Navigation Services to Avoid Rehospitalization (NavSTAR)

NCT ID: NCT02599818

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-15

Study Completion Date

2019-05-14

Brief Summary

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This study will examine the clinical effectiveness and health economic profile of services to link hospital patients with substance use disorders to addiction treatment, promote their medical stabilization, and reduce hospital re-admissions.

Detailed Description

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In recent years, the problem of rehospitalization has come under intense focus as a major contributor to preventable morbidity and escalating healthcare costs. Substance use disorders are strongly associated with poor health outcomes and highly inefficient use of healthcare services, including repeat hospitalizations. Interventions that increase adherence to recommendations for outpatient medical care and substance abuse treatment could potentially help recently-hospitalized individuals with substance use disorders to avoid unnecessary rehospitalization, associated morbidity, and medical expenses. The current study is a randomized controlled trial comparing the effectiveness of Navigation Services to Avoid Rehospitalization (NavSTAR) vs. Treatment-as-Usual (TAU) for hospital patients with co-occurring medical problems and substance use disorders. Applying Andersen's theoretical model of health service utilization, NavSTAR will employ the promising strategies of Patient Navigation and motivational interventions to facilitate engagement in outpatient medical and substance abuse treatment, thereby lowering the likelihood of rehospitalization. Patient Navigators embedded within the substance abuse consultation liaison service at a large urban hospital will deliver patient-centered, proactive navigation and motivational services initiated during the hospital stay and continued for 3 months post-discharge. Participants randomized to TAU will receive usual care from the hospital and the substance abuse consultation liaison service, which includes referral to substance abuse treatment but no continued contact post-hospital discharge. Participants will be assessed at study entry and again at 3-, 6-, and 12-months follow-up on various measures of healthcare utilization, substance use, and functioning. The primary outcome of interest is time-to-rehospitalization through 12 months. In addition, a range of secondary outcomes spanning the medical and substance abuse service areas will be assessed. The study will include an economic evaluation of the cost, incremental cost-effectiveness, and cost-benefits of NavSTAR from the service provider perspective.

Conditions

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Opioid-use Disorder Cocaine Use Disorder Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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NavSTAR

Participants in this arm will receive services from the NavSTAR Patient Navigation team. The Patient Navigator will work with patients for up to 3 months post-hospital discharge to resolve internal barriers (e.g., ambivalence about treatment; low motivation; competing life demands, etc.) and external barriers (e.g., lack of transportation; lack of ID card, etc.) to appropriate utilization and engagement in addiction treatment and medical care. Interventions include motivational interventions and patient navigation with proactive case management, tailored to participants' specific needs.

Group Type EXPERIMENTAL

NavSTAR

Intervention Type BEHAVIORAL

Participants in the NavSTAR program will work with a team of case workers who will provide motivational intervention and proactive barrier resolution services using patient navigation

TAU (Treatment as Usual)

Participants in this arm will receive usual care, which includes in-hospital services from a multidisciplinary substance use disorder consultation liaison team.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NavSTAR

Participants in the NavSTAR program will work with a team of case workers who will provide motivational intervention and proactive barrier resolution services using patient navigation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. adult (ages 18 and older) hospital patients;
2. current DSM-5 SUD (not in remission) for alcohol, cocaine, or opioids
3. willing and able to provide informed consent.

Exclusion Criteria

1. current enrollment in SUD treatment;
2. primary residence outside of Baltimore City;
3. pregnant;
4. terminal medical condition (e.g., planned discharge to hospice);
5. hospitalized for a suicide attempt.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Maryland, College Park

OTHER

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Gryczynski, PhD

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Nordeck CD, Kelly SM, Schwartz RP, Mitchell SG, Welsh C, O'Grady KE, Gryczynski J. Hospital admissions among patients with Comorbid Substance Use disorders: a secondary analysis of predictors from the NavSTAR Trial. Addict Sci Clin Pract. 2024 Apr 28;19(1):33. doi: 10.1186/s13722-024-00463-9.

Reference Type DERIVED
PMID: 38678216 (View on PubMed)

Mitchell SG, Monico LB, Gryczynski J, Ross T, Terplan M, O'Grady KE. Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention. J Adolesc Health. 2022 Oct;71(4S):S41-S48. doi: 10.1016/j.jadohealth.2022.04.013.

Reference Type DERIVED
PMID: 36122968 (View on PubMed)

Gryczynski J, Nordeck CD, Welsh C, Mitchell SG, O'Grady KE, Schwartz RP. Preventing Hospital Readmission for Patients With Comorbid Substance Use Disorder : A Randomized Trial. Ann Intern Med. 2021 Jul;174(7):899-909. doi: 10.7326/M20-5475. Epub 2021 Apr 6.

Reference Type DERIVED
PMID: 33819055 (View on PubMed)

Other Identifiers

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R01DA037942-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-07-224

Identifier Type: -

Identifier Source: org_study_id

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