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
ClinicalTrials.gov Identifier:
First received: March 19, 2009
Last updated: November 3, 2009
Last verified: November 2009

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 Intervention
Substance-related Disorder
Behavioral: Contingency Management
Other: Case management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Comprehensive Disease Management Program for Medically-Complex Substance Users

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Per member per month expenditures [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865956

Contact: J. Hunter A Young, MD MHS 410-502-5808 jhyoung@jhmi.edu

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
  More Information

Responsible Party: J Hunter Young MD Assistant Professor of Medicine, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00865956     History of Changes
Other Study ID Numbers: NA_00015261 
Study First Received: March 19, 2009
Last Updated: November 3, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 26, 2016