Two new studies of an intervention to improve end-of-life clinician-patient exchange of communication found that, although the intervention improved the quality and timing of serious illness conversations, these procedural gains did not result in increased “goal-concordant” care and peacefulness for patients.
A significantly higher proportion of patients receiving the Serious Illness Care Program (SICP) intervention had a clinician-documented discussion compared with controls (96% vs 79%, P=0.005) and these conversations occurred a median of 2.4 months earlier (median, 143 vs 71 days, P<0.001), Joanna Paladino, MD, of Brigham and Women's Hospital and Harvard T.H. Chan School of Public Health in Boston, and colleagues reported in JAMA Oncology.
A separate analysis by members of the same research group of goal-concordant care and peacefulness at the end-of-life in 64 patients found that the intervention had a null effect on these co-primary outcomes, although significant reductions were noted in moderate to severe anxiety and depression symptoms, reported Rachelle Bernacki, MD, of Harvard and the Department of Psychosocial Oncology and Palliative Care at Dana-Farber Cancer Institute in Boston, and colleagues in JAMA Internal Medicine.
Despite recommendations for inclusion of end-of-life conversations as part of routine oncological care, numerous barriers remain to be addressed, Paladino noted. While up to 87% of patients with terminal cancer have had a discussion with clinicians about their end-of-life goals, these generally begin about 1 month before death, in acute care settings with clinicians who are not the treating oncologist.
“While many interventions focus exclusively on clinician training and education, there is insufficient evidence that training alone leads to improvements in clinician conversation practices or patient-level outcomes,” Paladino observed.
The SICP is a complex program that provides training, coaching, and prompts for oncologists; patient/caregiver information; and finally, a structured template for documenting end-of-life discussions in the patient’s electronic medical record (EMR) – thus improving access to this critical information, an issue increasingly recognized as essential for patient safety, the group noted.
“It is disappointing that relatively strong improvements in measures of process translated into limited effects on patient outcomes [which are unlikely to change in a future trial repeated in a similar population and setting],” wrote Martin Stockler, MBBS, and Belinda E. Kiely, MBBS, PhD, both of the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney in Australia, in a JAMA Oncology editorial linked to the two studies.
Nevertheless, these findings should influence oncologists to consider initiating these conversations with patients whose expected survival time is 2 years or less, being “reassured that having these conversations is unlikely to increase anxiety or depression in their patients,” noted the editorialists.
The review of medical records after the patients’ death found that compared with controls, intervention patients were more likely to have a documented discussion (96% vs 79%, P=0.005), and intervention conversations occurred earlier by a median of 2.4 months (median 143 vs 71 days, P<0.001), noted Paladino and co-authors.
Conversation in the SICP was significantly more comprehensive and patient centered, with a greater focus on the following:
- Values/goals (89% vs 44%, P<0.001)
- Prognosis or illness understanding (91% vs 48%, P<0.001)
- Life-sustaining treatment preferences (63% vs 32%, P=0.004)
While documentation of end-of-life care planning was similar with or without the intervention (80% vs 68%, P=0.08), more of the intervention patients had documentation that was accessible in the EMR (61% vs 11%, P<0.001), the team found.
Of enrolled patients, 58% died during the study (n=161); mean age was 62.3 (95% CI 59-65); and 55% were women (n=88).
Of the 91 clinicians in 41 clusters, 98% rated the SICP training as effective, and of the 39 who required a reminder, 87% completed at least one conversation (median duration of 19 minutes; range of 5-70 minutes), Bernacki and colleagues reported.
Patients with advanced cancer (n = 278, 53% female) participated in the study from September 1, 2012 to June 30, 2016. Peacefulness, therapeutic alliance, anxiety, and depression did not differ between the intervention and control groups at baseline, the researchers reported.
At 14 weeks from baseline, compared with controls, patients randomized to the SICP intervention had half the frequency of moderate to severe symptoms of both anxiety (5% vs 10%, P=.05; number needed to treat [NNT] 20) and depression (11% vs 21%, P=.04; NNT 10), Bernacki and colleagues said, adding that these significant reductions seen with SICP “are clinically meaningful and require further study.”
At 24 weeks, anxiety was reduced in 10.4% of the intervention group versus 4.2% of controls (P=0.02), while the reduction in depression was not sustained (17.8% vs 12.5%; P=0.31), the researchers noted. Survival and therapeutic alliance did not differ between the groups.
Study limitations, the team said, included methodological issues such as measure selection and sample size, which limit the conclusions that can be drawn regarding the study’s primary outcomes.
The editorial concluded: “Helping oncologists recognize and act on indicators for initiating these conversations is a critical first step. Wider provision of information about prognosis to the public might help overcome the reluctance of physicians to address these needs themselves.”
The research was supported by the Branta Foundation, the Charina Endowment Fund, the Margaret T. Morris Foundation, the Richard A. Cantor Fund, Partners Healthcare, and the John A. Hartford Foundation.
Paladino and Bernacki reported having no disclosures.
Stockler reported financial relationships with Astellas, Amgen, AstraZeneca, Cancer Australia, Celgene, Bionomics, Bayer, and other companies.