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WithdrawnNCT00865956Updated Oct 10, 2018

A Comprehensive Disease Management Program for Medically-Complex Substance Users

An interventional study of Contingency Management and Case management in Substance-related Disorder, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-10.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
Lack of funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Substance-related Disorder

Keywords

  • disease management
  • substance use disorders
  • behavioral incentives
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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

Browse Substance-Related Disorders studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • currently enrolled in PPMCO Care Management
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralContingency Management

    Rite Aid vouchers (stepped value) for reinforcement of adherence to primary care

  • OtherCase management

    Nurse case manager assigned to participant

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What researchers measure

Primary outcomes

  1. Per member per month expenditures

    Time frame: 12 months

Secondary outcomes

  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

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Study locations

1 site
  • East Baltimore Medical Center
    Baltimore, Maryland 21202, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00865956
Lead sponsor
Johns Hopkins University
Collaborators
Johns Hopkins Community Physicians
Responsible party
Sponsor
First posted
Mar 20, 2009
Start date
Mar 2008
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Oct 10, 2018

Study contacts

J Hunter Young, MD, MHS
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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