search
Back to results

Navigation Services to Avoid Rehospitalization (NavSTAR) (NavSTAR)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NavSTAR
Sponsored by
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Maryland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NavSTAR

TAU (Treatment as Usual)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Time-to-Rehospitalization
Days to rehospitalization

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2015
Last Updated
February 4, 2020
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), University of Maryland, College Park, RTI International
search

1. Study Identification

Unique Protocol Identification Number
NCT02599818
Brief Title
Navigation Services to Avoid Rehospitalization (NavSTAR)
Acronym
NavSTAR
Official Title
Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (Actual)
Primary Completion Date
May 5, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), University of Maryland, College Park, RTI International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Cocaine Use Disorder, Alcohol Use Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NavSTAR
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU (Treatment as Usual)
Arm Type
No Intervention
Arm Description
Participants in this arm will receive usual care, which includes in-hospital services from a multidisciplinary substance use disorder consultation liaison team.
Intervention Type
Behavioral
Intervention Name(s)
NavSTAR
Intervention Description
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
Primary Outcome Measure Information:
Title
Time-to-Rehospitalization
Description
Days to rehospitalization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
30-day rehospitalization rate
Description
rate of rehospitalization within 30 days
Time Frame
30 days
Title
Cumulative days of inpatient hospitalization
Description
cumulative days of inpatient hospitalization
Time Frame
3, 6, 12 months
Title
Emergency Department utilization rate
Description
rate of Emergency Department utilization
Time Frame
3, 6, 12 months
Title
Emergency Department visits
Description
cumulative number of Emergency Department visits
Time Frame
3, 6, 12 months
Title
Mortality
Description
all-cause mortality
Time Frame
3, 6, 12 months
Title
addiction treatment entry
Description
rate of entry into addiction treatment
Time Frame
3, 6, 12 months
Title
medical follow-up care
Description
entry into recommended medical follow-up care post-hospital discharge
Time Frame
3, 6, 12 months
Title
self-reported quality of life rating
Description
quality of life scores as determined by the WHO-QOL BREF
Time Frame
3, 6, 12 months
Title
alcohol use (self-report)
Description
days of alcohol use in the past 30 days assessed via self-report
Time Frame
3, 6, 12 months
Title
opioid use (self-report)
Description
days of opioid use in the past 30 days assessed via self-report
Time Frame
3, 6, 12 months
Title
cocaine use (self-report)
Description
days of cocaine use in the past 30 days assessed via self-report
Time Frame
3, 6, 12 months
Title
opioid use (urine test)
Description
opioid use assessed via urine test
Time Frame
3, 6, 12 months
Title
cocaine use (urine test)
Description
cocaine use assessed via urine test
Time Frame
3, 6, 12 months
Title
alcohol use disorder criteria
Description
acute substance use disorder criteria for alcohol
Time Frame
3, 6, 12 months
Title
opioid use disorder criteria
Description
acute substance use disorder criteria for opioids
Time Frame
3, 6, 12 months
Title
cocaine use disorder criteria
Description
acute substance use disorder criteria for cocaine
Time Frame
3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult (ages 18 and older) hospital patients; current DSM-5 SUD (not in remission) for alcohol, cocaine, or opioids willing and able to provide informed consent. Exclusion Criteria: current enrollment in SUD treatment; primary residence outside of Baltimore City; pregnant; terminal medical condition (e.g., planned discharge to hospice); hospitalized for a suicide attempt.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Gryczynski, PhD
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
36122968
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.
Results Reference
derived
PubMed Identifier
33819055
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.
Results Reference
derived

Learn more about this trial

Navigation Services to Avoid Rehospitalization (NavSTAR)

We'll reach out to this number within 24 hrs