Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-02 @ 12:40 PM
Study NCT ID:
NCT04350866
Status:
COMPLETED
Last Update Posted:
2024-11-07
First Post:
2020-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Access to Insomnia Care in VA PCMHI Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-18', 'releaseDate': '2025-06-26'}], 'estimatedResultsFirstSubmitDate': '2025-06-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-11', 'size': 1061937, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-27T17:05', 'hasProtocol': True}, {'date': '2021-08-11', 'size': 257246, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-27T17:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2020-03-31', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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)', 'description': 'The number of new PCMHI visits related to insomnia, indicated by a PCMHI progress note in the medical records with an insomnia diagnostic code.'}, {'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)', 'description': 'The number of Veterans who initiate BBTI, indicated by a BBTI templated note in the medical records.'}, {'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)', 'description': '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).'}, {'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)', 'description': '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.'}, {'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)', 'description': 'The number of PCMHI clinicians who undergo training in BBTI relative to the number of PCMHI clinicians eligible for training.'}, {'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)', 'description': 'The number of PCMHI clinicians who treat at least one Veteran with BBTI relative to the number of PCMHI clinicians trained.'}, {'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)', 'description': '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).'}, {'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)', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Reach-2', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': 'The number of Veterans who initiate BBTI, indicated by a BBTI templated note in the medical records.'}, {'measure': 'Reach-1', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': 'The number of new PCMHI visits related to insomnia, indicated by a PCMHI progress note in the medical records with an insomnia diagnostic code.'}, {'measure': 'Reach-3', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': '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).'}, {'measure': 'Implementation Strategies (surveys)', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': '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.\n\nSite 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\\]).'}, {'measure': 'Implementation Strategies (qualitative interviews)', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Effectiveness', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': '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.'}, {'measure': 'Adoption-1', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': 'The number of PCMHI clinicians who undergo training in BBTI relative to the number of PCMHI clinicians eligible for training.'}, {'measure': 'Adoption-2', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': 'The number of PCMHI clinicians who treat at least one Veteran with BBTI relative to the number of PCMHI clinicians trained.'}, {'measure': 'Implementation/treatment fidelity-1', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': '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).'}, {'measure': 'Implementation/treatment fidelity-2', 'timeFrame': 'implementation phase (duration: 12 months)', 'description': '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.'}, {'measure': 'Maintenance', 'timeFrame': 'post-implementation phase (duration: 6 months)', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Veterans', 'stepped-wedge design', 'hybrid implementation-effectiveness trial', 'primary care mental health integration'], 'conditions': ['Chronic Insomnia']}, 'referencesModule': {'references': [{'pmid': '39745672', 'type': 'DERIVED', 'citation': "Bramoweth AD, Hough CE, O'Brien EM, Klingaman EA, Deininger CJ, Ulmer CS, Boudreaux-Kelly MY, McCoy JL, Youk AO. Implementing brief behavioral treatment for insomnia in Department of Veterans Affairs Primary Care Mental Health Integration clinics: Reach outcomes from a hybrid type 3 effectiveness-implementation trial. Psychol Serv. 2025 Aug;22(3):409-422. doi: 10.1037/ser0000924. Epub 2025 Jan 2."}], 'seeAlsoLinks': [{'url': 'https://www.youtube.com/watch?v=ZhFS5MLKrv0', 'label': 'BBTI introduction (for patients and providers)'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions to answer:\n\nDoes delivery of BBTI improve with training alone and does it improve further with the addition of implementation support?\n\nDoes delivery of BBTI remain at similar levels after implementation support is removed?\n\nDo Veterans who engage in BBTI reduce their insomnia symptoms?', 'detailedDescription': '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.\n\nThis 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.\n\nWe 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.\n\nOutcome measures have been updated (e.g., changed/removed) to more accurately reflect study protocol and analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll Veterans in Primary Care and Primary Care Mental Health Integration (PCMHI) at the participating sites.\n\nExclusion Criteria:\n\nNot meeting above criteria'}, 'identificationModule': {'nctId': 'NCT04350866', 'acronym': 'EASI Care', 'briefTitle': 'Enhancing Access to Insomnia Care in VA PCMHI Clinics', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Enhancing Access to Insomnia Care (EASI Care): Implementing Brief Behavioral Treatment for Insomnia in Primary Care Mental Health Integration Clinics', 'orgStudyIdInfo': {'id': 'IIR 19-340'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Minneapolis VAMC', 'description': 'BBTI; ERIC strategies', 'interventionNames': ['Behavioral: Expert Recommendations for Implementing Change bundle of strategies', 'Behavioral: Brief Behavioral Treatment for Insomnia']}, {'label': 'Philadelphia VAMC', 'description': 'BBTI; ERIC strategies', 'interventionNames': ['Behavioral: Expert Recommendations for Implementing Change bundle of strategies', 'Behavioral: Brief Behavioral Treatment for Insomnia']}, {'label': 'Durham VAMC', 'description': 'BBTI; ERIC strategies', 'interventionNames': ['Behavioral: Expert Recommendations for Implementing Change bundle of strategies', 'Behavioral: Brief Behavioral Treatment for Insomnia']}, {'label': 'Baltimore VAMC', 'description': 'BBTI; ERIC strategies', 'interventionNames': ['Behavioral: Expert Recommendations for Implementing Change bundle of strategies', 'Behavioral: Brief Behavioral Treatment for Insomnia']}], 'interventions': [{'name': 'Expert Recommendations for Implementing Change bundle of strategies', 'type': 'BEHAVIORAL', 'otherNames': ['ERIC'], 'description': '* Develop a formal implementation blueprint/checklist\n* Conduct educational meetings\n* Develop and distribute educational materials\n* Organize implementation meetings\n* Facilitation\n* Increase demand with marketing to patients\n* Promote adaptability', 'armGroupLabels': ['Baltimore VAMC', 'Durham VAMC', 'Minneapolis VAMC', 'Philadelphia VAMC']}, {'name': 'Brief Behavioral Treatment for Insomnia', 'type': 'BEHAVIORAL', 'otherNames': ['BBTI'], 'description': "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):\n\n1. Reduce time awake in bed.\n2. Don't go to bed unless ready for sleep.\n3. Don't stay in bed unless asleep.\n4. Get up and out of bed at the same time everyday.\n\nDelivered weekly to bi-weekly over 4-6 sessions, with each session typically 30 minutes or less, consistent with other interventions delivered in PCMHI.", 'armGroupLabels': ['Baltimore VAMC', 'Durham VAMC', 'Minneapolis VAMC', 'Philadelphia VAMC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15240', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Adam D. Bramoweth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'VA Pittsburgh Healthcare System', 'class': 'FED'}, {'name': 'VA Maryland Health Care System', 'class': 'FED'}, {'name': 'Durham VA Health Care System', 'class': 'FED'}, {'name': 'Minneapolis Veterans Affairs Medical Center', 'class': 'FED'}, {'name': 'Corporal Michael J. Crescenz VA Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-26', 'type': 'RELEASE'}, {'date': '2025-07-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'VA Office of Research and Development'}}}}