Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03336268 |
| Other study ID # |
1706859955 |
| Secondary ID |
R33DA045850 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 12, 2018 |
| Est. completion date |
December 9, 2021 |
Study information
| Verified date |
September 2023 |
| Source |
Indiana University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
