NCT02599818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

3.1 years

First QC Date

November 3, 2015

Last Update Submit

February 4, 2020

Conditions

Opioid-use DisorderCocaine Use DisorderAlcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Time-to-Rehospitalization

    Days to rehospitalization

    12 months

Secondary Outcomes (16)

  • 30-day rehospitalization rate

    30 days

  • Cumulative days of inpatient hospitalization

    3, 6, 12 months

  • Emergency Department utilization rate

    3, 6, 12 months

  • Emergency Department visits

    3, 6, 12 months

  • Mortality

    3, 6, 12 months

  • +11 more secondary outcomes

Study Arms (2)

NavSTAR

EXPERIMENTAL

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

TAU (Treatment as Usual)

NO INTERVENTION

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

Interventions

NavSTARBEHAVIORAL

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

NavSTAR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (3)

  • Nordeck CD, Kelly SM, Schwartz RP, Mitchell SG, Welsh C, O'Grady KE, Gryczynski J. Hospital admissions among patients with Comorbid Substance Use disorders: a secondary analysis of predictors from the NavSTAR Trial. Addict Sci Clin Pract. 2024 Apr 28;19(1):33. doi: 10.1186/s13722-024-00463-9.

    PMID: 38678216DERIVED

  • 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.

    PMID: 36122968DERIVED

  • 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.

    PMID: 33819055DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Officials

  • Jan Gryczynski, PhD

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

November 9, 2015

Study Start

March 15, 2016

Primary Completion

May 5, 2019

Study Completion

May 14, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After completion of key analyses and publication of planned manuscripts by the investigators.
Access Criteria
By request, contingent on approval by and execution of a data sharing agreement.

Locations

US(1)