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Enhancing Substance Use Treatment Services to Decrease Dropout and Improve Outpatient Treatment Utilization in Emerging Adults (P2P)

Primary Purpose

Substance Use Disorders

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Recovery Support-Delivered Dropout Prevention enhancement
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use Disorders focused on measuring peer recovery supports, emerging adults, recovery support services

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-25
  • initiating outpatient treatment for a substance use problem

Sites / Locations

  • UConn Health

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Services

Peer Recovery Support - Delivered Dropout Prevention + Usual Services

Arm Description

clinics will continue to deliver their normal outpatient services

clinics will continue to deliver their normal outpatient services plus the peer recovery support-delivered dropout prevention enhancement

Outcomes

Primary Outcome Measures

Number of patients who dropout from substance use services
Data will come from de-identified clinical charts. Dropout will be defined in two ways: 1) patient did not complete the total number of sessions prescribed in the treatment plan and 2) patient was in treatment for less than 90 days.
Number of missed sessions and no show sessions
Data will come from de-identified clinical charts. Number of missed sessions or no shows will be evaluated based on the number of scheduled sessions.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2022
Last Updated
March 28, 2023
Sponsor
UConn Health
Collaborators
Oregon Social Learning Center, University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05374395
Brief Title
Enhancing Substance Use Treatment Services to Decrease Dropout and Improve Outpatient Treatment Utilization in Emerging Adults
Acronym
P2P
Official Title
Enhancing Substance Use Treatment Services to Decrease Dropout and Improve Outpatient Treatment Utilization in Emerging Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Oregon Social Learning Center, University of Texas at Austin

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
Emerging adults (ages 18-25) are at higher risk for substance use disorders, including opiate addiction, than any other age group but are also more likely to drop out early from substance use treatment services. This project will evaluate an enhancement to usual services, delivered by peer recovery supports, specifically aimed at improving treatment adherence and reducing dropout in this age group. The study will also answer key questions about risk factors for dropout among emerging adults and the financial sustainability of enhancing services to reduce dropout.
Detailed Description
Emerging adults (EAs; ages 18-25) have higher rates of substance use disorders than any other age group and have been hit particularly hard by the opioid crisis. EAs also demonstrate poor adherence to healthcare regimens associated with substance use services, with higher dropout rates and lower service utilization than any other age group. This poor adherence leads to devastating outcomes, including continued substance use, incarceration, and overdose. In addition, high dropout rates contribute to skyrocketing costs to treatment systems as a result of more acute service needs, expensive service utilization, and long waitlists. Cost-effective strategies that are aimed at improving treatment adherence to substance use services and tailored to meet the unique developmental needs of EAs are an imminent need. Further, little is known about risk factors for dropout specific to this age group, hindering effective system responses to this significant problem. At the same time, substance use service systems are increasingly using peer recovery supports (PRS; i.e., paraprofessionals who have "lived experience" with substance use problems) to bolster treatment outcomes without incurring considerable additional costs. However, services delivered by PRS have not been tailored specifically to reduce EA dropout, and few have been rigorously tested at all. The current study will evaluate an innovative EA-specific dropout prevention enhancement to usual treatment services, delivered by PRS in community-based substance use treatment clinics (Aim 1). The investigators will employ a stepped-wedge cluster randomized design, resulting in each clinic having a longitudinal usual services phase and a longitudinal dropout prevention phase. The two phases will be compared on rates of EA dropout and service utilization using objective data from clinical charts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
peer recovery supports, emerging adults, recovery support services

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
A stepped-wedge cluster randomized design will include five blocks of two clinics randomized to the timing of the Peer recovery support-delivered Dropout Prevention enhancement, with each clinic having two phases: a longitudinal Usual Services (US) Phase and a longitudinal Usual Services + Peer recovery support-delivered Dropout Prevention (PDP) enhancement Phase. All clusters will have a baseline phase and will be randomized to the timing of the PDP phase. Once randomized to begin, all clusters will have a 24-month US+PDP Phase.
Masking
Outcomes Assessor
Masking Description
Primary outcomes will come from the clinics' chart data. Individuals pulling data from charts will be blind to study condition.
Allocation
Randomized
Enrollment
1750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Services
Arm Type
No Intervention
Arm Description
clinics will continue to deliver their normal outpatient services
Arm Title
Peer Recovery Support - Delivered Dropout Prevention + Usual Services
Arm Type
Experimental
Arm Description
clinics will continue to deliver their normal outpatient services plus the peer recovery support-delivered dropout prevention enhancement
Intervention Type
Behavioral
Intervention Name(s)
Peer Recovery Support-Delivered Dropout Prevention enhancement
Intervention Description
Peer recovery supports will meet with emerging adults for four weekly sessions plus monthly check-ins during the next two months. Peer recovery supports will engage the emerging adults in motivational and skills-based strategies aimed at increasing adherence to services and attendance to treatment sessions.
Primary Outcome Measure Information:
Title
Number of patients who dropout from substance use services
Description
Data will come from de-identified clinical charts. Dropout will be defined in two ways: 1) patient did not complete the total number of sessions prescribed in the treatment plan and 2) patient was in treatment for less than 90 days.
Time Frame
90 days from initiation of treatment
Title
Number of missed sessions and no show sessions
Description
Data will come from de-identified clinical charts. Number of missed sessions or no shows will be evaluated based on the number of scheduled sessions.
Time Frame
90 days from initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-25 initiating outpatient treatment for a substance use problem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristyn Zajac, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Enhancing Substance Use Treatment Services to Decrease Dropout and Improve Outpatient Treatment Utilization in Emerging Adults

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