Opioid DependenceCATCHNCT03611335
A Pragmatic Trial of the Consult for Addiction Treatment and Care in Hospitals (CATCH) Model for Engaging Patients in Opioid Use Disorder Treatment
An observational study of Opioid Dependence and Opioid Abuse, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Dependence, Opioid Abuse
- What is being tested?
- CATCH Interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 20 Mar 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Lack of fluency in English, unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Opioid Dependence, Opioid Abuse
- Being tested
- CATCH Interviews
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATCH InterviewsBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Site 1 H+H | Lincoln Medical and Mental Health Center Receives: Behavioral: CATCH Interviews | |
| Site 2 H+H | Bellevue Hospital Receives: Behavioral: CATCH Interviews | |
| Site 3 H+H | Metropolitan Hospital Receives: Behavioral: CATCH Interviews | |
| Site 4 H+H | Elmhurst Hospital Center Receives: Behavioral: CATCH Interviews | |
| Site 5 H+H | Coney Island Hospital Receives: Behavioral: CATCH Interviews | |
| Site 6 H+H | Woodhull Medical and Mental Health Center Receives: Behavioral: CATCH Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of CATCH in increasing MAT initiation among patients with OUD.
Effectiveness of patients hospitalized during the CATCH period to have higher rates of treatment initiation.
Measured: Initiate MAT outpatient treatment within 14 days of discharge.
Effectiveness of CATCH in increasing MAT engagement among patients with OUD.
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.
Measured: Have 2 or more additional MAT services within 30 days of treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start7 Dec 2018
- Primary completion15 Sep 2022
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer McNeely, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611335
- Sponsor's protocol ID
- 18-00096
- Acronym
- CATCH
- Status last verified
- Feb 2024
- First submitted
- 26 Jul 2018
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Rostam-Abadi Y, Wang S, King C, Kalyanaraman Marcello R, Van Wye G, Tuazon E, Kennedy J, Cooke C, Mazumdar M, Tarpey T, Billings J, Appleton N, Fernando J, Fawole A, Siddiqui S, Barron C, Schatz D, McNeely J. Addiction Consult Services, Mortality, and Acute Care Utilization in Inpatients With Opioid Use Disorder: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525222. doi: 10.1001/jamanetworkopen.2025.25222.
PubMed 40768148McNeely J, Wang SS, Rostam Abadi Y, Barron C, Billings J, Tarpey T, Fernando J, Appleton N, Fawole A, Mazumdar M, Weinstein ZM, Kalyanaraman Marcello R, Dolle J, Cooke C, Siddiqui S, King C. Addiction Consultation Services for Opioid Use Disorder Treatment Initiation and Engagement: A Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1106-1115. doi: 10.1001/jamainternmed.2024.3422.
PubMed 39073796McNeely J, Troxel AB, Kunins HV, Shelley D, Lee JD, Walley A, Weinstein ZM, Billings J, Davis NJ, Marcello RK, Schackman BR, Barron C, Bergmann L. Study protocol for a pragmatic trial of the Consult for Addiction Treatment and Care in Hospitals (CATCH) model for engaging patients in opioid use disorder treatment. Addict Sci Clin Pract. 2019 Feb 19;14(1):5. doi: 10.1186/s13722-019-0135-7.
PubMed 30777122
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03611335
- Acronym / sponsor ID
- CATCH / 18-00096
- Conditions
- Opioid Dependence, Opioid Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Site 1 H+H | – | Behavioral: CATCH InterviewsLincoln Medical and Mental Health Center |
| Site 2 H+H | – | Behavioral: CATCH InterviewsBellevue Hospital |
| Site 3 H+H | – | Behavioral: CATCH InterviewsMetropolitan Hospital |
| Site 4 H+H | – | Behavioral: CATCH InterviewsElmhurst Hospital Center |
| Site 5 H+H | – | Behavioral: CATCH InterviewsConey Island Hospital |
| Site 6 H+H | – | Behavioral: CATCH InterviewsWoodhull Medical and Mental Health Center |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Lack of fluency in English, unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CATCH InterviewsBaseline 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) | Behavioural | Site 1 H+H, Site 2 H+H, Site 3 H+H, Site 4 H+H, Site 5 H+H, Site 6 H+H |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 40768148Rostam-Abadi Y, Wang S, King C, Kalyanaraman Marcello R, Van Wye G, Tuazon E, Kennedy J, Cooke C, Mazumdar M, Tarpey T, Billings J, Appleton N, Fernando J, Fawole A, Siddiqui S, Barron C, Schatz D, McNeely J. Addiction Consult Services, Mortality, and Acute Care Utilization in Inpatients With Opioid Use Disorder: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525222. doi: 10.1001/jamanetworkopen.2025.25222.
- Derived from this study: PubMed 39073796McNeely J, Wang SS, Rostam Abadi Y, Barron C, Billings J, Tarpey T, Fernando J, Appleton N, Fawole A, Mazumdar M, Weinstein ZM, Kalyanaraman Marcello R, Dolle J, Cooke C, Siddiqui S, King C. Addiction Consultation Services for Opioid Use Disorder Treatment Initiation and Engagement: A Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1106-1115. doi: 10.1001/jamainternmed.2024.3422.
- Derived from this study: PubMed 30777122McNeely J, Troxel AB, Kunins HV, Shelley D, Lee JD, Walley A, Weinstein ZM, Billings J, Davis NJ, Marcello RK, Schackman BR, Barron C, Bergmann L. Study protocol for a pragmatic trial of the Consult for Addiction Treatment and Care in Hospitals (CATCH) model for engaging patients in opioid use disorder treatment. Addict Sci Clin Pract. 2019 Feb 19;14(1):5. doi: 10.1186/s13722-019-0135-7.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer McNeely, MD principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Dependence and Opioid Abuse, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of CATCH in increasing MAT initiation among patients with OUD. (time frame: Initiate MAT outpatient treatment within 14 days of discharge.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03611335, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.