Comparison of Teleintegrated Care and Telereferral Care for Treating Complex Psychiatric Disorders in Primary Care: A Pragmatic Randomized Comparative Effectiveness Trial

IMPORTANCE: Only one-third of patients with complex psychiatric disorders engage in specialty mental health care, and only one-tenth receive adequate treatment in primary care. Scalable approaches are critically needed to improve access to effective mental health treatments in underserved primary care settings. OBJECTIVE: To compare 2 clinic-to-clinic interactive video approaches to delivering evidence-based mental health treatments to patients in primary care clinics. DESIGN, SETTING, AND PARTICIPANTS: This pragmatic comparative effectiveness trial used a sequential, multiple-assignment, randomized trial (SMART) design with patient-level randomization. Adult patients treated at 24 primary care clinics without on-site psychiatrists or psychologists from 12 federally qualified health centers in 3 states who screened positive for posttraumatic stress disorder and/or bipolar disorder and who were not already receiving pharmacotherapy from a mental health specialist were recruited from November 16, 2016, to June 30, 2019, and observed for 12 months. INTERVENTIONS: Two approaches were compared: (1) telepsychiatry/telepsychology–enhanced referral (TER), where telepsychiatrists and telepsychologists assumed responsibility for treatment, and (2) telepsychiatry collaborative care (TCC), where telepsychiatrists provided consultation to the primary care team. TER included an adaptive intervention (phone-enhanced referral [PER]) for patients not engaging in treatment, which involved telephone outreach and motivational interviewing. MAIN OUTCOMES AND MEASURES: Survey questions assessed patient-reported outcomes. The Veterans RAND 12-item Health Survey Mental Component Summary (MCS) score was the primary outcome (range, 0-100). Secondary outcomes included posttraumatic stress disorder symptoms, manic symptoms, depressive symptoms, anxiety symptoms, recovery, and adverse effects. RESULTS: Of 1004 included participants, 701 of 1000 (70.1%) were female, 660 of 994 (66.4%) were White, and the mean (SD) age was 39.4 (12.9) years. Baseline MCS scores were 3 SDs below the US mean; the mean (SD) MCS scores were 39.7 (14.1) and 41.2 (14.2) in the TCC and TER groups, respectively. There was no significant difference in 12-month MCS score between those receiving TCC and TER (β = 1.7; 95% CI, 0 to 3.4; P = .05). Patients in both groups experienced large and clinically meaningful improvements from baseline to 12 months (TCC: Cohen d = 0.79; 95% CI, 0.65 to 0.94; TER: Cohen d = 0.87;