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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Other: Expert Recommendations for Implementing Change (ERIC) bundle of strategies

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 BBTI from a PCMHI clinician participating in the study. Our goal is to collect data on at least 332 Veterans during the implementation phase (n=83 Veterans over 12 months for each site).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-Implementation (0-, 6-, 12-, or 18-months); Following training in BBTI, all sites (except site 1) will enter the pre-implementation phase for 6-, 12-, or 18-months. During this phase, sites will not receive any access to or support for the implementation strategies. They will deliver and implement BBTI as they see fit. Qualitative interviews will be conducted at the end of this phase.
Implementation (12-months); After the pre-implementation phase, all sites will enter a 12-month implementation phase (except site 1, which will begin implementation following BBTI training). During this phase, sites will receive access to and support for the bundle of implementation strategies, both from the hub site and their local champion/internal facilitator. During this phase, PCMHI clinicians trained in BBTI will receive feedback as necessary regarding their BBTI skills from their local champion/internal facilitator. During this phase, PCMHI clinicians will also complete quarterly surveys regarding implementation strategies they are using and which strategies are/are not helpful. Qualitative interviews will be conducted at the end of this phase.	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
Post-Implementation (6-months); Following the 12-month implementation phase, each site will have access to and support for the implementation strategies removed and similar to the pre-implementation phase, will deliver and implement BBTI as they see fit. During this 6-month phase, PCMHI clinicians will also complete quarterly surveys regarding implementation strategies they are using and which strategies are/are not helpful. Qualitative interviews will be conducted at the end of this phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach-2	The number of Veterans who initiate BBTI, indicated by a BBTI templated note in the medical records.	implementation phase (duration: 12 months)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Minneapolis Veterans Affairs Medical Center; VA Pittsburgh Healthcare System; Corporal Michael J. Crescenz VA Medical Center; Durham VA Health Care System; VA Maryland Health Care System
• Investigators: Principal Investigator: Adam D. Bramoweth, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA; Principal Investigator: Christi S. Ulmer, PhD, Durham VA Medical Center, Durham, NC

Publications and helpful links

Helpful Links

• BBTI introduction (for patients and providers)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 30, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Veterans; stepped-wedge design; hybrid implementation-effectiveness trial; primary care mental health integration
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IIR 19-340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No