Clinical trial NCT03336268: Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention
Official title: Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Overdose
Keywords: Opioid Use Disorder
Peer Recovery Coach
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-11-08
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Researchers will not fully disclose the purposes of the research to the standard care arm because (1) Methodist Hospital and Ball Memorial were planning on implementing POINT outside of the context of this study and because their ability to staff recovery coaches is limited anyway, we are not creating any disparity in patients ability to access point that would not naturally exist and (2) we are concerned that full disclosure of the purposes would unnecessarily upset standard care patients who might desire the services after learning of them.

The study site plans to implement Project POINT regardless of the research study. Therefore, all recovery coach duties are part of POINT prescribed services that would be carried out regardless of the research. The investigators are randomizing the shift during which POINT is delivered to take advantage of the fact that they are not able to fully staff all hospital shifts with a recovery coach--thus allowing us to test the intervention's effectiveness. Only those patients in the standard care arm will be asked to complete data collection activities that would not be completed outside of the research study.

After study consent, all subjects will be asked to complete a structured interview with either a recovery coach (POINT group) or a research assistant (standard care). This interview will occur in the ED, and it can take between 30-60 minutes and covers the following topics: demographics, social support; living arrangements, drug use, context of current overdose, treatment history, interest in recovery services, use of strategies to reduce risks related to drug use, HIV and Hepatitis C, physical and mental health, adverse childhood experiences, and detailed contact information. Additionally, the RA or recovery coach will collect detailed contact information on the participant to increase chances of being able to follow up with the participant. This contact information will be entered into a separate database and will not be linked to questionnaire responses.

The investigators will also collect information from the following existing secondary data sources:

* Indiana Network for Patient Care (contains hospital and overdose admission data)
* INSPECT (contains prescription information for controlled substances)
* Division of Mental Health and Addiction (contains methadone treatment information)
* Indiana Office of Medicaid Planning and Policy (contains Medicaid enrollment information)
* Indiana Department of Child Services (contains child welfare involvement information)
* Valle Vista Health System (contains addiction and mental health treatment data)
* Midtown Community Mental Health (contains mental health treatment data)
* Clean Slate (contains addiction treatment data)

As part of the POINT project, recovery coaches engage with POINT patients for two weeks (reaching out to patients every 2-3 days until the patient is successfully engaged in recovery services), but this may last longer (several months) depending on patient need and desire for continued assistance. Recovery coaches will not be collecting data for study purposes during this time; rather, any information they collect will be their employment purposes as a recovery coach. Standard care patients are not seen after the initial referral.

The investigators will also collect data from hospital records and government and public health databases on patients enrolled in the study after obtaining a release for these information from subjects. The investigators will collect methadone data from the Division of Mental Health and Addiction (DMHA), prescribing information related to controlled substances from INSPECT (prescription drug monitoring system), the hospital admission data from Indiana Network for Patient Care (INPC), overdose death information form coroner records, insurance information from Medicaid, child welfare system involvement form the Department of Child Services (DCS), and publicly available criminal justice data. A third party, Regenstrief Institute, will work with all of these systems to securely obtain and merge the data and to de-identify the data before sharing it with the research team.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Score at least "1" on the DSM-5 for Opioid Use Disorder screening tool
3. Eligible for discharge from the Methodist or Ball Memorial Hospital Emergency Department and deemed able to speak to research staff by ED staff
4. Be 18 or older
5. 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.)

Primary outcomes:
measure: Opioid Overdose
timeFrame: 1 year pre-enrollment through 1 year post-enrollment
Secondary outcomes:
measure: Medication for Opioid Use Disorder (MOUD) Engagement
timeFrame: 1 year pre-enrollment through 1 year post-enrollment
measure: Duration of Medication for Opioid Use Disorder (MOUD) Engagement
timeFrame: 1 year pre-enrollment through 1 year post-enrollment
measure: Emergency Department Presentations
timeFrame: 1 year pre-enrollment through 1 year post-enrollment
measure: Inpatient Hospital Admissions
timeFrame: 1 year pre-enrollment through 1 year post-enrollment
measure: Time to Relapse
timeFrame: Enrollment through 6 & 12 months post-enrollment
measure: Medicaid Enrollment for Participants Without Insurance
timeFrame: Enrollment through 3 months, 6 months, and 12 months post-enrollment
measure: Child Welfare Involvement
timeFrame: 3 years pre-enrollment through 1 year post-enrollment
measure: Incarceration
timeFrame: 3 years pre-enrollment through 1 year post-enrollment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Muncie
country: United States
facility: Indiana University Health Ball Memorial Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Dennis P Watson, PhD
role: PRINCIPAL_INVESTIGATOR
References: