[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07716202":3,"trial-entities:NCT07716202":108,"trial-summary:NCT07716202":113},{"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":47,"secondary_outcomes":62,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":77,"locations":80,"central_contacts":90,"overall_officials":102,"references":106,"see_also_links":107},"NCT07716202","QUX 26-003","Homeless Overdose Prevention- Expansion","Homeless Overdose Prevention- Expansion (HOPE) (QUE 25-014)","NOT_YET_RECRUITING","2030-09-30","2026-07","2026-07-30","2026-08-31","VA Office of Research and Development","FED",false,"Homeless Overdose Prevention - Expansion (HOPE), tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing. HOPE sites will receive a playbook that offers step-by-step instructions, tools, templates, and checklists tailorable to site needs; sites will also receive performance feedback about their performance relative to a standard or benchmark.","The proposed HOPE project builds on the Phase 1 implementation trial at 6 Veterans Health Administration health care systems (part of the current Bridge QUERI). This trial evaluated a 6-month implementation approach that was tailored based on the determinants identified for each of the Housing and Urban Development-VA Supportive Housing (HUD-VASH) teams as part of pre-implementation formative evaluations at each site. During the Phase 1 HOPE trial, HUD-VASH case managers reached more than 1700 HUD-VASH Veterans at risk for opioid overdose, providing education about their risk and naloxone to those who accepted the prescription. The implementation trial was conducted with 33 HUD-VASH teams at 6 low performing VISN 21 sites selected in partnership with regional HUD-VASH leadership. Approximately 300 HUD-VASH social workers were trained on OEND. Five of the 6 healthcare systems also became high performers (i.e., above the national average for naloxone receipt across all VA healthcare systems).\n\nPhase 2 of the HOPE trial will rely on the core evidence-based practice (EBP) of OEND, including identifying community-based naloxone resources, but the investigators will also provide each HUD-VASH team education and training regarding xylazine (including how it may increase opioid-overdose mortality risk) and fentanyl test strips. The latter is particularly important given that the investigators will identify community partnerships for receipt of confidential OEND since many non-VA harm reduction services do offer drug test strips. Also, drug test strips are prohibited in certain states that identify them as illegal drug paraphernalia. States are regularly revisiting these laws, and the investigators will update each implementation site about the current status of laws regarding drug test strips as part of implementation.\n\nIn Phase 2 of the HOPE trial, the investigators will evaluate the use of an Implementation Playbook developed during HOPE's Phase 1 implementation trial. The Low Intensity (LI) implementation approach will include providing sites with the HOPE Implementation Playbook, including access to the associated resources (e.g., OEND note templates) on the HOPE SharePoint site. The investigators will begin with an initial training session with each site, and investigators will lead a monthly learning collaborative for 6 months. The LI phase will allow investigators to evaluate the effect of a comprehensive playbook on uptake of OEND. The High Intensity (HI) approach, led by investigators, includes: (1) creation of a novel clinical team (i.e., prescriber and HUD-VASH team) if not created under LI; (2) monthly overdose education and training delivered synchronously via MS Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance.",[19,20,21],"Homelessness","Opioid Education and Naloxone Distribution (OEND)","Substance Use Disorder",[23,24,25,26,27],"Veterans","Risk Mitigation","Unstably Housed","Social Work","Implementation Science","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[31],"NA",{"count":33,"type":34},1200,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity","Homeless Overdose Prevention - Expansion (HOPE) tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing. During pre-implementation, investigators will conduct a rapid qualitative evaluation with 5-10 key informants at each of the identified implementation sites to refine the implementation approach. Investigators will evaluate low-intensity (LI) vs high-intensity (HI) strategy. The LI implementation approach will include providing sites with the HOPE Implementation Playbook, including access to the associated resources on the HOPE SharePoint site.",[41],"Low-Intensity (LI)",{"type":37,"name":43,"description":44,"armGroupLabels":45},"Homeless Overdose Prevention- Expansion (HOPE) - High Intensity","Homeless Overdose Prevention - Expansion (HOPE) tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing. During pre-implementation, investigators will conduct a rapid qualitative evaluation with 5-10 key informants at each of the identified implementation sites to refine the implementation approach. Investigators will evaluate low-intensity (LI) vs high-intensity (HI) strategy. The HI approach includes: (1) creation of a novel clinical team if not created under LI; (2) monthly overdose education and training delivered synchronously via Microsoft Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance.",[46],"High-Intensity (HI)",[48,52,55,58],{"measure":49,"description":50,"timeFrame":51},"Reach - VA administrative data","Reach will be measured in terms of the proportion of Veterans who receive OEND, including overdose education and\u002For a naloxone prescription, using VA administrative data.","12 months",{"measure":53,"description":54,"timeFrame":51},"Adoption - VA administrative data","Adoption will be measured in terms of the proportion of VHA pharmacy and other prescriber staff who delivered OEND, using VA administrative data.",{"measure":56,"description":57,"timeFrame":51},"Implementation - Electronic Data Capture","Implementation will be measured in terms of adherence of sites to tailored implementation. Implementation fidelity will be captured using electronic data capture.",{"measure":59,"description":60,"timeFrame":61},"Maintenance - Rapid Qualitative Interviews","Maintenance will be assessed by the extent to which OEND has become part of routine organizational practices and policies, including clinical processes to maintain OEND. Maintenance will be assessed 6-12 months post-implementation using semi-structured interviews. Interviews will be conducted with HUD-VASH staff and measured using rapid qualitative methods and administrative data. Administrative data will be used to measure whether OEND continues to be provided in the maintenance period.","6-12 months",[63],{"measure":64,"description":65,"timeFrame":51},"Effectiveness","Among Veterans who received overdose education and\u002For naloxone, the number of Veterans at-risk of opioid overdose who were hospitalized for an opioid overdose or visited a VA emergency department for an opioid overdose, as measured by VA administrative data.","ALL","18 Years",null,{"inclusion":70,"exclusion":72,"raw_text":76},[71],"Veterans enrolled in HUD-VASH at risk for opioid overdose (based on existing HOPE algorithms aligned with Pharmacy Benefit Manager data definitions), drawing from VA administrative data.",[73,74,75],"Not flagged by existing HOPE algorithms","Not currently enrolled in HUD-VASH","Is not a patient at a participating site of the implementation trial","Inclusion Criteria:\n\n* Veterans enrolled in HUD-VASH at risk for opioid overdose (based on existing HOPE algorithms aligned with Pharmacy Benefit Manager data definitions), drawing from VA administrative data.\n\nExclusion Criteria:\n\n* Not flagged by existing HOPE algorithms\n* Not currently enrolled in HUD-VASH\n* Is not a patient at a participating site of the implementation trial",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"VA Palo Alto Health Care System, Palo Alto, CA","Palo Alto","California","94304-1207","United States",{"lat":88,"lon":89},37.44188,-122.14302,[91,97],{"name":92,"role":93,"phone":94,"phoneExt":95,"email":96},"Amanda M Midboe, PhD","CONTACT","(650) 493-5000","27829","Amanda.Midboe@va.gov",{"name":98,"role":93,"phone":99,"phoneExt":100,"email":101},"Madeleine C Golding, MPH BA","(650) 614-9997","27422","madeleine.golding@va.gov",[103],{"name":104,"affiliation":82,"role":105},"Amanda M. Midboe, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":112},[110,111],"Homeless","Substance use disorder",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This interventional study plans to enroll 1200 participants. It compares two approaches to providing overdose education and naloxone distribution: a low-intensity and a high-intensity behavioral intervention.","completed","Homeless Overdose Prevention- Expansion (HOPE) for Veterans","This study, called Homeless Overdose Prevention- Expansion (HOPE), is testing ways to provide overdose education and naloxone (a medication that can reverse opioid overdose) to Veterans experiencing homelessness. This includes Veterans living in supportive housing programs. The study aims to see how well these programs can reach and be used by Veterans at risk for opioid overdose. Researchers will also look at how well the programs are put into practice over 12 months. You might be able to join if you are a Veteran, at least 18 years old, enrolled in the HUD-VASH program, and identified as being at risk for opioid overdose based on existing HOPE program information. The current recruitment status is unclear.","The study will track how well the program reaches and is adopted by participants for 12 months.",115,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]