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

Primary Purpose

Substance Use Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer recovery coaching with linkage to recovery resources
Usual Care
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ED patient presenting during screening hours Age 18 years or older Able to speak and understand English Clinically sober, able to provide informed consent 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) Willing to follow study procedures and complete research follow-up calls Have at least two reliable contact numbers, e.g. subject and one or more relatives or close friends 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 Prior participation in the study

Sites / Locations

  • Grady Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

In-person peer recovery coaching with linkage to recovery resources

Telemedicine-based peer recovery coaching with linkage to recovery resources

Usual Care

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Change in number of episodes of re-linkage to recovery resources
Change in number of episodes of re-linkage to recovery resources
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.
Number of fatal overdose events
Number of fatal overdose events will be collected
Number of nonfatal overdose events
Number of nonfatal overdose events will be collected
Number of Emergency Department (ED) visits
Number of ED visits will be collected
Number of hospitalizations
Number of hospitalizations will be collected
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.
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.
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.

Full Information

First Posted
April 27, 2023
Last Updated
August 16, 2023
Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05847621
Brief Title
Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches
Acronym
LINCS UP: RCT
Official Title
Linking Individuals Needing Care for Substance Use Disorders in Urban Emergency Departments to Peer Coaches (LINCS UP): RCT Component
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-person peer recovery coaching with linkage to recovery resources
Arm Type
Experimental
Arm Description
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.
Arm Title
Telemedicine-based peer recovery coaching with linkage to recovery resources
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer recovery coaching with linkage to recovery resources
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants will be provided with a list of community recovery resources.
Primary Outcome Measure Information:
Title
Change in number of participants with successful linkage to at least one recovery resource
Description
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.
Time Frame
Baseline, 30 and 90 days after enrollment
Secondary Outcome Measure Information:
Title
Change in Brief Assessment of Recovery Capital (BARC-10)
Description
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.
Time Frame
Baseline, 7, 30, and 90 days after enrollment
Title
Change in number of successful engagements with PRC after ED visit
Description
Change in number of successful engagements with PRC (peer recovery coach) after ED visit
Time Frame
Baseline, 7, 30, and 90 days after enrollment
Title
Change in number of episodes of re-linkage to recovery resources
Description
Change in number of episodes of re-linkage to recovery resources
Time Frame
Baseline, 7, 30, and 90 days post intervention
Title
Self-reported substance use in last 30 days
Description
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.
Time Frame
Baseline, 30 and 90 days post intervention
Title
Number of fatal overdose events
Description
Number of fatal overdose events will be collected
Time Frame
90 days post intervention
Title
Number of nonfatal overdose events
Description
Number of nonfatal overdose events will be collected
Time Frame
90 days post intervention
Title
Number of Emergency Department (ED) visits
Description
Number of ED visits will be collected
Time Frame
90 days post intervention
Title
Number of hospitalizations
Description
Number of hospitalizations will be collected
Time Frame
90 days post intervention
Title
Change in employment status
Description
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.
Time Frame
90 days post intervention
Title
Change in number of participants based on Housing status
Description
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.
Time Frame
Baseline, 7, 30, and 90 days post intervention
Title
Change in Social connections and isolation score
Description
Social isolation scores range from 0 to 4, with 0 representing the highest level of social isolation and 4 representing the lowest level.
Time Frame
Baseline, 7, 30, 90 days post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ED patient presenting during screening hours Age 18 years or older Able to speak and understand English Clinically sober, able to provide informed consent 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) Willing to follow study procedures and complete research follow-up calls Have at least two reliable contact numbers, e.g. subject and one or more relatives or close friends 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 Prior participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph E Carpenter, MD
Phone
(404) 585-0218
Email
jecarpe@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph E Carpenter, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Carpenter, MD
First Name & Middle Initial & Last Name & Degree
Joseph Carpenter, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing will be initiated upon written request to the PI and would ultimately be shared via a secure portal such as Microsoft OneDrive. Deidentified data files, the data dictionary, and the final protocol will be uploaded to the Emory Dataverse, which is a long-term repository offered through a partnership between Emory and the Odum Institute at the University of North Carolina and Chapel Hill. This repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with federal data sharing policies and applicable laws and regulations. Datasets are uniquely named with a persistent digital object identifier (DOI), and are downloadable directly through a web-based interface. Additional data documentation and de-identified data will be deposited for sharing along with data consistent with applicable laws and regulations. Submitted data will confirm with relevant data and terminology standards.
IPD Sharing Time Frame
Data sharing will be initiated upon written request to the PI and would ultimately be shared via a secure portal such as Microsoft OneDrive. The investigators will make data publicly available within 30 months of completing data collection.
IPD Sharing Access Criteria
Written request to the PI.

Learn more about this trial

Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches

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