Peer Recovery Coaching for Substance Use Disorders

(LINCS UP: RCT Trial)

Overseen By Joseph E Carpenter, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Unstable medical, Unstable psychiatric, Prisoner, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Immediate intervention during ED visit

600 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a 3-arm randomized controlled trial. Participants will be randomized via a maximally tolerated imbalance randomization procedure using NCI's Clinical Trial Randomization Tool with 1:1:1 allocation to each group: in-person peer recovery coaching (PRC) with linkage to recovery resources, telemedicine-based peer recovery coaching with linkage to recovery resources, or usual care. In the PRC arms, PRCs will meet patients at bedside (in person) or via a tablet-based video call (telemedicine). They will assess the participant's state of change, engage in motivational interviewing techniques, and link the participant to community-based recovery resources according to the needs of the participant. They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed. Participants in the usual care arm will be provided with a list of community recovery resources, but there will be no PRC interaction or direct linkage to resources through the study. Follow up visits will take place at 7, 30, and 90 days after enrollment. Most will take place via telephone, but participants will be given the option of an in-person visit if they so desire.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the idea that Peer Recovery Coaching for Substance Use Disorders is an effective treatment?

The available research shows that Peer Recovery Coaching can be effective in helping people with substance use disorders. For example, one study found that it increases engagement in recovery services and can lead to cost savings by reducing the need for emergency care. Another study showed that adding peer support to standard care for people with both mental health and substance use issues helped reduce alcohol use and improve participation in outpatient services. Overall, these findings suggest that Peer Recovery Coaching can enhance recovery efforts and improve outcomes for individuals with substance use disorders. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Peer Recovery Coaching for Substance Use Disorders?

Research shows that peer recovery coaching can help people with substance use disorders by increasing their engagement in recovery services and reducing the use of acute care. Additionally, adding peer support to standard care can lead to reduced substance use and improved functioning over time. ^{1 2 3 4 5}

What safety data is available for peer recovery coaching in substance use disorders?

The provided research does not directly address safety data for peer recovery coaching in substance use disorders. The studies focus on patient safety reporting, adverse event reporting systems, and patient involvement in safety, but do not specifically evaluate the safety of peer recovery coaching or related interventions. ^{6 7 8 9 10}

Is peer recovery coaching a promising treatment for substance use disorders?

Yes, peer recovery coaching is a promising treatment for substance use disorders. It helps people set and achieve recovery goals, provides support in accessing treatment, and is especially useful for those facing barriers to care. It is a resource-efficient way to increase access to recovery services, particularly in low-income and minority communities. ^{1 5 11 12 13}

How is peer recovery coaching different from other treatments for substance use disorders?

Peer recovery coaching is unique because it involves individuals who have personal experience with substance use disorders helping others in their recovery journey. This approach is community-based and focuses on linking people to recovery resources and supporting them in overcoming barriers to treatment, especially in low-resource settings. ^{1 5 11 12 13}

Research Team

Joseph Carpenter, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for adults over 18 who visit the emergency department during certain hours, score moderately to severely on a drug abuse screening test, are sober enough to consent, speak English, and can be contacted reliably. It's not for prisoners, previous participants, those already in recovery programs or if too unstable medically or mentally.

Inclusion Criteria

Score of 3 or greater on Drug Abuse Screening Test (DAST-10) indicating moderate, substantial, or severe level of problems related to drug abuse

I am willing to follow the study's procedures and answer follow-up calls.

I have provided two reliable contact numbers, including mine.

Exclusion Criteria

Medically or psychiatrically unstable as determined by treating physician

Prisoner or in police custody

Actively engaged with recovery resources in the local community

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive peer recovery coaching either in-person or via telemedicine, or usual care with a list of community recovery resources

Immediate intervention during ED visit

1 visit (in-person or virtual)

Follow-up

Follow-up calls and data collection at 7, 30, and 90 days post-discharge to provide ongoing support and facilitate re-linkage to recovery resources

90 days

3 follow-up calls (telephone or in-person)

Long-term monitoring

Participants are monitored for changes in substance use, overdose events, and other health outcomes

90 days post intervention

Treatment Details

Interventions

• Peer recovery coaching with linkage to recovery resources
• Usual Care

Trial Overview The study tests two methods of peer recovery coaching (PRC) against usual care for substance use disorders. One group gets in-person PRC with resource linkage; another has telemedicine-based PRC; the third receives standard care lists without direct support. Follow-ups occur at 7, 30, and 90 days post-enrollment.

Participant Groups

Group I: Telemedicine-based peer recovery coaching with linkage to recovery resources Experimental Treatment 1 Intervention

PRCs will meet patients via a tablet-based video call (telemedicine). They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed. Follow-up data collection on day 7, 30, 90 post discharge.

Group II: In-person peer recovery coaching with linkage to recovery resources Experimental Treatment 1 Intervention

PRCs will meet patients at bedside (in person). They will also schedule and perform follow up calls after the participant is discharged from the ED to provide ongoing support and facilitate re-linkage to recovery resources, if needed. Follow-up data collection on day 7, 30, 90 post discharge.

Group III: Usual Care Active Control 1 Intervention

Participants in the usual care arm will be provided with a list of community recovery resources. No callbacks or re-linkage to recovery resources. Follow-up data collection on day 7, 30, 90 post discharge.

Peer recovery coaching with linkage to recovery resources is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Peer Recovery Coaching for:

• Substance Use Disorders

Approved in Canada as Peer Recovery Support Services for:

• Substance Use Disorders
• Mental Health Disorders

Approved in European Union as Peer Recovery Coaching for:

• Substance Use Disorders
• Addiction Recovery

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Findings from Research

Peer recovery support services are increasingly recognized as valuable in treating substance use disorders, offering a broader range of support than traditional mutual support groups.

The literature review highlights the need for more research to clearly differentiate the specific benefits of peer recovery support services from other recovery activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer recovery support for individuals with substance use disorders: assessing the evidence. Reif, S., Braude, L., Lyman, DR., et al.[2015]

Peer recovery support services (PRSS) have been integrated into the recovery process for opioid use disorder (OUD), but their effectiveness on clinical outcomes remains unclear, as only 12 out of 123 studies met the inclusion criteria for review.

Most studies reported on PRSS engagement and medication for OUD (MOUD) initiation, but findings were inconsistent and varied due to the lack of standardized PRSS interventions and methodological limitations, indicating a need for further research before widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of peer recovery support services on stages of the opioid use disorder treatment cascade: A systematic review. Gormley, MA., Pericot-Valverde, I., Diaz, L., et al.[2022]

The study involving 193 inpatient adults with substance use disorder found that peer recovery coaches (PRCs) did not significantly reduce overall acute care utilization, but they did lead to a notable decrease in emergency department visits for mental/behavioral issues.

While there was no significant impact on 30-day readmissions or other types of acute care encounters, the results suggest that PRCs may be effective in reducing specific emergency encounters related to substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Care Utilization After Recovery Coaching Linkage During Substance-Related Inpatient Admission: Results of Two Randomized Controlled Trials. Cupp, JA., Byrne, KA., Herbert, K., et al.[2023]

In a study of 137 adults with co-occurring psychosis and substance use disorders, adding peer recovery supports to standard care improved engagement in treatment and reduced alcohol use over time.

At three months, skills training alone helped reduce symptoms and alcohol use, while peer support enhanced social connections and outpatient service use; by nine months, it further decreased symptoms and inpatient readmissions, highlighting the long-term benefits of peer support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing outcomes for persons with co-occurring disorders through skills training and peer recovery support. O'Connell, MJ., Flanagan, EH., Delphin-Rittmon, ME., et al.[2020]

A six-month study involving 98 hospitalized individuals with Substance Use Disorder showed that those receiving peer recovery coaching had significantly higher engagement in recovery support services (84%) compared to those receiving standard care (34%).

Despite the increased engagement, the study found no significant differences in substance use frequency or self-reported physical and mental health between the two groups, suggesting that while recovery coaching improves service engagement, it may not immediately impact substance use or health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatient link to peer recovery coaching: Results from a pilot randomized control trial. Byrne, KA., Roth, PJ., Merchant, K., et al.[2021]

Industry-sponsored program reports in the FDA Adverse Event Reporting System were associated with a higher percentage of serious outcomes compared to non-industry-sponsored reports (58.8% vs. 51.4%), indicating they may capture more severe adverse events.

Despite containing more data elements, the overall usefulness of industry-sponsored and non-industry-sponsored reports for safety signal detection was similar, with only a small percentage of reports (4% for non-industry and 6.2% for industry) identifying serious, unlabeled adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance. Harinstein, L., Kalra, D., Kortepeter, CM., et al.[2020]

The project aims to develop two key patient safety interventions: a Patient Measure of Organisational Safety (PMOS) and a Patient Incident Reporting Tool (PIRT) to enhance learning about safety incidents in the NHS, involving 300 patients and multiple focus groups for development.

Both tools will be rigorously tested for validity and reliability, with the PMOS assessing patient perceptions of safety and the PIRT enabling patients to report incidents, ultimately aiming to improve patient safety across NHS hospital trusts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting. Ward, JK., McEachan, RR., Lawton, R., et al.[2021]

In a study involving 1329 patients from primary care settings in Australia and England, 5.3% reported safety incidents over the past year, with the most common issues being delays in accessing care and problems with diagnosis and assessment.

The study highlighted that patient-reported incidents often differ from those reported by staff, underscoring the importance of including patient perspectives to improve safety and service quality in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nature and type of patient-reported safety incidents in primary care: cross-sectional survey of patients from Australia and England. Hernan, AL., Giles, SJ., Carson-Stevens, A., et al.[2023]

Since the FDA began posting potential signals of serious risks in 2008, 555 signals have been identified, with nearly 80% leading to updates in product labeling, highlighting the program's effectiveness in enhancing drug safety.

The majority of updates focused on Warnings and Precautions, indicating ongoing concerns about product-use errors and drug-drug interactions, particularly in vulnerable populations like children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of FDA Amendments Act Section 921 Experience in Posting Data-mining Results from the FAERS Database. Beninger, P., Murray, M.[2021]

This study aims to assess the feasibility of a patient safety guide for primary care, involving 120 patients and/or carers across 8 general practices in the UK, to enhance patient safety and empowerment.

The intervention will evaluate its acceptability and potential impact on patient safety, health status, and healthcare utilization over a 6-month period, with results informing future larger effectiveness trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a non-randomised feasibility study evaluating a codesigned patient safety guide in primary care. Morris, RL., Gallacher, K., Hann, M., et al.[2023]

In a community-based program in Baltimore, a peer recovery coach (PRC) successfully linked 64.1% of interested clients to substance use treatment, demonstrating the effectiveness of peer support in overcoming barriers to care.

After 30 days, 52% of clients who were linked to treatment remained engaged, and even among those who dropped out, 77% continued to maintain contact with the PRC, indicating ongoing support is crucial for retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a peer recovery coach model to reach low-income, minority individuals not engaged in substance use treatment. Kleinman, MB., Doran, K., Felton, JW., et al.[2022]

Peer recovery coaches, who are individuals in sustained recovery from substance use, are a promising and efficient way to improve access to substance use services in low-resource communities, but they face significant barriers in their integration into existing recovery services.

Focus group discussions revealed that peer recovery coaches often feel a mismatch between their expected roles and actual responsibilities, along with personal challenges that can affect their own recovery, highlighting the need for policy and structural changes to better support them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Recovery Coaches Perceptions of Their Work and Their Implications for Training, Support and Personal Recovery. Felton, JW., Abidogun, TM., Senters, K., et al.[2023]

A study involving 17 peer support workers in Egypt revealed that these individuals play a crucial role in helping others with substance use disorders by providing recovery support through shared experiences.

The research highlighted the need for greater organizational and governmental support for peer support workers, as well as public education about their important role in recovery, to enhance the effectiveness of substance use disorder interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of peer support workers supporting individuals with substance use disorders in Egypt: phenomenological analysis. Ibrahim, N., Selim, A., Ng, F., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Peer recovery support for individuals with substance use disorders: assessing the evidence. [2015]

2. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of peer recovery support services on stages of the opioid use disorder treatment cascade: A systematic review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Acute Care Utilization After Recovery Coaching Linkage During Substance-Related Inpatient Admission: Results of Two Randomized Controlled Trials. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Enhancing outcomes for persons with co-occurring disorders through skills training and peer recovery support. [2020]

5. Ireland pubmed.ncbi.nlm.nih.gov

Inpatient link to peer recovery coaching: Results from a pilot randomized control trial. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Patient involvement in patient safety: Protocol for developing an intervention using patient reports of organisational safety and patient incident reporting. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Nature and type of patient-reported safety incidents in primary care: cross-sectional survey of patients from Australia and England. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Review of FDA Amendments Act Section 921 Experience in Posting Data-mining Results from the FAERS Database. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Protocol for a non-randomised feasibility study evaluating a codesigned patient safety guide in primary care. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Implementing a peer recovery coach model to reach low-income, minority individuals not engaged in substance use treatment. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Peer Recovery Coaches Perceptions of Their Work and Their Implications for Training, Support and Personal Recovery. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Experiences of peer support workers supporting individuals with substance use disorders in Egypt: phenomenological analysis. [2022]