Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches

Substance Use Disorders Clinical Trial

— LINCS UP: RCT  

Official title:

Linking Individuals Needing Care for Substance Use Disorders in Urban Emergency Departments to Peer Coaches (LINCS UP): RCT Component

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847621
• Other study ID #: STUDY00005553
• Secondary ID: R01CE003509
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2023
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: Emory University
• Contact: Joseph E Carpenter, MD
• Phone: (404) 585-0218
• Email: jecarpe[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Deaths from drug overdose have risen to record levels since the onset of the COVID-19 pandemic, disproportionately impacting Black individuals and people experiencing homelessness. Fewer than one-third of the 8.3 million individuals living with an illicit drug use disorder in 2019 reported receiving treatment. Telemedicine services have increased access to care for many patients living with substance use disorders (SUD), but the long-term role of this treatment approach in SUD care is uncertain. Multifaceted strategies are needed to build recovery capital and link vulnerable individuals to recovery resources.

Emergency department (ED) visits are an opportunity to screen for SUDs, initiate treatment, and link to recovery resources. Observational studies have noted that consultation with a peer recovery coach (PRC) was well-received in EDs, with high rates of engagement and satisfaction. PRCs facilitate conversations allowing patients to express their ideal pathway to recovery, provide linkage to services across the social ecology, and follow up to support recovery, including re-linkage to resources as needed. Nonetheless, their role in ED screening and linkage to resources, including the potential role of telemedicine, has not been rigorously evaluated.

The investigators will conduct a randomized controlled trial enrolling 600 subjects across three arms: in-person peer coaching with linkage to recovery support services and callbacks, telemedicine-based peer coaching with linkage and callbacks, or usual care. Results will inform other EDs considering a peer recovery coach program for patients presenting with SUD-related conditions. By utilizing telemedicine, this model will be rapidly scalable and readily implemented at other facilities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. ED patient presenting during screening hours

2. Age 18 years or older

3. Able to speak and understand English

4. Clinically sober, able to provide informed consent

5. Score of 3 or greater - "moderate level", "substantial level", or "severe level" of problems related to drug abuse - on Drug Abuse Screening Test (DAST-10).(103, 104)

6. Willing to follow study procedures and complete research follow-up calls

7. Have at least two reliable contact numbers, e.g. subject and one or more relatives or close friends

Exclusion Criteria:

1. Medically or psychiatrically unstable as determined by treating physician

2. Prisoner or in police custody

3. Actively engaged with recovery resources in the local community

4. Prior participation in the study

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Peer recovery coaching with linkage to recovery resources
Peer recovery coach (PRC) assessment of 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.
• Usual Care
Participants will be provided with a list of community recovery resources.

Locations

Country	Name	City	State
United States	Grady Memorial Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of participants with successful linkage to at least one recovery resource	Change in number of participants with successful linkage to at least one recovery resource (formal addiction treatment, Recovery Community Organization (RCO), or harm reduction organization) at 30 days and 90 days after enrollment.	Baseline, 30 and 90 days after enrollment
Secondary	Change in Brief Assessment of Recovery Capital (BARC-10)	This outcome will be evaluated obtaining a score on a scale. The range of possible responses is 10-60. Higher score correlates with better outcome.	Baseline, 7, 30, and 90 days after enrollment
Secondary	Change in number of successful engagements with PRC after ED visit	Change in number of successful engagements with PRC (peer recovery coach) after ED visit	Baseline, 7, 30, and 90 days after enrollment
Secondary	Change in number of episodes of re-linkage to recovery resources	Change in number of episodes of re-linkage to recovery resources	Baseline, 7, 30, and 90 days post intervention
Secondary	Self-reported substance use in last 30 days	Self-reported substance use in last 30 days as measured by Timeline Follow-back (TLFB). It will be reported in number of episodes per day.	Baseline, 30 and 90 days post intervention
Secondary	Number of fatal overdose events	Number of fatal overdose events will be collected	90 days post intervention
Secondary	Number of nonfatal overdose events	Number of nonfatal overdose events will be collected	90 days post intervention
Secondary	Number of Emergency Department (ED) visits	Number of ED visits will be collected	90 days post intervention
Secondary	Number of hospitalizations	Number of hospitalizations will be collected	90 days post intervention
Secondary	Change in employment status	Choices include: disabled, employed 32 hours or more per week, employed less than 32 hours per week, full-time student, homemaker, on medical leave, only temporarily laid off/sick leave/maternity leave, other, part-time student, retired, unemployed, and unknown. This outcome would measure a change in employment status from any of the choices to another one.	90 days post intervention
Secondary	Change in number of participants based on Housing status	Housing status will be reported specifying one of the categories: apartment, Single family house, homeless, shelter, dormitory, multifamily house. Number of participants will be reported in each category at 0, 7, 30, 90 days post intervention.	Baseline, 7, 30, and 90 days post intervention
Secondary	Change in Social connections and isolation score	Social isolation scores range from 0 to 4, with 0 representing the highest level of social isolation and 4 representing the lowest level.	Baseline, 7, 30, 90 days post intervention