NCT00865956

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

March 19, 2009

Last Update Submit

October 8, 2018

Conditions

Keywords

disease managementsubstance use disordersbehavioral incentives

Outcome Measures

Primary Outcomes (1)

  • Per member per month expenditures

    12 months

Secondary Outcomes (7)

  • Hospitalization days

    12 months

  • Outpatient visits

    12 months

  • Emergency Department visits

    12 months

  • Substance use disorder treatment

    12 months

  • Self-reported substance use

    12 months

  • +2 more secondary outcomes

Study Arms (2)

Care Management

EXPERIMENTAL

Care Management plus voucher incentives for adherence to primary care appointments.

Behavioral: Contingency ManagementOther: Case management

Usual care

NO INTERVENTION

Usual care

Interventions

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

Care Management

Nurse case manager assigned to participant

Care Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • currently enrolled in PPMCO Care Management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Baltimore Medical Center

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • J Hunter Young, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 20, 2009

Study Start

March 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations