The Navigator Trial

NCT03684681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2023-06-22

No results posted yet for this study

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.

Conditions

  • Opioid Use
  • Opioid Dependence
  • Opioid Abuse
  • Opioid-Related Disorders

Interventions

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.

BEHAVIORAL

Social Work Intervention

A hospital social workers uses their own previous training to help people meet their goals.

Sponsors & Collaborators

  • Brown University

    collaborator OTHER
  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • Francesca Beaudoin, MD · Brown Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2021-05-14
Completion
2022-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03684681 on ClinicalTrials.gov