A Comprehensive Peer Mentor-based Disease Management Program for Medically Complex Substance Users
Primary Purpose
Substance Addiction
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
peer mentor-based disease management
Sponsored by
About this trial
This is an interventional supportive care trial for Substance Addiction focused on measuring addiction, peer mentor, adherence
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peer Mentor Intervention
Arm Description
peer mentor-based disease management focusing on three domains: medical care, recovery, and social stabilization
Outcomes
Primary Outcome Measures
adherence to first prescription refill after discharge
Secondary Outcome Measures
Adherence to first medical appointment
Rate of readmission and emergency department visits
Length of stay in a recovery program
Number of days without substance use
Acquisition of medical insurance
acquisition of long-term housing
Acquisition of financial support
Full Information
NCT ID
NCT00993395
First Posted
October 9, 2009
Last Updated
October 8, 2018
Sponsor
Johns Hopkins University
Collaborators
Healthways, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00993395
Brief Title
A Comprehensive Peer Mentor-based Disease Management Program for Medically Complex Substance Users
Official Title
A Comprehensive Peer Mentor-based Disease Management Program for Medically Complex Substance Users
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
January 2010 (Actual)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Healthways, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Addiction
Keywords
addiction, peer mentor, adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer Mentor Intervention
Arm Type
Experimental
Arm Description
peer mentor-based disease management focusing on three domains: medical care, recovery, and social stabilization
Intervention Type
Behavioral
Intervention Name(s)
peer mentor-based disease management
Intervention Description
peer mentor-based disease management focused on three domains: medical care, recovery, and social stabilization
Primary Outcome Measure Information:
Title
adherence to first prescription refill after discharge
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Adherence to first medical appointment
Time Frame
60 days
Title
Rate of readmission and emergency department visits
Time Frame
3 years
Title
Length of stay in a recovery program
Time Frame
1 year
Title
Number of days without substance use
Time Frame
3 years
Title
Acquisition of medical insurance
Time Frame
1 year
Title
acquisition of long-term housing
Time Frame
3 years
Title
Acquisition of financial support
Time Frame
3 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
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A Comprehensive Peer Mentor-based Disease Management Program for Medically Complex Substance Users
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