Chronic Insomnia
Conditions
Keywords
Sleep Disorders, Implementation Science, Functional Status, Quality of Life, Cognitive Behavioral Therapy, Veterans
Brief summary
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.
Detailed description
Background/Purpose. As many as two-thirds of older Veterans meet criteria for chronic insomnia disorder, defined as three or more months of subjective complaints related to difficulty falling or staying asleep or waking too early and/or poor nighttime sleep associated with daytime impairment. Left untreated, chronic insomnia can negatively impact quality-of-life and contribute to accelerated cognitive and functional decline. CBTI is the recommended first-line treatment for chronic insomnia; however, despite several VA initiatives focused on the scale-up of CBTI, fewer than 5% of older Veterans with chronic insomnia have received this evidence-based therapy. To address this challenge, the team adapted CBTI for older Veterans. In a series of trials to evaluate the adapted program, Sleep Well, Live Well (SWELL), the team found significant improvements in nighttime sleep and daytime functioning that lasted up to one year after the end of treatment. Notably, using a comprehensive training and supervision model, these studies demonstrated that non-psychologists can effectively deliver CBTI. The investigators' evidence-based and age-friendly CBTI program, SWELL, involves five sessions delivered weekly with a trained provider. Content focuses on establishing a regular sleep-wake schedule, moving non-sleep activities out of the bedroom, establishing healthy sleep habits, relaxation near bedtime, and addressing unhealthy expectations about sleep. Objectives. The investigators plan to develop scalable approaches to implement and sustain SWELL as well as evaluate reach when delivered through the Foundational arm compared to an enhanced implementation strategy, the REACH (Reach Equity And Collective Health) arm. Key questions. How can the REACH arm be optimized? What are shareholder perspectives on the refinement needs for SWELL foundational arm activities, as well as strategies to enhance equitable reach via the REACH arm? To address the question "Are there differences in implementation outcomes (reach \[primary\], patient engagement, time to adoption) between arms?", the investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 12 and 18 months (primary). Average time to adoption will be compared between study arms. Methodology. To evaluate implementation, the investigators will randomize sites (n=20) 1:1 to either the foundational arm or REACH arm. The investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 18 months.
Interventions
The Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports, and education and training.
The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA sites) are randomly assigned to one of two interventions: Foundational support only (active comparator) vs. Foundational support plus Reach+Equity Implementation Bundle (experimental).
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Site Inclusion Criteria: * 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. Patient Inclusion Criteria: * meet diagnostic criteria for chronic insomnia disorder (with or without documented diagnosis) * absence of a CBTI contraindication oi.e., comorbid condition that makes CBTI unsafe), including uncontrolled seizure disorders, bipolar disorder I, and/or too medically or psychiatrically unstable to engage in a multi-session treatment opatients can be referred to SWELL by a clinician or self-referred
Exclusion criteria
Site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach | 18 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Reach | 12 months | 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 | 12 months | Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site. |
| Time to Adoption | 18 months | 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. |
Countries
United States
Contacts
CONTACTCaitlin B Kappler, MSW
PRINCIPAL_INVESTIGATORJaime Hughes, PhD
Durham VA Medical Center, Durham, NC
PRINCIPAL_INVESTIGATORJennifer L Martin, PhD
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Outcome results
None listed