[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06461962":3,"trial-entities:NCT06461962":102,"trial-summary:NCT06461962":106},{"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":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":50,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":14,"eligibility_criteria":61,"std_ages":73,"locations":76,"central_contacts":92,"overall_officials":97,"references":100,"see_also_links":101},"NCT06461962","STUDY00026150","Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement","RECRUITING","2029-06-30","2025-03","2025-03-21","2024-08-19","Oregon Health and Science University","OTHER",false,"The goal of PEER-Heart is to implement and assess feasibility and preliminary effectiveness of a community peer-facilitated screening for methamphetamine-associated heart failure (MAHF) and linkage to evidence-based cardiology care for people who use methamphetamine in rural areas.","Methamphetamine use has increased across the US in the midst of the opioid crisis, with rates of methamphetamine use in rural communities exceeding that in urban areas. Nationwide, methamphetamine-related hospitalizations increased 270% between 2007 and 2015, along with associated costs, lengths of stay and mortality. Methamphetamine-associated heart failure (MAHF) hospitalizations increased 12-fold over this time period; it is associated with worse symptoms (e.g. ejection fraction) and decreased adherence to guideline-directed medical therapy (GDMT) compared to heart failure not associated with methamphetamine use.\n\nDespite the increased risk of heart failure and overdose for people who use methamphetamine in rural areas, interventions to improve engagement in cardiac screening and treatment services are underdeveloped. Multiple barriers decrease access to cardiac care in rural communities, including social determinants of health and health systems care delivery barriers. Stigma and distrust of healthcare providers, particularly in rural communities are known barriers to engaging in medical care-COVID-19 has only worsened this gap for people who use drugs.\n\nTeam-based cardiology care interventions can improve outcomes for people with heart failure, including one multi-disciplinary program that focused on methamphetamine-associated heart failure MAHF. However, these interventions have been tested in urban, higher resourced settings than those typical in rural communities. Interventions for screening and linkage to care for people who use drugs in rural areas with MAHF have not been developed.\n\nThe \"experiential credentialing\" afforded by peer recovery support specialists (\"peers\") offers a unique opportunity to reach, engage, and retain non-treatment-seeking people using drugs. The PEER-Heart study extends the role of peers as trusted community health workers in rural communities to improve MAHF screening and linkage to cardiology care. Increasing evidence reports feasibility, acceptability, and effectiveness of telehealth interventions in rural communities including cardiology services and retention in substance use treatment. Virtual visits for heart failure demonstrate promise in improving follow-up care though more study is warranted to demonstrate clinical outcomes effectiveness, and ensure these interventions do not worsen existing health inequities and the rural digital divide, particularly in minoritized groups.\n\nThe PEER-Heart study aims to demonstrate feasibility of screening of MAHF and linkage to evidence-based cardiology care for people who use methamphetamine in rural areas.",[18,19],"Methamphetamine Use","Heart Failure",[21,22,19,23,24,25,26],"Screening","Implementation Science","Addiction","Stimulants","Health Services","Community Engaged Research","INTERVENTIONAL","SCREENING",[30],"NA",{"count":32,"type":33},200,"ESTIMATED",[35,40],{"type":13,"name":36,"description":37,"armGroupLabels":38},"Treatment as Usual","Peer-facilitated referral to a local primary care provider to follow-up their screening results.",[39],"Peer-supported Treatment as Usual",{"type":13,"name":41,"description":42,"armGroupLabels":43},"Telehealth-Cardiology","Peer-facilitated virtual consultation with cardiovascular specialist, for follow-up of their screening results. Activities may include: referral for a locally performed testing including echocardiogram and additional blood work, and transitional care management facilitated by a remote nurse care manager and the peer\n\nReferral for a locally performed testing including echocardiogram\n\nTransitional care management facilitated by a remote nurse care manager and the peer",[44],"Peer-Supported Telehealth Cardiology",[46],{"measure":47,"description":48,"timeFrame":49},"Linkage to cardiology care","Proportion of participants who are engaged in cardiac care at 2 months after screening.","2 months",[51,54],{"measure":52,"description":53,"timeFrame":49},"Linkage to diagnostic echocardiogram","Proportion of participants who complete a diagnostic echocardiogram within 2 months after randomization.",{"measure":55,"description":56,"timeFrame":57},"Goal Directed Medical Therapy (GDMT) prescribed","Proportion of eligible patients who are on any GDMT at 6 months after randomization","6 months","ALL","18 Years",null,{"inclusion":62,"exclusion":69,"raw_text":72},[63,64,65,66,67,68],"Patient-defined regular use of methamphetamine in the last year","Any methamphetamine use in the past 30 days","Age 18 years or older","No client-reported diagnosis of heart failure","Able to communicate in English","Screen positive for potential methamphetamine-associated heart failure (MAHF) defined as B type natriuretic peptide (BNP) ≥50 pg\u002Fml, or QRS width ≥120ms, or presence of any clinical heart failure symptoms",[70,71],"Self-reported engagement in medical care for heart failure in past 6 months.","Actively taking medications for heart failure.","Inclusion Criteria:\n\n* Patient-defined regular use of methamphetamine in the last year\n* Any methamphetamine use in the past 30 days\n* Age 18 years or older\n* No client-reported diagnosis of heart failure\n* Able to communicate in English\n* Screen positive for potential methamphetamine-associated heart failure (MAHF) defined as B type natriuretic peptide (BNP) ≥50 pg\u002Fml, or QRS width ≥120ms, or presence of any clinical heart failure symptoms\n\nExclusion Criteria:\n\n* Self-reported engagement in medical care for heart failure in past 6 months.\n* Actively taking medications for heart failure.",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":78,"status":7,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":89},"Oregon Health & Science University","Portland","Oregon","97239","United States",[84],{"name":85,"role":86,"phone":87,"email":88},"Brian Chan, MD, MPH","CONTACT","503-494-2010","chanbri@ohsu.edu",{"lat":90,"lon":91},45.52345,-122.67621,[93,94],{"name":85,"role":86,"phone":87,"email":88},{"name":95,"role":86,"email":96},"Kellie Pertl, MPH","pertl@ohsu.edu",[98],{"name":85,"affiliation":12,"role":99},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":103,"biomarkers":104},[19,18],[105],"NPPB wt Allele",{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 200 participants.","completed","Rural Community Peer Partnerships for Methamphetamine-Associated Heart Failure","This study, called PEER-Heart, is looking at ways to improve how people in rural areas who use methamphetamine get screened for and treated for heart failure related to methamphetamine use. You might be able to join if you are 18 or older, have used methamphetamine in the last year and past 30 days, and don't have a current heart failure diagnosis. You would also need to screen positive for potential methamphetamine-associated heart failure (MAHF) based on certain blood tests (BNP levels) or heart measurements (QRS width). The study is comparing two approaches: one where a peer helps you get referred to a local doctor, and another where a peer helps you get a virtual appointment with a heart specialist. The main goal is to see if these approaches help people connect with heart care within two months. The study aims to enroll 200 people and its current status is unclear.","Participants will be followed for linkage to cardiology care, measured at 2 months.",150,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]