University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
NCT Number: NCT02599818
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 12 months
Days to rehospitalization
Time frame: 30 days
rate of rehospitalization within 30 days
Time frame: 3, 6, 12 months
cumulative days of inpatient hospitalization
Time frame: 3, 6, 12 months
rate of Emergency Department utilization
Time frame: 3, 6, 12 months
cumulative number of Emergency Department visits
Time frame: 3, 6, 12 months
all-cause mortality
Time frame: 3, 6, 12 months
rate of entry into addiction treatment
Time frame: 3, 6, 12 months
entry into recommended medical follow-up care post-hospital discharge
Time frame: 3, 6, 12 months
quality of life scores as determined by the WHO-QOL BREF
Time frame: 3, 6, 12 months
days of alcohol use in the past 30 days assessed via self-report
Time frame: 3, 6, 12 months
days of opioid use in the past 30 days assessed via self-report
Time frame: 3, 6, 12 months
days of cocaine use in the past 30 days assessed via self-report
Time frame: 3, 6, 12 months
opioid use assessed via urine test
Time frame: 3, 6, 12 months
cocaine use assessed via urine test
Time frame: 3, 6, 12 months
acute substance use disorder criteria for alcohol
Time frame: 3, 6, 12 months
acute substance use disorder criteria for opioids
Time frame: 3, 6, 12 months
acute substance use disorder criteria for cocaine
Friends Research Institute, Inc.
Other
Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users
Acronym: NavSTAR
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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