Navigation Services to Avoid Rehospitalization (NavSTAR)

Alcohol Use Disorder Clinical Trial

— NavSTAR  

Official title:

Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599818
• Other study ID #: 14-07-224
• Secondary ID: R01DA037942-01A1
• Status: Completed
• Phase: N/A
• Start date: March 15, 2016
• Est. completion date: May 14, 2019

Study information

• Verified date: February 2020
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 14, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Cocaine Use Disorder
• Disease
• Opioid-use Disorder

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-to-Rehospitalization	Days to rehospitalization	12 months
Secondary	30-day rehospitalization rate	rate of rehospitalization within 30 days	30 days
Secondary	Cumulative days of inpatient hospitalization	cumulative days of inpatient hospitalization	3, 6, 12 months
Secondary	Emergency Department utilization rate	rate of Emergency Department utilization	3, 6, 12 months
Secondary	Emergency Department visits	cumulative number of Emergency Department visits	3, 6, 12 months
Secondary	Mortality	all-cause mortality	3, 6, 12 months
Secondary	addiction treatment entry	rate of entry into addiction treatment	3, 6, 12 months
Secondary	medical follow-up care	entry into recommended medical follow-up care post-hospital discharge	3, 6, 12 months
Secondary	self-reported quality of life rating	quality of life scores as determined by the WHO-QOL BREF	3, 6, 12 months
Secondary	alcohol use (self-report)	days of alcohol use in the past 30 days assessed via self-report	3, 6, 12 months
Secondary	opioid use (self-report)	days of opioid use in the past 30 days assessed via self-report	3, 6, 12 months
Secondary	cocaine use (self-report)	days of cocaine use in the past 30 days assessed via self-report	3, 6, 12 months
Secondary	opioid use (urine test)	opioid use assessed via urine test	3, 6, 12 months
Secondary	cocaine use (urine test)	cocaine use assessed via urine test	3, 6, 12 months
Secondary	alcohol use disorder criteria	acute substance use disorder criteria for alcohol	3, 6, 12 months
Secondary	opioid use disorder criteria	acute substance use disorder criteria for opioids	3, 6, 12 months
Secondary	cocaine use disorder criteria	acute substance use disorder criteria for cocaine	3, 6, 12 months