[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07309224":3,"trial-entities:NCT07309224":132,"trial-summary:NCT07309224":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":45,"secondary_outcomes":59,"sex":79,"minimum_age":80,"maximum_age":81,"healthy_volunteers":15,"eligibility_criteria":82,"std_ages":95,"locations":98,"central_contacts":118,"overall_officials":124,"references":126,"see_also_links":131},"NCT07309224","QUX 26-002","Employing Peer Outreach and Whole Health in Recovery for Homeless-Experienced Veterans","Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for Homeless-Experienced Veterans: A Hybrid Type III Implementation Trial (QUE 25-014)","NOT_YET_RECRUITING","2030-09-30","2026-07","2026-08-04","2026-10-01","VA Office of Research and Development","FED",false,"Homelessness is a national crisis in the United States, particularly in the veteran population. Due to multiple chronic conditions, homeless individuals frequently become hospitalized or are treated in emergency departments. Care engagement can mitigate this risk. Interventions grounded in evidence-based practices of peer support and whole health are effective for increasing care engagement. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, whole health intervention for homeless-experienced veterans in permanent supportive housing.","Background: Homelessness is a national crisis in the United States, particularly in the Veteran population. Due to multiple chronic conditions, homeless individuals have elevated risk for acute care service use. Engagement in primary and specialty care can mitigate this risk. Interventions grounded in evidence-based practices of peer support, patient-centered care, and whole health are effective for increasing service engagement. However, implementation of such interventions with high-acuity patients often requires multi-component strategies that are intensive and costly. This study protocol describes a hybrid type 3 effectiveness-implementation trial of Employing Peer Outreach and Whole Health in Recovery (EMPOWER) with high-need, homeless-experienced Veterans in permanent supportive housing and will evaluate the impact and cost of a high-intensity (vs. low-intensity) strategy on implementation outcomes.\n\nMethods: (Aim 1) At 7 sites in the Veterans Health Administration (VA), a mixed methods pre-implementation evaluation will identify determinants and their potential impact on uptake of the EMPOWER and inform modifications to the intervention and implementation strategies as needed. (Aim 2) A staircase cluster randomized design will evaluate the rollout of the implementation strategies, beginning with Audit and Feedback (low-intensity) and then switching to Facilitation (high-intensity) after 6 months. Facilitation is hypothesized to have a greater impact on the reach, effectiveness, adoption, implementation (fidelity), and maintenance of EMPOWER. (Aim 3) A budget impact analysis will estimate the average cost of implementing EMPOWER at future sites and comparative costs for implementing the low- and high-intensity strategies.\n\nAnticipated Impact: This study will provide information on the relative impacts and relative costs of strategies aimed at implementing a peer-led, patient-centered, whole health intervention for homeless-experienced Veterans in permanent supportive housing. The findings will provide guidance to VA and other healthcare systems that serve the aging population of homeless-experienced Veterans.",[19,20,21],"Substance Use Disorder","Mental Health Disorder","Homelessness",[23,24,25,26,27],"Veterans","Homeless Persons","Peer Influence","Whole Person Health","Implementation Science","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[31],"NA",{"count":33,"type":34},278,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":43},"BEHAVIORAL","Employing Peer Outreach and Whole Health in Recovery (EMPOWER)","EMPOWER is a multicomponent intervention to facilitate homeless-experienced veterans' (HEVs) care engagement: (DATA ANALYTICS) HUD-VASH case managers identify high-need, HUD-VASH Veterans on the Homeless Registry Hot Spot Report. Veterans' profiles are reviewed to learn about their chronic health conditions, housing status, acute care use, and engagement in supportive care. (PEER SUPPORT): HUD-VASH peers meet with identified Veterans for up to six months, averaging once-per week sessions for the first three months, with step-down in frequency as Veterans begin to engage in services and reach their goals. (WHOLE HEALTH): During sessions, peers use a Whole Health approach to collaboratively develop personal health goals that align with the Veteran's priorities and values-e.g, help Veterans completing a Personal Health Inventory and developing a Personal Health Plans. Provider communications: Peers communicate with a Veteran's care providers to share the Veteran's personal health goals.",[41,42],"High-Intensity (HI)","Low-Intensity (LI)",[44],"EMPOWER",[46,50,53,56],{"measure":47,"description":48,"timeFrame":49},"Reach","Reach will be measured in terms of the number of patients who are willing to receive EMPOWER, out of all patients that are estimated to be eligible at potential sites.","18 months",{"measure":51,"description":52,"timeFrame":49},"Adoption","Adoption will be measured in terms of the number of peers in HUD-VASH at sites that are trained in EMPOWER and initiate the intervention with eligible patients at their site.",{"measure":54,"description":55,"timeFrame":49},"Implementation","Implementation will be measured in terms of rate of completion of peer encounters at the site level and rate of completion of the elements of EMPOWER (e.g., percentage of EMPOWER patients with a Personal Health Plan entered into the EHR; percentage of EMPOWER patients who were referred to a Whole Health service at the local facility). These rates will be measured via activity logs embedded in the EHR and electronic data capture logs to document type and length of encounters.",{"measure":57,"description":58,"timeFrame":49},"Maintenance","Maintenance will be measured by the number of patients who are continuing to engage in EMPOWER and other VA services over the duration of the implementation phase (18 months).",[60,64,67,70,73,76],{"measure":61,"description":62,"timeFrame":63},"Effectiveness - Mental Health Outpatient Care","Among patients who receive EMPOWER and have a mental health diagnosis, the number of outpatient visits for mental health care they receive after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters).","6 months",{"measure":65,"description":66,"timeFrame":63},"Effectiveness - Substance Use Disorder Outpatient Care","Among patients who receive EMPOWER and have a diagnosis of a substance use disorder (SUD), the number of outpatient visits for SUD care they receive after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters).",{"measure":68,"description":69,"timeFrame":63},"Effectiveness - Primary Care","Among patients who receive EMPOWER, the number of primary care visits they attend after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters).",{"measure":71,"description":72,"timeFrame":63},"Effectiveness - Whole Health care","Among patients who receive EMPOWER, the number of outpatient visits for Whole Health-related care they receive after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters of health coaching and other complementary and integrative services).",{"measure":74,"description":75,"timeFrame":63},"Effectiveness - Hospitalizations","Among patients who receive EMPOWER, the number of bed days of care for ambulatory-care sensitive conditions after 6 months, as measured by VA administrative data (e.g., Bedsection codes).",{"measure":77,"description":78,"timeFrame":63},"Effectiveness - ED visits","Among patients who receive EMPOWER, the number of visits to an emergency department after 6 months, as measured by VA administrative data (e.g., stop codes).","ALL","18 Years",null,{"inclusion":83,"exclusion":89,"raw_text":94},[84,85,86,87,88],"Eligible patients will be identified from VA's Homeless Registry \"Hot Spot\" reports, which use real-time data on acute care service utilization to identify high-need, housing-insecure patients.","These reports identify Veterans on the VA Homeless Registry (i.e., those who had received VA housing services in the past two years) who had \\>1 hospital admissions and\u002For \\>2 ED visits in the past quarter of the fiscal year.","From these reports, the investigators will identify patients at each implementation site who are","(a) currently enrolled in HUD-VASH","(b) have a mental health and\u002For SUD diagnosis",[90,91,92,93],"Not flagged on the VA's Homeless Registry Hot Spot Report","Not currently enrolled in HUD-VASH","Does not have a mental health and\u002For substance use disorder diagnosis","Is not a patient at a participating site of the implementation trial","Inclusion Criteria:\n\n* Eligible patients will be identified from VA's Homeless Registry \"Hot Spot\" reports, which use real-time data on acute care service utilization to identify high-need, housing-insecure patients.\n* These reports identify Veterans on the VA Homeless Registry (i.e., those who had received VA housing services in the past two years) who had \\>1 hospital admissions and\u002For \\>2 ED visits in the past quarter of the fiscal year.\n* From these reports, the investigators will identify patients at each implementation site who are\n\n  * (a) currently enrolled in HUD-VASH\n  * (b) have a mental health and\u002For SUD diagnosis\n\nExclusion Criteria:\n\n* Not flagged on the VA's Homeless Registry Hot Spot Report\n* Not currently enrolled in HUD-VASH\n* Does not have a mental health and\u002For substance use disorder diagnosis\n* Is not a patient at a participating site of the implementation trial",[96,97],"ADULT","OLDER_ADULT",[99],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":115},"VA Palo Alto Health Care System, Palo Alto, CA","Palo Alto","California","94304-1207","United States",[106,112],{"name":107,"role":108,"phone":109,"phoneExt":110,"email":111},"Daniel M Blonigen, PhD MA","CONTACT","(650) 493-5000","27828","Daniel.Blonigen@va.gov",{"name":113,"role":114},"Daniel M. Blonigen, PhD MA","PRINCIPAL_INVESTIGATOR",{"lat":116,"lon":117},37.44188,-122.14302,[119,120],{"name":107,"role":108,"phone":109,"phoneExt":110,"email":111},{"name":121,"role":108,"phone":109,"phoneExt":122,"email":123},"Jennifer S Smith, MPH","27831","jennifer.s.smith@va.gov",[125],{"name":113,"affiliation":100,"role":114},[127],{"pmid":128,"type":129,"citation":130},"41952220","DERIVED","Blonigen DM, Hyde J, Smith J, TorresTower S, Podchiyska T, Taylor TJ, Raciborski RA, Roy SG, Midboe AM. Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for homeless-experienced veterans: protocol for a hybrid type 3 implementation trial. Implement Sci. 2026 Apr 8;21(1):35. doi: 10.1186\u002Fs13012-026-01499-y.",[],{"nct_id":4,"conditions":133,"biomarkers":136},[134,135],"Psychiatric Disorder","Substance use disorder",[],{"nct_id":4,"found":138,"summary":139,"prompt_version":149},true,{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This study is an interventional trial planning to enroll 278 participants. It will compare a high-intensity versus a low-intensity strategy for implementing the EMPOWER program.","completed","EMPOWER for Homeless-Experienced Veterans with Substance Use and Mental Health Disorders","This study is testing a program called EMPOWER (Employing Peer Outreach and Whole Health in Recovery) for veterans who have experienced homelessness and have substance use or mental health disorders. EMPOWER uses peer support and a 'whole health' approach to help veterans connect with and stay engaged in their healthcare. Researchers will identify veterans who are most in need from VA's Homeless Registry \"Hot Spot\" reports. The study aims to see how well EMPOWER can reach these veterans, how widely it can be adopted, and how effectively it can be put into practice over 18 months. The goal is to improve care engagement for this vulnerable population.","The study will measure its main goals for 18 months.",107,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]