Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention

NCT03336268 | Completed Results

• 2 other identifiers: 1706859955R33DA045850
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators seek to assess the effectiveness of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment). As originated in Indianapolis, Project POINT is a collaboration between Indianapolis Emergency Medical Services (EMS), the Eskenazi Emergency Department, Midtown Mental Health, and researchers at Indiana University. POINT is a quality improvement initiative that connects trained outreach workers with emergency department (ED) patients who experienced a non-fatal overdose. A member of the POINT team (a recovery coach or care coordinator with specialized training) meets patients after they have experienced an opioid overdose and, following a model of patient-centered care, offers them a range of evidence-based services including a brief assessment of high-risk behaviors, Hepatitis C and HIV testing, harm reduction counseling informed by motivational interviewing, and treatment referrals with follow-up to either a medication for opioid use disorder (MOUD) provider, detoxification services, or an inpatient treatment setting The primary goal of this project is the establishment of POINT as an effective and scalable intervention for engaging patients in MAT. This study employs a Hybrid Type 1 effectiveness implementation design to take full advantage of current POINT expansion efforts currently happening in Indiana. The goal of this study is to replicate POINT in new hospitals and test its feasibility through (a) assessment of the chosen implementation strategy and (b) the testing of research protocols and secondary data collection procedures.

Conditions

Substance Use Disorders; Overdose

Keywords

Opioid Use Disorder; Peer Recovery Coach

Outcome Measures

Primary Outcomes (1)

• Opioid Overdose

  Total participants presenting to the emergency department (ED) for an opioid overdose.

  1 year pre-enrollment through 1 year post-enrollment

Secondary Outcomes (8)

• Medication for Opioid Use Disorder (MOUD) Engagement

  1 year pre-enrollment through 1 year post-enrollment

• Duration of Medication for Opioid Use Disorder (MOUD) Engagement

  1 year pre-enrollment through 1 year post-enrollment

• Emergency Department Presentations

  1 year pre-enrollment through 1 year post-enrollment

• Inpatient Hospital Admissions

  1 year pre-enrollment through 1 year post-enrollment

• Time to Relapse

  Enrollment through 6 & 12 months post-enrollment

Study Arms (2)

POINT

EXPERIMENTAL

This arm will be offered both POINT services (in addition to standard emergency care) and enrollment in study data collection. If they choose to enroll in POINT, they may choose whether or not to enroll in data collection, as it is not required. Should they enroll in data collection, they will be consented and enrolled in the research study as a participant in the POINT study arm.

Behavioral: POINT

Standard Care

NO INTERVENTION

This arm will only be offered enrollment in study data collection, as they will receive standard emergency care. If they choose to enroll, they will be consented in the research study as the Standard Care arm.

Interventions

POINT BEHAVIORAL

A recovery coach meets patients in the ED after they have been revived from an overdose to offer a range of services including an assessment of high-risk behaviors, Hep C/HIV testing, harm reduction counseling, and treatment referrals with follow-up to either a medication for opioid use disorder (MOUD) provider, detoxification services, or an inpatient treatment setting. Patients are offered a take-home naloxone kit and assistance with Medicaid enrollment. Close collaboration with the local community mental health provider ensures POINT patients have their first assessment for MOUD within 1-2 business days of ED discharge. Also, recovery coaches offer to accompany patients to intake appointments or criminal justice and child welfare meetings as part of the standard care they deliver.

POINT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Revived from a drug overdose or admitted to the ED for an opioid-related health issue, including opioid withdrawal, abscess (from IV opioid use), endocarditis (from IV opioid use), or active opioid intoxication
• Score at least "1" on the DSM-5 for Opioid Use Disorder screening tool
• Eligible for discharge from the Methodist or Ball Memorial Hospital Emergency Department and deemed able to speak to research staff by ED staff
• Be 18 or older
• Be medically stable (i.e., cleared to leave the ED by a physician) and capable of providing consent.

You may not qualify if:

• (a) Unable to answer the 3 study competency questions that indicate capability of providing consent.
• (Individuals discharged from the ED during a POINT shift who do not wish to participate in the study are still eligible to receive POINT services.)

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States

Location

Related Publications (1)

• Watson DP, Tillson M, Taylor L, Xu H, Ouyang F, Beaudoin FL, O'Donnell D, McGuire AB. Results From the POINT Pragmatic Randomized Trial: An Emergency Department-Based Peer Support Specialist Intervention to Increase Opioid Use Disorder Treatment Linkage and Reduce Recurrent Overdose. Subst Use Addctn J. 2024 Jul;45(3):378-389. doi: 10.1177/29767342231221054. Epub 2024 Jan 9.

  PMID: 38258819 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Drug Overdose; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Prescription Drug Misuse; Drug Misuse; Narcotic-Related Disorders

Limitations and Caveats

Because of IRB requirements, the control arm was enrolled by research assistants and the treatment arm was enrolled by peers. Higher treatment arm enrollment was likely due to peers' relationship building role. The COVID pandemic stopped quality improvement efforts and enrollment before the issue could be full addressed. Thus, the study was unable to address enrollment discrepancies or reach the target sample (n=712). The study was likely underpowered to detect change in the primary outcome.

Results Point of Contact

• Title: Dr. Dennis Watson
• Organization: Chestnut Health Systems

dpwatson@chestnut.org

312-274-5316

Study Officials

• Dennis P Watson, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 8, 2017
• Study Start: February 12, 2018
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: October 6, 2023
• Results First Posted: April 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)