Clinical trial NCT04350866: Enhancing Access to Insomnia Care in VA PCMHI Clinics
Official title: Enhancing Access to Insomnia Care (EASI Care): Implementing Brief Behavioral Treatment for Insomnia in Primary Care Mental Health Integration Clinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Insomnia
Keywords: Veterans
stepped-wedge design
hybrid implementation-effectiveness trial
primary care mental health integration
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Pittsburgh Healthcare System
name: VA Maryland Health Care System
name: Durham VA Health Care System
name: Minneapolis Veterans Affairs Medical Center
name: Corporal Michael J. Crescenz VA Medical Center
First posted: 2020-04-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Four (4) VAMCs will be randomized to the order in which they will receive the intervention (stepped wedge). At each VAMC, retrospective data will be collected on Veterans who receive care in Primary Care and Primary Care Mental Health Integration (PCMHI). Our goal is to identify Veterans who engage in Brief Behavioral Treatment for Insomnia (BBTI) in a PCMHI clinic. Our goal is to collect data on at least 332 Veterans during the implementation phase (n=83 Veterans/site).

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.

Eligibility criteria: Inclusion Criteria:

All Veterans in Primary Care and Primary Care Mental Health Integration (PCMHI) at the participating sites.

Exclusion Criteria:

Not meeting above criteria

Primary outcomes:
measure: Reach-2
timeFrame: implementation phase (duration: 12 months)
measure: Reach-1
timeFrame: implementation phase (duration: 12 months)
measure: Reach-3
timeFrame: implementation phase (duration: 12 months)
measure: Implementation Strategies (surveys)
timeFrame: implementation phase (duration: 12 months)
measure: Implementation Strategies (qualitative interviews)
timeFrame: implementation phase (duration: 12 months)
Secondary outcomes:
measure: Effectiveness
timeFrame: implementation phase (duration: 12 months)
measure: Adoption-1
timeFrame: implementation phase (duration: 12 months)
measure: Adoption-2
timeFrame: implementation phase (duration: 12 months)
measure: Implementation/treatment fidelity-1
timeFrame: implementation phase (duration: 12 months)
measure: Implementation/treatment fidelity-2
timeFrame: implementation phase (duration: 12 months)
measure: Maintenance
timeFrame: post-implementation phase (duration: 6 months)
Other outcomes:
measure: Reach-1 (change)
timeFrame: change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
measure: Reach-2 (change)
timeFrame: change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
measure: Reach-3 (change)
timeFrame: change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
measure: Effectiveness (change)
timeFrame: change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
measure: Adoption-1 (change)
timeFrame: change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
measure: Adoption-2 (change)
timeFrame: change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
measure: Implementation/treatment fidelity-1 (change)
timeFrame: change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
measure: Implementation/treatment fidelity-2 (change)
timeFrame: change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Adam D. Bramoweth, PhD
role: PRINCIPAL_INVESTIGATOR
References: