LINCS UP: RCT: Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches

Sponsor
Emory University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05847621
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
600
1
3
19
31.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer recovery coaching with linkage to recovery resources
  • Behavioral: Usual Care
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Linking Individuals Needing Care for Substance Use Disorders in Urban Emergency Departments to Peer Coaches (LINCS UP): RCT Component
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: In-person peer recovery coaching with linkage to recovery resources

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.

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.

Experimental: Telemedicine-based peer recovery coaching with linkage to recovery resources

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.

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.

Active Comparator: Usual Care

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.

Behavioral: Usual Care
Participants will be provided with a list of community recovery resources.

Outcome Measures

Primary Outcome Measures

  1. Change in number of participants with successful linkage to at least one recovery resource [Baseline, 30 and 90 days after enrollment]

    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.

Secondary Outcome Measures

  1. Change in Brief Assessment of Recovery Capital (BARC-10) [Baseline, 7, 30, and 90 days after enrollment]

    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.

  2. Change in number of successful engagements with PRC after ED visit [Baseline, 7, 30, and 90 days after enrollment]

    Change in number of successful engagements with PRC (peer recovery coach) after ED visit

  3. Change in number of episodes of re-linkage to recovery resources [Baseline, 7, 30, and 90 days post intervention]

    Change in number of episodes of re-linkage to recovery resources

  4. Self-reported substance use in last 30 days [Baseline, 30 and 90 days post intervention]

    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.

  5. Number of fatal overdose events [90 days post intervention]

    Number of fatal overdose events will be collected

  6. Number of nonfatal overdose events [90 days post intervention]

    Number of nonfatal overdose events will be collected

  7. Number of Emergency Department (ED) visits [90 days post intervention]

    Number of ED visits will be collected

  8. Number of hospitalizations [90 days post intervention]

    Number of hospitalizations will be collected

  9. Change in employment status [90 days post intervention]

    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.

  10. Change in number of participants based on Housing status [Baseline, 7, 30, and 90 days post intervention]

    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.

  11. Change in Social connections and isolation score [Baseline, 7, 30, 90 days post intervention]

    Social isolation scores range from 0 to 4, with 0 representing the highest level of social isolation and 4 representing the lowest level.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Grady Memorial Hospital Atlanta Georgia United States 30303

Sponsors and Collaborators

  • Emory University
  • Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Joseph E Carpenter, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joseph Carpenter, Assistant Professor, Emory University
ClinicalTrials.gov Identifier:
NCT05847621
Other Study ID Numbers:
  • STUDY00005553
  • R01CE003509
First Posted:
May 6, 2023
Last Update Posted:
May 9, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2023