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Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention

Project POINT: Effectiveness and Scalability of an Overdose Survivor Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03336268
Acronym
POINT
Enrollment
249
Registered
2017-11-08
Start date
2018-02-12
Completion date
2021-12-09
Last updated
2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overdose, Substance Use Disorders

Keywords

Opioid Use Disorder, Peer Recovery Coach

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.

Interventions

BEHAVIORALPOINT

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 for opioid use disorder (MOUD) 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 MOUD 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
Opioid Overdose1 year pre-enrollment through 1 year post-enrollmentTotal participants presenting to the emergency department (ED) for an opioid overdose.

Secondary

MeasureTime frameDescription
Duration of Medication for Opioid Use Disorder (MOUD) Engagement1 year pre-enrollment through 1 year post-enrollmentTotal days of supply of buprenorphine prescriptions, naltrexone prescriptions, or methadone dosed for participants with a medication for opioid use disorder (MOUD).
Emergency Department Presentations1 year pre-enrollment through 1 year post-enrollmentTotal participants presented to the Emergency Department for any medical reason.
Inpatient Hospital Admissions1 year pre-enrollment through 1 year post-enrollmentTotal participants admitted to the hospital for any medical reason.
Medication for Opioid Use Disorder (MOUD) Engagement1 year pre-enrollment through 1 year post-enrollmentTotal participants with buprenorphine prescriptions, naltrexone prescriptions, or dosed methadone.
Medicaid Enrollment for Participants Without InsuranceEnrollment through 3 months, 6 months, and 12 months post-enrollmentTotal participants without insurance coverage at enrollment that enrolled in Medicaid.
Child Welfare Involvement3 years pre-enrollment through 1 year post-enrollmentTotal open child welfare cases.
Incarceration3 years pre-enrollment through 1 year post-enrollmentTotal days experienced incarceration.
Time to RelapseEnrollment through 6 & 12 months post-enrollmentRelapse-free survival probability for 6 months and 12 months. Participants who did not have ED presentation were censored at 1) time of 6 month or 12 months, 2) one's last day in the study, 3) overdose death date, whichever is the earliest.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
157
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.
86
Total243

Baseline characteristics

CharacteristicPOINTStandard CareTotal
Age, Continuous35 years
STANDARD_DEVIATION 10.1
37.2 years
STANDARD_DEVIATION 11.7
35.8 years
STANDARD_DEVIATION 10.7
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants2 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
153 Participants84 Participants237 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Insurance Status
Healthy Indiana Plan (HIP)
91 Participants45 Participants136 Participants
Insurance Status
Medicaid
17 Participants8 Participants25 Participants
Insurance Status
Medicare
7 Participants6 Participants13 Participants
Insurance Status
None
30 Participants20 Participants50 Participants
Insurance Status
Other
1 Participants4 Participants5 Participants
Insurance Status
Private (exchange, employer-based)
10 Participants3 Participants13 Participants
Insurance Status
Unknown
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
17 Participants11 Participants28 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
139 Participants75 Participants214 Participants
Region of Enrollment
United States
157 participants86 participants243 participants
Sex/Gender, Customized
Female
68 Participants32 Participants100 Participants
Sex/Gender, Customized
Male
88 Participants54 Participants142 Participants
Sex/Gender, Customized
Other
1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
25 / 15716 / 86
other
Total, other adverse events
0 / 1570 / 86
serious
Total, serious adverse events
102 / 15756 / 86

Outcome results

Primary

Opioid Overdose

Total participants presenting to the emergency department (ED) for an opioid overdose.

Time frame: 1 year pre-enrollment through 1 year post-enrollment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POINTOpioid OverdoseWithin 12 months pre-enrollment18 Participants
POINTOpioid OverdoseWithin 6 months pre-enrollment10 Participants
POINTOpioid OverdoseWithin 3 months pre-enrollment5 Participants
POINTOpioid OverdoseWithin 1 month pre-enrollment0 Participants
POINTOpioid OverdoseWithin 1 month post-enrollment3 Participants
POINTOpioid OverdoseWithin 3 months post-enrollment11 Participants
POINTOpioid OverdoseWithin 6 months post-enrollment15 Participants
POINTOpioid OverdoseWithin 12 months post-enrollment26 Participants
Standard CareOpioid OverdoseWithin 12 months post-enrollment15 Participants
Standard CareOpioid OverdoseWithin 12 months pre-enrollment9 Participants
Standard CareOpioid OverdoseWithin 1 month post-enrollment3 Participants
Standard CareOpioid OverdoseWithin 6 months pre-enrollment6 Participants
Standard CareOpioid OverdoseWithin 6 months post-enrollment11 Participants
Standard CareOpioid OverdoseWithin 3 months pre-enrollment4 Participants
Standard CareOpioid OverdoseWithin 3 months post-enrollment6 Participants
Standard CareOpioid OverdoseWithin 1 month pre-enrollment3 Participants
Secondary

Child Welfare Involvement

Total open child welfare cases.

Time frame: 3 years pre-enrollment through 1 year post-enrollment

ArmMeasureGroupValue (NUMBER)
POINTChild Welfare Involvement6 months post-enrollment4 open cases
POINTChild Welfare Involvement36 months pre-enrollment20 open cases
POINTChild Welfare Involvement24 months pre-enrollment19 open cases
POINTChild Welfare Involvement12 months pre-enrollment10 open cases
POINTChild Welfare Involvement6 months pre-enrollment5 open cases
POINTChild Welfare Involvement3 months pre-enrollment2 open cases
POINTChild Welfare Involvement1 month pre-enrollment0 open cases
POINTChild Welfare Involvement1 month post-enrollment1 open cases
POINTChild Welfare Involvement3 months post-enrollment1 open cases
POINTChild Welfare Involvement12 months post-enrollment9 open cases
Standard CareChild Welfare Involvement1 month post-enrollment1 open cases
Standard CareChild Welfare Involvement6 months post-enrollment4 open cases
Standard CareChild Welfare Involvement3 months pre-enrollment1 open cases
Standard CareChild Welfare Involvement36 months pre-enrollment13 open cases
Standard CareChild Welfare Involvement12 months post-enrollment4 open cases
Standard CareChild Welfare Involvement24 months pre-enrollment12 open cases
Standard CareChild Welfare Involvement1 month pre-enrollment0 open cases
Standard CareChild Welfare Involvement12 months pre-enrollment8 open cases
Standard CareChild Welfare Involvement3 months post-enrollment2 open cases
Standard CareChild Welfare Involvement6 months pre-enrollment4 open cases
Secondary

Duration of Medication for Opioid Use Disorder (MOUD) Engagement

Total days of supply of buprenorphine prescriptions, naltrexone prescriptions, or methadone dosed for participants with a medication for opioid use disorder (MOUD).

Time frame: 1 year pre-enrollment through 1 year post-enrollment

Population: Of the 243 participants matched to administrative records, only 243 unique participants were found to have a prescription for a MOUD within the outcome measure time frame and included in this analysis.

ArmMeasureGroupValue (MEDIAN)
POINTDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 12 months pre-enrollment45.0 days
POINTDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 6 months pre-enrollment41.0 days
POINTDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 3 months pre-enrollment16.0 days
POINTDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 1 month pre-enrollment14.0 days
POINTDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 1 month post-enrollment17.7 days
POINTDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 3 months post-enrollment39.0 days
POINTDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 6 months post-enrollment47.6 days
POINTDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 12 months post-enrollment84.0 days
Standard CareDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 12 months post-enrollment53.5 days
Standard CareDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 12 months pre-enrollment44.6 days
Standard CareDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 1 month post-enrollment15.9 days
Standard CareDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 6 months pre-enrollment29.0 days
Standard CareDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 6 months post-enrollment47.3 days
Standard CareDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 3 months pre-enrollment36.9 days
Standard CareDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 3 months post-enrollment30.0 days
Standard CareDuration of Medication for Opioid Use Disorder (MOUD) EngagementWithin 1 month pre-enrollment14.0 days
Secondary

Emergency Department Presentations

Total participants presented to the Emergency Department for any medical reason.

Time frame: 1 year pre-enrollment through 1 year post-enrollment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POINTEmergency Department PresentationsWithin 12 months pre-enrollment99 Participants
POINTEmergency Department PresentationsWithin 1 month post-enrollment34 Participants
POINTEmergency Department PresentationsWithin 3 months pre-enrollment55 Participants
POINTEmergency Department PresentationsWithin 3 months post-enrollment63 Participants
POINTEmergency Department PresentationsWithin 6 months post-enrollment82 Participants
POINTEmergency Department PresentationsWithin 6 months pre-enrollment77 Participants
POINTEmergency Department PresentationsWithin 12 months post-enrollment102 Participants
POINTEmergency Department PresentationsWithin 1 month pre-enrollment29 Participants
Standard CareEmergency Department PresentationsWithin 12 months post-enrollment56 Participants
Standard CareEmergency Department PresentationsWithin 12 months pre-enrollment52 Participants
Standard CareEmergency Department PresentationsWithin 6 months pre-enrollment43 Participants
Standard CareEmergency Department PresentationsWithin 3 months pre-enrollment30 Participants
Standard CareEmergency Department PresentationsWithin 1 month pre-enrollment18 Participants
Standard CareEmergency Department PresentationsWithin 1 month post-enrollment18 Participants
Standard CareEmergency Department PresentationsWithin 6 months post-enrollment47 Participants
Standard CareEmergency Department PresentationsWithin 3 months post-enrollment30 Participants
Secondary

Incarceration

Total days experienced incarceration.

Time frame: 3 years pre-enrollment through 1 year post-enrollment

Population: Though enrollment occurred in two Indiana counties, incarceration records were only accessible for the 212 participants enrolled in Marion County (129 in the POINT arm and 83 in Standard Care) as the other county does not have publicly accessible records. Of these, a total of 145 unique participants were found to have been incarcerated within the outcome measure time frame and included in this analysis.

ArmMeasureGroupValue (MEDIAN)
POINTIncarcerationWithin 3 years pre-enrollment88.0 days
POINTIncarcerationWithin 2 years pre-enrollment39.0 days
POINTIncarcerationWithin 12 months pre-enrollment10.0 days
POINTIncarcerationWithin 6 months pre-enrollment6.5 days
POINTIncarcerationWithin 3 months pre-enrollment5.5 days
POINTIncarcerationWithin 1 month pre-enrollment6.5 days
POINTIncarcerationWithin 1 month post-enrollment13.0 days
POINTIncarcerationWithin 3 months post-enrollment11.0 days
POINTIncarcerationWithin 6 months post-enrollment15.0 days
POINTIncarcerationWithin 12 months post-enrollment19.0 days
Standard CareIncarcerationWithin 3 months post-enrollment9.0 days
Standard CareIncarcerationWithin 3 years pre-enrollment73.5 days
Standard CareIncarcerationWithin 1 month pre-enrollment3.0 days
Standard CareIncarcerationWithin 2 years pre-enrollment30.5 days
Standard CareIncarcerationWithin 12 months post-enrollment13.0 days
Standard CareIncarcerationWithin 12 months pre-enrollment18.0 days
Standard CareIncarcerationWithin 1 month post-enrollment5.5 days
Standard CareIncarcerationWithin 6 months pre-enrollment10.5 days
Standard CareIncarcerationWithin 6 months post-enrollment10.0 days
Standard CareIncarcerationWithin 3 months pre-enrollment8.5 days
Secondary

Inpatient Hospital Admissions

Total participants admitted to the hospital for any medical reason.

Time frame: 1 year pre-enrollment through 1 year post-enrollment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POINTInpatient Hospital AdmissionsWithin 12 months pre-enrollment44 Participants
POINTInpatient Hospital AdmissionsWithin 6 months pre-enrollment29 Participants
POINTInpatient Hospital AdmissionsWithin 3 months pre-enrollment21 Participants
POINTInpatient Hospital AdmissionsWithin 1 month pre-enrollment10 Participants
POINTInpatient Hospital AdmissionsWithin 1 month post-enrollment48 Participants
POINTInpatient Hospital AdmissionsWithin 3 months post-enrollment52 Participants
POINTInpatient Hospital AdmissionsWithin 6 months post-enrollment58 Participants
POINTInpatient Hospital AdmissionsWithin 12 months post-enrollment71 Participants
Standard CareInpatient Hospital AdmissionsWithin 12 months post-enrollment36 Participants
Standard CareInpatient Hospital AdmissionsWithin 12 months pre-enrollment23 Participants
Standard CareInpatient Hospital AdmissionsWithin 1 month post-enrollment17 Participants
Standard CareInpatient Hospital AdmissionsWithin 6 months pre-enrollment17 Participants
Standard CareInpatient Hospital AdmissionsWithin 6 months post-enrollment27 Participants
Standard CareInpatient Hospital AdmissionsWithin 3 months pre-enrollment9 Participants
Standard CareInpatient Hospital AdmissionsWithin 3 months post-enrollment20 Participants
Standard CareInpatient Hospital AdmissionsWithin 1 month pre-enrollment4 Participants
Secondary

Medicaid Enrollment for Participants Without Insurance

Total participants without insurance coverage at enrollment that enrolled in Medicaid.

Time frame: Enrollment through 3 months, 6 months, and 12 months post-enrollment

Population: Only participants without insurance at the time of enrollment (N=50) were included in this analysis.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POINTMedicaid Enrollment for Participants Without InsuranceWithin 3 months post-enrollment10 Participants
POINTMedicaid Enrollment for Participants Without InsuranceWithin 6 months post-enrollment13 Participants
POINTMedicaid Enrollment for Participants Without InsuranceWithin 12 months post-enrollment16 Participants
Standard CareMedicaid Enrollment for Participants Without InsuranceWithin 3 months post-enrollment7 Participants
Standard CareMedicaid Enrollment for Participants Without InsuranceWithin 6 months post-enrollment8 Participants
Standard CareMedicaid Enrollment for Participants Without InsuranceWithin 12 months post-enrollment15 Participants
Secondary

Medication for Opioid Use Disorder (MOUD) Engagement

Total participants with buprenorphine prescriptions, naltrexone prescriptions, or dosed methadone.

Time frame: 1 year pre-enrollment through 1 year post-enrollment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POINTMedication for Opioid Use Disorder (MOUD) EngagementWithin 12 months pre-enrollment46 Participants
POINTMedication for Opioid Use Disorder (MOUD) EngagementWithin 6 months pre-enrollment36 Participants
POINTMedication for Opioid Use Disorder (MOUD) EngagementWithin 3 months pre-enrollment24 Participants
POINTMedication for Opioid Use Disorder (MOUD) EngagementWithin 1 month pre-enrollment8 Participants
POINTMedication for Opioid Use Disorder (MOUD) EngagementWithin 1 month post-enrollment36 Participants
POINTMedication for Opioid Use Disorder (MOUD) EngagementWithin 3 months post-enrollment49 Participants
POINTMedication for Opioid Use Disorder (MOUD) EngagementWithin 6 months post-enrollment65 Participants
POINTMedication for Opioid Use Disorder (MOUD) EngagementWithin 12 months post-enrollment77 Participants
Standard CareMedication for Opioid Use Disorder (MOUD) EngagementWithin 12 months post-enrollment38 Participants
Standard CareMedication for Opioid Use Disorder (MOUD) EngagementWithin 12 months pre-enrollment16 Participants
Standard CareMedication for Opioid Use Disorder (MOUD) EngagementWithin 1 month post-enrollment14 Participants
Standard CareMedication for Opioid Use Disorder (MOUD) EngagementWithin 6 months pre-enrollment9 Participants
Standard CareMedication for Opioid Use Disorder (MOUD) EngagementWithin 6 months post-enrollment28 Participants
Standard CareMedication for Opioid Use Disorder (MOUD) EngagementWithin 3 months pre-enrollment7 Participants
Standard CareMedication for Opioid Use Disorder (MOUD) EngagementWithin 3 months post-enrollment26 Participants
Standard CareMedication for Opioid Use Disorder (MOUD) EngagementWithin 1 month pre-enrollment3 Participants
Secondary

Time to Relapse

Relapse-free survival probability for 6 months and 12 months. Participants who did not have ED presentation were censored at 1) time of 6 month or 12 months, 2) one's last day in the study, 3) overdose death date, whichever is the earliest.

Time frame: Enrollment through 6 & 12 months post-enrollment

ArmMeasureGroupValue (NUMBER)
POINTTime to RelapseWithin 6 months post-enrollment0.85 probability
POINTTime to RelapseWithin 12 months post-enrollment0.77 probability
Standard CareTime to RelapseWithin 6 months post-enrollment0.84 probability
Standard CareTime to RelapseWithin 12 months post-enrollment0.74 probability
Post Hoc

Benzodiazepine Prescriptions

Total participants with benzodiazepine prescriptions.

Time frame: 1 year pre-enrollment through 1 year post-enrollment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POINTBenzodiazepine PrescriptionsWithin 12 months pre-enrollment17 Participants
POINTBenzodiazepine PrescriptionsWithin 6 months pre-enrollment16 Participants
POINTBenzodiazepine PrescriptionsWithin 3 months pre-enrollment13 Participants
POINTBenzodiazepine PrescriptionsWithin 1 month pre-enrollment6 Participants
POINTBenzodiazepine PrescriptionsWithin 1 month post-enrollment10 Participants
POINTBenzodiazepine PrescriptionsWithin 3 months post-enrollment15 Participants
POINTBenzodiazepine PrescriptionsWithin 6 months post-enrollment17 Participants
POINTBenzodiazepine PrescriptionsWithin 12 months post-enrollment21 Participants
Standard CareBenzodiazepine PrescriptionsWithin 12 months post-enrollment11 Participants
Standard CareBenzodiazepine PrescriptionsWithin 12 months pre-enrollment11 Participants
Standard CareBenzodiazepine PrescriptionsWithin 1 month post-enrollment5 Participants
Standard CareBenzodiazepine PrescriptionsWithin 6 months pre-enrollment8 Participants
Standard CareBenzodiazepine PrescriptionsWithin 6 months post-enrollment7 Participants
Standard CareBenzodiazepine PrescriptionsWithin 3 months pre-enrollment6 Participants
Standard CareBenzodiazepine PrescriptionsWithin 3 months post-enrollment6 Participants
Standard CareBenzodiazepine PrescriptionsWithin 1 month pre-enrollment5 Participants
Post Hoc

Medicaid Enrollment for Participants With Insurance

Total participants with insurance coverage at enrollment that enrolled in Medicaid.

Time frame: Enrollment through 3 months, 6 months, and 12 months post-enrollment.

Population: Only participants with insurance at the time of enrollment (N=193) were included in this analysis.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POINTMedicaid Enrollment for Participants With InsuranceWithin 3 months post-enrollment78 Participants
POINTMedicaid Enrollment for Participants With InsuranceWithin 6 months post-enrollment83 Participants
POINTMedicaid Enrollment for Participants With InsuranceWithin 12 months post-enrollment86 Participants
Standard CareMedicaid Enrollment for Participants With InsuranceWithin 3 months post-enrollment38 Participants
Standard CareMedicaid Enrollment for Participants With InsuranceWithin 6 months post-enrollment41 Participants
Standard CareMedicaid Enrollment for Participants With InsuranceWithin 12 months post-enrollment47 Participants
Post Hoc

Narcan Prescriptions

Total participants with Narcan prescriptions.

Time frame: 1 year pre-enrollment through 1 year post-enrollment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POINTNarcan PrescriptionsWithin 12 months pre-enrollment10 Participants
POINTNarcan PrescriptionsWithin 6 months pre-enrollment7 Participants
POINTNarcan PrescriptionsWithin 3 months pre-enrollment5 Participants
POINTNarcan PrescriptionsWithin 1 month pre-enrollment3 Participants
POINTNarcan PrescriptionsWithin 1 month post-enrollment7 Participants
POINTNarcan PrescriptionsWithin 3 months post-enrollment11 Participants
POINTNarcan PrescriptionsWithin 6 months post-enrollment13 Participants
POINTNarcan PrescriptionsWithin 12 months post-enrollment17 Participants
Standard CareNarcan PrescriptionsWithin 12 months post-enrollment9 Participants
Standard CareNarcan PrescriptionsWithin 12 months pre-enrollment4 Participants
Standard CareNarcan PrescriptionsWithin 1 month post-enrollment3 Participants
Standard CareNarcan PrescriptionsWithin 6 months pre-enrollment3 Participants
Standard CareNarcan PrescriptionsWithin 6 months post-enrollment6 Participants
Standard CareNarcan PrescriptionsWithin 3 months pre-enrollment3 Participants
Standard CareNarcan PrescriptionsWithin 3 months post-enrollment3 Participants
Standard CareNarcan PrescriptionsWithin 1 month pre-enrollment0 Participants
Post Hoc

Opioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)

Total participants with opioid prescriptions, excluding Medications for Opioid Use Disorder (MOUD) prescriptions.

Time frame: 1 year pre-enrollment through 1 year post-enrollment

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
POINTOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 12 months pre-enrollment44 Participants
POINTOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 6 months pre-enrollment31 Participants
POINTOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 3 months pre-enrollment18 Participants
POINTOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 1 month pre-enrollment18 Participants
POINTOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 1 month post-enrollment18 Participants
POINTOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 3 months post-enrollment8 Participants
POINTOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 6 months post-enrollment14 Participants
POINTOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 12 months post-enrollment19 Participants
Standard CareOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 12 months post-enrollment9 Participants
Standard CareOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 12 months pre-enrollment30 Participants
Standard CareOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 1 month post-enrollment15 Participants
Standard CareOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 6 months pre-enrollment20 Participants
Standard CareOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 6 months post-enrollment7 Participants
Standard CareOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 3 months pre-enrollment15 Participants
Standard CareOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 3 months post-enrollment6 Participants
Standard CareOpioid Prescriptions (Excluding Medications for Opioid Use Disorder (MOUD) Prescriptions)Within 1 month pre-enrollment15 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026