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

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Gawande received compensation from writing and other media on health care, including the subject of serious illness care and checklists, during the conduct of the study, and is employed by the new nonprofit-seeking health care venture parented by Amazon, Berkshire Hathaway, and JP Morgan Chase. Dr Block receives compensation from Up to Date Palliative Care Editor. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram for the Serious Illness Care Program Cluster Randomized Clinical Trial

The number of clusters decreased from 41 (number of clinician clusters) to 35 (number of clusters for analyzable patients) because some clinician clusters either enrolled no patients or their patients’ data were not able to be analyzed. Patient participation rate (45.8%) and clinician participation rate (72.9%) were calculated as the number who consented and enrolled divided by total number invited to participate.

Figure 2.. Outcomes of Assessments of Therapeutic Alliance, Anxiety, and Depression

A, Therapeutic alliance between patients and their clinicians was assessed using The Human Connection (THC) scale, a 16-item measure that evaluates the extent to which patients feel a sense of mutual understanding, caring, and trust with their physicians. The original THC includes 16 items (Cronbach α = .90). To decrease patient burden and avoid redundancy, we included 7 of the items, a reduction that was supported by the tool developer (J. W. Mack, MD, PhD, and R. E. Bernacki, MD, MS, in-person communication, May 7, 2012). Scores on this shortened THC range from 7 to 28 (Cronbach α = .83 in these trial data). B, Depressive symptoms were assessed using the Patient Health Questionnaire 9, a 9-item measure that evaluates symptoms of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). The score ranges from 0 to 27, with scores in the moderate or severe category (≥10) considered clinically significant. C, Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7 Scale (GAD-7), a 7-item measure that evaluates symptoms of generalized anxiety disorder according to the criteria of the DSM-IV. The score ranges from 0 to 21, with scores in the moderate or severe category (≥10) considered clinically significant. The baseline proportions of patients with moderate or severe anxiety or depression for each arm were adjusted for slight, nonsignificant differences in baseline proportions using a weighted propensity score approach so that differences between arms over time were not due to any baseline differences., Error bars indicate 95% CIs.