Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
1 other identifier
interventional
97
1 country
1
Brief Summary
This study will assess Specialized Community Disease Management (SCDM), an intervention which employs various evidence-based strategies to engage substance using co-morbid patients while in the hospital and follow them into the community via an empirically validated telephone approach as well as contact with a trained community health worker peer specialist. The investigators will first adapt and refine the core SCDM intervention with patient, provider, and stakeholder input through an active community advisory board. The investigators will then conduct a three-year, randomized controlled trial of 222 patients enrolled prior to hospital discharge who are diagnosed with congestive heart failure, pneumonia, acute myocardial infarction, chronic obstructive pulmonary disease, diabetes mellitus, or end-stage renal disease, and a substance use disorder (SUD). Patients will be randomized to either the SCDM intervention or Treatment as Usual (TAU), in which a team of nurse navigators and community health workers follow patients (primarily by telephone) for 90 days post-discharge, but do not address the specific needs of SUDs. The investigators will test the following four hypotheses: (1) patients randomized to SCDM will demonstrate larger reductions in substance use measured by urine-confirmed self-reported days using over the 6-month follow-up compared to patients randomized to TAU, (2) patients randomized to SCDM will attend more specialty substance abuse intervention and treatment sessions over the 6 month follow-up than patients randomized to TAU, (3) patients randomized to SCDM will demonstrate reduced HIV transmission risk behaviors and greater rates of HIV testing over the 6 month follow-up than patients randomized to TAU, and (4) patients randomized to SCDM will experience fewer days of rehospitalization and use of acute emergency services than patients randomized to TAU.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 7, 2014
CompletedFirst Posted
Study publicly available on registry
February 11, 2014
CompletedStudy Start
First participant enrolled
November 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedResults Posted
Study results publicly available
August 10, 2018
CompletedMarch 29, 2023
March 1, 2023
2.2 years
February 7, 2014
May 24, 2017
March 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Substance Use Rates From Baseline
Urinalysis confirmed self-reported days of use for any substance, including alcohol, cocaine, marijuana, opiates, sedatives, and hallucinogens over time. Participants reported substance use for the 90 days prior to the assessment date.
0, 3, 6 months
Secondary Outcomes (2)
Change in Treatment Session Attendance From Baseline
0, 3, 6, months
Number of Hospitalizations and Use of Emergency Services
0, 3, 6, months
Study Arms (2)
Specialized Community Disease Management
EXPERIMENTALSpecialized Community Disease Management
Treatment As Usual
ACTIVE COMPARATORTreatment as Usual: standard post-hospital discharge with medical monitoring.
Interventions
Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge.
Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use.
Eligibility Criteria
You may qualify if:
- patient is 18 years or older
- alcohol and/or drug screening score that indicates at least mild problem severity
You may not qualify if:
- medical or psychiatric complications
- patient was admitted to hospital directly from a drug and alcohol inpatient rehabilitation facility
- patient reports plans to leave the area within the next 12 months
- patient is unable to provide valid informed consent
- patient is attending dialysis
- patient is not English-speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam Brooks, PhD
- Organization
- Treatment Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Adam C Brooks, PhD
Treatment Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2014
First Posted
February 11, 2014
Study Start
November 18, 2014
Primary Completion
February 16, 2017
Study Completion
February 28, 2017
Last Updated
March 29, 2023
Results First Posted
August 10, 2018
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
in line with HIPAA protections, we will make our final dataset available to other researchers. Fully de-identified data will be available to any researcher. If a researcher should request a limited dataset then we will only share that data after obtaining an appropriate data use agreement which includes an agreement not to attempt to re-identify or contact participants. We will not share directly identifiable data with outside researchers per our HIPAA authorization for this study.