Navigation Services to Avoid Rehospitalization (NavSTAR) (NavSTAR)

Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder; Opioid-use Disorder; Cocaine Use Disorder
• Intervention / Treatment: Behavioral: NavSTAR

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-Rehospitalization	Days to rehospitalization	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); RTI International; University of Maryland, College Park
• Investigators: Principal Investigator: Jan Gryczynski, PhD, Friends Research Institute, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2016
• Primary Completion (Actual): May 5, 2019
• Study Completion (Actual): May 14, 2019

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Alcoholism; Disease; Opioid-Related Disorders
• Other Study ID Numbers: 14-07-224; R01DA037942-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be provided upon request and execution of a data sharing agreement specific to each use request after the key analyses are completed and manuscripts have been published.
• IPD Sharing Time Frame: After completion of key analyses and publication of planned manuscripts by the investigators.
• IPD Sharing Access Criteria: By request, contingent on approval by and execution of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No