- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00993395
A Comprehensive Peer Mentor-based Disease Management Program for Medically Complex Substance Users
October 8, 2018 updated by: Johns Hopkins University
Substance-using adults are admitted to hospital for medical complication from their drug and alcohol use at very high rates; yet, their care is often defined by low rates of referral to addiction treatment programs and recidivism.
In 1997, we instituted an integrated medical-substance use treatment program at Johns Hopkins, the First Step Day Hospital, designed for intensive post-acute care of previously hospitalized substance using adults.
We have shown that patients with dual diagnoses admitted to First Step more often complete their course of medical care and stay in recovery longer than patients not admitted to First Step.(1;2)
On discharge from First Step, patients are medically stable and drug-free.
Their substance abuse care is transferred to an out-patient substance abuse treatment facility and their medical care is transferred to their primary care provider.
Unfortunately, many patients are lost to follow-up during this transition.
We believe that a peer mentor-based disease management program (PM) can provide continuity of care that begins in First Step and continues after discharge thereby increasing the proportion of patients who remain in treatment for their addiction and medical conditions.
Peer mentors are persons from the target community who have been in recovery for 5 or more years.
In cooperation with patients and providers, peer mentors improve the integration of care, quality of care, and access to healthcare services.
This pilot study will test the effectiveness of a peer mentor-based disease management program.
The specific aims are to compare the impact of the PM intervention verses enhanced usual care on outcomes in three domains (1) medical/psychiatric health status, (2) addiction recovery, and (3) social resource acquisition.
If successful, this study will provide evidence supporting a larger randomized controlled trial of the impact of field workers on post-acute care among patients with dual diagnoses.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients admitted to an intensive day hospital focused on medically complex substanse users are eligible for enrolment
Exclusion Criteria:
- Inability to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer Mentor Intervention
peer mentor-based disease management focusing on three domains: medical care, recovery, and social stabilization
|
peer mentor-based disease management focused on three domains: medical care, recovery, and social stabilization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
adherence to first prescription refill after discharge
Time Frame: 60 days
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adherence to first medical appointment
Time Frame: 60 days
|
60 days
|
|
Rate of readmission and emergency department visits
Time Frame: 3 years
|
3 years
|
|
Length of stay in a recovery program
Time Frame: 1 year
|
1 year
|
|
Number of days without substance use
Time Frame: 3 years
|
3 years
|
|
Acquisition of medical insurance
Time Frame: 1 year
|
1 year
|
|
acquisition of long-term housing
Time Frame: 3 years
|
3 years
|
|
Acquisition of financial support
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
October 9, 2009
First Submitted That Met QC Criteria
October 9, 2009
First Posted (Estimate)
October 12, 2009
Study Record Updates
Last Update Posted (Actual)
October 10, 2018
Last Update Submitted That Met QC Criteria
October 8, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00020931
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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