NCT04797962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2023

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

March 10, 2021

Last Update Submit

March 21, 2024

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days from treatment initiation

Study Arms (2)

Intervention

EXPERIMENTAL

dedicated case management

Behavioral: Case management

Usual care

NO INTERVENTION

usual care

Interventions

Case managementBEHAVIORAL

dedicated case management to address social support needs

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health

Denver, Colorado, 80203, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Alia Al-Tayyib, PhD

    Denver Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Research Scientist

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 15, 2021

Study Start

March 30, 2021

Primary Completion

August 8, 2022

Study Completion

September 29, 2023

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations

US(1)