- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03611335
A Pragmatic Trial of the Consult for Addiction Treatment and Care in Hospitals (CATCH) Model for Engaging Patients in Opioid Use Disorder Treatment (CATCH)
February 1, 2024 updated by: NYU Langone Health
Effectiveness of the Consult for Addiction Treatment and Care in Hospitals (CATCH) Model for Engaging Patients in Opioid Use Disorder Treatment: Pragmatic Trial in a Large Municipal Hospital System
This pragmatic clinical trial seeks to evaluate the effectiveness of the Consult for Addiction Treatment and Care in Hospitals (CATCH) intervention as a strategy for engaging patients with Opiod Use Disorder (OUD) in addiction treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The overarching objective of our study is to evaluate the effectiveness of CATCH as a strategy for engaging patients with OUD in MAT.
A pragmatic trial at 6 hospitals, conducted in collaboration with the New York City Health and Hospitals system (H+H) and the New York City Department of Health and Mental Hygiene (DOHMH), will study the CATCH intervention in real-world settings and at scale.
Guided by the RE-AIM evaluation framework, this hybrid effectiveness-implementation study (Type 1) focuses primarily on effectiveness, but also measures implementation outcomes to inform the intervention's adoption and sustainability.
A rigorous stepped-wedge cluster randomized trial design determines the impact of CATCH on opioid treatment outcomes in comparison to usual care for a control period, followed by a 12-month intervention period and a maintenance period, and utilizes existing administrative data to evaluate outcomes.
Aim 1 (primary aim) is to evaluate the effectiveness of CATCH in increasing post-discharge initiation and engagement in MAT, defined respectively as receiving outpatient MAT within 14 days of discharge, and having at least 2 additional MAT visits in the first month.
Aim 2 is to assess the effectiveness of CATCH for increasing treatment retention, defined as continuous receipt of MAT for 6 months.
Aim 3 is to compare the frequency of acute care utilization and overdose deaths, and their associated costs, among patients with OUD who are hospitalized during the CATCH period versus usual care.
Aim 4 is to evaluate implementation outcomes at CATCH sites using a mixed methods approach to assess the intervention's Reach (proportion of eligible patients reached); Adoption (utilization by medical staff); and Implementation fidelity (barriers to delivering high-quality MAT).
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Our study retrospectively analyzes administrative data for patients with OUD who have been hospitalized at the participating sites.
These patients are not recruited or enrolled.The cases identified through administrative data consists of individuals with OUD who are hospitalized at one of the six study sites.
We anticipate that the characteristics of this population will vary by site, given the differences in patient populations served by each of the participating hospitals.
Overall, we expect that cases will have the following demographic characteristics: 28% female; 14% Hispanic; 24% Black, 37% White, 1% Asian, 38% mixed race/other; 4% age 18-25, 33% age 26-45, 55% age 46-65, 7% >65 years.
Description
Inclusion Criteria:
- Adult patients (≥18 years);
- Hospitalized for at least 1 night on an inpatient service (not including intensive care);
- Admission or discharge diagnosis (based on ICD-10 codes) of opioid use disorder or opioid poisoning.
Cases are excluded if they received MAT (buprenorphine, methadone maintenance treatment, or naltrexone) in the 30 days prior to admission. Cases included in the intervention condition must have been admitted on a date following implementation of CATCH.
Exclusion Criteria:
- Lack of fluency in English, unable to provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Site 1 H+H
Lincoln Medical and Mental Health Center
|
Baseline interviews are conducted with CATCH staff (5/site); while Post-implementation interviews are conducted 9-12 months after introduction of CATCH, with CATCH staff (5/site) and patients (5/site)
|
|
Site 2 H+H
Bellevue Hospital
|
Baseline interviews are conducted with CATCH staff (5/site); while Post-implementation interviews are conducted 9-12 months after introduction of CATCH, with CATCH staff (5/site) and patients (5/site)
|
|
Site 3 H+H
Metropolitan Hospital
|
Baseline interviews are conducted with CATCH staff (5/site); while Post-implementation interviews are conducted 9-12 months after introduction of CATCH, with CATCH staff (5/site) and patients (5/site)
|
|
Site 4 H+H
Elmhurst Hospital Center
|
Baseline interviews are conducted with CATCH staff (5/site); while Post-implementation interviews are conducted 9-12 months after introduction of CATCH, with CATCH staff (5/site) and patients (5/site)
|
|
Site 5 H+H
Coney Island Hospital
|
Baseline interviews are conducted with CATCH staff (5/site); while Post-implementation interviews are conducted 9-12 months after introduction of CATCH, with CATCH staff (5/site) and patients (5/site)
|
|
Site 6 H+H
Woodhull Medical and Mental Health Center
|
Baseline interviews are conducted with CATCH staff (5/site); while Post-implementation interviews are conducted 9-12 months after introduction of CATCH, with CATCH staff (5/site) and patients (5/site)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of CATCH in increasing MAT initiation among patients with OUD.
Time Frame: Initiate MAT outpatient treatment within 14 days of discharge.
|
Effectiveness of patients hospitalized during the CATCH period to have higher rates of treatment initiation.
|
Initiate MAT outpatient treatment within 14 days of discharge.
|
|
Effectiveness of CATCH in increasing MAT engagement among patients with OUD.
Time Frame: Have 2 or more additional MAT services within 30 days of treatment initiation.
|
Effectiveness of patients hospitalized during the CATCH period to have higher rates of treatment engagement, defined as having 2 or more additional MAT services within 30 days of treatment initiation.
|
Have 2 or more additional MAT services within 30 days of treatment initiation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer McNeely, MD, NYU Langone
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2018
Primary Completion (Actual)
September 15, 2022
Study Completion (Actual)
March 20, 2023
Study Registration Dates
First Submitted
July 26, 2018
First Submitted That Met QC Criteria
July 26, 2018
First Posted (Actual)
August 2, 2018
Study Record Updates
Last Update Posted (Actual)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 1, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-00096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The individual patient data collected for this study will not be made available to others, as data has been extracted from New York State Medicaid claims, which is highly confidential.
The data use agreement which allows the study team access to this data does not permit sharing with individuals unless they are approved by New York State.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Requests should be directed to jennifer.mcneely@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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