Clinical trial NCT02599818: Navigation Services to Avoid Rehospitalization (NavSTAR)
Official title: Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Cocaine Use Disorder
Alcohol Use Disorder
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Maryland, College Park
name: RTI International
First posted: 2015-11-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time-to-Rehospitalization
timeFrame: 12 months
Secondary outcomes:
measure: 30-day rehospitalization rate
timeFrame: 30 days
measure: Cumulative days of inpatient hospitalization
timeFrame: 3, 6, 12 months
measure: Emergency Department utilization rate
timeFrame: 3, 6, 12 months
measure: Emergency Department visits
timeFrame: 3, 6, 12 months
measure: Mortality
timeFrame: 3, 6, 12 months
measure: addiction treatment entry
timeFrame: 3, 6, 12 months
measure: medical follow-up care
timeFrame: 3, 6, 12 months
measure: self-reported quality of life rating
timeFrame: 3, 6, 12 months
measure: alcohol use (self-report)
timeFrame: 3, 6, 12 months
measure: opioid use (self-report)
timeFrame: 3, 6, 12 months
measure: cocaine use (self-report)
timeFrame: 3, 6, 12 months
measure: opioid use (urine test)
timeFrame: 3, 6, 12 months
measure: cocaine use (urine test)
timeFrame: 3, 6, 12 months
measure: alcohol use disorder criteria
timeFrame: 3, 6, 12 months
measure: opioid use disorder criteria
timeFrame: 3, 6, 12 months
measure: cocaine use disorder criteria
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: Friends Research Institute, Inc.
name: Jan Gryczynski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.