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Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions

Primary Purpose

Drug Use, Alcohol Use, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specialized Community Disease Management
Treatment As Usual
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Use focused on measuring Addiction, Substance Use Disorder, Rehospitalization, Community Disease Management, Behavioral Health, Community Health Worker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient is 18 years or older
  • alcohol and/or drug screening score that indicates at least mild problem severity

Exclusion Criteria:

  • 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

Sites / Locations

  • Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Specialized Community Disease Management

Treatment As Usual

Arm Description

Specialized Community Disease Management

Treatment as Usual: standard post-hospital discharge with medical monitoring.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Treatment Session Attendance From Baseline
Treatment sessions attended for alcohol or drug use issues over time. Participants self-reported attendance for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported attendance since the last assessment date.
Number of Hospitalizations and Use of Emergency Services
Days of hospitalization and days of use of acute emergency services after Baseline. Participants self-reported their service utilization for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported their service utilization since the last assessment date.

Full Information

First Posted
February 7, 2014
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02059005
Brief Title
Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
Official Title
Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2014 (Actual)
Primary Completion Date
February 16, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Hospitalized patients with substance use disorders (SUDs) face significant complications in their medical care. They are more likely to be discharged against medical advice, rehospitalized after discharge, and experience personal chaos and reduced family support. Hospital systems are moving to implement hospital-based and community disease management strategies to help patients transition post-discharge, however, few provide specialized follow-up for patients with SUDs. This proposal will test whether an extended, specialized community disease management program can improve outcomes over an existing nurse navigator disease management strategy for patients with co-morbid medical conditions and SUDs. The investigators will enroll 222 inpatients with co-occurring medical conditions and SUDs and will randomly assign them to either 1) Treatment as Usual - a 90-day, post-discharge program that consists of medical monitoring by workers who have no special training in working with SUD patients, or 2) the Specialized Community Disease Management program - a 90-day program that will employ specialized teams including a trained clinical social worker and a peer-specialist community health worker who will provide evidence-based telephone continuing care, home visits, and increased focus on patients' substance use. All participants will be followed at 3- and 6-months post-discharge. The investigators hypothesize that (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use, Alcohol Use, Congestive Heart Failure, Pneumonia, Acute Myocardial Infarction, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, End-Stage Renal Disease
Keywords
Addiction, Substance Use Disorder, Rehospitalization, Community Disease Management, Behavioral Health, Community Health Worker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specialized Community Disease Management
Arm Type
Experimental
Arm Description
Specialized Community Disease Management
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
Treatment as Usual: standard post-hospital discharge with medical monitoring.
Intervention Type
Behavioral
Intervention Name(s)
Specialized Community Disease Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Substance Use Rates From Baseline
Description
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.
Time Frame
0, 3, 6 months
Secondary Outcome Measure Information:
Title
Change in Treatment Session Attendance From Baseline
Description
Treatment sessions attended for alcohol or drug use issues over time. Participants self-reported attendance for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported attendance since the last assessment date.
Time Frame
0, 3, 6, months
Title
Number of Hospitalizations and Use of Emergency Services
Description
Days of hospitalization and days of use of acute emergency services after Baseline. Participants self-reported their service utilization for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported their service utilization since the last assessment date.
Time Frame
0, 3, 6, months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient is 18 years or older alcohol and/or drug screening score that indicates at least mild problem severity Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam C Brooks, PhD
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Links:
URL
http://www.pcori.org/research-results/2013/specialized-community-disease-management-reduce-substance-use-and-hospital
Description
Patient-Centered Outcomes Research Institute Project Abstract

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Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions

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