NCT03684681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2022

Enrollment Period

2.5 years

First QC Date

September 17, 2018

Last Update Submit

June 20, 2023

Conditions

Opioid UseOpioid DependenceOpioid AbuseOpioid-Related Disorders

Outcome Measures

Primary Outcomes (2)

  • The proportion of participants who are admitted to a formal addiction treatment program within thirty days following the initial ED visit.

    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.

    30 days

  • 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.

    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).

    18 months

Secondary Outcomes (4)

  • Compare the the time to subsequent opioid overdose rates between groups.

    18 month

  • Successful completion or retention in addiction treatment

    18 month

  • Overdose death

    18 months

  • Heterogeneity of intervention effect

    18 months

Study Arms (2)

Peer Navigator

OTHER

Current standard of care

Behavioral: Peer Navigator Intervention

Social Worker

OTHER

Current standard of care

Behavioral: Social Work Intervention

Interventions

Peer Navigator InterventionBEHAVIORAL

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.

Peer Navigator
Social Work InterventionBEHAVIORAL

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

Social Worker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (4)

  • Collins AB, Baird J, Nimaja E, Ashenafi Y, Clark MA, Beaudoin FL. Experiences of patients at high risk of opioid overdose accessing emergency department and behavioral health interventions: a qualitative analysis in an urban emergency department. BMC Health Serv Res. 2023 Apr 18;23(1):370. doi: 10.1186/s12913-023-09387-7.

    PMID: 37069593DERIVED

  • Beaudoin FL, Jacka BP, Li Y, Samuels EA, Hallowell BD, Peachey AM, Newman RA, Daly MM, Langdon KJ, Marshall BDL. Effect of a Peer-Led Behavioral Intervention for Emergency Department Patients at High Risk of Fatal Opioid Overdose: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225582. doi: 10.1001/jamanetworkopen.2022.25582.

    PMID: 35943744DERIVED

  • Jacka B, Beaudoin F, Li Y, Nimaja E, Yedinak J, Samuels E, Marshall BDL. Objective Outcome Measures in Randomized Clinical Trials of Interventions to Reduce Risk of Opioid Overdose Following Discharge From the Emergency Department: Utility of Administrative Data Linkage. J Addict Med. 2021 Apr 1;15(2):174-175. doi: 10.1097/ADM.0000000000000705. No abstract available.

    PMID: 32769773DERIVED

  • Goedel WC, Marshall BDL, Samuels EA, Brinkman MG, Dettor D, Langdon KJ, Mahoney LA, Merchant RC, Nizami T, O'Toole GA, Ramsey SE, Yedinak JL, Beaudoin FL. Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial. BMJ Open. 2019 Nov 11;9(11):e032052. doi: 10.1136/bmjopen-2019-032052.

    PMID: 31719087DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Social Work

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Francesca Beaudoin, MD

    Brown Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 26, 2018

Study Start

November 14, 2018

Primary Completion

May 14, 2021

Study Completion

November 30, 2022

Last Updated

June 22, 2023

Record last verified: 2022-06

Locations

US(1)