Abstract
IMPORTANCE: Few randomized clinical trials have been conducted with ethnic/racial minorities to improve shared decision making (SDM) and quality of care. OBJECTIVE: To test the effectiveness of patient and clinician interventions to improve SDM and quality of care among an ethnically/racially diverse sample. DESIGN, SETTING, AND PARTICIPANTS: This cross-level 2 × 2 randomized clinical trial included clinicians at level 2 and patients (nested within clinicians) at level 1 from 13 Massachusetts behavioral health clinics. Clinicians and patients were randomly selected at each site in a 1:1 ratio for each 2-person block. Clinicians were recruited starting September 1, 2013; patients, starting November 3, 2013. Final data were collected on September 30, 2016. Data were analyzed based on intention to treat. INTERVENTIONS: The clinician intervention consisted of a workshop and as many as 6 coaching telephone calls to promote communication and therapeutic alliance to improve SDM. The 3-session patient intervention sought to improve SDM and quality of care. MAIN OUTCOMES AND MEASURES: The SDM was assessed by a blinded coder based on clinical recordings, patient perception of SDM and quality of care, and clinician perception of SDM. RESULTS: Of 312 randomized patients, 212 (67.9%) were female and 100 (32.1%) were male; mean (SD) age was 44.0 (15.0) years. Of 74 randomized clinicians, 56 (75.7%) were female and 18 (4.3%) were male; mean (SD) age was 39.8 (12.5) years. Patient-clinician pairs were assigned to 1 of the following 4 design arms: patient and clinician in the control condition (n = 72), patient in intervention and clinician in the control condition (n = 68), patient in the control condition and clinician in intervention (n = 83), or patient and clinician in intervention (n = 89). All pairs underwent analysis. The clinician intervention significantly increased SDM as rated by blinded coders using the 12-item Observing Patient Involvement in Shared Decision Making instrument (b = 4.52; SE = 2.17; P = .04; Cohen d = 0.29) but not as assessed by clinician or patient. More clinician coaching sessions (dosage) were significantly associated with increased SDM as rated by blinded coders (b = 12.01; SE = 3.72; P = .001; Cohen d = 0.78). The patient intervention significantly increased patient-perceived quality of care (b = 2.27; SE = 1.16; P = .05; Cohen d = 0.19). There was a significant interaction between patient and clinician dosage (b = 7.40; SE = 3.56; P = .04; Cohen d = 0.62), with the greatest benefit when both obtained the recommended dosage. CONCLUSIONS AND RELEVANCE: The clinician intervention could improve SDM with minority populations, and the patient intervention could augment patient-reported quality of care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01947283.