Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions

Diabetes Mellitus Clinical Trial

Official title:

Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059005
• Other study ID #: PCORI-1306-03482
• Status: Completed
• Phase: N/A
• Start date: November 18, 2014
• Est. completion date: February 28, 2017

Study information

• Verified date: March 2023
• Source: Public Health Management Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: February 28, 2017
• Est. primary completion date: February 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Alcohol Use
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Diabetes Mellitus
• Drug Use
• End-Stage Renal Disease
• Heart Failure
• Infarction
• Kidney Failure, Chronic
• Lung Diseases, Obstructive
• Myocardial Infarction
• Pneumonia
• Pulmonary Disease, Chronic Obstructive
• Substance-Related Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Treatment Research Institute	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	0, 3, 6, months
Secondary	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.	0, 3, 6, months

External Links

•   Patient-Centered Outcomes Research Institute Project Abstract