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The Navigator Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684681
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Brown University
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:

In this study, the investigators will investigate if there is a better intervention for patients who present to the emergency department with an overdose or with symptoms consistent with drug use. There are currently two interventions that are routinely used when a patient comes to the Emergency Department with these criteria, and the investigators will compare the two. The first is when hospital social workers uses their own previous training to help people meet their goals. The second is when a person called a peer navigator, who is someone that has been in long-term drug recovery for over two years and has completed a lot of training to work with current drug users, delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals. The investigators hope to determine if patients have better outcomes if they work with one of these two groups.

If a patient agrees to be in the study, the research staff will randomize them (like flipping a coin) to see if they will work with a social worker or a peer navigator. The research staff will distribute a survey in RedCap and the following information will be collected: age, sex, race, type of opioid used, and history of chronic pain, depression or post-traumatic stress disorder. Once the patient is assigned to a group, they will work with their assigned interventionist for the duration of the study. After this, the research team will track the patient to see if they joined an addiction-treatment program within 30 days of when the joined the study. The study team will also track patients to see if they had additional emergency department visits, additional overdoses, and if they successfully completed a treatment program over an 18-month period.

650 patients will be enrolled into the study.


Condition or disease Intervention/treatment Phase
Opioid Use Opioid Dependence Opioid Abuse Opioid-Related Disorders Behavioral: Peer Navigator Intervention Behavioral: Social Work Intervention Not Applicable

Detailed Description:

Opioid overdoses are a leading cause of death for Americans under 50 years old, with recent years recording the most opioid overdose deaths on record. US Emergency Departments (EDs) have seen a parallel increase in opioid-related visits (a 100% increase from 2005 - 2014). ED patients presenting for an overdose are at greatly elevated risk for a repeat overdose and death. Thus, an overdose-related ED visit is both a critical and opportune time to prevent recurrent opioid overdose and overdose death through increased uptake in addiction treatment. The most effective means to promote engagement in treatment following an ED visit for opioid overdose remains unknown. To address this critical evidence gap, the investigators will compare the effectiveness of two ED-based behavioral interventions to increase treatment uptake and reduce the risk of future overdose among ED patients who are at greatest risk of accidental drug-related death.

In response to RI's overdose crisis, in 2014, the state's largest ED (Rhode Island Hospital) began a proactive campaign to improve the care of overdose patients. The program includes an ED-based behavioral intervention either by in-house clinical social work staff or peer recovery support specialists ("peer navigators"). Following the introduction of these interventions in the ED, there was 10-fold increase in the proportion of patients engaging in addiction treatment within 30 days of the initial ED visit. While this preliminary data is promising, the effectiveness of the peer navigators versus the social work intervention is not known.

The investigators propose a randomized controlled trial of early ED behavioral interventions following an opioid overdose. The investigators hypothesize that peer navigation will result in greater early treatment engagement and reduction in recurrent opioid overdose compared to a standard intervention delivered by a clinical social worker.

The investigators will determine the effectiveness of peer navigation versus a standard behavioral intervention delivered in the ED to overdose patients and those at risk of recurrent opioid overdose. A total of 650 ED patients will be recruited (n=325 per arm) and followed for 18 months. Effectiveness will be measured objectively through linkage to administrative statewide databases, with two primary endpoints: (1) engagement in formal addiction treatment (e.g., inpatient services, outpatient services, medication assisted treatment (MAT)) from a licensed substance abuse treatment provider within 30 days following the ED visit, and (2) reduction in 18-month recurrent ED visits for an opioid overdose. Exploratory outcomes of interest are: overdose fatality, repeat ED visits related to opioids, and successful completion of an addiction treatment program and/or long-term retention in MAT.

The investigators will explore if there is heterogeneity of treatment effect related to patient characteristics. The investigators anticipate that there will be individuals within each treatment arm who will vary in their response to the intervention. Specifically, the investigators will examine if the effects of the interventions are modified by baseline characteristics such as age, sex, race, type of opioid used, and history of comorbid chronic pain, depression or PTSD. Understanding these factors will allow us to further optimize subsequent interventions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Navigator Trial
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Peer Navigator
Current standard of care
Behavioral: Peer Navigator Intervention
A peer navigator delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals.

Social Worker
Current standard of care
Behavioral: Social Work Intervention
A hospital social workers uses their own previous training to help people meet their goals.




Primary Outcome Measures :
  1. The proportion of participants who are admitted to a formal addiction treatment program within thirty days following the initial ED visit. [ Time Frame: 30 days ]
    Engagement in addiction treatment will be defined as the proportion who are admitted to a formal addiction treatment program within thirty days following the initial ED visit. The research team will be using BHDDH and Prescription Drug Monitoring Program (PDMP) records. The BHDDH database contains information on all admissions to publicly funded substance abuse treatment programs in the state. The RI PDMP manages a database that contains information on all prescriptions for schedule II-IV substances filled in the state. The database is updated daily; all pharmacies are required to report prescriptions within 48-hours of the fill date. All records will be linked deterministically to participant data using identifiable information (e.g., name, social security number) within the Stronghold computing environment, a HIPAA-compliant server maintained by the team at Brown University.

  2. The proportion of participants who are treated in any Rhode Island ED for an opioid overdose at any time during the 18-month follow-up period following the initial ED visit. [ Time Frame: 18 months ]
    The proportion of participants who are treated in any Rhode Island ED for an opioid overdose at any time during the 18-month follow-up period following the initial ED visit, will be assessed by first accessing the electronic medical records (EMRs) of the 12 EDs in Rhode Island (RI) through the Rhode Island Quality Institute Statewide Health Information Exchange. This unified data system provides access to EMR data from all major health systems in RI, capturing repeat visits for an opioid overdose that occur in all 12 EDs in RI. Secondly the research team will query the RI Department of Health (RIDOH) Opioid 48-Hour Overdose Surveillance System which mandates all suspected opioid overdose cases presenting to an RI hospital be reported to the department within 48 hours. This data source will capture recurrent overdoses not identified by ICD codes in the unified EMR data system, and also contains additional fields of interest (e.g., pre-existing risk factors for overdose).


Secondary Outcome Measures :
  1. Compare the the time to subsequent opioid overdose rates between groups. [ Time Frame: 18 month ]
    The principal investigator will use Breslow's method to test if the time to subsequent opioid overdose rates differs between the groups.

  2. Successful completion or retention in addiction treatment [ Time Frame: 18 month ]
    Successful completion and/or retention in addiction treatment will be defined based on discharge data collected in BHOLD and prescription refill data in the PDMP. The principal investigator will examine the time to ED visit for an opioid overdose using a Kaplan-Meier analysis. Patients will be censored at the end of the 18-month follow-up period, considered the last point of contact.

  3. Overdose death [ Time Frame: 18 months ]
    Cox proportional hazards modeling will be used to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for occurrence of repeat overdose between groups. HRs will be adjusted for clinical and demographic characteristics believed to predict the outcome of opioid overdose in order to adjust for possible residual confounding and treatment-factor interactions.

  4. Heterogeneity of intervention effect [ Time Frame: 18 months ]
    The principal investigator will perform stratified subgroup analyses to determine if treatment effects vary between groups of individuals.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English-speaking
  • 18 years of age or older
  • Treatment for an opioid overdose or identified as having had an opioid overdose in the past 12 months or are being treated for a visit related to illicit opioid use (e.g., abscess, opioid withdrawal)
  • Able to provide informed consent.

Exclusion Criteria:

  • Less than 18 years of age
  • Previously enrolled in the study
  • In police custody
  • Incarcerated
  • Live outside of Rhode Island
  • Pregnant
  • Critically ill or injured

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684681


Contacts
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Contact: Kristin M Basso, BSN (401) 451-2263 Kristin.Basso@Lifespan.org

Locations
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United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Erin Ryan, MPH    401-444-9264    erin.ryan@lifespan.org   
Principal Investigator: Francesca Beaudoin, MD, PhD         
Sponsors and Collaborators
Rhode Island Hospital
Brown University
Investigators
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Principal Investigator: Francesca Beaudoin, MD Brown Emergency Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03684681    
Other Study ID Numbers: Navigator
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders