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Partnering with Health Systems Leadership to Develop a Randomized, Controlled Implementation Trial

Bauer MS, Miller C, Kim B, Lew R, Weaver K, Coldwell CM, Henderson KL, Holmes SK, Seibert MN, Stolzmann K, Elwy AR, Kirchner JE. Partnering with Health Systems Leadership to Develop a Randomized, Controlled Implementation Trial. Paper presented at: AcademyHealth Annual Research Meeting; 2016 Jun 26; Boston, MA.


Research Objective: Outcome for mental health conditions is suboptimal and care is fragmented. Evidence from controlled trials indicates that collaborative chronic care models (CCMs) can improve outcomes in a broad array of mental health conditions. US Department of Veterans Affairs (VA) leadership launched a nationwide initiative to establish interdisciplinary teams in general mental health clinics in all medical centers. The CCM provides an evidence-based structure for such teams, but requires support for its adoption. This presentation describes the development of a controlled trial protocol, designed in partnership with VA health system leaders, to test the impact of a facilitation-based implementation strategy in VA general mental health clinics which are instituting interdisciplinary teams Study Design: Both health system and research partners identified the need to provide rigorous scientific data to address two implementation questions: (1) Can evidence-based CCMs be successfully implemented using existing staff in general mental health clinics supported by internal and external implementation facilitation? (2) What is the impact of CCM implementation efforts on patient health status and perceptions of care? These aims were addressed by designing an implementation-intervention Hybrid Type III randomized controlled trial using a stepped wedge design, developed collaboratively with health system leaders. The project was competitively funded by the VA Quality Enhancement Research Initiative (QUERI). Population Studied: Veterans and providers in general mental health clinics in the VA healthcare system who are involved with (providers) or impacted by (Veterans) interdisciplinary team formation. Principal Findings: Health system leaders and researchers partnered in an iterative process to design a protocol that balances operational priorities, scientific rigor, and feasibility. The target sample size of nine sites has already been enrolled in the trial. Using balanced randomization, sites have been assigned to receive implementation support in one of three waves beginning at four-month intervals, with support lasting 12 months. Implementation support consists of blended external-internal facilitation. Formative evaluation focuses on the recipients, context, innovation, and facilitation process, guided by the i-PARIHS framework. Summative evaluation combines quantitative and qualitative outcomes. Quantitative CCM fidelity measures (at the site level) plus health outcome measures (at the Veteran level; n = 765) are collected in a repeated measures design, and analyzed with general linear modeling. Qualitative data from provider interviews at baseline and one year elaborate CCM fidelity data and provide insights into barriers and facilitators of implementation. Conclusions: Major aspects of joint decision-making included several aspects of identification of study sites, patient population of interest, intervention design, and outcome assessment and analysis. Decisions balanced scientific rigor, health system priority, and practicality. Implications for Policy or Practice: Conducting a jointly designed, highly controlled protocol in the context of health system operational priorities increases the likelihood that time-sensitive questions of operational importance will be answered rigorously, and that the outcomes will result in sustainable change in the healthcare system.

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