A Comprehensive Disease Management Program for Medically-Complex Substance Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00865956
Recruitment Status : Unknown
Verified November 2009 by Johns Hopkins University.
Recruitment status was:  Recruiting
First Posted : March 20, 2009
Last Update Posted : November 4, 2009
Johns Hopkins Community Physicians
Information provided by:
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Substance-related Disorder Behavioral: Contingency Management Other: Case management Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Comprehensive Disease Management Program for Medically-Complex Substance Users
Study Start Date : March 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Care Management
Care Management plus voucher incentives for adherence to primary care appointments.
Behavioral: Contingency Management
Rite Aid vouchers (stepped value) for reinforcement of adherence to primary care

Other: Case management
Nurse case manager assigned to participant

No Intervention: Usual care
Usual care

Primary Outcome Measures :
  1. Per member per month expenditures [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Hospitalization days [ Time Frame: 12 months ]
  2. Outpatient visits [ Time Frame: 12 months ]
  3. Emergency Department visits [ Time Frame: 12 months ]
  4. Substance use disorder treatment [ Time Frame: 12 months ]
  5. Self-reported substance use [ Time Frame: 12 months ]
  6. Physical and mental functioning [ Time Frame: 12 months ]
  7. Depression [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00865956

Contact: J. Hunter A Young, MD MHS 410-502-5808

United States, Maryland
East Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Johns Hopkins University
Johns Hopkins Community Physicians
Principal Investigator: J Hunter Young, MD, MHS Johns Hopkins University

Responsible Party: J Hunter Young MD Assistant Professor of Medicine, Johns Hopkins University School of Medicine Identifier: NCT00865956     History of Changes
Other Study ID Numbers: NA_00015261
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: November 4, 2009
Last Verified: November 2009

Keywords provided by Johns Hopkins University:
disease management
substance use disorders
behavioral incentives

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders