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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03611335
Other study ID # 18-00096
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 7, 2018
Est. completion date March 20, 2023

Study information

Verified date February 2024
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 20, 2023
Est. primary completion date September 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CATCH Interviews
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)

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Initiate MAT outpatient treatment within 14 days of discharge.
Primary 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. Have 2 or more additional MAT services within 30 days of treatment initiation.
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