Enhancing Access to Insomnia Care in VA PCMHI Clinics
- Conditions
- Chronic Insomnia
- Interventions
- Other: Expert Recommendations for Implementing Change (ERIC) bundle of strategies
- Registration Number
- NCT04350866
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
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?
- Detailed Description
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 (e.g., changed/removed) to more accurately reflect study protocol and analyses.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
All Veterans in Primary Care and Primary Care Mental Health Integration (PCMHI) at the participating sites.
Not meeting above criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Implementation (12-months) Expert Recommendations for Implementing Change (ERIC) bundle of strategies After the pre-implementation phase, all sites will enter a 12-month implementation phase (except site 1, which will begin implementation following BBTI training). During this phase, sites will receive access to and support for the bundle of implementation strategies, both from the hub site and their local champion/internal facilitator. During this phase, PCMHI clinicians trained in BBTI will receive feedback as necessary regarding their BBTI skills from their local champion/internal facilitator. During this phase, PCMHI clinicians will also complete quarterly surveys regarding implementation strategies they are using and which strategies are/are not helpful. Qualitative interviews will be conducted at the end of this phase.
- Primary Outcome Measures
Name Time Method Reach-1 implementation phase (duration: 12 months) The number of new PCMHI visits related to insomnia, indicated by a PCMHI progress note in the medical records with an insomnia diagnostic code.
Reach-3 implementation phase (duration: 12 months) The proportion of BBTI treatment starts (numerator) relative to the number of Veterans who are potentially eligible based on a PCMHI visit related to insomnia and/or Veterans seen in Primary Care since the start of a study phase (pre, implementation, post) with an insomnia diagnosis and/or a new or refilled sedative-hypnotic (denominator).
Reach-2 implementation phase (duration: 12 months) The number of Veterans who initiate BBTI, indicated by a BBTI templated note in the medical records.
Implementation Strategies (qualitative interviews) implementation phase (duration: 12 months) Consolidated Framework for Implementation Research (CFIR)-guided phone-based qualitative interviews will be conducted with site PIs and 2-3 PCMHI clinicians per site. Interviews will help to provide context for the implementation process and to better differentiate sites on strategies that worked (or not).
Implementation Strategies (surveys) implementation phase (duration: 12 months) Site PIs and PCMHI clinicians trained to deliver BBTI will complete a quarterly survey about strategies from the bundle being utilized (e.g., "Did providers use X strategy to promote delivery of BBTI?"). These surveys will assess the uptake of strategies, longitudinally, across study phases. Response choices will be yes, no, or not able to accurately assess.
Site PIs and PCMHI clinicians will also be asked to rate each strategy on its importance (i.e., how vital a strategy is to improving implementation \[high/low\]) and its feasibility (i.e., how possible a strategy is to implement \[high/low\]).
- Secondary Outcome Measures
Name Time Method Implementation/treatment fidelity-1 implementation phase (duration: 12 months) Implementation will be measured by rating mock treatment sessions with trained PCMHI clinicians. Ratings will be completed by site PIs using the BBTI-Competency Rating Scale (BBTI-CRS). During the pre- and post-implementation phases, PCMHI clinicians will be rated quarterly but will not receive feedback. However, during the implementation phase, clinicians will receive feedback and any necessary re-training, from their site PI, if they score below the competency cutoff (\<50% or \<2 per item; 2=satisfactory).
Implementation/treatment fidelity-2 implementation phase (duration: 12 months) As a secondary check of Implementation, PCMHI clinicians will have a random selection of BBTI progress notes reviewed, by their site PI, to assess BBTI elements being utilized (10% or at least 1 per month of eligible notes). Like the rated mock sessions, only during the implementation phase will PCMHI clinicians receive feedback regarding their progress notes.
Adoption-2 implementation phase (duration: 12 months) The number of PCMHI clinicians who treat at least one Veteran with BBTI relative to the number of PCMHI clinicians trained.
Maintenance post-implementation phase (duration: 6 months) Maintenance will measure the sustainability of Reach, Effectiveness, Adoption, and Implementation during the 6-month post-implementation phase as well as during the long-term sustainability period (\>6-months). The outcomes from the sustainability periods will then be compared to the outcomes during the pre- and implementation phases. The same operational definitions as described above will be used for Reach, Effectiveness, and Implementation. For Adoption, comparisons will be based on the rate a clinician delivers BBTI over time within each study phase. For example, the number months of successful Adoption relative to the number of months \[n=6\] in the post-implementation phase).
Effectiveness implementation phase (duration: 12 months) Change on the Insomnia Severity Index (ISI) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the last BBTI session. For Effectiveness to be calculated, ISI scores from each BBTI session (e.g., entered in a BBTI templated note) by PCMHI clinicians will be extracted through the automated Corporate Data Warehouse (CDW) queries to calculate outcomes for each Veteran. Rates of treatment response and remission will also be calculated. Response is a reduction of 8 points on the ISI from pre- to post-treatment. Remission is achieving a post-treatment response and an ISI \<8.
Adoption-1 implementation phase (duration: 12 months) The number of PCMHI clinicians who undergo training in BBTI relative to the number of PCMHI clinicians eligible for training.
Trial Locations
- Locations (1)
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
🇺🇸Pittsburgh, Pennsylvania, United States