Clinical trial NCT05847621: Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches
Official title: Linking Individuals Needing Care for Substance Use Disorders in Urban Emergency Departments to Peer Coaches (LINCS UP): RCT Component
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2023-05-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. ED patient or hospitalized through the ED within last 24 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 one reliable contact number

Exclusion Criteria:

1. Medically or psychiatrically unstable as determined by treating physician
2. Prisoner or in police custody
3. Prior participation in the study

Primary outcomes:
measure: Change in number of participants with successful linkage to at least one recovery resource
timeFrame: Baseline, 30 and 90 days after enrollment
Secondary outcomes:
measure: Change in Brief Assessment of Recovery Capital (BARC-10)
timeFrame: Baseline, 7, 30, and 90 days after enrollment
measure: Change in number of successful engagements with PRC after ED visit
timeFrame: Baseline, 7, 30, and 90 days after enrollment
measure: Change in number of episodes of re-linkage to recovery resources
timeFrame: Baseline, 7, 30, and 90 days post intervention
measure: Self-reported substance use in last 30 days
timeFrame: Baseline, 30 and 90 days post intervention
measure: Number of fatal overdose events
timeFrame: 90 days post intervention
measure: Number of nonfatal overdose events
timeFrame: 90 days post intervention
measure: Number of Emergency Department (ED) visits
timeFrame: 90 days post intervention
measure: Number of hospitalizations
timeFrame: 90 days post intervention
measure: Change in employment status
timeFrame: 90 days post intervention
measure: Change in number of participants based on Housing status
timeFrame: Baseline, 7, 30, and 90 days post intervention
measure: Change in Social connections and isolation score
timeFrame: Baseline, 7, 30, 90 days post intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Joseph E Carpenter, MD
role: PRINCIPAL_INVESTIGATOR
References: