Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 12:00 PM
Study NCT ID:
NCT06011759
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintaining Implementation Through Dynamic Adaptations (MIDAS) Suicide Prevention 2.0 Clinical Telehealth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-18', 'releaseDate': '2025-08-27'}, {'resetDate': '2025-11-07', 'releaseDate': '2025-10-27'}, {'releaseDate': '2025-12-04', 'unreleaseDate': '2025-12-05'}, {'releaseDate': '2025-12-08'}], 'estimatedResultsFirstSubmitDate': '2025-08-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092864', 'term': 'Suicide Prevention'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A multi-faceted implementation intervention including qualitative interviews and feedback and optional delivery of Academic Detailing and/or LEAP.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in quality improvement skills application', 'timeFrame': 'Baseline to 12-months post-baseline', 'description': '16-item measure of change in quality improvement skills application. Values 1 to 4 where higher values indicate more frequent use of quality improvement skills.'}, {'measure': 'Change in provider satisfaction with academic detailing', 'timeFrame': 'Baseline to 12-months post-baseline', 'description': '7-item measure of satisfaction with Academic Detailing. Values 1 to 5 where higher values indicate higher satisfaction.'}, {'measure': 'Change in provider satisfaction with LEAP', 'timeFrame': 'Baseline to 12-months post-baseline', 'description': '6-item measure of satisfaction with LEAP. Values 1 to 5 where higher values indicate higher satisfaction.'}], 'primaryOutcomes': [{'measure': 'SP2Clin metric', 'timeFrame': 'Baseline to 12-months post-baseline', 'description': 'The percentage of reported suicide behavior events in the past 4 quarters that had an SP 2.0 Consult submitted. This is calculated by the number of suicide behavior event days among cohort with at least one Suicide Prevention Telehealth Program Consult submitted divided by the number of suicide behavior event days among eligible VHA Veterans within the past four quarters.'}], 'secondaryOutcomes': [{'measure': 'Referral to SP 2.0 Clinic', 'timeFrame': 'Baseline to 12-months post-baseline', 'description': 'Change in number of referrals to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implementation science', 'implementation strategy', 'suicide prevention', 'academic detailing', 'quality improvement'], 'conditions': ['Suicidal Self-directed Violence', 'Suicidal Preparatory Behavior']}, 'descriptionModule': {'briefSummary': 'Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice. The MIDAS QUERI program helps providers improve the way they treat VA patients. This project will focus on increasing referrals to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative through the delivery of Academic Detailing and LEAP (a team-based quality improvement program). SP 2.0 provides accessible, evidence-based suicide prevention treatment to all Veterans with a history of suicidal self-directed violence or preparatory behaviors in the past 12 months.', 'detailedDescription': 'Sustained integration of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of EBPs. The current project focuses on increasing referrals to the Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) initiative.\n\nThe investigators have recruited 4 sites for this non-randomized intervention project. Sites have agreed to participate in pre-implementation interviews to gather information regarding barriers and facilitators to use of the SP 2.0 initiative. Sites will then be provided with tailored feedback regarding interview findings and potential use of Academic Detailing and LEAP to address these. Sites may then select to receive either Academic Detailing and/or LEAP which will be provided by MIDAS QUERI. Primary outcome will be rate of SP 2.0 referral adjusted for pre-intervention rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNote- the investigators are recruiting clinics/medical centers - not individual patients. Prior to implementation, the investigators will work with sites to ensure they have met the preconditions necessary to begin sustained optimization of the EBP:\n\n* 1\\) a team leader or champion\n* 2\\) an identified department with service leadership buy-in and control over the processes/practices impacted by the implementation\n* 3\\) readily accessible data to measure process and impact of the implementation and use of the EBP\n* 4\\) availability of required resources\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT06011759', 'acronym': 'MIDAS SPCT', 'briefTitle': 'Maintaining Implementation Through Dynamic Adaptations (MIDAS) Suicide Prevention 2.0 Clinical Telehealth', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Maintaining Implementation Through Dynamic Adaptations (MIDAS) - Suicide Prevention 2.0 Clinical Telehealth (SP 2.0) (QUE 20-025)', 'orgStudyIdInfo': {'id': 'QUX 23-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'A multi-faceted implementation intervention including qualitative interviews and feedback and optional delivery of Academic Detailing and/or LEAP.', 'interventionNames': ['Behavioral: Academic Detailing (AD)', 'Behavioral: LEAP']}], 'interventions': [{'name': 'Academic Detailing (AD)', 'type': 'BEHAVIORAL', 'description': 'The National Resource Center for Academic Detailing (NaRCAD) describes AD as "an innovative, one-on-one outreach education technique that helps clinicians provide evidence-based care to their patients. Using an accurate, up-to-date synthesis of the best clinical evidence in an engaging format, academic detailers ignite clinician behavior change, ultimately improving patient health. A successful AD visit is highly interactive, always a dialogue, and assesses a clinician\'s individual needs, beliefs, attitudes, issues, and concerns in order to promote better \\[practice\\]."', 'armGroupLabels': ['Intervention']}, {'name': 'LEAP', 'type': 'BEHAVIORAL', 'description': "Learn. Engage. Act. Process (LEAP) program is a structured 6-month core curriculum plus 6 monthly collaborative sessions. The LEAP quality improvement program engages frontline teams in sustained incremental improvements of EBPs over a six-month period, allowing space for busy clinicians to learn and immediately apply fundamental QI skills. LEAP encompasses: 1) a structured, accessible curriculum based on the Institute for Healthcare Improvement's (IHI) Model for Improvement and Plan-Do-Study-Act cycles of change; 2) team-based, hands-on learning, and 3) coaching support and a QI network to enhance learning and accountability.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105-2303', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Paul N Pfeiffer, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}, {'name': 'Jacob E Kurlander, MD MS MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}, {'name': 'Jeremy B. Sussman, MD MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'For 36 months after article is published.', 'ipdSharing': 'YES', 'description': 'Site-level data that underlie results reported, after de-identification will be available.', 'accessCriteria': 'Upon request by researchers who provide a methodologically sound proposal. Further details will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-27', 'type': 'RELEASE'}, {'date': '2025-09-18', 'type': 'RESET'}, {'date': '2025-10-27', 'type': 'RELEASE'}, {'date': '2025-11-07', 'type': 'RESET'}, {'date': '2025-12-04', 'type': 'RELEASE'}, {'date': '2025-12-05', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'VA Office of Research and Development'}}}}