Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention (POINT)

• ClinicalTrials.gov Identifier: NCT03336268
• Recruitment Status: Enrolling by invitation
• First Posted: November 8, 2017
• Last Update Posted: September 24, 2020
• Sponsor: Indiana University
• Information provided by (Responsible Party): Dennis Watson, Indiana University

Study Description

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 assisted treatment (MAT) 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 pilot 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.

Condition or disease	Intervention/treatment	Phase
Substance Use Disorders; Overdose	Behavioral: POINT	Not Applicable

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 assisted treatment (MAT) provider, detoxification services, or an inpatient treatment setting-with most patients choosing MAT 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 MAT 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-4pm), evening (4pm-12am), and overnight (12am-8am). 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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention
• Actual Study Start Date: February 12, 2018
• Estimated Primary Completion Date: July 31, 2021
• Estimated Study Completion Date: December 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: POINT; 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; 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 assisted treatment (MAT) 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 MAT 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.
No Intervention: Standard Care; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Duration of Medication Assisted Treatment (MAT) Engagement [ Time Frame: 3 years pre-enrollment through 6 & 12 months post-enrollment ]
   Change in duration of MAT engagement
2. Change in Frequency of Medication Assisted Treatment (MAT) Engagement [ Time Frame: 3 years pre-enrollment through 6 & 12 months post-enrollment ]
   Change in frequency of MAT engagement
3. Change in Frequency of Overdoses [ Time Frame: 3 years pre-enrollment through 6 & 12 months post-enrollment ]
   Change in the frequency of emergency department overdose admissions
4. Change in the Time to Relapse [ Time Frame: Enrollment through 6 & 12 months post-enrollment ]
   Changes in the duration of time before one experiences a relapse
5. Change in Hospital and Emergency Department Admissions [ Time Frame: 3 years pre-enrollment through 6 & 12 months post-enrollment ]
   Change in Hospital or Emergency Departments admissions (for any medical reason)
6. Change in Medicaid Enrollment [ Time Frame: Enrollment through 6 & 12 months post-enrollment ]
   Change in Medicaid enrollment (for those patients who are eligible and did not have insurance at ED admission)
7. Change in Child Welfare Involvement [ Time Frame: 3 years pre-enrollment through 6 & 12 months post-enrollment ]
   Change in Department of Child Services (DCS) involvement, including number of open cases and number of children in foster care
8. Change in Incarceration [ Time Frame: 3 years pre-enrollment through 6 & 12 months post-enrollment ]
   Change in the number of days one experienced incarceration (county jail and department of corrections)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

(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.)

Contacts and Locations

Locations

United States, Indiana

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States, 46202

Indiana University Health Ball Memorial Hospital

Muncie, Indiana, United States, 47303

Sponsors and Collaborators

Indiana University

Investigators

• Principal Investigator: Dennis P Watson, PhD; Indiana University

More Information

• Responsible Party: Dennis Watson, Principal Investigator, Indiana University
• ClinicalTrials.gov Identifier: NCT03336268
• Other Study ID Numbers: 1706859955
• First Posted: November 8, 2017
• Last Update Posted: September 24, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dennis Watson, Indiana University:

Opioid Use Disorder; Peer Recovery Coach

Additional relevant MeSH terms:

Substance-Related Disorders; Drug Overdose; Chemically-Induced Disorders; Mental Disorders