Connection, Navigation, Engagement in Care and Treatment for Opioid Use Disorder (ConNECT)
Primary Purpose
Opioid-use Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Case management
Sponsored by
About this trial
This is an interventional prevention trial for Opioid-use Disorder
Eligibility Criteria
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
Sites / Locations
- Denver Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Usual care
Arm Description
dedicated case management
usual care
Outcomes
Primary Outcome Measures
Retention in treatment at 90 days
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04797962
First Posted
March 10, 2021
Last Updated
December 23, 2022
Sponsor
Denver Health and Hospital Authority
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04797962
Brief Title
Connection, Navigation, Engagement in Care and Treatment for Opioid Use Disorder
Acronym
ConNECT
Official Title
Linkage Navigation to Enhance Initiation and Engagement in Treatment for Opioid Use Disorder to Prevent Overdose
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
September 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Denver Health and Hospital Authority
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
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
dedicated case management
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
Case management
Intervention Description
dedicated case management to address social support needs
Primary Outcome Measure Information:
Title
Retention in treatment at 90 days
Description
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.
Time Frame
90 days from treatment initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alia Al-Tayyib, PhD
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Connection, Navigation, Engagement in Care and Treatment for Opioid Use Disorder
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