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Completed

NCT Number: NCT02599818

Navigation Services to Avoid Rehospitalization (NavSTAR)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NavSTAR

Behavioral

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 outcomes

  1. Time-to-Rehospitalization

    Time frame: 12 months

    Days to rehospitalization

Secondary outcomes

  1. 30-day rehospitalization rate

    Time frame: 30 days

    rate of rehospitalization within 30 days

  2. Cumulative days of inpatient hospitalization

    Time frame: 3, 6, 12 months

    cumulative days of inpatient hospitalization

  3. Emergency Department utilization rate

    Time frame: 3, 6, 12 months

    rate of Emergency Department utilization

  4. Emergency Department visits

    Time frame: 3, 6, 12 months

    cumulative number of Emergency Department visits

  5. Mortality

    Time frame: 3, 6, 12 months

    all-cause mortality

  6. addiction treatment entry

    Time frame: 3, 6, 12 months

    rate of entry into addiction treatment

  7. medical follow-up care

    Time frame: 3, 6, 12 months

    entry into recommended medical follow-up care post-hospital discharge

  8. self-reported quality of life rating

    Time frame: 3, 6, 12 months

    quality of life scores as determined by the WHO-QOL BREF

  9. alcohol use (self-report)

    Time frame: 3, 6, 12 months

    days of alcohol use in the past 30 days assessed via self-report

  10. opioid use (self-report)

    Time frame: 3, 6, 12 months

    days of opioid use in the past 30 days assessed via self-report

  11. cocaine use (self-report)

    Time frame: 3, 6, 12 months

    days of cocaine use in the past 30 days assessed via self-report

  12. opioid use (urine test)

    Time frame: 3, 6, 12 months

    opioid use assessed via urine test

  13. cocaine use (urine test)

    Time frame: 3, 6, 12 months

    cocaine use assessed via urine test

  14. alcohol use disorder criteria

    Time frame: 3, 6, 12 months

    acute substance use disorder criteria for alcohol

  15. opioid use disorder criteria

    Time frame: 3, 6, 12 months

    acute substance use disorder criteria for opioids

  16. cocaine use disorder criteria

    Time frame: 3, 6, 12 months

    acute substance use disorder criteria for cocaine

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • RTI International
  • University of Maryland, College Park

Registry information

Official study title

Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users

Acronym: NavSTAR

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2015
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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