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A program to encourage difficult discussions between seriously ill patients and their oncologists reduced anxiety and depression in a recent randomized trial, but its impact on patient-centered outcomes were uncertain.
Goal-concordant care and peacefulness at the end of life, the coprimary study outcomes, were not significantly different between patients who received the quality improvement intervention and controls in the study, which included 91 clinicians providing care for 278 patients with advanced cancer.
However, it’s not clear whether the intervention, known as the Serious Illness Care Program (SICP), failed to improve those outcomes, or if there simply weren’t enough patients in the trial to detect a meaningful difference, according to investigators led by Rachelle Bernacki, MD, of Brigham and Women’s Hospital and the Harvard School of Public Health, Boston.
“Our challenges reflect the need in our field for patient-centered measures of communication that are agreed upon, validated, and demonstrably sensitive to communication interventions,” wrote Dr. Bernacki and her coinvestigators in a report on the study published in JAMA Internal Medicine.
However, the SICP intervention did clearly result in a larger number of serious-illness conversations that occurred earlier and were of higher quality, the investigators wrote in a separate report published in JAMA Oncology. In medical records reviewed after the patients’ deaths, 96% of those who received the intervention had a documented serious-illness conversation with their oncology clinician, compared with 79% of controls (P = .005), according to that report.
The conversations among SICP recipients occurred a median of 2.4 months earlier than controls, and had a greater focus on values and goals, prognosis and understanding of illness, and treatment preferences.
These outcomes are reassuring, since patients “want, require, and deserve” conversations about serious illness, regardless of their impact on measurable outcomes, the authors of an editorial published in JAMA Oncology wrote.
The SICP intervention included a communication guide for clinicians, who also participated in a 2.5-hour training session designed to improve their serious-illness conversation skills. Other aspects of the program for clinicians included email reminders before outpatient visits, a specialized EMR template, and personal coaching. The program also included patient tools, including a letter introducing the intervention and a guide for continuing the conversation with their family.
The study did not demonstrate a significant difference in peacefulness, as measured by the validated Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire, or in goal-concordant care, which was measured by asking patients to select goals of importance, and then asking caregivers to rate whether those goals had been met at the end of life.
However, patients in the SICP group reported less anxiety and depression 14 weeks into the trial, according to the investigators. The proportion of patients reporting moderate to severe anxiety at that time point was 10.2% for the intervention group versus 5.0% for controls (P = .05), while the proportion reporting depression symptoms was 20.8% for the intervention versus 10.6% for controls (P = .04).
The anxiety reduction was maintained at 24 weeks, though the depression reduction was not, the investigators wrote, adding that there were no differences in survival between arms.
Taken together, these results suggest that oncology clinicians can discuss difficult topics without causing harm, and with potential benefit, the investigators wrote in a discussion of their results.
“Further development of serious illness communication interventions will require more reliable and well-accepted patient-centered outcome measures and additional testing of the effect on patients throughout their illness trajectory,” they concluded.
Dr. Bernacki reported no disclosures. Coauthor Susan D. Block, MD, reported compensation from Up to Date and Atul A. Gawande, MD, MPH, reported receiving compensation from health care writing and media and is employed by a health care venture formed by Amazon, Berkshire Hathaway, and JPMorgan Chase.
SOURCE: Bernacki R et al. JAMA Intern Med. 2018 Mar 14. doi: 10.1001/jamainternmed.2019.0077.
While results of this rigorous and innovative clinical trial are disappointing because of an apparent lack of impact on the primary outcomes of care, oncologists still must initiate serious illness conversations with advanced cancer patients at risk of dying in the foreseeable future, according to the authors of an editorial.
Doing so is important “not because this will necessarily improve outcomes, but because patients want, require, and deserve to know what is coming,” wrote Belinda E. Kiely, MBBS, PhD, FRACP, and Martin R. Stockler, MBBS, MSc, FRACP.
Those difficult conversations should not stop at discussing the limits of care, but should include a discussion of the patient’s preferences, priorities, and values, Dr. Kiely and Dr. Stockler wrote, adding that they should be documented in the EMR to ensure they are accessible to other health care providers.
“If nothing else, oncologists should be reassured that having these conversations is unlikely to increase anxiety or depression in their patients,” wrote the editorial authors, referencing the significantly reduced incidence of those secondary endpoints in the study.
However, conversations alone may not be enough to improve other patient-centered outcomes, based on the inability of this trial to demonstrate significant improvements in goal-centered care or peacefulness at the end of life.
Moreover, building this Serious Illness Care Program intervention into a health system could be complicated and may require significant resources.
“Simple, pragmatic, and effective tactics are needed to ensure greater generalizability and widespread applicability of such programs,” the authors concluded.
Dr. Kiely and Dr. Stockler are with the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney. Their editorial appears in JAMA Oncology. Dr. Stockler reported grants outside the submitted work from Astellas, Amgen, AstraZeneca, Cancer Australia, Celgene, Bionomics, Bayer, Medivation, Merck, National Health and Medical Research Council Australia, Pfizer, Roche, Sanofi, and Tilray.
While results of this rigorous and innovative clinical trial are disappointing because of an apparent lack of impact on the primary outcomes of care, oncologists still must initiate serious illness conversations with advanced cancer patients at risk of dying in the foreseeable future, according to the authors of an editorial.
Doing so is important “not because this will necessarily improve outcomes, but because patients want, require, and deserve to know what is coming,” wrote Belinda E. Kiely, MBBS, PhD, FRACP, and Martin R. Stockler, MBBS, MSc, FRACP.
Those difficult conversations should not stop at discussing the limits of care, but should include a discussion of the patient’s preferences, priorities, and values, Dr. Kiely and Dr. Stockler wrote, adding that they should be documented in the EMR to ensure they are accessible to other health care providers.
“If nothing else, oncologists should be reassured that having these conversations is unlikely to increase anxiety or depression in their patients,” wrote the editorial authors, referencing the significantly reduced incidence of those secondary endpoints in the study.
However, conversations alone may not be enough to improve other patient-centered outcomes, based on the inability of this trial to demonstrate significant improvements in goal-centered care or peacefulness at the end of life.
Moreover, building this Serious Illness Care Program intervention into a health system could be complicated and may require significant resources.
“Simple, pragmatic, and effective tactics are needed to ensure greater generalizability and widespread applicability of such programs,” the authors concluded.
Dr. Kiely and Dr. Stockler are with the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney. Their editorial appears in JAMA Oncology. Dr. Stockler reported grants outside the submitted work from Astellas, Amgen, AstraZeneca, Cancer Australia, Celgene, Bionomics, Bayer, Medivation, Merck, National Health and Medical Research Council Australia, Pfizer, Roche, Sanofi, and Tilray.
While results of this rigorous and innovative clinical trial are disappointing because of an apparent lack of impact on the primary outcomes of care, oncologists still must initiate serious illness conversations with advanced cancer patients at risk of dying in the foreseeable future, according to the authors of an editorial.
Doing so is important “not because this will necessarily improve outcomes, but because patients want, require, and deserve to know what is coming,” wrote Belinda E. Kiely, MBBS, PhD, FRACP, and Martin R. Stockler, MBBS, MSc, FRACP.
Those difficult conversations should not stop at discussing the limits of care, but should include a discussion of the patient’s preferences, priorities, and values, Dr. Kiely and Dr. Stockler wrote, adding that they should be documented in the EMR to ensure they are accessible to other health care providers.
“If nothing else, oncologists should be reassured that having these conversations is unlikely to increase anxiety or depression in their patients,” wrote the editorial authors, referencing the significantly reduced incidence of those secondary endpoints in the study.
However, conversations alone may not be enough to improve other patient-centered outcomes, based on the inability of this trial to demonstrate significant improvements in goal-centered care or peacefulness at the end of life.
Moreover, building this Serious Illness Care Program intervention into a health system could be complicated and may require significant resources.
“Simple, pragmatic, and effective tactics are needed to ensure greater generalizability and widespread applicability of such programs,” the authors concluded.
Dr. Kiely and Dr. Stockler are with the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney. Their editorial appears in JAMA Oncology. Dr. Stockler reported grants outside the submitted work from Astellas, Amgen, AstraZeneca, Cancer Australia, Celgene, Bionomics, Bayer, Medivation, Merck, National Health and Medical Research Council Australia, Pfizer, Roche, Sanofi, and Tilray.
A program to encourage difficult discussions between seriously ill patients and their oncologists reduced anxiety and depression in a recent randomized trial, but its impact on patient-centered outcomes were uncertain.
Goal-concordant care and peacefulness at the end of life, the coprimary study outcomes, were not significantly different between patients who received the quality improvement intervention and controls in the study, which included 91 clinicians providing care for 278 patients with advanced cancer.
However, it’s not clear whether the intervention, known as the Serious Illness Care Program (SICP), failed to improve those outcomes, or if there simply weren’t enough patients in the trial to detect a meaningful difference, according to investigators led by Rachelle Bernacki, MD, of Brigham and Women’s Hospital and the Harvard School of Public Health, Boston.
“Our challenges reflect the need in our field for patient-centered measures of communication that are agreed upon, validated, and demonstrably sensitive to communication interventions,” wrote Dr. Bernacki and her coinvestigators in a report on the study published in JAMA Internal Medicine.
However, the SICP intervention did clearly result in a larger number of serious-illness conversations that occurred earlier and were of higher quality, the investigators wrote in a separate report published in JAMA Oncology. In medical records reviewed after the patients’ deaths, 96% of those who received the intervention had a documented serious-illness conversation with their oncology clinician, compared with 79% of controls (P = .005), according to that report.
The conversations among SICP recipients occurred a median of 2.4 months earlier than controls, and had a greater focus on values and goals, prognosis and understanding of illness, and treatment preferences.
These outcomes are reassuring, since patients “want, require, and deserve” conversations about serious illness, regardless of their impact on measurable outcomes, the authors of an editorial published in JAMA Oncology wrote.
The SICP intervention included a communication guide for clinicians, who also participated in a 2.5-hour training session designed to improve their serious-illness conversation skills. Other aspects of the program for clinicians included email reminders before outpatient visits, a specialized EMR template, and personal coaching. The program also included patient tools, including a letter introducing the intervention and a guide for continuing the conversation with their family.
The study did not demonstrate a significant difference in peacefulness, as measured by the validated Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire, or in goal-concordant care, which was measured by asking patients to select goals of importance, and then asking caregivers to rate whether those goals had been met at the end of life.
However, patients in the SICP group reported less anxiety and depression 14 weeks into the trial, according to the investigators. The proportion of patients reporting moderate to severe anxiety at that time point was 10.2% for the intervention group versus 5.0% for controls (P = .05), while the proportion reporting depression symptoms was 20.8% for the intervention versus 10.6% for controls (P = .04).
The anxiety reduction was maintained at 24 weeks, though the depression reduction was not, the investigators wrote, adding that there were no differences in survival between arms.
Taken together, these results suggest that oncology clinicians can discuss difficult topics without causing harm, and with potential benefit, the investigators wrote in a discussion of their results.
“Further development of serious illness communication interventions will require more reliable and well-accepted patient-centered outcome measures and additional testing of the effect on patients throughout their illness trajectory,” they concluded.
Dr. Bernacki reported no disclosures. Coauthor Susan D. Block, MD, reported compensation from Up to Date and Atul A. Gawande, MD, MPH, reported receiving compensation from health care writing and media and is employed by a health care venture formed by Amazon, Berkshire Hathaway, and JPMorgan Chase.
SOURCE: Bernacki R et al. JAMA Intern Med. 2018 Mar 14. doi: 10.1001/jamainternmed.2019.0077.
A program to encourage difficult discussions between seriously ill patients and their oncologists reduced anxiety and depression in a recent randomized trial, but its impact on patient-centered outcomes were uncertain.
Goal-concordant care and peacefulness at the end of life, the coprimary study outcomes, were not significantly different between patients who received the quality improvement intervention and controls in the study, which included 91 clinicians providing care for 278 patients with advanced cancer.
However, it’s not clear whether the intervention, known as the Serious Illness Care Program (SICP), failed to improve those outcomes, or if there simply weren’t enough patients in the trial to detect a meaningful difference, according to investigators led by Rachelle Bernacki, MD, of Brigham and Women’s Hospital and the Harvard School of Public Health, Boston.
“Our challenges reflect the need in our field for patient-centered measures of communication that are agreed upon, validated, and demonstrably sensitive to communication interventions,” wrote Dr. Bernacki and her coinvestigators in a report on the study published in JAMA Internal Medicine.
However, the SICP intervention did clearly result in a larger number of serious-illness conversations that occurred earlier and were of higher quality, the investigators wrote in a separate report published in JAMA Oncology. In medical records reviewed after the patients’ deaths, 96% of those who received the intervention had a documented serious-illness conversation with their oncology clinician, compared with 79% of controls (P = .005), according to that report.
The conversations among SICP recipients occurred a median of 2.4 months earlier than controls, and had a greater focus on values and goals, prognosis and understanding of illness, and treatment preferences.
These outcomes are reassuring, since patients “want, require, and deserve” conversations about serious illness, regardless of their impact on measurable outcomes, the authors of an editorial published in JAMA Oncology wrote.
The SICP intervention included a communication guide for clinicians, who also participated in a 2.5-hour training session designed to improve their serious-illness conversation skills. Other aspects of the program for clinicians included email reminders before outpatient visits, a specialized EMR template, and personal coaching. The program also included patient tools, including a letter introducing the intervention and a guide for continuing the conversation with their family.
The study did not demonstrate a significant difference in peacefulness, as measured by the validated Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire, or in goal-concordant care, which was measured by asking patients to select goals of importance, and then asking caregivers to rate whether those goals had been met at the end of life.
However, patients in the SICP group reported less anxiety and depression 14 weeks into the trial, according to the investigators. The proportion of patients reporting moderate to severe anxiety at that time point was 10.2% for the intervention group versus 5.0% for controls (P = .05), while the proportion reporting depression symptoms was 20.8% for the intervention versus 10.6% for controls (P = .04).
The anxiety reduction was maintained at 24 weeks, though the depression reduction was not, the investigators wrote, adding that there were no differences in survival between arms.
Taken together, these results suggest that oncology clinicians can discuss difficult topics without causing harm, and with potential benefit, the investigators wrote in a discussion of their results.
“Further development of serious illness communication interventions will require more reliable and well-accepted patient-centered outcome measures and additional testing of the effect on patients throughout their illness trajectory,” they concluded.
Dr. Bernacki reported no disclosures. Coauthor Susan D. Block, MD, reported compensation from Up to Date and Atul A. Gawande, MD, MPH, reported receiving compensation from health care writing and media and is employed by a health care venture formed by Amazon, Berkshire Hathaway, and JPMorgan Chase.
SOURCE: Bernacki R et al. JAMA Intern Med. 2018 Mar 14. doi: 10.1001/jamainternmed.2019.0077.
FROM JAMA INTERNAL MEDICINE