Effect of the Serious Illness Care Program in Outpatient Oncology

Abstract

IMPORTANCE High-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently. OBJECTIVE To examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes. DESIGN, SETTING, AND PARTICIPANTS A cluster randomized clinical trial of the Serious Illness Care Program in an outpatient oncology setting was conducted. Patients with advanced cancer (n = 278) and oncology clinicians (n = 91) participated between September 1, 2012, and June 30, 2016. Data analysis was performed from September 1, 2016, to December 27, 2018. All analyses were conducted based on intention to treat. INTERVENTIONS Tools, training, and system changes. MAIN OUTCOMES AND MEASURES The coprimary outcomes included goal-concordant care (Life Priorities) and peacefulness (Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire) at the end of life. Secondary outcomes included therapeutic alliance (Human Connection Scale), anxiety (Generalized Anxiety Disorder 7 scale), depression (Patient Health Questionnaire 9), and survival. Uptake and effectiveness of clinician training, clinician use of the conversation tool, and conversation duration were evaluated. RESULTS Data from 91 clinicians in 41 clusters (72.9% participation; intervention, n = 48; control, n = 43; 52 [57.1%] women) and 278 patients (45.8% participation; intervention, n = 134; control, n = 144; 148 [53.2%] women) were analyzed. Forty-seven clinicians (97.9%) rated the training as effective (mean [SD] score, 4.3 [0.7] of 5.0 possible); of 39 who received a reminder, 34 (87.2%) completed at least 1 conversation (median duration, 19 minutes; range, 5-70). Peacefulness, therapeutic alliance, anxiety, and depression did not differ at baseline. The coprimary outcomes were evaluated in 64 patients; no significant differences were found between the intervention and control groups. However, the trial demonstrated significant reductions in the proportion of patients with moderate to severe anxiety (10.2% vs 5.0%; P = .05) and depression symptoms (20.8% vs 10.6%; P = .04) in the intervention group at 14 weeks after baseline. Anxiety reduction was sustained at 24 weeks (10.4% vs 4.2%; P = .02), but depression reduction was not sustained (17.8% vs 12.5%; P = .31). Survival and therapeutic alliance did not differ between groups. CONCLUSIONS AND RELEVANCE The results of this cluster randomized clinical trial were null with respect to the coprimary outcomes of goal-concordant care and peacefulness at the end of life. Methodologic challenges for the primary outcomes, including measure selection and sample size, limit the conclusions that can be drawn from the study. However, the significant reductions in anxiety and depression in the intervention group are clinically meaningful and require further study. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01786811

Factors associated with prognostic awareness in patients with cancer: A systematic review

“…Also, protocols for goals of care discussions, which use open‐ended questions to cover the values and preferences of the patients, can be very useful in addressing individual mechanisms which patients use while work with their prognostication needs. Serious Illness Care Program (SICP), created by Bernacki et al 74 can be a good example of this approach.…”

Medical students’ experiences with goals of care discussions and their impact on professional identity formation

“…By focusing on observable behaviours, however, competency‐based medical education may also encourage reversion to behavioural models of professionalism in which complex, integrated tasks like GoC discussions are reduced to discrete behaviours . Indeed, although structured communication interventions may promote person‐centred communication, some participants in this study pursued overly scripted approaches because they were uncomfortable with uncertainty and complexity. Physicians’ tolerance of uncertainty is invaluable, however, and curricular interventions to acknowledge and normalise complexity, uncertainty and associated anxiety should be encouraged …”

Views of advanced cancer patients, families, and oncologists on initiating and engaging in advance care planning: a qualitative study

“…There is limited literature discussing physician ACP training. However, those who have tested training sessions have observed improved patient outcomes, including ACP documentation (30) and decreased patient anxiety and depression following ACP training with the Serious Illness Care Program for clinicians working with oncology patients (44,45).…”