Overview

This trial is active, not recruiting.

Conditions drug use, alcohol use, congestive heart failure, pneumonia, acute myocardial infarction, diabetes mellitus, chronic obstructive pulmonary disease, end-stage renal disease
Treatments specialized community disease management, treatment as usual
Sponsor Treatment Research Institute
Collaborator Patient-Centered Outcomes Research Institute
Start date November 2014
End date December 2016
Trial size 97 participants
Trial identifier NCT02059005, PCORI-1306-03482

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Specialized Community Disease Management
specialized community disease management
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.
(Active Comparator)
Treatment as Usual: standard post-hospital discharge with medical monitoring.
treatment as usual
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 Outcomes

Measure
Change in Substance Use Rates from Baseline
time frame: 0, 3, 6 months

Secondary Outcomes

Measure
Change in Treatment Session Attendance from Baseline
time frame: 0, 3, 6, months
Change in HIV risk scores from Baseline
time frame: 0, 3, 6, months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
Principal investigator Adam C Brooks, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Treatment Research Institute.