Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Comprehensive Disease Management Program for Medically-Complex Substance Users

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Johns Hopkins University.
Recruitment status was  Recruiting
Johns Hopkins Community Physicians
Information provided by:
Johns Hopkins University Identifier:
First received: March 19, 2009
Last updated: November 3, 2009
Last verified: November 2009

March 19, 2009
November 3, 2009
March 2008
June 2010   (final data collection date for primary outcome measure)
Per member per month expenditures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865956 on Archive Site
  • Hospitalization days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Outpatient visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Emergency Department visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Substance use disorder treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Self-reported substance use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Physical and mental functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
A Comprehensive Disease Management Program for Medically-Complex Substance Users
A Comprehensive Disease Management Program for Medically-Complex Substance Users

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.

Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Substance-related Disorder
  • Behavioral: Contingency Management
    Rite Aid vouchers (stepped value) for reinforcement of adherence to primary care
  • Other: Case management
    Nurse case manager assigned to participant
  • Experimental: Care Management
    Care Management plus voucher incentives for adherence to primary care appointments.
    • Behavioral: Contingency Management
    • Other: Case management
  • No Intervention: Usual care
    Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2010
June 2010   (final data collection date for primary outcome measure)

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
18 Years and older
Contact: J. Hunter A Young, MD MHS 410-502-5808
United States
J Hunter Young MD Assistant Professor of Medicine, Johns Hopkins University School of Medicine
Johns Hopkins University
Johns Hopkins Community Physicians
Principal Investigator: J Hunter Young, MD, MHS Johns Hopkins University
Johns Hopkins University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP