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Barriers to Substance Use Disorder Recovery

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery Coach Intervention
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring recovery coaching, risk factors, substance abuse, EEG

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 - 60
  • English speaking;
  • Identified by healthcare provider as having Substance Use Disorder
  • Recent substance use
  • Currently admitted to the Medical Teaching Services, general medicine hospitalist services, or Infectious Disease Consult service at Greenville Memorial Hospital

Exclusion Criteria:

  • Are unable to provide informed consent (intubation, confusion, etc.) during hospitalization
  • Are admitted for marijuana use only
  • Are admitted for cocaine use only
  • Are pregnant

Sites / Locations

  • Greenville Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Recovery Coach Intervention

Standard of Care Control

Arm Description

Experimental: Recovery Coach Intervention Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants.

Patients in the control condition receive the current standard of care, which entails a treatment referral with a list of addiction recovery facilities, groups, and resources. It is the patient's responsibility to call a treatment facility or group on the list and thus relies on self-referral. The medical team is not permitted to call a facility or group on behalf of the patient. The physician may counsel the patient on the dangers of substance abuse and addiction, but the extent of counseling is variable and dependent on the individual physician.

Outcomes

Primary Outcome Measures

Change in Social Support
Participants will complete the 5-item Social Support subscale of the Assessment of Recovery Capital (ARC) to assess social support. The difference between the post-baseline and baseline measures will be assessed.
Change in Financial Barriers to SUD Recovery
These barriers include lack of stable housing, transportation, and cost of recovery services. Participants will complete the Housing and Safety Subscale of the Assessment of Recovery Capital (ARC) to assess social support and housing stability. The difference between the post-baseline and baseline measures will be assessed.
Change in Situational Barriers to SUD Recovery
The barriers measured will be (1) long delays for treatment, (2) complexity of navigating the healthcare system, (3) lack of programs in one's community, (4)lack of professional help, (4) and not knowing where to go for help. The response options are binary (yes, they think this is a barrier to their recovery', or 'no, not a barrier to recovery'). Responses to these questions (0=no, 1=yes) will be summed to determine situational barriers. The difference between the post-baseline and baseline measures will be assessed.
Change in Inhibitory Control
Inhibitory control will be assessed behaviorally using a 150 - 200 trial computerized 'Stop Signal' Task, the most common measure of this construct. Stop Signal Reaction Time (SSRT) and Stop trial accuracy will be measured and compared across time points.
Change in Resting State EEG beta poewer
We will measure both absolute and relative powers for beta (14-25 Hz) bands using a 24-channel Soterix Medical EEG.
Change in Striatal Dopaminergic Functioning
Consistent with previous research, we will assess average spontaneous eyeblink rate, a well-validated indirect proxy for available levels of striatal tonic dopamine.
Change in Risk-Taking
Risk-taking will be measured using the 7-item Risk Propensity Scale (Meertens & Lion, 2008). Higher scores on this scale indicate greater risk-taking propensity.
Change in Emotion Regulation
The Emotion Regulation Questionnaire (ERQ-10) will be used to assess these emotion regulation strategies and skills.
Change in Goal-Related Activities
Participants will complete the 5-item Meaningful Activities from the Assessment of Recovery Capital questionnaire. The 5 items will be summed for a total score.

Secondary Outcome Measures

Engagement in Recovery Services
Active involvement in recovery programs. This is a binary response question. Participants are asked "Are you actively involved in a recovery program right now?". Response options are 'yes' or 'no'. We will measure the change over time in engagement for each participant and compare the percentage of those in the intervention and control arm that are actively involved in recovery services at each time point.
Hospital Visit Frequency
number of readmissions and number of emergency department visits
Substance Use Severity
Frequency of substance use in past 30 days measured using the Addiction Severity Index (ASI-Lite).
Emotional Well-being
Participants will be asked to self-report two items about their emotion well-being on a scale of 0 (Not at all) to 9 (Severely). The questions are "In the past 30 days, how much have you been bothered by feeling sad, down, or uninterested in life?" and "In the past 30-days, have you felt anxious or nervous?".
Life Satisfaction
Participants will be asked to self-report their life satisfaction using a single item question on a scale of 1 (Very Satisfied) to 4 (Very Dissatisfied). Change across time on this scale will be measured.

Full Information

First Posted
June 11, 2019
Last Updated
February 23, 2021
Sponsor
Prisma Health-Upstate
Collaborators
Clemson University, University of South Carolina School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04098614
Brief Title
Barriers to Substance Use Disorder Recovery
Official Title
Barriers to Substance Use Disorder Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prisma Health-Upstate
Collaborators
Clemson University, University of South Carolina School of Medicine

4. Oversight

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

5. Study Description

Brief Summary
The study purpose is to investigate how an inpatient recovery coaching intervention can overcome or mitigate specific risk factors and barriers to initiating and maintaining Substance Use Disorder recovery. This study will offer insight into how and why an inpatient link to recovery coaching is effective for promoting long-term Substance Use Disorder recovery.
Detailed Description
Substance Use Disorder (SUD) is a prevalent disease that impacts an estimated 24 million Americans each year. The life-altering consequences of SUD are both diverse and severe, influencing mortality, the workplace, and economics. The goal of this study is to determine how specific risk factors of relapse and barriers to recovery, including neurocognitive, health, personal, social, financial, and situational barriers, can be overcome or changed through a recovery coaching intervention. This work seeks to provide a mechanism to demonstrate exactly how and why this potential new model of care (recovery coaching) is effective, rather than simply assessing if it can work. To accomplish this aim, the change between baseline and 6-month assessments will be assessed. Then, the difference in the change between individuals assigned to the current standard of care and patients assigned to inpatient recovery will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
recovery coaching, risk factors, substance abuse, EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigator/study personnel inform the participant regarding which arm they have been assigned and inform a recovery coach if the participant is randomized to the intervention arm.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recovery Coach Intervention
Arm Type
Experimental
Arm Description
Experimental: Recovery Coach Intervention Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants.
Arm Title
Standard of Care Control
Arm Type
No Intervention
Arm Description
Patients in the control condition receive the current standard of care, which entails a treatment referral with a list of addiction recovery facilities, groups, and resources. It is the patient's responsibility to call a treatment facility or group on the list and thus relies on self-referral. The medical team is not permitted to call a facility or group on behalf of the patient. The physician may counsel the patient on the dangers of substance abuse and addiction, but the extent of counseling is variable and dependent on the individual physician.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Coach Intervention
Intervention Description
Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants.
Primary Outcome Measure Information:
Title
Change in Social Support
Description
Participants will complete the 5-item Social Support subscale of the Assessment of Recovery Capital (ARC) to assess social support. The difference between the post-baseline and baseline measures will be assessed.
Time Frame
intervals of 1, 2, 3, and 6 months post-baseline assessment
Title
Change in Financial Barriers to SUD Recovery
Description
These barriers include lack of stable housing, transportation, and cost of recovery services. Participants will complete the Housing and Safety Subscale of the Assessment of Recovery Capital (ARC) to assess social support and housing stability. The difference between the post-baseline and baseline measures will be assessed.
Time Frame
intervals of 1, 2, 3, and 6 months post-baseline assessment
Title
Change in Situational Barriers to SUD Recovery
Description
The barriers measured will be (1) long delays for treatment, (2) complexity of navigating the healthcare system, (3) lack of programs in one's community, (4)lack of professional help, (4) and not knowing where to go for help. The response options are binary (yes, they think this is a barrier to their recovery', or 'no, not a barrier to recovery'). Responses to these questions (0=no, 1=yes) will be summed to determine situational barriers. The difference between the post-baseline and baseline measures will be assessed.
Time Frame
intervals of 1, 2, 3, and 6 months post-baseline assessment
Title
Change in Inhibitory Control
Description
Inhibitory control will be assessed behaviorally using a 150 - 200 trial computerized 'Stop Signal' Task, the most common measure of this construct. Stop Signal Reaction Time (SSRT) and Stop trial accuracy will be measured and compared across time points.
Time Frame
baseline and 6 months post-baseline assessment
Title
Change in Resting State EEG beta poewer
Description
We will measure both absolute and relative powers for beta (14-25 Hz) bands using a 24-channel Soterix Medical EEG.
Time Frame
baseline and 6 months post-baseline assessment
Title
Change in Striatal Dopaminergic Functioning
Description
Consistent with previous research, we will assess average spontaneous eyeblink rate, a well-validated indirect proxy for available levels of striatal tonic dopamine.
Time Frame
baseline and 6 months post-baseline assessment
Title
Change in Risk-Taking
Description
Risk-taking will be measured using the 7-item Risk Propensity Scale (Meertens & Lion, 2008). Higher scores on this scale indicate greater risk-taking propensity.
Time Frame
baseline and 6 months post-baseline assessment
Title
Change in Emotion Regulation
Description
The Emotion Regulation Questionnaire (ERQ-10) will be used to assess these emotion regulation strategies and skills.
Time Frame
baseline and 6 months post-baseline assessment
Title
Change in Goal-Related Activities
Description
Participants will complete the 5-item Meaningful Activities from the Assessment of Recovery Capital questionnaire. The 5 items will be summed for a total score.
Time Frame
baseline and 6 months post-baseline assessment
Secondary Outcome Measure Information:
Title
Engagement in Recovery Services
Description
Active involvement in recovery programs. This is a binary response question. Participants are asked "Are you actively involved in a recovery program right now?". Response options are 'yes' or 'no'. We will measure the change over time in engagement for each participant and compare the percentage of those in the intervention and control arm that are actively involved in recovery services at each time point.
Time Frame
intervals of 1, 2, 3, and 6 months post-baseline assessment
Title
Hospital Visit Frequency
Description
number of readmissions and number of emergency department visits
Time Frame
six months pre- and post-baseline assessment
Title
Substance Use Severity
Description
Frequency of substance use in past 30 days measured using the Addiction Severity Index (ASI-Lite).
Time Frame
intervals of 1, 2, 3, and 6 months post-baseline assessment
Title
Emotional Well-being
Description
Participants will be asked to self-report two items about their emotion well-being on a scale of 0 (Not at all) to 9 (Severely). The questions are "In the past 30 days, how much have you been bothered by feeling sad, down, or uninterested in life?" and "In the past 30-days, have you felt anxious or nervous?".
Time Frame
intervals of 1, 2, 3, and 6 months post-baseline assessment
Title
Life Satisfaction
Description
Participants will be asked to self-report their life satisfaction using a single item question on a scale of 1 (Very Satisfied) to 4 (Very Dissatisfied). Change across time on this scale will be measured.
Time Frame
intervals of 1, 2, 3, and 6 months post-baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 - 60 English speaking; Identified by healthcare provider as having Substance Use Disorder Recent substance use Currently admitted to the Medical Teaching Services, general medicine hospitalist services, or Infectious Disease Consult service at Greenville Memorial Hospital Exclusion Criteria: Are unable to provide informed consent (intubation, confusion, etc.) during hospitalization Are admitted for marijuana use only Are admitted for cocaine use only Are pregnant
Facility Information:
Facility Name
Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35296984
Citation
Cupp JA, Byrne KA, Herbert K, Roth PJ. Acute Care Utilization After Recovery Coaching Linkage During Substance-Related Inpatient Admission: Results of Two Randomized Controlled Trials. J Gen Intern Med. 2022 Aug;37(11):2768-2776. doi: 10.1007/s11606-021-07360-w. Epub 2022 Mar 16.
Results Reference
derived

Learn more about this trial

Barriers to Substance Use Disorder Recovery

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