Peer Partnerships for Methamphetamine-Associated Heart Failure

(PEER-Heart Trial)

Overseen By Kellie Pertl, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Heart failure medications

Disqualifiers: Heart failure care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to identify and treat heart issues related to methamphetamine use in rural communities. It focuses on collaborating with local community partners to screen for methamphetamine-associated heart failure and connect individuals to heart care. Participants will either receive support to visit a local doctor or have virtual consultations with heart specialists. Known as Rural Community Peer Partnerships, this trial may suit individuals who have used methamphetamine regularly in the past year, have not received treatment for heart failure in the last six months, and might exhibit symptoms of heart failure. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart care solutions in rural areas.

Will I have to stop taking my current medications?

If you are currently taking medications for heart failure, you cannot participate in this trial. The trial does not specify if you need to stop other medications, so it's best to discuss with the trial team.

What prior data suggests that this protocol is safe for methamphetamine-associated heart failure screening?

Research has shown that community peer partnerships, such as those in the Peer-Supported Telehealth Cardiology treatment, are generally safe. These partnerships connect individuals with healthcare providers and offer support throughout the process. Past studies have received this approach well.

Since this trial involves a new method of providing care rather than a new drug or medical procedure, the safety concerns differ. The main focus is on how well individuals accept and use this support system. Reports have not indicated any harmful effects from using peer partnerships for healthcare support.

For the Peer-Supported Telehealth Cardiology treatment, some studies have shown that video consultations with specialists and tests like heart ultrasounds are safe and well-received by patients. The treatment's safety largely depends on the technology functioning properly and the support from peers and nurses.

In summary, the safety of these treatments appears promising, as they utilize existing, tested healthcare methods with added community support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatment approaches for methamphetamine-associated heart failure because they leverage peer support and telehealth, offering a fresh angle compared to traditional care. The "Peer-supported Treatment as Usual" method is distinctive as it integrates peer partnerships to guide patients to local primary care for personalized heart failure management, adding a supportive dimension that can enhance adherence and outcomes. Meanwhile, the "Peer-Supported Telehealth Cardiology" approach stands out by providing virtual access to cardiologists and remote care management, making specialized heart care more accessible in rural areas. These innovations could be game-changers in providing more personalized and accessible care for heart failure patients linked to methamphetamine use.

What evidence suggests that this trial's treatments could be effective for methamphetamine-associated heart failure?

Research has shown that similar telehealth methods, supported by peers, have been promising in improving heart failure care, especially in rural areas. In this trial, participants in the Peer-Supported Telehealth Cardiology arm will receive virtual consultations with heart specialists, enabling them to access expert care without traveling long distances. For those with heart failure linked to methamphetamine use, this method can be vital for receiving timely treatment. Participants in the Peer-supported Treatment as Usual arm will receive peer-supported referrals to local primary care providers. The peer-supported system in both arms connects patients to the heart care they need, potentially leading to better health. This strategy aims to simplify access to necessary heart care for people in rural areas. ^{1 2 3 4 6}

Who Is on the Research Team?

Brian Chan, MD, MPH

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for individuals in rural areas who use methamphetamine and may have heart failure linked to drug use. They should be willing to undergo screening and follow-up care via telehealth with a cardiology specialist.

Inclusion Criteria

I have never been diagnosed with heart failure.

Able to communicate in English

Patient-defined regular use of methamphetamine in the last year

Exclusion Criteria

I am currently on medication for heart failure.

I have been actively seeking treatment for heart failure in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peer-supported Treatment

Participants receive a peer-supported referral to a local primary care provider for heart failure treatment

2 months

1 visit (in-person), multiple virtual consultations

Peer-Supported Telehealth Cardiology

Participants receive a virtual consultation with a cardiovascular specialist and transitional care management

2 months

1 virtual consultation, ongoing remote management

Follow-up

Participants are monitored for engagement in cardiac care and completion of diagnostic echocardiogram

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Rural Community Peer Partnerships

Trial Overview The study is testing if having community peers help with screening for heart issues caused by methamphetamine, plus getting cardiology care through telehealth, can work well in rural settings.

How Is the Trial Designed?

Group I: Peer-Supported Telehealth Cardiology Experimental Treatment 1 Intervention

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.

Group II: Peer-supported Treatment as Usual Active Control 1 Intervention

Participants will receive a peer-supported referral to a local primary care provider who will create a plan to treat the participants heart failure.

Rural Community Peer Partnerships is already approved in United States for the following indications:

Approved in United States as PEER-Heart for:

• Methamphetamine-associated heart failure screening and engagement

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Bay Area First Step

Collaborator

Trials

1

Recruited

200+

Published Research Related to This Trial

The PROUD-R2 study aims to improve retention in clinical trials for rural people who use drugs (PWUD) by testing a peer-driven intervention, involving 'study buddies' to support participants, across 21 rural counties in Kentucky, Ohio, and Oregon.

Participants in the study will be randomly assigned to either a control group receiving standard outreach or an intervention group with a study buddy, with assessments conducted at 6 and 12 months to evaluate the effectiveness of these retention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-based Retention Of people who Use Drugs in Rural Research (PROUD-R2): a multisite, randomised, 12-month trial to compare efficacy of standard versus peer-based approaches to retain rural people who use drugs in research. Young, AM., Lancaster, KE., Bielavitz, S., et al.[2022]

A study involving 32 participants indicated that a peer recovery specialist-delivered behavioral activation intervention could be both feasible and acceptable for supporting retention in methadone treatment for opioid use disorder.

Participants highlighted the potential of this intervention to address challenges related to unstructured time in treatment, suggesting that peer support could enhance engagement and outcomes for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sometimes you have to take the person and show them how": adapting behavioral activation for peer recovery specialist-delivery to improve methadone treatment retention. Kleinman, MB., Anvari, MS., Bradley, VD., et al.[2023]

In a study of 710 rural stimulant users over three years, 34-39% reported using outpatient medical care (OMC), with an average of 1-2 visits, highlighting a significant but underutilized resource for managing substance use.

Factors such as having medical insurance and previous engagement in substance use disorder care increased the likelihood and frequency of OMC use, while being male and having more severe addiction issues were linked to lower usage rates, indicating a need for targeted public health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of three-year outpatient medical care use among rural stimulant users. Cucciare, MA., Han, X., Timko, C., et al.[2018]

Training drug users from Puerto Rico in methadone maintenance programs to conduct HIV-related peer outreach led to positive short-term outcomes, including increased community engagement and discussions about HIV.

Participants who conducted outreach reported feeling more helpful to their community and showed a trend towards more vocational activities compared to those who did not participate in outreach, indicating the potential effectiveness of peer outreach models in addressing HIV risk behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conducting peer outreach to migrants: outcomes for drug treatment patients. Deren, S., Kang, SY., Mino, M., et al.[2021]

Peer outreach initiatives in Dakar, Senegal, show promise in reducing harm related to drug use by fostering community-level change and responsibilization among individuals who use drugs, based on qualitative interviews with 44 participants.

The study highlights the importance of peer educators in delivering harm reduction activities, but emphasizes that for these initiatives to be truly effective, broader structural changes are necessary to support sustainable health improvements and prevent the potential for these programs to shift responsibility solely onto individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"They accept me, because I was one of them": formative qualitative research supporting the feasibility of peer-led outreach for people who use drugs in Dakar, Senegal. Stengel, CM., Mane, F., Guise, A., et al.[2019]

The W3 Project, a 5-year study involving peer organizations and researchers, highlighted the importance of recognizing people who use drugs (PWUD) as active participants in research, rather than just subjects or consultants.

The study identified that meaningful participation of PWUD in research is influenced by system-level factors, suggesting that enhancing their involvement requires addressing broader community and policy systems, not just focusing on research methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving meaningful participation of people who use drugs and their peer organizations in a strategic research partnership. Brown, G., Crawford, S., Perry, GE., et al.[2020]

The study outlines a successful low-barrier hiring process for Peer Research Associates (PRAs) from affected communities, specifically targeting people living with HIV who have a history of illicit drug use, to enhance community engagement in research.

Over a 2-year period, this model effectively employed five PRAs, demonstrating that meaningful involvement of affected communities can lead to better research outcomes and opportunities for future employment in community-based participatory research projects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaningful engagement of people living with HIV who use drugs: methodology for the design of a Peer Research Associate (PRA) hiring model. Closson, K., McNeil, R., McDougall, P., et al.[2018]

The Risk Avoidance Partnership trained active drug users as peer health advocates (PHAs), who effectively conducted harm reduction outreach from 2001 to 2005, demonstrating their ability to provide critical HIV prevention materials in both public and high-risk settings.

PHAs were seen as credible and trusted sources of information by their peers, which highlights the importance of peer-led interventions in HIV prevention and the need for process evaluations to refine such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Times and places: Process evaluation of a peer-led HIV prevention intervention. Dickson-Gomez, J., Weeks, M., Martinez, M., et al.[2021]

The PEER program effectively identified clients with substance use disorders who had high needs for social support and were at risk of recidivism, demonstrating its potential to address complex health and social issues among this population.

Despite challenges in client contact and funding stability, the program's sustainability was rated as stable, suggesting that with adjustments to service delivery and risk stratification, it could be further optimized for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Where It Really Counts: Feasibility and Potential of the Peer Engaged Empowered Recovery Program for Substance-Dependent Jail Inmates. Parekh, T., Cuellar, AE., Farina-Morse, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06461962

Study Details | NCT06461962 | Rural Community Peer ... The PEER-Heart study aims to demonstrate feasibility of screening of MAHF and linkage to evidence-based cardiology care for people who use ...

2. newsroom.heart.org newsroom.heart.org/news/20-million-awarded-for-scientific-research-to-address-health-challenges-in-rural-areas

$20 million awarded for scientific research to address ... Similar peer-based telemedicine approaches may also improve heart failure care in rural Oregon communities where 97% of people who use drugs ...

3. ruralprocare.org ruralprocare.org/project/peer-heart/

PEER-Heart The overarching goal of PEER-Heart is to improve screening of MAHF and linkage to evidence-based cardiology care for people who use methamphetamine in rural ...

4. smartpatients.com smartpatients.com/trials/NCT06461962

Rural Community Peer Partnerships for Improving ... The goal of PEER-Heart is to implement and assess feasibility and preliminary effectiveness of a community peer-facilitated screening for methamphetamine- ...

5. researchgate.net researchgate.net/publication/388637642_Rural_Community_Peer_Partnerships_for_Improving_Methamphetamine-Associated_Heart_Failure_Screening_and_Engagement_PEER-HEART_A_Research_and_Implementation_Protocol

Rural Community Peer Partnerships for Improving ... ... Community Peer Partnerships for Improving Methamphetamine-Associated Heart Failure Screening and Engagement (PEER-HEART): A Research and Implementation ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39733607/

Clinical characteristics and outcomes in a safety net population Despite having higher all-cause and HF readmission risk, individuals with methamphetamine-associated HF did not have higher mortality risk.