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Navigation Services to Avoid Rehospitalization (NavSTAR)

Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02599818
Acronym
NavSTAR
Enrollment
400
Registered
2015-11-09
Start date
2016-03-15
Completion date
2019-05-14
Last updated
2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Cocaine Use Disorder, Opioid-use Disorder

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.

Interventions

BEHAVIORALNavSTAR

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

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Maryland, College Park
CollaboratorOTHER
RTI International
CollaboratorOTHER
Friends Research Institute, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time-to-Rehospitalization12 monthsDays to rehospitalization

Secondary

MeasureTime frameDescription
Cumulative days of inpatient hospitalization3, 6, 12 monthscumulative days of inpatient hospitalization
Emergency Department utilization rate3, 6, 12 monthsrate of Emergency Department utilization
Emergency Department visits3, 6, 12 monthscumulative number of Emergency Department visits
Mortality3, 6, 12 monthsall-cause mortality
addiction treatment entry3, 6, 12 monthsrate of entry into addiction treatment
medical follow-up care3, 6, 12 monthsentry into recommended medical follow-up care post-hospital discharge
self-reported quality of life rating3, 6, 12 monthsquality of life scores as determined by the WHO-QOL BREF
30-day rehospitalization rate30 daysrate of rehospitalization within 30 days
opioid use (self-report)3, 6, 12 monthsdays of opioid use in the past 30 days assessed via self-report
cocaine use (self-report)3, 6, 12 monthsdays of cocaine use in the past 30 days assessed via self-report
opioid use (urine test)3, 6, 12 monthsopioid use assessed via urine test
cocaine use (urine test)3, 6, 12 monthscocaine use assessed via urine test
alcohol use disorder criteria3, 6, 12 monthsacute substance use disorder criteria for alcohol
opioid use disorder criteria3, 6, 12 monthsacute substance use disorder criteria for opioids
cocaine use disorder criteria3, 6, 12 monthsacute substance use disorder criteria for cocaine
alcohol use (self-report)3, 6, 12 monthsdays of alcohol use in the past 30 days assessed via self-report

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026