Methamphetamine UsePEER-HeartNCT06461962
Rural Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement
A study testing Treatment as Usual and Telehealth-Cardiology in people with Methamphetamine Use and Heart Failure, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Use, Heart Failure
- What is being tested?
- Treatment as Usual and Telehealth-Cardiology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 30 Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Self-reported engagement in medical care for heart failure in past 6 months.
- Actively taking medications for heart failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kellie Pertl, MPH contact
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Brian Chan, MD, MPH, 503-494-2010, chanbri@ohsu.edu
About this study
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.
Read the detailed 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.
- Conditions
- Methamphetamine Use, Heart Failure
- Being tested
- Treatment as Usual, Telehealth-Cardiology
- Keywords
- Screening, Implementation Science, Heart Failure, Addiction, Stimulants, Health Services, Community Engaged Research
- Medical subject headings
- Heart Failure, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as UsualOther
Peer-facilitated referral to a local primary care provider to follow-up their screening results.
Telehealth-CardiologyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Peer-supported Treatment as Usual | Active comparator | Participants will receive a peer-supported referral to a local primary care provider who will create a plan to treat the participants heart failure. Receives: Other: Treatment as Usual |
| Peer-Supported Telehealth Cardiology | Experimental | Participants will receive a virtual consultation with a cardiovascular specialist, referral for a locally performed echocardiogram (ECG), and transitional care management facilitated by a remote nurse care manager and the peer to treat the participants heart failure. Receives: Other: Telehealth-Cardiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to cardiology care
Proportion of participants who are engaged in cardiac care at 2 months after screening.
Measured: 2 months
Secondary outcomes (2)
Linkage to diagnostic echocardiogram
Proportion of participants who complete a diagnostic echocardiogram within 2 months after randomization.
Measured: 2 months
Goal Directed Medical Therapy (GDMT) prescribed
Proportion of eligible patients who are on any GDMT at 6 months after randomization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start19 Aug 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Bay Area First Step
- Responsible party
- Principal investigator, Brian L Chan, Oregon Health and Science University
- Investigators
- Brian Chan, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461962
- Sponsor's protocol ID
- STUDY00026150
- Acronym
- PEER-Heart
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared following data lock with the data coordinating center at University of Washington.