About this trial
Implementing Cognitive Behavioral Therapy for Insomnia with Older Veterans (SWELL): Function QUERI 3.0 aims to compare implementation approaches while also gathering information on clinical effectiveness of the EBP in its new context. The overall goal is to implement, evaluate, and sustain SWELL in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Facility is part of the U.S. Department of Veterans Affairs (VA) health system.
Primary care clinic providing care to older Veterans
Clinic is located 25 miles from the nearest other VA clinic participating in the program
Identified site champion (e.g., clinician or staff member) who is willing to assume required program responsibilities for implementation.
Disqualifiers
No members of the SWELL team working in the clinic
younger than 60
do not meet criteria for enrollment
Trial design
Parallel
Treatments tested in this trial
Implementation Strategy: Foundational Arm
Other interventionThe Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports, and education and training.
Implementation Strategy: REACH arm
Other interventionThe REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.
Treatment groups
Trial outcomes
Primary outcomes
Reach
Reach will be defined as the number of older Veterans who initiate SWELL at a site. Initiation is defined as completing the first SWELL treatment session.
Secondary outcomes
Reach
Reach will be defined as the number of older Veterans who initiate SWELL at a site. Initiation is defined as completing the first SWELL treatment session.
Patient Engagement
Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site.
Patient Engagement
Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site.
Time to Adoption
Time to Adoption will be defined as the time from baseline to the time at which a site crosses the adoption threshold (Adoption is defined at 5 or more enrolled Veterans who have initiated SWELL). This will be computed for each site meeting the adoption criteria.
Sponsors and contacts
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