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Clinical Trials/NCT03336268
NCT03336268CompletedNot Applicable

Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention

Indiana University2 sites in 1 country249 target enrollmentStarted: February 12, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
249
Locations
2
Primary Endpoint
Opioid Overdose

Study Overview

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.

Detailed Description

STUDY DESIGN The investigators will conduct the pilot study at Indiana University Health Methodist Hospital in Indianapolis, Indiana and at Indiana University Health Ball Memorial Hospital in Muncie, Indiana.

The pilot study includes two study arms.

Arm(1): Regarding the POINT intervention, a recovery coach (someone certified by the Indiana Counselors' Association on Alcohol and Drug Abuse to deliver recovery supports who has lived experience with addiction) meets patients in the ED after they have been revived from an overdose (patients are typically alert and oriented, as the overdoes reversal drug completely stops the effect of opioids in their system, and patients will not be approached until a physician has determined they are eligible for release). As part of the POINT program, the recovery coach offers the patient 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-with most patients choosing MOUD referral. Patients are offered a take-home naloxone kit (the overdose reversing drug, which is offered as part care delivered by the recovery coach) 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. Grounded in the concept of critical time intervention, recovery coaches provide over the phone or in person support to navigate barriers to care throughout the recovery process. Also as part of the POINT program, recovery coaches offer to accompany patients to intake appointments or criminal justice and child welfare meetings as part of the standard care they deliver (no data collection for research purposes will occur as part of this service provision). The entire care transition process takes between 2 weeks and several months, and POINT leaves the door open so patients can re-engage at any point they require help overcoming recovery barriers.

Arm (2): The standard care arm will consist of basic referral to services by informing patients of available treatment options in the community.

RANDOMIZATION & ENROLLMENT For each day of the study, researchers will randomly select during which of the shifts patients will enroll into the POINT arm and which will enroll into standard care (morning shift (8am-3:59pm), evening (4pm-11:59pm), and overnight (12am-7:59am). Any individual who is discharged from the ED for an opioid overdose or for an opioid-related health issue, including opioid withdrawal, abscess (from IV drug use) or active opioid intoxication will be eligible for the study. The research team and recovery coaches will receive an electronic alert from emergency medical services any time an overdose patient is admitted to the ED. A recovery coach will be sent to the ED on POINT shifts, and a research assistant will be sent on non-POINT shifts. Once they have confirmed that the admit is reason is either an opioid overdose or an opioid-related issue, they will read the questions on the DSM-5 for Opioid Use Disorder screening tool. Any individual who is at least 18 years of age and is discharged from the ED for an overdose an opioid related health issue AND scores at least a "1" on the opioid use disorder screening tool will be initially eligible for the study; they must also be cleared for discharge and medically stable and capable of providing consent. Depending on the arm of the study patients are being recruited to on that shift, either the recovery coach or the research assistant will inform the patient of the study and request their consent to participate.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •(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.)

Arms & Interventions

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.

Intervention: POINT (Behavioral)

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.

Outcomes

Primary Outcomes

Opioid Overdose

Time Frame: 1 year pre-enrollment through 1 year post-enrollment

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

Secondary Outcomes

  • 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)
  • Medication for Opioid Use Disorder (MOUD) Engagement(1 year pre-enrollment through 1 year post-enrollment)
  • Medicaid Enrollment for Participants Without Insurance(Enrollment through 3 months, 6 months, and 12 months post-enrollment)
  • Child Welfare Involvement(3 years pre-enrollment through 1 year post-enrollment)
  • Incarceration(3 years pre-enrollment through 1 year post-enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alan McGuire

Principal Investigator

Indiana University

Study Sites (2)

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