Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement

Heart Failure Clinical Trial

— PEER-Heart  

Official title:

Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06461962
• Other study ID #: STUDY00026150
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: June 30, 2029

Study information

• Verified date: June 2024
• Source: Oregon Health and Science University
• Contact: Brian Chan, MD, MPH
• Phone: 503-494-2010
• Email: chanbri[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. Despite 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. Team-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. The "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. The 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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/ml, or QRS width =120ms, or presence of any clinical heart failure symptoms

Exclusion Criteria:

• Self-reported engagement in medical care for heart failure in past 6 months.
• Actively taking medications for heart failure.

Related Conditions & MeSH terms

• Heart Failure
• Methamphetamine Use

Intervention

Other:
• Treatment as Usual
Peer-facilitated referral to a local primary care provider to follow-up their screening results.
• 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 Referral for a locally performed testing including echocardiogram Transitional care management facilitated by a remote nurse care manager and the peer

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Bay Area First Step, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage to cardiology care	Proportion of participants who are engaged in cardiac care at 2 months after screening.	2 months
Secondary	Linkage to diagnostic echocardiogram	Proportion of participants who complete a diagnostic echocardiogram within 2 months after randomization.	2 months
Secondary	Goal Directed Medical Therapy (GDMT) prescribed	Proportion of eligible patients who are on any GDMT at 6 months after randomization	6 months