Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-02 @ 10:22 PM
Study NCT ID:
NCT02599818
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
2015-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigation Services to Avoid Rehospitalization (NavSTAR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-16', 'releaseDate': '2021-03-19'}], 'estimatedResultsFirstSubmitDate': '2021-03-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2015-11-05', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-to-Rehospitalization', 'timeFrame': '12 months', 'description': 'Days to rehospitalization'}], 'secondaryOutcomes': [{'measure': '30-day rehospitalization rate', 'timeFrame': '30 days', 'description': 'rate of rehospitalization within 30 days'}, {'measure': 'Cumulative days of inpatient hospitalization', 'timeFrame': '3, 6, 12 months', 'description': 'cumulative days of inpatient hospitalization'}, {'measure': 'Emergency Department utilization rate', 'timeFrame': '3, 6, 12 months', 'description': 'rate of Emergency Department utilization'}, {'measure': 'Emergency Department visits', 'timeFrame': '3, 6, 12 months', 'description': 'cumulative number of Emergency Department visits'}, {'measure': 'Mortality', 'timeFrame': '3, 6, 12 months', 'description': 'all-cause mortality'}, {'measure': 'addiction treatment entry', 'timeFrame': '3, 6, 12 months', 'description': 'rate of entry into addiction treatment'}, {'measure': 'medical follow-up care', 'timeFrame': '3, 6, 12 months', 'description': 'entry into recommended medical follow-up care post-hospital discharge'}, {'measure': 'self-reported quality of life rating', 'timeFrame': '3, 6, 12 months', 'description': 'quality of life scores as determined by the WHO-QOL BREF'}, {'measure': 'alcohol use (self-report)', 'timeFrame': '3, 6, 12 months', 'description': 'days of alcohol use in the past 30 days assessed via self-report'}, {'measure': 'opioid use (self-report)', 'timeFrame': '3, 6, 12 months', 'description': 'days of opioid use in the past 30 days assessed via self-report'}, {'measure': 'cocaine use (self-report)', 'timeFrame': '3, 6, 12 months', 'description': 'days of cocaine use in the past 30 days assessed via self-report'}, {'measure': 'opioid use (urine test)', 'timeFrame': '3, 6, 12 months', 'description': 'opioid use assessed via urine test'}, {'measure': 'cocaine use (urine test)', 'timeFrame': '3, 6, 12 months', 'description': 'cocaine use assessed via urine test'}, {'measure': 'alcohol use disorder criteria', 'timeFrame': '3, 6, 12 months', 'description': 'acute substance use disorder criteria for alcohol'}, {'measure': 'opioid use disorder criteria', 'timeFrame': '3, 6, 12 months', 'description': 'acute substance use disorder criteria for opioids'}, {'measure': 'cocaine use disorder criteria', 'timeFrame': '3, 6, 12 months', 'description': 'acute substance use disorder criteria for cocaine'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-use Disorder', 'Cocaine Use Disorder', 'Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '38678216', 'type': 'DERIVED', 'citation': "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': '36122968', 'type': 'DERIVED', '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."}, {'pmid': '33819055', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adult (ages 18 and older) hospital patients;\n2. current DSM-5 SUD (not in remission) for alcohol, cocaine, or opioids\n3. willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. current enrollment in SUD treatment;\n2. primary residence outside of Baltimore City;\n3. pregnant;\n4. terminal medical condition (e.g., planned discharge to hospice);\n5. hospitalized for a suicide attempt.'}, 'identificationModule': {'nctId': 'NCT02599818', 'acronym': 'NavSTAR', 'briefTitle': 'Navigation Services to Avoid Rehospitalization (NavSTAR)', 'organization': {'class': 'OTHER', 'fullName': 'Friends Research Institute, Inc.'}, 'officialTitle': 'Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users', 'orgStudyIdInfo': {'id': '14-07-224'}, 'secondaryIdInfos': [{'id': 'R01DA037942-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01DA037942-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NavSTAR', '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.", 'interventionNames': ['Behavioral: NavSTAR']}, {'type': 'NO_INTERVENTION', 'label': 'TAU (Treatment as Usual)', 'description': 'Participants in this arm will receive usual care, which includes in-hospital services from a multidisciplinary substance use disorder consultation liaison team.'}], 'interventions': [{'name': 'NavSTAR', 'type': 'BEHAVIORAL', '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', 'armGroupLabels': ['NavSTAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jan Gryczynski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friends Research Institute, Inc.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'After completion of key analyses and publication of planned manuscripts by the investigators.', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'By request, contingent on approval by and execution of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friends Research Institute, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'University of Maryland, College Park', 'class': 'OTHER'}, {'name': 'RTI International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-03-19', 'type': 'RELEASE'}, {'date': '2021-04-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Friends Research Institute, Inc.'}}}}