Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention (POINT)
|First Submitted Date ICMJE||October 26, 2017|
|First Posted Date ICMJE||November 8, 2017|
|Last Update Posted Date||November 9, 2017|
|Anticipated Start Date ICMJE||March 1, 2018|
|Estimated Primary Completion Date||August 1, 2018 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT03336268 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention|
|Official Title ICMJE||Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention|
The investigators seek to assess the effectiveness of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment). Located 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 a new hospital and test its feasibility through (a) assessment of the chosen implementation strategy and (b) the testing of research protocols and secondary data collection procedures.
STUDY DESIGN The investigators will conduct the pilot study at Methodist Hospital in Indianapolis, 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 The investigators will enroll patients during two hospital shifts of the day. Each of these shifts will be 8-hours long. For each day of the study, the investigators will randomly select during which of the two shifts patients will enroll into the POINT arm and which will enroll into standard care. Any individual who enters the ED for an overdose during first or second shift will be eligible for the study. The research team and recovery coaches will receive an automatic email alert from emergency medical services any time a 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. 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. The investigators will not fully disclose the purposes of the research to the standard care arm because (1) Methodist Hospital was planning on implementing POINT outside of the context of this study and because their ability to staff recovery coaches is limited anyway, the investigators are not creating any disparity in patients ability to access point that would not naturally exist and (2) the investigators 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 (Methodist) 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:
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 research assistant will work with all of these systems to obtain and merge the data.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Intervention ICMJE||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.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||60|
|Estimated Completion Date||December 30, 2018|
|Estimated Primary Completion Date||August 1, 2018 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
(Individuals arriving during a POINT shift who do not wish to participate in the study are still eligible to receive POINT services.)
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries|
|NCT Number ICMJE||NCT03336268|
|Other Study ID Numbers ICMJE||1706859955|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||
|Responsible Party||Dennis Watson, Indiana University|
|Study Sponsor ICMJE||Indiana University|
|Collaborators ICMJE||Not Provided|
|PRS Account||Indiana University|
|Verification Date||November 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP