A Comprehensive Disease Management Program for Medically-Complex Substance Users
Primary Purpose
Substance-related Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Case management
Sponsored by
About this trial
This is an interventional supportive care trial for Substance-related Disorder focused on measuring disease management, substance use disorders, behavioral incentives
Eligibility Criteria
Inclusion Criteria:
- Age over 18
- Continuous enrollment in Priority Partners MCO for past 12 months
- Primary care site East Baltimore Medical Center (EBMC)
- PPMCO substance abuse flag other than nicotine only within past 24 months
Exclusion Criteria:
- currently enrolled in PPMCO Care Management
Sites / Locations
- East Baltimore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Care Management
Usual care
Arm Description
Care Management plus voucher incentives for adherence to primary care appointments.
Usual care
Outcomes
Primary Outcome Measures
Per member per month expenditures
Secondary Outcome Measures
Hospitalization days
Outpatient visits
Emergency Department visits
Substance use disorder treatment
Self-reported substance use
Physical and mental functioning
Depression
Full Information
NCT ID
NCT00865956
First Posted
March 19, 2009
Last Updated
October 8, 2018
Sponsor
Johns Hopkins University
Collaborators
Johns Hopkins Community Physicians
1. Study Identification
Unique Protocol Identification Number
NCT00865956
Brief Title
A Comprehensive Disease Management Program for Medically-Complex Substance Users
Official Title
A Comprehensive Disease Management Program for Medically-Complex Substance Users
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Johns Hopkins Community Physicians
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Disease management (DM) programs are being increasingly utilized by health plans to coordinate care, improve quality of care, and control costs in chronically ill individuals. DM programs for specific medical conditions, such as diabetes mellitus, congestive heart failure, and asthma, have demonstrated improvements in health outcomes and a number of studies have found economic benefits to these programs as well. There are fewer data evaluating multi-disease DM programs, and results have been mixed. Additionally, data on such programs specifically targeting substance-using populations are limited, although they are promising. Prior utilization and hospitalization data from Johns Hopkins Hospital, Johns Hopkins Health Care, and Priority Partners Managed Care Organization (PPMCO) suggest that a substantial portion of high-utilizing, high-cost, medically complex patients have a substance use diagnosis.
The investigators hypothesize that a comprehensive DM program for medically-complex substance users with a history of hospitalization, consisting of intensive nurse case management along with behavioral incentives to reinforce engagement in primary care, can decrease inpatient days and costs, as well as improve outcomes for substance use, depression, and physical and mental functioning. The investigators will compare the case management/behavioral incentives intervention to usual care among a group of medically-complex, substance-using, PPMCO enrollees. Usual care will include access to all existing Priority Partners care management programs, and usual The investigators believe that this research will make an important contribution to the development of models of chronic care that improve health and promote the best use of health care resources. Additionally, the investigators believe this project will promote the study and development of systems to improve the health of substance-using adults, an underserved and often marginalized group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-related Disorder
Keywords
disease management, substance use disorders, behavioral incentives
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Care Management
Arm Type
Experimental
Arm Description
Care Management plus voucher incentives for adherence to primary care appointments.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
Rite Aid vouchers (stepped value) for reinforcement of adherence to primary care
Intervention Type
Other
Intervention Name(s)
Case management
Intervention Description
Nurse case manager assigned to participant
Primary Outcome Measure Information:
Title
Per member per month expenditures
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hospitalization days
Time Frame
12 months
Title
Outpatient visits
Time Frame
12 months
Title
Emergency Department visits
Time Frame
12 months
Title
Substance use disorder treatment
Time Frame
12 months
Title
Self-reported substance use
Time Frame
12 months
Title
Physical and mental functioning
Time Frame
12 months
Title
Depression
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18
Continuous enrollment in Priority Partners MCO for past 12 months
Primary care site East Baltimore Medical Center (EBMC)
PPMCO substance abuse flag other than nicotine only within past 24 months
Exclusion Criteria:
currently enrolled in PPMCO Care Management
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J Hunter Young, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
12. IPD Sharing Statement
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A Comprehensive Disease Management Program for Medically-Complex Substance Users
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