[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05312229":3,"trial-entities:NCT05312229":142,"trial-summary:NCT05312229":145},{"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":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":55,"secondary_outcomes":68,"sex":89,"minimum_age":90,"maximum_age":90,"healthy_volunteers":91,"eligibility_criteria":92,"std_ages":98,"locations":102,"central_contacts":122,"overall_officials":128,"references":130,"see_also_links":138},"NCT05312229","PIX 22-001","Housing Transitions QUERI","Implementing and Sustaining Critical Time Intervention (CTI) in Case Management Programs for Homeless-experienced Veterans (PII 21-285)","RECRUITING","2026-09-30","2026-07","2026-07-30","2021-10-01","VA Office of Research and Development","FED",false,"The VA Grant and Per Diem (GPD) case management aftercare program provides six months of case management for homeless-experienced Veterans undergoing housing transitions. This Partnered Implementation Initiative (PII) proposes to implement and evaluate Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case management practice-in 32 GPD case management aftercare sites across the nation.","The VA Grant and Per Diem case management (GPD-CM) program provides six months of case management for homeless-experienced Veterans (HEVs) undergoing housing transitions. At present, no specific case management paradigm is required in the GPD-CM program, resulting in practice variation across sites. This Partnered Implementation Initiative (PII) implements Critical Time Intervention (CTI)-an evidence-based, structured, and time-limited case management practice-at 32 VA GPD-CM sites. The investigators will use the Replicating Effective Programs (REP) implementation bundle to support CTI implementation at all 32 sites. Half of these sites will also receive 9 months of external facilitation (enhanced REP) as additional support for CTI implementation. In a type 3 hybrid trial, the investigators will use mixed methods to examine the impacts of REP versus enhanced REP. Using trial data, the investigators will develop a business case analysis and implementation playbook for the investigators' program partners to support continued CTI spread and sustainment in the GPD-CM program.",[19],"Homelessness",[21,22,23,24,25],"Care Management","Homeless","Implementation","Mental Health Care","Quality Assurance, Improvement","INTERVENTIONAL","OTHER",[29],"PHASE1",{"count":31,"type":32},153,"ESTIMATED",[34,43,49],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":41},"BEHAVIORAL","Critical Time Intervention","An evidence-based, structured, and time-limited case management practice",[39,40],"REP + External Facilitation (Enhanced REP)","Replicating Effective Programs (REP)",[42],"CTI",{"type":27,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"External Facilitation","Site-specific support to help sites develop tailored plans to implement CTI.",[39],[48],"Coaching",{"type":27,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Replicating Effective Programs","A stakeholder-informed training and technical assistance implementation strategy",[39,40],[54],"REP",[56,60,64],{"measure":57,"description":58,"timeFrame":59},"Fidelity to CTI","% of Sites with adequate fidelity to CTI at 12 months, as measured by the CTI fidelity scale","12 months after implementation start",{"measure":61,"description":62,"timeFrame":63},"Sustainment of CTI","% of Sites with adequate fidelity to CTI at 18 months, as measured by the CTI fidelity scale","18 months after implementation start",{"measure":65,"description":66,"timeFrame":67},"Dollars spent delivering CTI at each site","Case manager salary and benefits","Between 6 and 18 months after implementation start",[69,72,75,78,82,86],{"measure":70,"description":71,"timeFrame":67},"Housing stability","Days between entry into the GPD case management program and indicator of housing instability",{"measure":73,"description":74,"timeFrame":67},"Cost of CTI as Implemented","Mean monthly cost of CTI case management per GPD case management Veteran served, compared to the mean monthly cost in the non-CTI GPD case management programs.",{"measure":76,"description":77,"timeFrame":67},"Hospitalization rates","Number of days between entry into the GPD case management program and hospitalization, number of hospitalizations, number of bed days",{"measure":79,"description":80,"timeFrame":81},"Cost of Implementation Strategies","Dollars spent on REP versus enhanced REP","Through study completion, 4 years",{"measure":83,"description":84,"timeFrame":85},"Return on Investment (ROI) of CTI","Dollars saved via improved housing stability and decreased hospitalizations among patients engaged in CTI versus control participants","6-, 12-, and 18-months after GPD case management program enrollment",{"measure":87,"description":88,"timeFrame":67},"Outpatient service use","Number of outpatient appointments","ALL",null,true,{"inclusion":93,"exclusion":95,"raw_text":97},[94],"Grant and Per Diem (GPD) case management aftercare grantees in 7 Veterans Integrated Service Networks (VISN), all of whom provide 6-months of case management to Veterans who have experienced homelessness.",[96],"None","Inclusion Criteria:\n\n* Grant and Per Diem (GPD) case management aftercare grantees in 7 Veterans Integrated Service Networks (VISN), all of whom provide 6-months of case management to Veterans who have experienced homelessness.\n\nExclusion Criteria:\n\n* None",[99,100,101],"CHILD","ADULT","OLDER_ADULT",[103],{"facility":104,"status":8,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":119},"VA Greater Los Angeles Healthcare System, West Los Angeles, CA","West Los Angeles","California","90073-1003","United States",[110,116],{"name":111,"role":112,"phone":113,"phoneExt":114,"email":115},"Sonya E Gabrielian, MD MPH","CONTACT","(310) 478-3711","49853","Sonya.Gabrielian@va.gov",{"name":117,"role":118},"Sonya Emi Gabrielian, MD MPH","PRINCIPAL_INVESTIGATOR",{"lat":120,"lon":121},34.0462,-118.43068,[123,124],{"name":111,"role":112,"phone":113,"phoneExt":114,"email":115},{"name":125,"role":112,"phone":126,"email":127},"Jenny M Barnard, BA","(626) 367-1077","Jenny.Barnard@va.gov",[129],{"name":117,"affiliation":104,"role":118},[131,135],{"pmid":132,"type":133,"citation":134},"42304402","DERIVED","Cummings C, Rawal M, Tan G, Finley E, Cordasco KM, Herman D, Edwards L, Gabrielian S. Assessing fidelity to Critical Time Intervention (CTI) for homeless-experienced persons. BMC Health Serv Res. 2026 Jun 16. doi: 10.1186\u002Fs12913-026-14939-8. Online ahead of print.",{"pmid":136,"type":133,"citation":137},"36192785","Gabrielian S, Finley EP, Ganz DA, Barnard JM, Jackson NJ, Montgomery AE, Nelson RE, Cordasco KM. Comparing two implementation strategies for implementing and sustaining a case management practice serving homeless-experienced veterans: a protocol for a type 3 hybrid cluster-randomized trial. Implement Sci. 2022 Oct 3;17(1):67. doi: 10.1186\u002Fs13012-022-01236-1.",[139],{"label":140,"url":141},"Resources for VA Grant and Per Diem (GPD) case management aftercare grantee sites to implement and sustain Critical Time Intervention (CTI) at their sites.","https:\u002F\u002Fwww.VACTItoolkit.com",{"nct_id":4,"conditions":143,"biomarkers":144},[22],[],{"nct_id":4,"found":15,"summary":90,"prompt_version":90}]