Effect of the Serious Illness Care Program in Outpatient Oncology: A Cluster Randomized Clinical Trial.

Key PointsQuestionDoes a quality-improvement intervention designed to enhance communication between oncology clinicians and patients with advanced cancer improve goal-concordant care, peacefulness, therapeutic alliance, anxiety, and depression? FindingsIn this cluster randomized clinical trial evaluating use of a communication quality-improvement intervention by 91 clinicians for 278 patients with advanced cancer, results were null with respect to the coprimary outcomes of goal-concordant care and peacefulness for decedents, but there were fewer than expected patients with evaluable coprimary outcomes. However, the trial demonstrated significant reductions in moderate to severe anxiety and depression symptoms among intervention patients in the total population. MeaningThis cluster randomized clinical trial highlighted the challenges of measuring outcomes near the end of life among patients with advanced cancer; secondary outcomes of anxiety and depression are important and require further study. ImportanceHigh-quality conversations between clinicians and seriously ill patients about values and goals are associated with improved outcomes but occur infrequently. ObjectiveTo examine feasibility, acceptability, and effect of a communication quality-improvement intervention (Serious Illness Care Program) on patient outcomes. Design, Setting, and ParticipantsA 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. InterventionsTools, training, and system changes. Main Outcomes and MeasuresThe 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. ResultsData 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 RelevanceThe 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 RegistrationClinicalTrials.gov identifier: NCT01786811 This cluster randomized clinical trial evaluates the effect of a communication quality-improvement intervention on a goal-concordant care and peacefulness at the end of life among oncology clinicians and patients with advanced cancer.