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 2 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 (ß = 1.0; 95% CI, -0.8 to 2.8; P = .28). Patients in both groups experienced large and clinically meaningful improvements from baseline to 12 months (TCC: Cohen d = 0.81; 95% CI, 0.67 to 0.95; TER: Cohen d = 0.90; 95% CI, 0.76 to 1.04). For patients not engaging in TER at 6 months, there was no significant difference in 12-month MCS score between those receiving PER and TER (ß = 2.0; 95% CI, -1.7 to 5.7; P = .29). Conclusions and Relevance: In this comparative effectiveness trial of patients with complex psychiatric disorders randomized to receive TCC or TER, significantly and substantially improved outcomes were observed in both groups. From a health care system perspective, clinical leadership should implement whichever approach is most sustainable. Trial Registration: ClinicalTrials.gov Identifier: NCT02738944.

Study to promote innovation in rural integrated telepsychiatry (SPIRIT): Rationale and design of a randomized comparative effectiveness trial of managing complex psychiatric disorders in rural primary care clinics.

OBJECTIVE: Managing complex psychiatric disorders like PTSD and bipolar disorder is challenging in Federally Qualified Health Centers (FQHCs) delivering care to U.S residents living in underserved rural areas. This protocol paper describes SPIRIT, a pragmatic comparative effectiveness trial designed to compare two approaches to managing PTSD and bipolar disorder in FQHCs. INTERVENTIONS: Treatment comparators are: 1) Telepsychiatry Collaborative Care, which integrates consulting telepsychiatrists into primary care teams, and 2) Telepsychiatry Enhanced Referral, where telepsychiatrists and telepsychologists treat patients directly. METHODS: Because Telepsychiatry Enhanced Referral is an adaptive intervention, a Sequential, Multiple Assignment, Randomized Trial design is used. Twenty-four FQHC clinics without on-site psychiatrists or psychologists are participating in the trial. The sample is patients screening positive for PTSD and/or bipolar disorder who are not already engaged in pharmacotherapy with a mental health specialist. Intervention fidelity is measured but not controlled. Patient treatment engagement is measured but not required, and intent-to-treat analysis will be used. Survey questions measure treatment engagement and effectiveness. The Short-Form 12 Mental Health Component Summary (SF-12 MCS) is the primary outcome. RESULTS: A third (34%) of those enrolled (n = 1004) are racial/ethnic minorities, 81% are not fully employed, 68% are Medicaid enrollees, 7% are uninsured, and 62% live in poverty. Mental health related quality of life (SF-12 MCS) is 2.5 standard deviations below the national mean. DISCUSSION: We hypothesize that patients randomized to Telepsychiatry Collaborative Care will have better outcomes than those randomized to Telepsychiatry Enhanced Referral because a higher proportion will engage in evidence-based treatment.

Developing Telemental Health Partnerships Between State Medical Schools and Federally Qualified Health Centers: Navigating the Regulatory Landscape and Policy Recommendations.

BACKGROUND: Federally Qualified Health Centers (FQHCs) deliver care to 26 million Americans living in underserved areas, but few offer telemental health (TMH) services. The social missions of FQHCs and publicly funded state medical schools create a compelling argument for the development of TMH partnerships. In this paper, we share our experience and recommendations from launching TMH partnerships between 12 rural FQHCs and 3 state medical schools. EXPERIENCE: There was consensus that medical school TMH providers should practice as part of the FQHC team to promote integration, enhance quality and safety, and ensure financial sustainability. For TMH providers to practice and bill as FQHC providers, the following issues must be addressed: (1) credentialing and privileging the TMH providers at the FQHC, (2) expanding FQHC Scope of Project to include telepsychiatry, (3) remote access to medical records, (4) insurance credentialing/paneling, billing, and supplemental payments, (5) contracting with the medical school, and (6) indemnity coverage for TMH. RECOMMENDATIONS: We make recommendations to both state medical schools and FQHCs about how to overcome existing barriers to TMH partnerships. We also make recommendations about changes to policy that would mitigate the impact of these barriers. Specifically, we make recommendations to the Centers for Medicare and Medicaid about insurance credentialing, facility fees, eligibility of TMH encounters for supplemental payments, and Medicare eligibility rules for TMH billing by FQHCs. We also make recommendations to the Health Resources and Services Administration about restrictions on adding telepsychiatry to the FQHCs' Scope of Project and the eligibility of TMH providers for indemnity coverage under the Federal Tort Claims Act.

Value-based payment in implementing evidence-based care: the Mental Health Integration Program in Washington state.

OBJECTIVES: To assess the role of value-based payment (VBP) in improving fidelity and patient outcomes in community implementation of an evidence-based mental health intervention, the Collaborative Care Model (CCM). STUDY DESIGN: Retrospective study based on a natural experiment. METHODS: We used the clinical tracking data of 1806 adult patients enrolled in a large implementation of the CCM in community health clinics in Washington state. VBP was initiated in year 2 of the program, creating a natural experiment. We compared implementation fidelity (measured by 3 process-of-care elements of the CCM) between patient-months exposed to VBP and patient-months not exposed to VBP. A series of regressions were estimated to check robustness of findings. We estimated a Cox proportional hazard model to assess the effect of VBP on time to achieving clinically significant improvement in depression (measured based on changes in depression symptom scores over time). RESULTS: Estimated marginal effects of VBP on fidelity ranged from 9% to 30% of the level of fidelity had there been no exposure to VBP (P <.05 for every fidelity measure). Improvement in fidelity in response to VBP was greater among providers with a larger patient panel and among providers with a lower level of fidelity at baseline. Exposure to VBP was associated with an adjusted hazard ratio of 1.45 (95% confidence interval, 1.04-2.03) for achieving clinically significant improvement in depression. CONCLUSIONS: VBP improved fidelity to key elements of the CCM, both directly incentivized and not explicitly incentivized by the VBP, and improved patient depression outcomes.

The COMPASS initiative: description of a nationwide collaborative approach to the care of patients with depression and diabetes and/or cardiovascular disease.

OBJECTIVE: To describe a national effort to disseminate and implement an evidence-based collaborative care management model for patients with both depression and poorly controlled diabetes and/or cardiovascular disease across multiple, real-world diverse clinical practice sites. METHODS: Goals for the initiative were as follows: (1) to improve depression symptoms in 40% of patients, (2) to improve diabetes and hypertension control rates by 20%, (3) to increase provider satisfaction by 20%, (4) to improve patient satisfaction with their care by 20% and (5) to demonstrate cost savings. A Care Management Tracking System was used for collecting clinical care information to create performance measures for quality improvement while also assessing the overall accomplishment of these goals. RESULTS: The Care of Mental, Physical and Substance-use Syndromes (COMPASS) initiative spread an evidence-based collaborative care model among 18 medical groups and 172 clinics in eight states. We describe the initiative's evidence-base and methods for others to replicate our work. CONCLUSIONS: The COMPASS initiative demonstrated that a diverse set of health care systems and other organizations can work together to rapidly implement an evidence-based care model for complex, hard-to-reach patients. We present this model as an example of how the time gap between research and practice can be reduced on a large scale.

Quality improvement with pay-for-performance incentives in integrated behavioral health care.

OBJECTIVES: We evaluated a quality improvement program with a pay-for-performance (P4P) incentive in a population-focused, integrated care program for safety-net patients in 29 community health clinics. METHODS: We used a quasi-experimental design with 1673 depressed adults before and 6304 adults after the implementation of the P4P program. Survival analyses examined the time to improvement in depression before and after implementation of the P4P program, with adjustments for patient characteristics and clustering by health care organization. RESULTS: Program participants had high levels of depression, other psychiatric and substance abuse problems, and social adversity. After implementation of the P4P incentive program, participants were more likely to experience timely follow-up, and the time to depression improvement was significantly reduced. The hazard ratio for achieving treatment response was 1.73 (95% confidence interval=1.39, 2.14) after the P4P program implementation compared with pre-program implementation. CONCLUSIONS: Although this quasi-experiment cannot prove that the P4P initiative directly caused improved patient outcomes, our analyses strongly suggest that when key quality indicators are tracked and a substantial portion of payment is tied to such quality indicators, the effectiveness of care for safety-net populations can be substantially improved.