician or other qualified health care professional; first 30 minutes, face-to-face with patient, family member(s) and/or surrogate.” CPT code 99498 is used for each additional 30 minutes spent in such face-to-face ACP counseling.

The nuts and bolts of how these ACP CPT codes work:

How many times can these code(s) be used? There are no limits on the number of times ACP can be reported for a given beneficiary in a given time period. For example, if an ACP discussion was held with a patient and/or family member and/or surrogate prior to a major elective procedure and again in the postoperative period, the above CPT codes could be used twice. In each instance, the ACP discussion must be documented, along with any relevant change in the patient’s clinical status that prompted another ACP discussion.

Can a patient or their family member/surrogate refuse ACP services? ACP services are voluntary; therefore, a patient or their family member/surrogate can refuse ACP services. These CPT codes only can be used if a patient or family member/surrogate consents for ACP services.

What must be documented in ACP services? Physicians should consult their Medicare Administrative Contractors for documentation requirements. Examples of elements to be included in the documentation are a brief description of the discussion with the patient or family/surrogate regarding the voluntary nature of ACP services, an explanation of advance directives and documentation if an advance directive is completed, who was present during the discussion, and time spent in the face-to-face encounter.

Does an advance directive have to be completed to bill the service? No. If an advance directive is completed, this should be documented (see above), but completion of the directive is not a requirement for billing the service.

Can ACP be reported in addition to an evaluation and management (E/M) service (such as an office visit)? Yes. CPT codes 99497 and 99498 may be billed on the same day or a different day as most other E/M services. They may be billed within the global surgical period.

Is a specific diagnosis required to use the ACP CPT codes? No, a specific diagnosis is not required for the ACP codes to be billed.

According to the 2016 Medicare Physician Fee Schedule, the reimbursement is $85.99 for CPT 99497 and $74.88 for CPT 99498. For comparison, the reimbursement for E/M CPT 99203 (30-minute initial evaluation) = $108.85, CPT 99204 (45-minute initial evaluation) = $166.13, and CPT 99205 (60-minute initial evaluation) = $208.38. Far more important than the financial remuneration for these discussions, however, is the critical need for surgeons to have and document their ACP discussions with their patients and/or their family member/surrogate. As surgeons, we are often called to see patients when they are facing a significant change in their health – whether that is a new diagnosis of cancer or after a traumatic injury. Understanding a patient’s values, hopes, and concerns is an essential component to ensuring that our patients receive the best care, as defined by them.

Dr. Fahy is associate professor of surgery and internal medicine at the University of New Mexico, Albuquerque. She is a surgical oncologist who is also board certified in hospice and palliative medicine. Dr. Fahy does not have any relevant conflicts of interest to disclose.

Clinicians outside of the surgical specialties may consider surgeons primarily providers of technical services, but those of us who provide surgical care fully appreciate that communicating with patients and families is a large component of routine surgical practice. Typical communications in surgical practice include obtaining a history of present illness, which is a key element in the ultimate decision to offer a surgical intervention, or not; discussing the risks, benefits, and alternatives of any operation being considered; and the numerous discussions held following any surgical procedure. What many surgeons may not fully appreciate, however, is how these routine communication events can fall under the general category of advance care planning (ACP).

ACP is defined as a process in which physicians (and other health care providers) discuss a patient’s goals, values, and beliefs and determine how these inform a patient’s desire for current or future medical care. Hickman et al. (Hastings Center Report Special Report 35, no. 6 (2005):S26-S30) note that ACP should focus on defining “good” care for each patient. Furthermore, changes in a patient’s medical condition represent an opportune time to revisit a patient’s hopes and goals. Consideration of surgical intervention often represents a major change in a patient’s medical condition and therefore is an excellent opportunity to engage a patient in an ACP discussion.

Given that ACP discussions are likely occurring in surgical practices on a regular basis, surgeons need to be aware of a recent change in the Physician Fee Schedule that took effect Jan. 1, 2016. Effective this date, Current Procedural Terminology (CPT) codes 99497 and 99498 now allow for billing for ACP services. CPT code 99497 includes ACP “including the explanation and discussion of advance directives such as standard forms (with the completion of such forms, when performed), by the physician or other qualified health care professional; first 30 minutes, face-to-face with patient, family member(s) and/or surrogate.” CPT code 99498 is used for each additional 30 minutes spent in such face-to-face ACP counseling.

The nuts and bolts of how these ACP CPT codes work:

How many times can these code(s) be used? There are no limits on the number of times ACP can be reported for a given beneficiary in a given time period. For example, if an ACP discussion was held with a patient and/or family member and/or surrogate prior to a major elective procedure and again in the postoperative period, the above CPT codes could be used twice. In each instance, the ACP discussion must be documented, along with any relevant change in the patient’s clinical status that prompted another ACP discussion.

Can a patient or their family member/surrogate refuse ACP services? ACP services are voluntary; therefore, a patient or their family member/surrogate can refuse ACP services. These CPT codes only can be used if a patient or family member/surrogate consents for ACP services.

What must be documented in ACP services? Physicians should consult their Medicare Administrative Contractors for documentation requirements. Examples of elements to be included in the documentation are a brief description of the discussion with the patient or family/surrogate regarding the voluntary nature of ACP services, an explanation of advance directives and documentation if an advance directive is completed, who was present during the discussion, and time spent in the face-to-face encounter.

Does an advance directive have to be completed to bill the service? No. If an advance directive is completed, this should be documented (see above), but completion of the directive is not a requirement for billing the service.

Can ACP be reported in addition to an evaluation and management (E/M) service (such as an office visit)? Yes. CPT codes 99497 and 99498 may be billed on the same day or a different day as most other E/M services. They may be billed within the global surgical period.

Is a specific diagnosis required to use the ACP CPT codes? No, a specific diagnosis is not required for the ACP codes to be billed.

According to the 2016 Medicare Physician Fee Schedule, the reimbursement is $85.99 for CPT 99497 and $74.88 for CPT 99498. For comparison, the reimbursement for E/M CPT 99203 (30-minute initial evaluation) = $108.85, CPT 99204 (45-minute initial evaluation) = $166.13, and CPT 99205 (60-minute initial evaluation) = $208.38. Far more important than the financial remuneration for these discussions, however, is the critical need for surgeons to have and document their ACP discussions with their patients and/or their family member/surrogate. As surgeons, we are often called to see patients when they are facing a significant change in their health – whether that is a new diagnosis of cancer or after a traumatic injury. Understanding a patient’s values, hopes, and concerns is an essential component to ensuring that our patients receive the best care, as defined by them.

Dr. Fahy is associate professor of surgery and internal medicine at the University of New Mexico, Albuquerque. She is a surgical oncologist who is also board certified in hospice and palliative medicine. Dr. Fahy does not have any relevant conflicts of interest to disclose.

Clinicians outside of the surgical specialties may consider surgeons primarily providers of technical services, but those of us who provide surgical care fully appreciate that communicating with patients and families is a large component of routine surgical practice. Typical communications in surgical practice include obtaining a history of present illness, which is a key element in the ultimate decision to offer a surgical intervention, or not; discussing the risks, benefits, and alternatives of any operation being considered; and the numerous discussions held following any surgical procedure. What many surgeons may not fully appreciate, however, is how these routine communication events can fall under the general category of advance care planning (ACP).

ACP is defined as a process in which physicians (and other health care providers) discuss a patient’s goals, values, and beliefs and determine how these inform a patient’s desire for current or future medical care. Hickman et al. (Hastings Center Report Special Report 35, no. 6 (2005):S26-S30) note that ACP should focus on defining “good” care for each patient. Furthermore, changes in a patient’s medical condition represent an opportune time to revisit a patient’s hopes and goals. Consideration of surgical intervention often represents a major change in a patient’s medical condition and therefore is an excellent opportunity to engage a patient in an ACP discussion.

Given that ACP discussions are likely occurring in surgical practices on a regular basis, surgeons need to be aware of a recent change in the Physician Fee Schedule that took effect Jan. 1, 2016. Effective this date, Current Procedural Terminology (CPT) codes 99497 and 99498 now allow for billing for ACP services. CPT code 99497 includes ACP “including the explanation and discussion of advance directives such as standard forms (with the completion of such forms, when performed), by the physician or other qualified health care professional; first 30 minutes, face-to-face with patient, family member(s) and/or surrogate.” CPT code 99498 is used for each additional 30 minutes spent in such face-to-face ACP counseling.

The nuts and bolts of how these ACP CPT codes work:

How many times can these code(s) be used? There are no limits on the number of times ACP can be reported for a given beneficiary in a given time period. For example, if an ACP discussion was held with a patient and/or family member and/or surrogate prior to a major elective procedure and again in the postoperative period, the above CPT codes could be used twice. In each instance, the ACP discussion must be documented, along with any relevant change in the patient’s clinical status that prompted another ACP discussion.

Can a patient or their family member/surrogate refuse ACP services? ACP services are voluntary; therefore, a patient or their family member/surrogate can refuse ACP services. These CPT codes only can be used if a patient or family member/surrogate consents for ACP services.

What must be documented in ACP services? Physicians should consult their Medicare Administrative Contractors for documentation requirements. Examples of elements to be included in the documentation are a brief description of the discussion with the patient or family/surrogate regarding the voluntary nature of ACP services, an explanation of advance directives and documentation if an advance directive is completed, who was present during the discussion, and time spent in the face-to-face encounter.

Does an advance directive have to be completed to bill the service? No. If an advance directive is completed, this should be documented (see above), but completion of the directive is not a requirement for billing the service.

Can ACP be reported in addition to an evaluation and management (E/M) service (such as an office visit)? Yes. CPT codes 99497 and 99498 may be billed on the same day or a different day as most other E/M services. They may be billed within the global surgical period.

Is a specific diagnosis required to use the ACP CPT codes? No, a specific diagnosis is not required for the ACP codes to be billed.

According to the 2016 Medicare Physician Fee Schedule, the reimbursement is $85.99 for CPT 99497 and $74.88 for CPT 99498. For comparison, the reimbursement for E/M CPT 99203 (30-minute initial evaluation) = $108.85, CPT 99204 (45-minute initial evaluation) = $166.13, and CPT 99205 (60-minute initial evaluation) = $208.38. Far more important than the financial remuneration for these discussions, however, is the critical need for surgeons to have and document their ACP discussions with their patients and/or their family member/surrogate. As surgeons, we are often called to see patients when they are facing a significant change in their health – whether that is a new diagnosis of cancer or after a traumatic injury. Understanding a patient’s values, hopes, and concerns is an essential component to ensuring that our patients receive the best care, as defined by them.

Dr. Fahy is associate professor of surgery and internal medicine at the University of New Mexico, Albuquerque. She is a surgical oncologist who is also board certified in hospice and palliative medicine. Dr. Fahy does not have any relevant conflicts of interest to disclose.

Although effective palliative care has always been a must-have for patients and caregivers facing serious illness, it hasn’t always been readily available. With the emergence of value-based healthcare models—and their potent incentives to reduce avoidable readmissions—there is renewed hope that such care will be accessible to those who need it.

Palliative and end-of-life care have long been promoted as core skills for hospitalists. The topic has regularly been included at SHM annual meetings and other prominent hospital medicine conferences, in the American Board of Internal Medicine blueprint for recognition of focused practice in hospital medicine, and in a number of influential references for hospitalists. Still, as I look at hospitalist programs around the country, there is a clear need to improve hospitalists’ delivery of palliative and end-of-life care.

Care of patients with chronic illness in their last two years of life accounts for a third of all Medicare spending.1 As hospitalists, we encounter many of these patients as they are hospitalized—and often re-hospitalized. Palliative care, which can improve quality of life and decrease costs for patients while leading to increased satisfaction and better outcomes for caregivers, can help alleviate unneeded and unwanted aggressive interventions like hospitalization.2,3

In its 2014 report, Dying in America, the Institute of Medicine (IOM) identified several areas for improvement, including better advance care planning and payment systems supporting high quality end-of-life care.4 As I write this column in mid 2016, there are two notable achievements since the IOM report: two E&M codes for advance care planning and a substantial and growing number of hospitalist patients in alternative payment models like bundled payments or ACOs.5 I believe we are entering a time when the availability of good palliative care will be accelerated due to broader forces in healthcare that for the first time align incentives between patients’ wishes and how care is paid for.

Palliative Care Skills for Hospitalists

The following are key actions for physicians in addressing palliative care for the hospitalized patient. At the risk of oversimplifying the discipline, I offer a few key actions for hospitalists to keep in mind.

Identify patients who would benefit from palliative care. The surprise question—“Would I be surprised if this patient died in the next year?”—has the ability to predict which patients would benefit from palliative care. In one observation from a group of patients with cancer, a “no” answer identified 60% of patients who died within a year.6 The surprise question has previously been shown to be predictive in other cancer and non-cancer populations.7,8

Weisman and Meier suggest using the following in a checklist at the time of hospital admission as “primary criteria to screen for unmet palliative care needs”:9

• The surprise question
• Frequent admissions
• Admission prompted by difficult-to-control physical or psychological symptoms
• Complex care requirements
• Decline in function, feeding intolerance, or unintended decline in weight

Hold a “goals of care” meeting. A notable step forward for supporting conversations between physicians and patients occurred on Jan. 1, when the Centers for Medicare & Medicaid Services (CMS) announced the Advance Care Planning E&M codes. These are CPT codes 99497 and 99498. They can be used on the same day as other E&M codes and cover discussions regarding advance care planning issues including discussing advance directives, appointing a healthcare proxy or durable power of attorney, discussing a living will, or addressing orders for life-sustaining treatment like the role of hydration or future hospitalizations. (For more information on how to use them, visit the CMS website and search for the FAQ.)

What should hospitalists concentrate on when having “goals of care” conversations with patients and caregivers? Ariadne Labs, a Harvard-affiliated health innovation group, offers the following as elements of a serious illness conversation:10

• Patients’ understanding of their illness
• Patients’ preferences for information and for family involvement
• Personal life goals, fears, and anxieties
• Trade-offs they are willing to accept

For hospitalists, an important area to pay particular attention to is the role of future hospitalizations in patients’ wishes for care, as some patients, if offered appropriate symptom control, would prefer to remain at home.

Two other crucial elements of inpatient palliative care—offer psychosocial support and symptom relief and hand off patient to effective post-hospital palliative care—are outside the scope of this article. However, they should be kept in mind and, of course, applied.

Understand the role of the palliative care consultation. Busy hospitalists might reasonably think, “I simply don’t have time to address palliative care in patients who aren’t likely to die during this hospitalization or soon after.” The palliative care consult service, if available, should be accessed when patients are identified as palliative care candidates but the primary hospitalist does not have the time or resources—including specialized knowledge in some cases—to deliver adequate palliative care. Palliative care specialists can also help bridge the gap between inpatient and outpatient palliative care resources.

In sum, the move to value-based payment models and the new advance care planning E&M codes provide a renewed focus—with more aligned incentives—and the opportunity to provide good palliative care to all who need it.

For hospitalists, identifying those who would benefit from palliative care and working with the healthcare team to ensure the care is delivered are at the heart of our professional mission. TH

References

1. End-of-life care. The Darmouth Atlas of Health Care website. Accessed June 23, 2016.
2. Gade G, Venohr I, Conner D, et al. Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med. 2008;11(2):180-190.
3. Morrison RS, Penrod JD, Cassel JB, et al. Cost savings associated with US hospital palliative care consultation programs. Arch Int Med. 2008;168(16):1783-1790.
4. Institute of Medicine. Dying in America: Improving Quality and Honoring Individual Preferences near the End of Life. 2014.
5. BPCI Model 2: Retrospective acute & post acute care episode. Centers for Medicare & Medicaid Services website. Accessed June 24, 2016.
6. Vick JB, Pertsch N, Hutchings M, et al. The utility of the surprise question in identifying patients most at risk of death. J Clin Oncol. 2015;33(suppl):8.
7. Moss AH, Ganjoo J, Sharma S, et al. Utility of the “surprise” question to identify dialysis patients with high mortality. Clin J Am Soc Nephrol. 2008;3:1379-1384.
8. Moss AH, Lunney JR, Culp S, et al. Prognostic significance of the “surprise” question in cancer patients. J Palliat Med. 2010;13(7):837-840.
9. Weissman D, Meier C. Identifying patients in need of a palliative care assessment in the hospital setting: a consensus report from the Center to Advance Palliative Care. J Palliat Med. 2011;14(1):17-23.
10. Serious illness care resources. Ariadne Labs website. Accessed June 24, 2016.

Although effective palliative care has always been a must-have for patients and caregivers facing serious illness, it hasn’t always been readily available. With the emergence of value-based healthcare models—and their potent incentives to reduce avoidable readmissions—there is renewed hope that such care will be accessible to those who need it.

Palliative and end-of-life care have long been promoted as core skills for hospitalists. The topic has regularly been included at SHM annual meetings and other prominent hospital medicine conferences, in the American Board of Internal Medicine blueprint for recognition of focused practice in hospital medicine, and in a number of influential references for hospitalists. Still, as I look at hospitalist programs around the country, there is a clear need to improve hospitalists’ delivery of palliative and end-of-life care.

Care of patients with chronic illness in their last two years of life accounts for a third of all Medicare spending.1 As hospitalists, we encounter many of these patients as they are hospitalized—and often re-hospitalized. Palliative care, which can improve quality of life and decrease costs for patients while leading to increased satisfaction and better outcomes for caregivers, can help alleviate unneeded and unwanted aggressive interventions like hospitalization.2,3

In its 2014 report, Dying in America, the Institute of Medicine (IOM) identified several areas for improvement, including better advance care planning and payment systems supporting high quality end-of-life care.4 As I write this column in mid 2016, there are two notable achievements since the IOM report: two E&M codes for advance care planning and a substantial and growing number of hospitalist patients in alternative payment models like bundled payments or ACOs.5 I believe we are entering a time when the availability of good palliative care will be accelerated due to broader forces in healthcare that for the first time align incentives between patients’ wishes and how care is paid for.

Palliative Care Skills for Hospitalists

The following are key actions for physicians in addressing palliative care for the hospitalized patient. At the risk of oversimplifying the discipline, I offer a few key actions for hospitalists to keep in mind.

Identify patients who would benefit from palliative care. The surprise question—“Would I be surprised if this patient died in the next year?”—has the ability to predict which patients would benefit from palliative care. In one observation from a group of patients with cancer, a “no” answer identified 60% of patients who died within a year.6 The surprise question has previously been shown to be predictive in other cancer and non-cancer populations.7,8

Weisman and Meier suggest using the following in a checklist at the time of hospital admission as “primary criteria to screen for unmet palliative care needs”:9

• The surprise question
• Frequent admissions
• Admission prompted by difficult-to-control physical or psychological symptoms
• Complex care requirements
• Decline in function, feeding intolerance, or unintended decline in weight

Hold a “goals of care” meeting. A notable step forward for supporting conversations between physicians and patients occurred on Jan. 1, when the Centers for Medicare & Medicaid Services (CMS) announced the Advance Care Planning E&M codes. These are CPT codes 99497 and 99498. They can be used on the same day as other E&M codes and cover discussions regarding advance care planning issues including discussing advance directives, appointing a healthcare proxy or durable power of attorney, discussing a living will, or addressing orders for life-sustaining treatment like the role of hydration or future hospitalizations. (For more information on how to use them, visit the CMS website and search for the FAQ.)

What should hospitalists concentrate on when having “goals of care” conversations with patients and caregivers? Ariadne Labs, a Harvard-affiliated health innovation group, offers the following as elements of a serious illness conversation:10

• Patients’ understanding of their illness
• Patients’ preferences for information and for family involvement
• Personal life goals, fears, and anxieties
• Trade-offs they are willing to accept

For hospitalists, an important area to pay particular attention to is the role of future hospitalizations in patients’ wishes for care, as some patients, if offered appropriate symptom control, would prefer to remain at home.

Two other crucial elements of inpatient palliative care—offer psychosocial support and symptom relief and hand off patient to effective post-hospital palliative care—are outside the scope of this article. However, they should be kept in mind and, of course, applied.

Understand the role of the palliative care consultation. Busy hospitalists might reasonably think, “I simply don’t have time to address palliative care in patients who aren’t likely to die during this hospitalization or soon after.” The palliative care consult service, if available, should be accessed when patients are identified as palliative care candidates but the primary hospitalist does not have the time or resources—including specialized knowledge in some cases—to deliver adequate palliative care. Palliative care specialists can also help bridge the gap between inpatient and outpatient palliative care resources.

In sum, the move to value-based payment models and the new advance care planning E&M codes provide a renewed focus—with more aligned incentives—and the opportunity to provide good palliative care to all who need it.

For hospitalists, identifying those who would benefit from palliative care and working with the healthcare team to ensure the care is delivered are at the heart of our professional mission. TH

References

1. End-of-life care. The Darmouth Atlas of Health Care website. Accessed June 23, 2016.
2. Gade G, Venohr I, Conner D, et al. Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med. 2008;11(2):180-190.
3. Morrison RS, Penrod JD, Cassel JB, et al. Cost savings associated with US hospital palliative care consultation programs. Arch Int Med. 2008;168(16):1783-1790.
4. Institute of Medicine. Dying in America: Improving Quality and Honoring Individual Preferences near the End of Life. 2014.
5. BPCI Model 2: Retrospective acute & post acute care episode. Centers for Medicare & Medicaid Services website. Accessed June 24, 2016.
6. Vick JB, Pertsch N, Hutchings M, et al. The utility of the surprise question in identifying patients most at risk of death. J Clin Oncol. 2015;33(suppl):8.
7. Moss AH, Ganjoo J, Sharma S, et al. Utility of the “surprise” question to identify dialysis patients with high mortality. Clin J Am Soc Nephrol. 2008;3:1379-1384.
8. Moss AH, Lunney JR, Culp S, et al. Prognostic significance of the “surprise” question in cancer patients. J Palliat Med. 2010;13(7):837-840.
9. Weissman D, Meier C. Identifying patients in need of a palliative care assessment in the hospital setting: a consensus report from the Center to Advance Palliative Care. J Palliat Med. 2011;14(1):17-23.
10. Serious illness care resources. Ariadne Labs website. Accessed June 24, 2016.

Although effective palliative care has always been a must-have for patients and caregivers facing serious illness, it hasn’t always been readily available. With the emergence of value-based healthcare models—and their potent incentives to reduce avoidable readmissions—there is renewed hope that such care will be accessible to those who need it.

Palliative and end-of-life care have long been promoted as core skills for hospitalists. The topic has regularly been included at SHM annual meetings and other prominent hospital medicine conferences, in the American Board of Internal Medicine blueprint for recognition of focused practice in hospital medicine, and in a number of influential references for hospitalists. Still, as I look at hospitalist programs around the country, there is a clear need to improve hospitalists’ delivery of palliative and end-of-life care.

Care of patients with chronic illness in their last two years of life accounts for a third of all Medicare spending.1 As hospitalists, we encounter many of these patients as they are hospitalized—and often re-hospitalized. Palliative care, which can improve quality of life and decrease costs for patients while leading to increased satisfaction and better outcomes for caregivers, can help alleviate unneeded and unwanted aggressive interventions like hospitalization.2,3

In its 2014 report, Dying in America, the Institute of Medicine (IOM) identified several areas for improvement, including better advance care planning and payment systems supporting high quality end-of-life care.4 As I write this column in mid 2016, there are two notable achievements since the IOM report: two E&M codes for advance care planning and a substantial and growing number of hospitalist patients in alternative payment models like bundled payments or ACOs.5 I believe we are entering a time when the availability of good palliative care will be accelerated due to broader forces in healthcare that for the first time align incentives between patients’ wishes and how care is paid for.

Palliative Care Skills for Hospitalists

The following are key actions for physicians in addressing palliative care for the hospitalized patient. At the risk of oversimplifying the discipline, I offer a few key actions for hospitalists to keep in mind.

Identify patients who would benefit from palliative care. The surprise question—“Would I be surprised if this patient died in the next year?”—has the ability to predict which patients would benefit from palliative care. In one observation from a group of patients with cancer, a “no” answer identified 60% of patients who died within a year.6 The surprise question has previously been shown to be predictive in other cancer and non-cancer populations.7,8

Weisman and Meier suggest using the following in a checklist at the time of hospital admission as “primary criteria to screen for unmet palliative care needs”:9

• The surprise question
• Frequent admissions
• Admission prompted by difficult-to-control physical or psychological symptoms
• Complex care requirements
• Decline in function, feeding intolerance, or unintended decline in weight

Hold a “goals of care” meeting. A notable step forward for supporting conversations between physicians and patients occurred on Jan. 1, when the Centers for Medicare & Medicaid Services (CMS) announced the Advance Care Planning E&M codes. These are CPT codes 99497 and 99498. They can be used on the same day as other E&M codes and cover discussions regarding advance care planning issues including discussing advance directives, appointing a healthcare proxy or durable power of attorney, discussing a living will, or addressing orders for life-sustaining treatment like the role of hydration or future hospitalizations. (For more information on how to use them, visit the CMS website and search for the FAQ.)

What should hospitalists concentrate on when having “goals of care” conversations with patients and caregivers? Ariadne Labs, a Harvard-affiliated health innovation group, offers the following as elements of a serious illness conversation:10

• Patients’ understanding of their illness
• Patients’ preferences for information and for family involvement
• Personal life goals, fears, and anxieties
• Trade-offs they are willing to accept

For hospitalists, an important area to pay particular attention to is the role of future hospitalizations in patients’ wishes for care, as some patients, if offered appropriate symptom control, would prefer to remain at home.

Two other crucial elements of inpatient palliative care—offer psychosocial support and symptom relief and hand off patient to effective post-hospital palliative care—are outside the scope of this article. However, they should be kept in mind and, of course, applied.

Understand the role of the palliative care consultation. Busy hospitalists might reasonably think, “I simply don’t have time to address palliative care in patients who aren’t likely to die during this hospitalization or soon after.” The palliative care consult service, if available, should be accessed when patients are identified as palliative care candidates but the primary hospitalist does not have the time or resources—including specialized knowledge in some cases—to deliver adequate palliative care. Palliative care specialists can also help bridge the gap between inpatient and outpatient palliative care resources.

In sum, the move to value-based payment models and the new advance care planning E&M codes provide a renewed focus—with more aligned incentives—and the opportunity to provide good palliative care to all who need it.

For hospitalists, identifying those who would benefit from palliative care and working with the healthcare team to ensure the care is delivered are at the heart of our professional mission. TH

References

1. End-of-life care. The Darmouth Atlas of Health Care website. Accessed June 23, 2016.
2. Gade G, Venohr I, Conner D, et al. Impact of an inpatient palliative care team: a randomized control trial. J Palliat Med. 2008;11(2):180-190.
3. Morrison RS, Penrod JD, Cassel JB, et al. Cost savings associated with US hospital palliative care consultation programs. Arch Int Med. 2008;168(16):1783-1790.
4. Institute of Medicine. Dying in America: Improving Quality and Honoring Individual Preferences near the End of Life. 2014.
5. BPCI Model 2: Retrospective acute & post acute care episode. Centers for Medicare & Medicaid Services website. Accessed June 24, 2016.
6. Vick JB, Pertsch N, Hutchings M, et al. The utility of the surprise question in identifying patients most at risk of death. J Clin Oncol. 2015;33(suppl):8.
7. Moss AH, Ganjoo J, Sharma S, et al. Utility of the “surprise” question to identify dialysis patients with high mortality. Clin J Am Soc Nephrol. 2008;3:1379-1384.
8. Moss AH, Lunney JR, Culp S, et al. Prognostic significance of the “surprise” question in cancer patients. J Palliat Med. 2010;13(7):837-840.
9. Weissman D, Meier C. Identifying patients in need of a palliative care assessment in the hospital setting: a consensus report from the Center to Advance Palliative Care. J Palliat Med. 2011;14(1):17-23.
10. Serious illness care resources. Ariadne Labs website. Accessed June 24, 2016.

Purpose: Describe symptom burden and distress among Veteran cancer survivors.

Background: Survivorship is an important component of cancer care as patients transition from treatment to surveillance and cope with long-term effects of therapy. Veterans receiving care at the VA are quite different from those described in existing survivorship literature, with lower income and health literacy, poorer physical andmental health, and more comorbidities compared to the general population. Survivorship needs have not been well defined in this population.

Methods: Veterans are referred or recruited to survivorship clinic after completing definitive therapy. An NCCN distress thermometer (DT) is completed in survivorship clinic as part of routine clinical care.

Data Analysis: This analysis was restricted to cancer survivors meeting Commission on Cancer guidance for survivorship care eligibility. Descriptive statistics summarized findings from the DT. To place symptom burden in context, a comparison group was selected consisting of Veterans with comparable cancer site and stage who completed a DT at their first treatment appointment. Reported symptoms were compared to those from survivors with chi-square analysis.

Results: The DT was completed by 47 lung, colorectal, anal, and head and neck cancer survivors between February 2015 and April 2016. Most were white males, with an average age of 66. Of 39 practical, family, emotional, and physical problems included on the DT, survivors reported an average of 9.2 issues (range 0-22). The most common problems were dyspnea (64%), fatigue (60%), pain (57%), sleep (45%), worry (43%), and depression (40%). The average distress score was 3.6 (range 0-9).

The comparison group contained 147 Veterans; they reported an average of 7.4 issues as sources of distress.

Survivors were significantly more likely to report difficulty with breathing, constipation, depression, anhedonia, sadness, sleep concerns, and tingling in the hands and feet. The only issues more common in patients at the start of treatment compared to survivors were nervousness and transportation concerns. There was no difference in concerns regarding treatment decisions, pain, or finances.

Implications: Veteran cancer survivors reported significant symptom burden, particularly concerning mental health and side effects of treatment. Cancer survivorship clinic can play an important role in identifying and addressing the significant symptom burden. A multidisciplinary approach, particularly one including mental health services, is very important.

Purpose: Describe symptom burden and distress among Veteran cancer survivors.

Background: Survivorship is an important component of cancer care as patients transition from treatment to surveillance and cope with long-term effects of therapy. Veterans receiving care at the VA are quite different from those described in existing survivorship literature, with lower income and health literacy, poorer physical andmental health, and more comorbidities compared to the general population. Survivorship needs have not been well defined in this population.

Methods: Veterans are referred or recruited to survivorship clinic after completing definitive therapy. An NCCN distress thermometer (DT) is completed in survivorship clinic as part of routine clinical care.

Data Analysis: This analysis was restricted to cancer survivors meeting Commission on Cancer guidance for survivorship care eligibility. Descriptive statistics summarized findings from the DT. To place symptom burden in context, a comparison group was selected consisting of Veterans with comparable cancer site and stage who completed a DT at their first treatment appointment. Reported symptoms were compared to those from survivors with chi-square analysis.

Results: The DT was completed by 47 lung, colorectal, anal, and head and neck cancer survivors between February 2015 and April 2016. Most were white males, with an average age of 66. Of 39 practical, family, emotional, and physical problems included on the DT, survivors reported an average of 9.2 issues (range 0-22). The most common problems were dyspnea (64%), fatigue (60%), pain (57%), sleep (45%), worry (43%), and depression (40%). The average distress score was 3.6 (range 0-9).

The comparison group contained 147 Veterans; they reported an average of 7.4 issues as sources of distress.

Survivors were significantly more likely to report difficulty with breathing, constipation, depression, anhedonia, sadness, sleep concerns, and tingling in the hands and feet. The only issues more common in patients at the start of treatment compared to survivors were nervousness and transportation concerns. There was no difference in concerns regarding treatment decisions, pain, or finances.

Implications: Veteran cancer survivors reported significant symptom burden, particularly concerning mental health and side effects of treatment. Cancer survivorship clinic can play an important role in identifying and addressing the significant symptom burden. A multidisciplinary approach, particularly one including mental health services, is very important.

Purpose: Describe symptom burden and distress among Veteran cancer survivors.

Background: Survivorship is an important component of cancer care as patients transition from treatment to surveillance and cope with long-term effects of therapy. Veterans receiving care at the VA are quite different from those described in existing survivorship literature, with lower income and health literacy, poorer physical andmental health, and more comorbidities compared to the general population. Survivorship needs have not been well defined in this population.

Methods: Veterans are referred or recruited to survivorship clinic after completing definitive therapy. An NCCN distress thermometer (DT) is completed in survivorship clinic as part of routine clinical care.

Data Analysis: This analysis was restricted to cancer survivors meeting Commission on Cancer guidance for survivorship care eligibility. Descriptive statistics summarized findings from the DT. To place symptom burden in context, a comparison group was selected consisting of Veterans with comparable cancer site and stage who completed a DT at their first treatment appointment. Reported symptoms were compared to those from survivors with chi-square analysis.

Results: The DT was completed by 47 lung, colorectal, anal, and head and neck cancer survivors between February 2015 and April 2016. Most were white males, with an average age of 66. Of 39 practical, family, emotional, and physical problems included on the DT, survivors reported an average of 9.2 issues (range 0-22). The most common problems were dyspnea (64%), fatigue (60%), pain (57%), sleep (45%), worry (43%), and depression (40%). The average distress score was 3.6 (range 0-9).

The comparison group contained 147 Veterans; they reported an average of 7.4 issues as sources of distress.

Survivors were significantly more likely to report difficulty with breathing, constipation, depression, anhedonia, sadness, sleep concerns, and tingling in the hands and feet. The only issues more common in patients at the start of treatment compared to survivors were nervousness and transportation concerns. There was no difference in concerns regarding treatment decisions, pain, or finances.

Implications: Veteran cancer survivors reported significant symptom burden, particularly concerning mental health and side effects of treatment. Cancer survivorship clinic can play an important role in identifying and addressing the significant symptom burden. A multidisciplinary approach, particularly one including mental health services, is very important.

Purpose: Palliative Care is essential to Oncology. The purpose of this abstract is to describe the AVAHO Palliative Care Research subcommittee, its objectives, and evidence of its productive multi-disciplinary and inter-institutional collaboration.

Background: The American Society of Clinical Oncology (ASCO) recommends Palliative Care for all patients with metastatic lung cancer and other symptomatic advanced malignancies. VA mandates Palliative Care inpatient consult teams for all medical facilities. It is not clearly known how Palliative Care is integrated into standard VA outpatient Oncology practice. In addition, questions remain regarding the optimal way(s) to provide Palliative Oncology Care. The AVAHO Palliative Care Research subcommittee was established in 2015 and currently has 7 members from 7 VA institutions. The mission of the subcommittee is to develop partnerships among VA clinicians, pharmacists, social workers, researchers, and VA leadership with the shared goal of providing optimal Palliative Oncology Care within the VA. In laying the groundwork for productive collaboration, we have identified a need to better understand the current interface between VA Oncology Clinics and Palliative Care teams. In particular, we seek to review the evidence for providing on-site Palliative Care to patients with advanced malignancies, and we seek to understand the current availability of outpatient Palliative Care within VA outpatient Oncology clinics.

Methods: We have identified 2 initial approaches to address these questions. First, we have submitted a proposal to the VA Evidence-Based Synthesis Program (ESP) to review the evidence regarding optimal Palliative Care delivery methods for patients with advanced malignancies and
the feasibility of providing on-site Palliative Care embedded into VA Oncology clinics. Second, we plan to survey current VA Oncology providers to understand their Palliative Care referral patterns, available on-site resources, and barriers to providing optimal Palliative Care for their patients.

Analysis/Results: At the AVAHO 2016 meeting, we will provide updated information on the ESP proposal and the Palliative Care in Oncology Survey.

Conclusion: The AVAHO Palliative Care Research subcommittee represents a multidisciplinary and inter-institutional collaboration with a common goal of optimizing VA Palliative Oncology Care. This subcommittee is a model of how AVAHO can foster productive collaborations. We welcome new members.

Purpose: Palliative Care is essential to Oncology. The purpose of this abstract is to describe the AVAHO Palliative Care Research subcommittee, its objectives, and evidence of its productive multi-disciplinary and inter-institutional collaboration.

Background: The American Society of Clinical Oncology (ASCO) recommends Palliative Care for all patients with metastatic lung cancer and other symptomatic advanced malignancies. VA mandates Palliative Care inpatient consult teams for all medical facilities. It is not clearly known how Palliative Care is integrated into standard VA outpatient Oncology practice. In addition, questions remain regarding the optimal way(s) to provide Palliative Oncology Care. The AVAHO Palliative Care Research subcommittee was established in 2015 and currently has 7 members from 7 VA institutions. The mission of the subcommittee is to develop partnerships among VA clinicians, pharmacists, social workers, researchers, and VA leadership with the shared goal of providing optimal Palliative Oncology Care within the VA. In laying the groundwork for productive collaboration, we have identified a need to better understand the current interface between VA Oncology Clinics and Palliative Care teams. In particular, we seek to review the evidence for providing on-site Palliative Care to patients with advanced malignancies, and we seek to understand the current availability of outpatient Palliative Care within VA outpatient Oncology clinics.

Methods: We have identified 2 initial approaches to address these questions. First, we have submitted a proposal to the VA Evidence-Based Synthesis Program (ESP) to review the evidence regarding optimal Palliative Care delivery methods for patients with advanced malignancies and
the feasibility of providing on-site Palliative Care embedded into VA Oncology clinics. Second, we plan to survey current VA Oncology providers to understand their Palliative Care referral patterns, available on-site resources, and barriers to providing optimal Palliative Care for their patients.

Analysis/Results: At the AVAHO 2016 meeting, we will provide updated information on the ESP proposal and the Palliative Care in Oncology Survey.

Conclusion: The AVAHO Palliative Care Research subcommittee represents a multidisciplinary and inter-institutional collaboration with a common goal of optimizing VA Palliative Oncology Care. This subcommittee is a model of how AVAHO can foster productive collaborations. We welcome new members.

Purpose: Palliative Care is essential to Oncology. The purpose of this abstract is to describe the AVAHO Palliative Care Research subcommittee, its objectives, and evidence of its productive multi-disciplinary and inter-institutional collaboration.

Background: The American Society of Clinical Oncology (ASCO) recommends Palliative Care for all patients with metastatic lung cancer and other symptomatic advanced malignancies. VA mandates Palliative Care inpatient consult teams for all medical facilities. It is not clearly known how Palliative Care is integrated into standard VA outpatient Oncology practice. In addition, questions remain regarding the optimal way(s) to provide Palliative Oncology Care. The AVAHO Palliative Care Research subcommittee was established in 2015 and currently has 7 members from 7 VA institutions. The mission of the subcommittee is to develop partnerships among VA clinicians, pharmacists, social workers, researchers, and VA leadership with the shared goal of providing optimal Palliative Oncology Care within the VA. In laying the groundwork for productive collaboration, we have identified a need to better understand the current interface between VA Oncology Clinics and Palliative Care teams. In particular, we seek to review the evidence for providing on-site Palliative Care to patients with advanced malignancies, and we seek to understand the current availability of outpatient Palliative Care within VA outpatient Oncology clinics.

Methods: We have identified 2 initial approaches to address these questions. First, we have submitted a proposal to the VA Evidence-Based Synthesis Program (ESP) to review the evidence regarding optimal Palliative Care delivery methods for patients with advanced malignancies and
the feasibility of providing on-site Palliative Care embedded into VA Oncology clinics. Second, we plan to survey current VA Oncology providers to understand their Palliative Care referral patterns, available on-site resources, and barriers to providing optimal Palliative Care for their patients.

Analysis/Results: At the AVAHO 2016 meeting, we will provide updated information on the ESP proposal and the Palliative Care in Oncology Survey.

Conclusion: The AVAHO Palliative Care Research subcommittee represents a multidisciplinary and inter-institutional collaboration with a common goal of optimizing VA Palliative Oncology Care. This subcommittee is a model of how AVAHO can foster productive collaborations. We welcome new members.