[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06782516":3,"trial-entities:NCT06782516":106,"trial-summary:NCT06782516":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":42,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":63,"locations":66,"central_contacts":91,"overall_officials":92,"references":97,"see_also_links":105},"NCT06782516","IRB00026145","Native-RISE (Risk Identification for Suicide and Enhanced Care)","ENROLLING_BY_INVITATION","2028-12-31","2026-01","2026-02-02","2024-12-01","Johns Hopkins Bloomberg School of Public Health","OTHER",true,"The goal of this research is to test a systems-level suicide prevention strategy, Native-RISE (Risk Identification for Suicide and Enhanced care), that combines predictive analytics and brief contact interventions (BCIs) to reduce suicide in health systems serving Native Americans (NAs). This project aims to prove the effectiveness and scalability of Native-RISE within three Indian Health Service (IHS) health care clinics (Whiteriver, Chinle and Shiprock) already implementing suicide prevention programs and serving the White Mountain Apache Tribe (WMAT) and Navajo Nation (NN).",null,[18],"Suicide Prevention",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[23],"NA",{"count":25,"type":26},1687,"ESTIMATED",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","System of Care - combination of algorithm and Brief Contact Intervention","Case managers see the Native-RISE algorithm classification and Clinical Providers receive a risk notification. A resource card is provided to the participant.",[33,34],"Case Managers WITH algorithm AND provider risk notification (high risk history, no SI\u002FSA\u002FBinge\u002FNSSI","Case Managers WITH algorithm AND with provider risk notification (SI\u002FSA\u002FBinge\u002FNSSI)",{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Active Comparator - Provider notification of risk status","Clinical Providers receive a risk notification and a resource card is provided to the participant.",[40,41],"Case Managers withOUT algorithm AND with provider risk notification (SI\u002FSA\u002FBinge\u002FNSSI)","Provider risk notification alone (high risk history, without SI\u002FSA\u002FBinge\u002FNSSI)",[43],{"measure":44,"description":45,"timeFrame":46},"Rate of suicide attempts among individuals flagged at elevated risk","Rate of suicide attempts among individuals flagged at elevated risk is tracked through International Classification of Diseases (ICD) codes and chief complaints as recorded in the participating health system.","12 months",[48],{"measure":49,"description":50,"timeFrame":46},"Number of contacts with Case Managers (Reach of Brief Contact Interventions (BCI))","Reach of BCI is defined as at least three or more contacts with Case Managers within the first year following identification of elevated risk.","ALL","18 Years","75 Years",false,{"inclusion":56,"exclusion":60,"raw_text":62},[57,58,59],"Adults aged 18-75","Visit at least one of the three participating IHS clinics","Identified as at risk of suicide by either an existing method or the new Native-RISE risk model algorithm",[61],"None","Inclusion Criteria:\n\n* Adults aged 18-75\n* Visit at least one of the three participating IHS clinics\n* Identified as at risk of suicide by either an existing method or the new Native-RISE risk model algorithm\n\nExclusion Criteria:\n\n* None",[64,65],"ADULT","OLDER_ADULT",[67,76,83],{"facility":68,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"Chinle Navajo Nation Center for Indigenous Health","Chinle","Arizona","86503","United States",{"lat":74,"lon":75},36.15445,-109.55261,{"facility":77,"city":78,"state":70,"zip":79,"country":72,"geoPoint":80},"Whiteriver Center for Indigenous Health","Whiteriver","85941",{"lat":81,"lon":82},33.83699,-109.96427,{"facility":84,"city":85,"state":86,"zip":87,"country":72,"geoPoint":88},"Shiprock Center for Indigenous Health","Shiprock","New Mexico","87420",{"lat":89,"lon":90},36.78555,-108.68703,[],[93],{"name":94,"affiliation":95,"role":96},"Emily Haroz, PhD","Johns Hopkins University","PRINCIPAL_INVESTIGATOR",[98,102],{"pmid":99,"type":100,"citation":101},"39401036","BACKGROUND","Haroz EE, Rebman P, Goklish N, Garcia M, Suttle R, Maggio D, Clattenburg E, Mega J, Adams R. Performance of Machine Learning Suicide Risk Models in an American Indian Population. JAMA Netw Open. 2024 Oct 1;7(10):e2439269. doi: 10.1001\u002Fjamanetworkopen.2024.39269.",{"pmid":103,"type":100,"citation":104},"39414996","Adams R, Haroz EE, Rebman P, Suttle R, Grosvenor L, Bajaj M, Dayal RR, Maggio D, Kettering CL, Goklish N. Developing a suicide risk model for use in the Indian Health Service. Npj Ment Health Res. 2024 Oct 16;3(1):47. doi: 10.1038\u002Fs44184-024-00088-5.",[],{"nct_id":4,"conditions":107,"biomarkers":108},[18],[],{"nct_id":4,"found":54,"summary":16,"prompt_version":16}]