Connection, Navigation, Engagement in Care and Treatment for Opioid Use Disorder

Not Applicable

Completed

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: Case management

• Registration Number: NCT04797962
• Lead Sponsor: Denver Health and Hospital Authority

Brief Summary

The overarching goal of the study is to develop, pilot, and evaluate an intervention that aims to retain patients who initiate buprenorphine at Denver Health in ongoing treatment for opioid use disorder.

Detailed Description

Initiating patients identified with opioid use disorder in hospital settings onto buprenorphine is a relatively new strategy to prevent overdose. While the literature is beginning to amass showing the effectiveness of this strategy for initiating people into treatment, a dearth of data to describe how well people are maintained in treatment remains. The current research project aims to 1) develop an intervention to enhance engagement and retention in treatment for individuals with opioid use disorder who initiate buprenorphine at Denver Health and 2) assess acceptability, feasibility, and initial efficacy of an intervention to enhance engagement and retention in treatment for individuals with opioid disorder compared to usual care.

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-15
• Study Start: 2021-03-30
• Primary Completion: 2022-08-08
• Study Completion: 2023-09-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• 18 years and older
• inducted onto buprenorphine at Denver Health
• successfully completed an intake visit at Denver Health's Outpatient Behavioral Health Services clinic.

Exclusion Criteria

• unable to provide informed consent
• unable to provide detailed contact information
• previously enrolled in the current study
• pregnant women will be excluded given that they are a priority treatment population and receive special services

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Case management	dedicated case management

Primary Outcome Measures

Name	Time	Method
Retention in treatment at 90 days	90 days from treatment initiation	Defined by proportion of participants retained in care at 90 days, as measured by the total number of intakes where patient has continued to be engaged in medication assisted treatment at 90 days from start of treatment divided by the total number of intakes where patients linked to follow up dosing or prescription, for each arm.

Trial Locations

Locations (1)

Denver Health; 🇺🇸 Denver, Colorado, United States