Chronic Insomnia
Conditions
Keywords
Veterans, stepped-wedge design, hybrid implementation-effectiveness trial, primary care mental health integration
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 to reflect study protocol and analyses more accurately. Some of the prespecified Primary and Secondary Outcome Measures have been combined with one removed due to no data collection. The results reported reflect data that has been collected and analyzed.
Interventions
BEHAVIORALExpert Recommendations for Implementing Change bundle of strategies
* Develop a formal implementation blueprint/checklist * Conduct educational meetings * Develop and distribute educational materials * Organize implementation meetings * Facilitation * Increase demand with marketing to patients * Promote adaptability
BEHAVIORALBrief Behavioral Treatment for Insomnia
An adapted version of Cognitive Behavioral Therapy for Insomnia (CBT-I) that is focused on behavioral components stimulus control and sleep restriction (the four rules): 1. Reduce time awake in bed. 2. Don't go to bed unless ready for sleep. 3. Don't stay in bed unless asleep. 4. Get up and out of bed at the same time everyday. Delivered weekly to bi-weekly over 4-6 sessions, with each session typically 30 minutes or less, consistent with other interventions delivered in PCMHI.
Sponsors
VA Pittsburgh Healthcare System
VA Maryland Health Care System
Durham VA Health Care System
Minneapolis Veterans Affairs Medical Center
Corporal Michael J. Crescenz VA Medical Center
VA Office of Research and Development
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All Veterans in Primary Care and Primary Care Mental Health Integration (PCMHI) at the participating sites.
Exclusion criteria
Not meeting above criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Veteran Participants Who Engaged in BBTI | 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation) | The number of Veterans in PCMHI who engaged in BBTI as indicated in the medical records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Veterans in Primary Care Identified With Insomnia | 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation) | The number of Veterans with encounters in Primary Care related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication. |
| BBTI Effectiveness (Intent to Treat) | 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 1-13 weeks. | Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session. |
| BBTI Effectiveness (Per Protocol) | 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 2-13 weeks. | Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session. |
| Veterans in PCMHI Identified With Insomnia | 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation) | The number of Veterans with encounters in PCMHI related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication. |
| Implementation/Treatment Fidelity (Staff) | 42 months; the BBTI-CRS was administered during pre-implementation (up to 3 times), implementation (1 time, at the end), and post-implementation (1 time, at the end) | Mean Competency Rating Score (0-36, higher scores indicate higher competency, \>17 indicates competency) PCMHI providers (Staff) were measured via mock treatment sessions by site PIs/subject matter experts using the BBTI-Competency Rating Scale (BBTI-CRS) during the pre-implementation, implementation, and post-implementation phases. Overall refers to aggregate ratings (averaged) from all phases in which BBTI-CRS was delivered - providers could complete up to 5 ratings (up to 3 for pre-implementation, 1 for implementation, and 1 for post-implementation). |
| Barriers & Facilitators (CFIR Determinants) | 42 months; qualitative interviews took place at the end of the pre-implementation, implementation, and post-implementation phases. | Strength and valence rating for identified barriers and facilitators (determinants) from the Consolidated Framework for Implementation Research (CFIR) qualitative interviews. CFIR determinants, identified through qualitative interviews with PCMHI providers, were rated on strength (0, 1, 2; higher numbers indicate stronger influence) and valence (- indicates negative/harmful influence; + indicates positive/helpful influence) to determine how helpful or harmful an identified CFIR determinant is for implementing BBTI in PCMHI. Ratings were aggregated across sites and phases (consensus by 3 raters with adjudication by PI as needed). |
| Implementation Strategy Utilization Survey | 12 months: 4 times - every 3-months during the Implementation phase. | Indication of implementation strategy utilization (yes/no) and rating of its importance (1 = not at all important, 5 = very important) and feasibility ((1 = not at all feasible, 5 = very feasible). |
| PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | 42 months; during the pre-implementation, implementation, and post-implementation phases. | PCMHI providers (Staff) who delivered (adopted) BBTI (adopted) to at least 1 Veteran - measured in each phase (pre-implementation, implementation, post-implementation). |
Countries
United States
Participant flow
Recruitment details
Four (4) VA Medical Centers (VAMC) were enrolled in this project. Within each VAMC, we identified Veterans (Participants) who engaged in care within PCMHI clinics. Veterans' data was collected retrospectively starting from January 1, 2020 until July 31, 2024. PCMHI providers (Staff) at each site were also consented for feedback and intervention fidelity ratings. 277,920 unique Veteran Participants and Staff were enrolled across all phases; however, enrollment differs at each phase.
Pre-assignment details
Staff did not participate in the Pre-Training phase. Data collection for a site could have ranged from 36 to 54 months (including phases 1-4; excluding the 1-month BBTI training period January 1, 2021 - January 31, 2021).
Participants by arm
| Arm | Count |
|---|---|
| Minneapolis VAMC All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Implementation (Month 1 - Month 12), then Post-Implementation (Month 13-24). Note, this site was randomized to skip Pre-Implementation (phase 2). | 75,147 |
| Philadelphia VAMC All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-6), Implementation (Month 7-18), then Post-Implementation (Month 19-30). | 37,577 |
| Durham VAMC All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-12), Implementation (Month 13-24), then Post-Implementation (Month 25-36). | 49,853 |
| Baltimore VAMC All sites underwent a 12-month pre-training period (phase 1) before undergoing training (month 0) for BBTI. Then sites were randomized to 0, 6, 12, or 18 months of the Pre-Implementation (phase 2), followed by 12 months of Implementation (phase 3, ERIC strategies were accessible and supported during this phase), and 12 months of Post-Implementation monitoring (phase 4).
\*This site was assigned to: Pre-Training, then Pre-Implementation (Month 1-18), Implementation (Month 19-30), then Post-Implementation (Month 31-42). | 33,549 |
| Staff Staff consented from all 4 sites in the Pre-Implementation, Implementation, and Post-Implementation phases. | 27 |
| Total | 196,153 |
Baseline characteristics
| Characteristic | Philadelphia VAMC | Minneapolis VAMC | Durham VAMC | Baltimore VAMC | Total | Staff |
|---|---|---|---|---|---|---|
| Age, Continuous PCMHI Participants | 55.35 years STANDARD_DEVIATION 16.05 | 57.18 years STANDARD_DEVIATION 17.57 | 52.75 years STANDARD_DEVIATION 15.23 | 54.19 years STANDARD_DEVIATION 14.35 | 55.25 years STANDARD_DEVIATION 16.26 | — |
| Age, Continuous Primary Care Participants | 64.08 years STANDARD_DEVIATION 15.7 | 65.46 years STANDARD_DEVIATION 15.87 | 60.57 years STANDARD_DEVIATION 15.16 | 61.69 years STANDARD_DEVIATION 14.9 | 63.30 years STANDARD_DEVIATION 15.63 | — |
| Age, Continuous Staff | — | — | — | — | 40.23 years STANDARD_DEVIATION 9.5 | 40.23 years STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized PCMHI Participants Non-White | 1985 Participants | 495 Participants | 1543 Participants | 1345 Participants | 5368 Participants | — |
| Race/Ethnicity, Customized PCMHI Participants Unknown | 263 Participants | 405 Participants | 156 Participants | 129 Participants | 953 Participants | — |
| Race/Ethnicity, Customized PCMHI Participants White | 1679 Participants | 4024 Participants | 1276 Participants | 784 Participants | 7763 Participants | — |
| Race/Ethnicity, Customized Primary Care Participants Non-White | 14620 Participants | 4195 Participants | 20842 Participants | 15203 Participants | 54860 Participants | — |
| Race/Ethnicity, Customized Primary Care Participants Unknown | 1574 Participants | 6515 Participants | 1756 Participants | 1632 Participants | 11477 Participants | — |
| Race/Ethnicity, Customized Primary Care Participants White | 17456 Participants | 59513 Participants | 24280 Participants | 14456 Participants | 115705 Participants | — |
| Race/Ethnicity, Customized Staff Non-White | — | — | — | — | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Staff Unknown | — | — | — | — | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Staff White | — | — | — | — | 25 Participants | 25 Participants |
| Sex: Female, Male PCMHI Participants Female | 646 Participants | 832 Participants | 557 Participants | 561 Participants | 2596 Participants | — |
| Sex: Female, Male PCMHI Participants Male | 3281 Participants | 4092 Participants | 2418 Participants | 1697 Participants | 11488 Participants | — |
| Sex: Female, Male Primary Care Participants Female | 3167 Participants | 4610 Participants | 5936 Participants | 4386 Participants | 18099 Participants | — |
| Sex: Female, Male Primary Care Participants Male | 30483 Participants | 65613 Participants | 40942 Participants | 26905 Participants | 163943 Participants | — |
| Sex: Female, Male Staff Female | — | — | — | — | 22 Participants | 22 Participants |
| Sex: Female, Male Staff Male | — | — | — | — | 5 Participants | 5 Participants |
| Sleep Medication PCMHI Participants No | 3684 Participants | 4368 Participants | 2523 Participants | 2120 Participants | 12695 Participants | 0 Participants |
| Sleep Medication PCMHI Participants Yes | 243 Participants | 556 Participants | 452 Participants | 138 Participants | 1389 Participants | 0 Participants |
| Sleep Medication Primary Care Participants No | 32246 Participants | 65740 Participants | 42784 Participants | 30264 Participants | 171034 Participants | — |
| Sleep Medication Primary Care Participants Yes | 1404 Participants | 4483 Participants | 4094 Participants | 1027 Participants | 11008 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Veteran Participants Who Engaged in BBTI
The number of Veterans in PCMHI who engaged in BBTI as indicated in the medical records
Time frame: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)
Population: Veterans in PCMHI who engaged in BBTI
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Minneapolis VAMC | Veteran Participants Who Engaged in BBTI | Pre-Training | 14 Participants |
| Minneapolis VAMC | Veteran Participants Who Engaged in BBTI | Pre-Implementation | 0 Participants |
| Minneapolis VAMC | Veteran Participants Who Engaged in BBTI | Implementation | 203 Participants |
| Minneapolis VAMC | Veteran Participants Who Engaged in BBTI | Post-Implementation | 217 Participants |
| Philadelphia VAMC | Veteran Participants Who Engaged in BBTI | Pre-Implementation | 14 Participants |
| Philadelphia VAMC | Veteran Participants Who Engaged in BBTI | Implementation | 35 Participants |
| Philadelphia VAMC | Veteran Participants Who Engaged in BBTI | Post-Implementation | 28 Participants |
| Philadelphia VAMC | Veteran Participants Who Engaged in BBTI | Pre-Training | 1 Participants |
| Durham VAMC | Veteran Participants Who Engaged in BBTI | Implementation | 88 Participants |
| Durham VAMC | Veteran Participants Who Engaged in BBTI | Pre-Implementation | 90 Participants |
| Durham VAMC | Veteran Participants Who Engaged in BBTI | Post-Implementation | 162 Participants |
| Durham VAMC | Veteran Participants Who Engaged in BBTI | Pre-Training | 21 Participants |
| Baltimore VAMC | Veteran Participants Who Engaged in BBTI | Post-Implementation | 75 Participants |
| Baltimore VAMC | Veteran Participants Who Engaged in BBTI | Pre-Implementation | 67 Participants |
| Baltimore VAMC | Veteran Participants Who Engaged in BBTI | Pre-Training | 0 Participants |
| Baltimore VAMC | Veteran Participants Who Engaged in BBTI | Implementation | 50 Participants |
Comparison: pre-training to implementationp-value: <0.000195% CI: [8.99, 21.11]Regression, Logistic
Comparison: pre-implementation to implementationp-value: 0.1895% CI: [0.81, 3]Regression, Logistic
Comparison: pre-implementation to implementationp-value: 0.00395% CI: [1.17, 2.22]Regression, Logistic
Comparison: pre-implementation to implementationp-value: 0.4895% CI: [0.77, 1.76]Regression, Logistic
Secondary
Barriers & Facilitators (CFIR Determinants)
Strength and valence rating for identified barriers and facilitators (determinants) from the Consolidated Framework for Implementation Research (CFIR) qualitative interviews. CFIR determinants, identified through qualitative interviews with PCMHI providers, were rated on strength (0, 1, 2; higher numbers indicate stronger influence) and valence (- indicates negative/harmful influence; + indicates positive/helpful influence) to determine how helpful or harmful an identified CFIR determinant is for implementing BBTI in PCMHI. Ratings were aggregated across sites and phases (consensus by 3 raters with adjudication by PI as needed).
Time frame: 42 months; qualitative interviews took place at the end of the pre-implementation, implementation, and post-implementation phases.
Population: 16 Staff participants were engaged in CFIR interviews with 3 study team members coding the interviews and conducting strength and valence ratings. Strength (0, 1, 2) and valence (- / +) ratings help to determine how helpful or harmful an identified CFIR determinant is for implementation of BBTI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Innovation: Adaptability | 1 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Innovation: Trialability | 1 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Innovation: Relative Advantage | 2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Innovation: Design | 2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Outer: Partnerships & Connections | 1 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Inner: Work Infrastructure | -2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Inner: Communications | 1 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Inner: Compatibility | 2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Inner: Mission Alignment | 2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Inner: Available Resources | 1 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Inner: Access to Knowledge & Information | 2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Inner: Relative Priority | -1 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Individuals: Innovation Deliverers - Capability | 2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Individuals: Innovation Recipients - Need | 2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Individuals: Innovation Recipients - Motivation | -1 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Process: Teaming | 2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Process: Tailoring Strategies | 2 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Process: Engaging Recipients | -1 rating score for each CFIR determinant |
| Minneapolis VAMC | Barriers & Facilitators (CFIR Determinants) | Process: Adapting | 2 rating score for each CFIR determinant |
Secondary
BBTI Effectiveness (Intent to Treat)
Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session.
Time frame: 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 1-13 weeks.
Population: This is the intent to treat (ITT) analysis and all ISI data are included from participants who initiated BBTI. Results provided for all sites combined and individual sites. Data at the participant-level (Veterans in PCMHI), with data extracted from BBTI progress notes in the electronic health records, retrospectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minneapolis VAMC | BBTI Effectiveness (Intent to Treat) | Minneapolis VAMC | 16.09 score on a scale | Standard Deviation 5.46 |
| Minneapolis VAMC | BBTI Effectiveness (Intent to Treat) | Durham VAMC | 18.05 score on a scale | Standard Deviation 6.03 |
| Minneapolis VAMC | BBTI Effectiveness (Intent to Treat) | Philadelphia VAMC | 18.30 score on a scale | Standard Deviation 5.32 |
| Minneapolis VAMC | BBTI Effectiveness (Intent to Treat) | Baltimore VAMC | 18.36 score on a scale | Standard Deviation 5.34 |
| Minneapolis VAMC | BBTI Effectiveness (Intent to Treat) | All Sites | 16.85 score on a scale | Standard Deviation 5.79 |
| Philadelphia VAMC | BBTI Effectiveness (Intent to Treat) | Baltimore VAMC | 12.70 score on a scale | Standard Deviation 6.99 |
| Philadelphia VAMC | BBTI Effectiveness (Intent to Treat) | All Sites | 13.41 score on a scale | Standard Deviation 7.02 |
| Philadelphia VAMC | BBTI Effectiveness (Intent to Treat) | Minneapolis VAMC | 11.40 score on a scale | Standard Deviation 7.6 |
| Philadelphia VAMC | BBTI Effectiveness (Intent to Treat) | Philadelphia VAMC | 13.69 score on a scale | Standard Deviation 6.17 |
| Philadelphia VAMC | BBTI Effectiveness (Intent to Treat) | Durham VAMC | 14.30 score on a scale | Standard Deviation 6.69 |
p-value: <0.0001Mixed Models Analysis
Comparison: Minneapolis VAMCp-value: <0.0001Mixed Models Analysis
Comparison: Philadelphia VAMCp-value: <0.0001Mixed Models Analysis
Comparison: Durham VAMCp-value: <0.0001Mixed Models Analysis
Comparison: Baltimore VAMCp-value: <0.0001Mixed Models Analysis
Secondary
BBTI Effectiveness (Per Protocol)
Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session.
Time frame: 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 2-13 weeks.
Population: This is the per protocol (PP) analysis and all ISI data are included from participants who completed at least 3 sessions of BBTI. Results provided for all sites combined and individual sites. Data at the participant-level (Veterans in PCMHI), with data extracted from BBTI progress notes in the electronic health records, retrospectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minneapolis VAMC | BBTI Effectiveness (Per Protocol) | Minneapolis VAMC | 17.13 score on a scale | Standard Deviation 4.7 |
| Minneapolis VAMC | BBTI Effectiveness (Per Protocol) | Durham VAMC | 18.00 score on a scale | Standard Deviation 6.14 |
| Minneapolis VAMC | BBTI Effectiveness (Per Protocol) | Philadelphia VAMC | 18.88 score on a scale | Standard Deviation 5.34 |
| Minneapolis VAMC | BBTI Effectiveness (Per Protocol) | Baltimore VAMC | 20.05 score on a scale | Standard Deviation 4.32 |
| Minneapolis VAMC | BBTI Effectiveness (Per Protocol) | All Sites | 18.48 score on a scale | Standard Deviation 5.42 |
| Philadelphia VAMC | BBTI Effectiveness (Per Protocol) | Baltimore VAMC | 12.45 score on a scale | Standard Deviation 6.71 |
| Philadelphia VAMC | BBTI Effectiveness (Per Protocol) | All Sites | 12.31 score on a scale | Standard Deviation 6.38 |
| Philadelphia VAMC | BBTI Effectiveness (Per Protocol) | Minneapolis VAMC | 8.13 score on a scale | Standard Deviation 6.04 |
| Philadelphia VAMC | BBTI Effectiveness (Per Protocol) | Philadelphia VAMC | 13.79 score on a scale | Standard Deviation 5.84 |
| Philadelphia VAMC | BBTI Effectiveness (Per Protocol) | Durham VAMC | 13.00 score on a scale | Standard Deviation 6.19 |
Comparison: All Sitesp-value: <0.0001Mixed Models Analysis
Comparison: Minneapolis VAMCp-value: <0.0001Mixed Models Analysis
Comparison: Philadelphia VAMCp-value: <0.0001Mixed Models Analysis
Comparison: Durham VAMCp-value: <0.0001Mixed Models Analysis
Comparison: Baltimore VAMCp-value: <0.0001Mixed Models Analysis
Secondary
Implementation Strategy Utilization Survey
Indication of implementation strategy utilization (yes/no) and rating of its importance (1 = not at all important, 5 = very important) and feasibility ((1 = not at all feasible, 5 = very feasible).
Time frame: 12 months: 4 times - every 3-months during the Implementation phase.
Population: This measure was abandoned during the study, early on with no data collected, since much of the data intended to be collected through this survey could be captured/collected as part of the CFIR interviews and ratings (Outcome #8).
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Implementation Strategy Utilization Survey | Remind clinicians | — |
| Unknown | Implementation Strategy Utilization Survey | Conduct ongoing training for PCMHI clinicians who deliver BBTI | — |
| Unknown | Implementation Strategy Utilization Survey | Develop and utilize a formal implementation blueprint | — |
| Unknown | Implementation Strategy Utilization Survey | Organize clinician implementation team meetings | — |
| Unknown | Implementation Strategy Utilization Survey | Identify and/or prepare champions | — |
| Unknown | Implementation Strategy Utilization Survey | Conduct local needs assessment | — |
| Unknown | Implementation Strategy Utilization Survey | Conduct educational meetings | — |
| Unknown | Implementation Strategy Utilization Survey | Develop educational materials (if needed) | — |
| Unknown | Implementation Strategy Utilization Survey | Distribute educational materials | — |
| Unknown | Implementation Strategy Utilization Survey | Facilitation | — |
| Unknown | Implementation Strategy Utilization Survey | Audit and provide feedback - utilize data locally if/when provided | — |
| Unknown | Implementation Strategy Utilization Survey | Develop or implement tools for quality monitoring - mock therapy sessions | — |
| Unknown | Implementation Strategy Utilization Survey | Obtain formal commitments from leadership | — |
| Unknown | Implementation Strategy Utilization Survey | Develop academic partnerships | — |
| Unknown | Implementation Strategy Utilization Survey | Increase demand (if capacity allows) | — |
Secondary
Implementation/Treatment Fidelity (Staff)
Mean Competency Rating Score (0-36, higher scores indicate higher competency, \>17 indicates competency) PCMHI providers (Staff) were measured via mock treatment sessions by site PIs/subject matter experts using the BBTI-Competency Rating Scale (BBTI-CRS) during the pre-implementation, implementation, and post-implementation phases. Overall refers to aggregate ratings (averaged) from all phases in which BBTI-CRS was delivered - providers could complete up to 5 ratings (up to 3 for pre-implementation, 1 for implementation, and 1 for post-implementation).
Time frame: 42 months; the BBTI-CRS was administered during pre-implementation (up to 3 times), implementation (1 time, at the end), and post-implementation (1 time, at the end)
Population: PCMHI providers (Staff) trained in BBTI who consented to participate in the competency ratings. Not all Staff completed ratings at all phases and there was no plan to compare between sites. Only descriptive statistics (Mean/Standard Deviation) reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minneapolis VAMC | Implementation/Treatment Fidelity (Staff) | Overall (phases 2-4) | 31.46 score on a scale | Standard Deviation 5.14 |
| Minneapolis VAMC | Implementation/Treatment Fidelity (Staff) | Pre-Implementation (phase 2) | 31.02 score on a scale | Standard Deviation 5.57 |
| Minneapolis VAMC | Implementation/Treatment Fidelity (Staff) | Implementation (phase 3) | 33.64 score on a scale | Standard Deviation 3.52 |
| Minneapolis VAMC | Implementation/Treatment Fidelity (Staff) | Post-Implementation (phase 4) | 33.55 score on a scale | Standard Deviation 2.77 |
Secondary
PCMHI Providers (Staff) Who Delivered (Adopted) BBTI
PCMHI providers (Staff) who delivered (adopted) BBTI (adopted) to at least 1 Veteran - measured in each phase (pre-implementation, implementation, post-implementation).
Time frame: 42 months; during the pre-implementation, implementation, and post-implementation phases.
Population: Number of PCMHI providers who delivered BBTI relative to providers who were eligible to deliver BBTI. Not all of these providers were considered enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Minneapolis VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Post-Implementation | 27 providers |
| Minneapolis VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Implementation | 23 providers |
| Philadelphia VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Pre-Implementation | 17 providers |
| Philadelphia VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Post-Implementation | 20 providers |
| Philadelphia VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Implementation | 29 providers |
| Durham VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Implementation | 27 providers |
| Durham VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Pre-Implementation | 33 providers |
| Durham VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Post-Implementation | 27 providers |
| Baltimore VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Pre-Implementation | 17 providers |
| Baltimore VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Post-Implementation | 17 providers |
| Baltimore VAMC | PCMHI Providers (Staff) Who Delivered (Adopted) BBTI | Implementation | 17 providers |
Secondary
Veterans in PCMHI Identified With Insomnia
The number of Veterans with encounters in PCMHI related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication.
Time frame: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Minneapolis VAMC | Veterans in PCMHI Identified With Insomnia | Pre-Training | 718 Participants |
| Minneapolis VAMC | Veterans in PCMHI Identified With Insomnia | Pre-Implementation | 0 Participants |
| Minneapolis VAMC | Veterans in PCMHI Identified With Insomnia | Implementation | 857 Participants |
| Minneapolis VAMC | Veterans in PCMHI Identified With Insomnia | Post-Implementation | 680 Participants |
| Philadelphia VAMC | Veterans in PCMHI Identified With Insomnia | Pre-Implementation | 167 Participants |
| Philadelphia VAMC | Veterans in PCMHI Identified With Insomnia | Implementation | 280 Participants |
| Philadelphia VAMC | Veterans in PCMHI Identified With Insomnia | Post-Implementation | 163 Participants |
| Philadelphia VAMC | Veterans in PCMHI Identified With Insomnia | Pre-Training | 314 Participants |
| Durham VAMC | Veterans in PCMHI Identified With Insomnia | Implementation | 505 Participants |
| Durham VAMC | Veterans in PCMHI Identified With Insomnia | Pre-Implementation | 778 Participants |
| Durham VAMC | Veterans in PCMHI Identified With Insomnia | Post-Implementation | 386 Participants |
| Durham VAMC | Veterans in PCMHI Identified With Insomnia | Pre-Training | 717 Participants |
| Baltimore VAMC | Veterans in PCMHI Identified With Insomnia | Post-Implementation | 243 Participants |
| Baltimore VAMC | Veterans in PCMHI Identified With Insomnia | Pre-Implementation | 327 Participants |
| Baltimore VAMC | Veterans in PCMHI Identified With Insomnia | Pre-Training | 354 Participants |
| Baltimore VAMC | Veterans in PCMHI Identified With Insomnia | Implementation | 217 Participants |
Secondary
Veterans in Primary Care Identified With Insomnia
The number of Veterans with encounters in Primary Care related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication.
Time frame: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Minneapolis VAMC | Veterans in Primary Care Identified With Insomnia | Pre-Training | 6383 Participants |
| Minneapolis VAMC | Veterans in Primary Care Identified With Insomnia | Pre-Implementation | 0 Participants |
| Minneapolis VAMC | Veterans in Primary Care Identified With Insomnia | Post-Implementation | 5175 Participants |
| Minneapolis VAMC | Veterans in Primary Care Identified With Insomnia | Implementation | 6135 Participants |
| Philadelphia VAMC | Veterans in Primary Care Identified With Insomnia | Pre-Implementation | 1875 Participants |
| Philadelphia VAMC | Veterans in Primary Care Identified With Insomnia | Post-Implementation | 1859 Participants |
| Philadelphia VAMC | Veterans in Primary Care Identified With Insomnia | Pre-Training | 2737 Participants |
| Philadelphia VAMC | Veterans in Primary Care Identified With Insomnia | Implementation | 2257 Participants |
| Durham VAMC | Veterans in Primary Care Identified With Insomnia | Implementation | 5482 Participants |
| Durham VAMC | Veterans in Primary Care Identified With Insomnia | Pre-Training | 7038 Participants |
| Durham VAMC | Veterans in Primary Care Identified With Insomnia | Post-Implementation | 4690 Participants |
| Durham VAMC | Veterans in Primary Care Identified With Insomnia | Pre-Implementation | 6547 Participants |
| Baltimore VAMC | Veterans in Primary Care Identified With Insomnia | Post-Implementation | 1467 Participants |
| Baltimore VAMC | Veterans in Primary Care Identified With Insomnia | Pre-Training | 2378 Participants |
| Baltimore VAMC | Veterans in Primary Care Identified With Insomnia | Pre-Implementation | 2383 Participants |
| Baltimore VAMC | Veterans in Primary Care Identified With Insomnia | Implementation | 1571 Participants |