NCT04350866

Enhancing Access to Insomnia (EASI) Care in VA PCMHI Clinics

Enhancing Access to Insomnia (EASI) Care: Implementing Brief Behavioral Treatment for Insomnia in Primary Care Mental Health Integration Clinics

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 277,920 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Expert Recommendations for Implementing Change bundle of strategies	* 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
BEHAVIORAL	Brief Behavioral Treatment for Insomnia	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.

Timeline

• Start date: 2021-02-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2020-04-17
• Last updated: 2026-01-12
• Results posted: 2026-01-12

Locations

1 site across 1 country: United States