Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention (POINT)
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|ClinicalTrials.gov Identifier: NCT03336268|
Recruitment Status : Enrolling by invitation
First Posted : November 8, 2017
Last Update Posted : September 24, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|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|
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.
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.
- 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
- 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
- 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
- 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
- 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)
- 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)
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336268
|United States, Indiana|
|Indiana University Health Methodist Hospital|
|Indianapolis, Indiana, United States, 46202|
|Indiana University Health Ball Memorial Hospital|
|Muncie, Indiana, United States, 47303|
|Principal Investigator:||Dennis P Watson, PhD||Indiana University|