Sequenced Treatment Effectiveness for Posttraumatic Stress (STEPS) Trial: A protocol for a pragmatic comparative effectiveness trial with baseline results.

BACKGROUND: There have only been two efficacy trials reporting a head-to-head comparison of medications and psychotherapy for PTSD, and neither was conducted in primary care. Therefore, this protocol paper describes a pragmatic trial that compares outcomes of primary care patients randomized to initially receive a brief trauma-focused psychotherapy or a choice of three antidepressants. In addition, because there are few trials examining the effectiveness of subsequent treatments for patients not responding to the initial treatment, this pragmatic trial also compares the outcomes of those switching or augmenting treatments. METHOD: Patients screening positive for PTSD (n = 700) were recruited from the primary care clinics of 7 Federally Qualified Health Centers (FQHC) and 8 Department of Veterans Affairs (VA) Medical Centers and randomized in the ratio 1:1:2 to one of three treatment sequences: 1) selective serotonin reuptake inhibitor (SSRI) followed by augmentation with Written Exposure Therapy (WET), 2) SSRI followed by a switch to serotonin-norepinephrine reuptake inhibitor (SNRI), or 3) WET followed by a switch to SSRI. Participants complete surveys at baseline, 4 months, and 8 months. The primary outcome is PTSD symptom severity as measured by the PTSD Checklist (PCL-5). RESULTS: Average PCL-5 scores (M = 52.8, SD = 11.1) indicated considerable severity. The most common bothersome traumatic event for VA enrollees was combat (47.8%), and for FQHC enrollees was other (28.2%), followed by sexual assault (23.4%), and child abuse (19.8%). Only 22.4% were taking an antidepressant at baseline. CONCLUSION: Results will help healthcare systems and clinicians make decisions about which treatments to offer to patients.

Care managers' experiences in a collaborative care program for the treatment of bipolar disorder and PTSD in underserved communities.

OBJECTIVES: To understand care managers' experiences treating primary care patients with bipolar disorder and PTSD in a telepsychiatry collaborative care (TCC) program, as part of a large pragmatic trial. METHODS: We conducted individual qualitative interviews with 12 care managers to evaluate barriers and facilitators to implementation of a previously completed TCC intervention for patients with bipolar disorder and/or PTSD. We used directed and conventional content analysis and Consolidated Framework for Implementation Research (CFIR) constructs to organize care manager experiences. RESULTS: Participants described clinical and medication management support from telepsychiatrists and satisfaction with the TCC model as facilitators of success for patients with bipolar disorder and PTSD in underserved communities. Participants also described onboarding of primary care providers and clinic leadership as keys to successful team-care and credited satisfaction with providing Behavioral Activation as essential to sustained delivery of the psychotherapy component of TCC. CONCLUSIONS: Participants described high satisfaction with TCC for patients with bipolar disorder and PTSD. Challenges included lack of clinic leadership and PCP engagement. Early and ongoing promotion of integrated care and prioritizing telepsychiatry consultation with patients, behavioral health professionals and PCPs, may improve patient care, provide ongoing training and improve workforce satisfaction.

Psychometric properties of the Telepsych User Experience Scale (TUES).

PURPOSE: To develop and psychometrically evaluate a brief measure of the telemental health experience among people receiving psychiatric and psychological care-the Telepsych User Experience Scale (TUES). METHODS: The TUES was administered at 6 months to 364 study participants who screened positive for posttraumatic stress disorder and/or bipolar disorder and used telepsych services. The factor structure of the TUES was examined using exploratory and confirmatory factor analyses. Psychometric testing of the final scale examined (1) internal reliability, (2) criterion validity, (3) convergent validity, and (4) test-retest reliability using omega coefficients, negative binomial regression, and correlations, respectively. A week after the 12-month follow-up survey was completed, a retest was administered to 29 patients to assess reliability. FINDINGS: Factor analytic methods indicated a single latent factor (user experience) and correlated error variance (method effect of item wording) for 2 items. To enhance clinical utility, we removed the 2 negatively worded items, resulting in a 5-item scale. Confirmatory analyses indicated excellent fit of the final model, which retained the best performing items from each hypothesized construct. The TUES demonstrated evidence of internal consistency (omega = 0.88-0.90), convergent validity, (r = 0.58), and criterion validity through telepsych engagement (incidence rate ratio = 1.19, P < .001), though test-retest reliability was unacceptable (r = 0.41). CONCLUSION: The TUES is a pragmatic instrument with evidence of validity and internal reliability. Replication is necessary, but this initial psychometric evaluation suggests the TUES is a promising, brief yet comprehensive measure of telemental health user experience with clinical populations in rural settings.

Outcomes of a health informatics technology-supported behavioral activation training for care managers in a collaborative care program.

INTRODUCTION: Health informatics-supported strategies for training and ongoing support may aid the delivery of evidence-based psychotherapies. The objective of this study was to describe the development, implementation, and practice outcomes of a scalable health informatics-supported training program for behavioral activation for patients who screened positive for posttraumatic stress disorder and/or bipolar disorder. METHOD: We trained 34 care managers in 12 rural health centers. They used a registry checklist to document the delivery of 10 behavioral activation skills for 4,632 sessions with 455 patients. Care managers received performance feedback based on registry data. Using encounter-level data reported by care managers, we described the implementation outcomes of patient reach and care manager skill adoption. We used cross-classified multilevel modeling to explore variation in skill delivery accounting for patient characteristics, provider characteristics, and change over time. RESULTS: Care managers engaged 88% of patients in behavioral activation and completed a minimum course for 57%. The average patient received 5.9 skills during treatment, with substantial variation driven more by providers (63%) than patients (29%). Care managers significantly increased the range of skills offered to patients over time. DISCUSSION: The registry-based checklist was a feasible training and support tool for community-based providers to deliver behavioral activation. Providers received data-driven performance feedback and demonstrated skill improvement over time, promoting sustainment. Future research will examine patient-level outcomes. Results underscore the potential public health impact of a simple registry-based skills checklist coupled with a scalable remote training program for evidence-based psychotherapy. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Psychometric Properties of the Assessment of Perceived Access to Care (APAC) Instrument.

Valid measures of perceived access are needed to measure whether health care systems are providing adequate access. This research reports on the psychometric properties of the Assessment of Perceived Access to Care (APAC), which was administered to 1004 Community Health Center patients screening positive for psychiatric disorders. Known-group validity was good, with 6 of the 8 hypothesized associations between social determinants of access and perceived access being significant (P < .01). Better access was significantly (P < .01) correlated with more outpatient mental health visits, indicating good convergent validity. The test-retest Pearson correlation coefficient (0.64) was statistically significant (P < .01). The APAC has acceptable psychometric properties.

Care manager perspectives on integrating an mHealth app system into clinical workflows: A mixed methods study.

OBJECTIVE: mHealth can be a valuable means of monitoring symptoms and supporting care for rural patients, but barriers to implementation remain. This study aimed to examine care manager perspectives on the adoption, use and impact of an mHealth system deployed within a pragmatic Collaborative Care trial for rural patients with PTSD and/or Bipolar Disorder. METHOD: Sixteen care managers at 12 Federally Qualified Health Centers in 3 states participated in semi-structured interviews. Interviews were transcribed, coded, and thematically analyzed using the Unified Theory of Adoption and Use of Technology as a conceptual framework. App metadata was used to assess the frequency of a care manager reported phenomenon, clinically disengaged app use. RESULTS: 4 themes were identified: infrastructural limitations; redundant and incompatible clinical and mHealth workflows; cross platform and web access; and patient engagement and clinically disengaged app use. Most users had a period of consistently submitting symptom measures via the app while disengaged from care for >4 weeks.

Applying the Principles for Digital Development: Case Study of a Smartphone App to Support Collaborative Care for Rural Patients With Posttraumatic Stress Disorder or Bipolar Disorder.

BACKGROUND: Despite a proliferation of patient-facing mobile apps for mental disorders, there is little literature guiding efforts to incorporate mobile tools into clinical care delivery and integrate patient-generated data into care processes for patients with complex psychiatric disorders. OBJECTIVE: The aim of this study was to seek to gain an understanding of how to incorporate a patient-provider mobile health (mHealth) platform to support the delivery of integrated primary care-based mental health services (Collaborative Care) to rural patients with posttraumatic stress disorder and/or bipolar disorder. METHODS: Using the Principles for Digital Development as a framework, we describe our experience designing, developing, and deploying a mobile system to support Collaborative Care. The system consists of a patient-facing smartphone app that integrates with a Web-based clinical patient registry used by behavioral health care managers and consulting psychiatrists. Throughout development, we engaged representatives from the system's two user types: (1) providers, who use the Web-based registry and (2) patients, who directly use the mobile app. We extracted mobile metadata to describe the early adoption and use of the system by care managers and patients and report preliminary results from an in-app patient feedback survey that includes a System Usability Scale (SUS). RESULTS: Each of the nine Principles for Digital Development is illustrated with examples. The first 10 patients to use the smartphone app have completed symptom measures on average every 14 days over an average period of 20 weeks. The mean SUS score at week 8 among four patients who completed this measure was 91.9 (range 72.5-100). We present lessons learned about the technical and training requirements for integration into practice that can inform future efforts to incorporate health technologies to improve care for patients with psychiatric conditions. CONCLUSIONS: Adhering to the Principles for Digital Development, we created and deployed an mHealth system to support Collaborative Care for patients with complex psychiatric conditions in rural health centers. Preliminary data among the initial users support high system usability and show promise for sustained use. On the basis of our experience, we propose five additional principles to extend this framework and inform future efforts to incorporate health technologies to improve care for patients with psychiatric conditions: design for public health impact, add value for all users, test the product and the process, acknowledge disruption, and anticipate variability.

Lessons from the Deployment of the SPIRIT App to Support Collaborative Care for Rural Patients with Complex Psychiatric Conditions.

We report the design and deployment of a mobile health system for patients receiving primary care-based mental health services (Collaborative Care) for post-traumatic stress disorder and/or bipolar disorder in rural health centers. Here we describe the clinical model, our participatory approach to designing and deploying the mobile system, and describe the final system. We focus on the integration of the system into providers' clinical workflow and patient registry system. We present lessons learned about the technical and training requirements for integration into practice that can inform future efforts to incorporate health technologies to improve care for patients with psychiatric conditions.