Enhancing Access to Insomnia Care in VA PCMHI Clinics

Chronic Insomnia Clinical Trial

— EASI Care  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04350866
• Other study ID #: IIR 19-340
• Status: Active, not recruiting
• Start date: September 1, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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. Aim 1 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. Aim 2 will identify specific strategies that promote successful implementation of BBTI in PCMHI through the use of qualitative interviews and surveys with clinical stakeholders at each study site.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: July 31, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Any PCMHI clinician, at the participating sites, who completes BBTI training and volunteers to participate in this study. All Veterans in Primary Care, at the participating sites, who receive BBTI from a PCMHI clinician participant. Exclusion Criteria: Not meeting above criteria

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Expert Recommendations for Implementing Change (ERIC) bundle of strategies
Develop a formal implementation blueprint/checklist Conduct educational meetings; Develop & distribute educational materials Organize implementation meetings Audit and provide feedback Facilitation Increase demand with marketing to patients Promote adaptability Involve patients and family; Use their feedback; Prepare them to be active participants

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
VA Office of Research and Development	Corporal Michael J. Crescenz VA Medical Center, Durham VA Health Care System, Minneapolis Veterans Affairs Medical Center, VA Maryland Health Care System, VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reach-1 (change)	The number of new PCMHI visits related to insomnia, indicated by a PCMHI progress note in the medical records with an insomnia diagnostic code.	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)
Other	Reach-2 (change)	The number of Veterans who initiate BBTI, indicated by a BBTI templated note in the medical records.	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)
Other	Reach-3 (change)	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).	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)
Other	Effectiveness (change)	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.	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)
Other	Adoption-1 (change)	The number of PCMHI clinicians who undergo training in BBTI relative to the number of PCMHI clinicians eligible for training.	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)
Other	Adoption-2 (change)	The number of PCMHI clinicians who treat at least one Veteran with BBTI relative to the number of PCMHI clinicians trained.	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)
Other	Implementation/treatment fidelity-1 (change)	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).	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)
Other	Implementation/treatment fidelity-2 (change)	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.	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)
Primary	Reach-2	The number of Veterans who initiate BBTI, indicated by a BBTI templated note in the medical records.	implementation phase (duration: 12 months)
Primary	Reach-1	The number of new PCMHI visits related to insomnia, indicated by a PCMHI progress note in the medical records with an insomnia diagnostic code.	implementation phase (duration: 12 months)
Primary	Reach-3	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).	implementation phase (duration: 12 months)
Primary	Implementation Strategies (surveys)	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]).	implementation phase (duration: 12 months)
Primary	Implementation Strategies (qualitative interviews)	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 phase (duration: 12 months)
Secondary	Effectiveness	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.	implementation phase (duration: 12 months)
Secondary	Adoption-1	The number of PCMHI clinicians who undergo training in BBTI relative to the number of PCMHI clinicians eligible for training.	implementation phase (duration: 12 months)
Secondary	Adoption-2	The number of PCMHI clinicians who treat at least one Veteran with BBTI relative to the number of PCMHI clinicians trained.	implementation phase (duration: 12 months)
Secondary	Implementation/treatment fidelity-1	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 phase (duration: 12 months)
Secondary	Implementation/treatment fidelity-2	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.	implementation phase (duration: 12 months)
Secondary	Maintenance	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).	post-implementation phase (duration: 6 months)

External Links

•   BBTI introduction (for patients and providers)