This multi-site project (four VA Medical Centers) will test two approaches to improving the delivery of a behavioral insomnia treatment in the Primary Care setting to Veterans. The first approach is training providers to deliver Brief Behavioral Treatment for Insomnia (BBTI). The second approach is to give providers trained in BBTI additional support and resources to enhance their ability to deliver BBTI, what we call implementation. This project will measure delivery of BBTI over four phases: (1) pre-training; (2) pre-implementation; (3) implementation; and (4) post-implementation. The main questions to answer: Does delivery of BBTI improve with training alone and does it improve further with the addition of implementation support? Does delivery of BBTI remain at similar levels after implementation support is removed? Do Veterans who engage in BBTI reduce their insomnia symptoms?
Chronic insomnia, one of the most common health problems among Veterans, significantly impacts health, function, and quality of life. Cognitive Behavioral Therapy for Insomnia (CBTI) is the first line treatment; however, despite efforts to train VA clinicians to deliver CBTI, there are still significant barriers to providing adequate access to insomnia care. Up to 44% of Veterans seen in Primary Care report insomnia, making it an optimal clinical setting for improving access to insomnia care. Furthermore, Brief Behavioral Treatment for Insomnia (BBTI), adapted from CBTI as a briefer, more flexible treatment, is easily delivered by Primary Care Mental Health Integration (PCMHI) clinicians and can greatly improve access to care for Veterans with insomnia. Yet, simply training PCMHI clinicians to deliver BBTI is not enough. Implementation strategies are needed for successful uptake, adoption, and sustainable delivery of care. This stepped-wedge, hybrid III implementation-effectiveness trial involves four VA Medical Centers: Baltimore, Durham, Minneapolis, and Philadelphia. The hybrid design allows for testing of implementation and treatment effectiveness. The stepped-wedge design allows for fewer sites to achieve adequate power as all sites are exposed to BBTI training (BBTI) and BBTI + Implementation Strategies (BBTI+IS). The target sample are PCMHI clinicians and the impact of a bundle of strategies on the success of sustainable delivery of BBTI in Primary Care. Retrospective data collected from VA electronic health records will be used to obtain variables of interest related to Veteran treatment outcomes and data related to PCMHI clinician delivery of BBTI. We will compare the impact PCMHI clinicians trained to deliver BBTI vs. the impact of BBTI training plus 12-months of access to an implementation strategy bundle (BBTI+IS). BBTI+IS vs. BBTI training alone is expected to result in more Veterans with access to insomnia care in PCMHI. We will also compare delivery of BBTI across all four phases, from pre-training to post-implementation. We will also measure Veteran-level outcomes for insomnia severity and PCMHI clinician fidelity on delivery of BBTI. Outcome measures have been updated to reflect study protocol and analyses more accurately. Some of the prespecified Primary and Secondary Outcome Measures have been combined with one removed due to no data collection. The results reported reflect data that has been collected and analyzed.
Study Type
OBSERVATIONAL
Enrollment
277,920
* Develop a formal implementation blueprint/checklist * Conduct educational meetings * Develop and distribute educational materials * Organize implementation meetings * Facilitation * Increase demand with marketing to patients * Promote adaptability
An adapted version of Cognitive Behavioral Therapy for Insomnia (CBT-I) that is focused on behavioral components stimulus control and sleep restriction (the four rules): 1. Reduce time awake in bed. 2. Don't go to bed unless ready for sleep. 3. Don't stay in bed unless asleep. 4. Get up and out of bed at the same time everyday. Delivered weekly to bi-weekly over 4-6 sessions, with each session typically 30 minutes or less, consistent with other interventions delivered in PCMHI.
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
Veteran Participants Who Engaged in BBTI
The number of Veterans in PCMHI who engaged in BBTI as indicated in the medical records
Time frame: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)
Veterans in PCMHI Identified With Insomnia
The number of Veterans with encounters in PCMHI related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication.
Time frame: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)
Veterans in Primary Care Identified With Insomnia
The number of Veterans with encounters in Primary Care related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication.
Time frame: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)
BBTI Effectiveness (Intent to Treat)
Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session.
Time frame: 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 1-13 weeks.
BBTI Effectiveness (Per Protocol)
Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session.
Time frame: 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 2-13 weeks.
PCMHI Providers (Staff) Who Delivered (Adopted) BBTI
PCMHI providers (Staff) who delivered (adopted) BBTI (adopted) to at least 1 Veteran - measured in each phase (pre-implementation, implementation, post-implementation).
Time frame: 42 months; during the pre-implementation, implementation, and post-implementation phases.
Implementation/Treatment Fidelity (Staff)
Mean Competency Rating Score (0-36, higher scores indicate higher competency, \>17 indicates competency) PCMHI providers (Staff) were measured via mock treatment sessions by site PIs/subject matter experts using the BBTI-Competency Rating Scale (BBTI-CRS) during the pre-implementation, implementation, and post-implementation phases. Overall refers to aggregate ratings (averaged) from all phases in which BBTI-CRS was delivered - providers could complete up to 5 ratings (up to 3 for pre-implementation, 1 for implementation, and 1 for post-implementation).
Time frame: 42 months; the BBTI-CRS was administered during pre-implementation (up to 3 times), implementation (1 time, at the end), and post-implementation (1 time, at the end)
Barriers & Facilitators (CFIR Determinants)
Strength and valence rating for identified barriers and facilitators (determinants) from the Consolidated Framework for Implementation Research (CFIR) qualitative interviews. CFIR determinants, identified through qualitative interviews with PCMHI providers, were rated on strength (0, 1, 2; higher numbers indicate stronger influence) and valence (- indicates negative/harmful influence; + indicates positive/helpful influence) to determine how helpful or harmful an identified CFIR determinant is for implementing BBTI in PCMHI. Ratings were aggregated across sites and phases (consensus by 3 raters with adjudication by PI as needed).
Time frame: 42 months; qualitative interviews took place at the end of the pre-implementation, implementation, and post-implementation phases.
Implementation Strategy Utilization Survey
Indication of implementation strategy utilization (yes/no) and rating of its importance (1 = not at all important, 5 = very important) and feasibility ((1 = not at all feasible, 5 = very feasible).
Time frame: 12 months: 4 times - every 3-months during the Implementation phase.
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