Opioid-use DisorderNavSTARNCT02599818
Navigation Services to Avoid Rehospitalization (NavSTAR)
A study testing NavSTAR in people with Opioid-use Disorder and Cocaine Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Cocaine Use Disorder, Alcohol Use Disorder
- What is being tested?
- NavSTAR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2016to 14 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users
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.
Read the 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.
- Being tested
- NavSTAR
- Medical subject headings
- Opioid-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavSTARBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Rehospitalization
Days to rehospitalization
Measured: 12 months
Secondary outcomes (16)
30-day rehospitalization rate
rate of rehospitalization within 30 days
Measured: 30 days
Cumulative days of inpatient hospitalization
cumulative days of inpatient hospitalization
Measured: 3, 6, 12 months
Emergency Department utilization rate
rate of Emergency Department utilization
Measured: 3, 6, 12 months
Emergency Department visits
cumulative number of Emergency Department visits
Measured: 3, 6, 12 months
Mortality
all-cause mortality
Measured: 3, 6, 12 months
addiction treatment entry
rate of entry into addiction treatment
Measured: 3, 6, 12 months
medical follow-up care
entry into recommended medical follow-up care post-hospital discharge
Measured: 3, 6, 12 months
self-reported quality of life rating
quality of life scores as determined by the WHO-QOL BREF
Measured: 3, 6, 12 months
alcohol use (self-report)
days of alcohol use in the past 30 days assessed via self-report
Measured: 3, 6, 12 months
opioid use (self-report)
days of opioid use in the past 30 days assessed via self-report
Measured: 3, 6, 12 months
cocaine use (self-report)
days of cocaine use in the past 30 days assessed via self-report
Measured: 3, 6, 12 months
opioid use (urine test)
opioid use assessed via urine test
Measured: 3, 6, 12 months
cocaine use (urine test)
cocaine use assessed via urine test
Measured: 3, 6, 12 months
alcohol use disorder criteria
acute substance use disorder criteria for alcohol
Measured: 3, 6, 12 months
opioid use disorder criteria
acute substance use disorder criteria for opioids
Measured: 3, 6, 12 months
cocaine use disorder criteria
acute substance use disorder criteria for cocaine
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study start15 Mar 2016
- Primary completion5 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Maryland, College Park, RTI International
- Responsible party
- Sponsor
- Investigators
- Jan Gryczynski, PhD, Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599818
- Sponsor's protocol ID
- 14-07-224
- Other IDs
- R01DA037942-01A1
- Acronym
- NavSTAR
- Status last verified
- Feb 2020
- First submitted
- 3 Nov 2015
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38678216Mitchell 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.
PubMed 36122968Gryczynski 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.
PubMed 33819055
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigation Services to Avoid Rehospitalization (NavSTAR) Among Substance Users
- ClinicalTrials.gov ID
- NCT02599818
- Acronym / sponsor ID
- NavSTAR / 14-07-224
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Maryland, College Park, RTI International
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NavSTAR | Experimental | Behavioral: NavSTARParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavSTARParticipants 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 | Behavioural | NavSTAR |
Primary outcome
Time-to-Rehospitalization
Time frame: 12 months
Days to rehospitalization
16 secondary outcomes
30-day rehospitalization rate
Time frame: 30 days
Cumulative days of inpatient hospitalization
Time frame: 3, 6, 12 months
Emergency Department utilization rate
Time frame: 3, 6, 12 months
Emergency Department visits
Time frame: 3, 6, 12 months
Mortality
Time frame: 3, 6, 12 months
addiction treatment entry
Time frame: 3, 6, 12 months
medical follow-up care
Time frame: 3, 6, 12 months
self-reported quality of life rating
Time frame: 3, 6, 12 months
alcohol use (self-report)
Time frame: 3, 6, 12 months
opioid use (self-report)
Time frame: 3, 6, 12 months
cocaine use (self-report)
Time frame: 3, 6, 12 months
opioid use (urine test)
Time frame: 3, 6, 12 months
cocaine use (urine test)
Time frame: 3, 6, 12 months
alcohol use disorder criteria
Time frame: 3, 6, 12 months
opioid use disorder criteria
Time frame: 3, 6, 12 months
cocaine use disorder criteria
Time frame: 3, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Derived from this study: PubMed 38678216Nordeck 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.
- Derived from this study: PubMed 36122968Mitchell 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.
- Derived from this study: PubMed 33819055Gryczynski 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Gryczynski, PhD principal investigator
Friends Research Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NavSTAR in people with Opioid-use Disorder and Cocaine Use Disorder, run by Friends Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Rehospitalization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599818, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.