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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03985163
Other study ID # 2000024667
Secondary ID 3UG1DA015831-17S
Status Completed
Phase
First received
Last updated
Start date June 7, 2019
Est. completion date February 16, 2020

Study information

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

Clinical Trial Summary

The goal of the project is to build a clinical data research infrastructure that will begin to enhance capacity to use electronic health record (EHR) data and patient reported outcomes measures (PROs) to conduct opioid related research in emergency departments (EDs). 200 adult patients with a history of non-medical opioid use, opioid use disorder, or acute opioid overdose will be enrolled and will be asked to complete three PRO surveys (baseline, 3 days post ED discharge, and 30 days post discharge).


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date February 16, 2020
Est. primary completion date February 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patient presenting to the Yale New Haven Hospital York Street Campus emergency department - History of opioid use disorder or non-medical use of opioids, as measured by screening assessment OR receiving treatment for opioid overdose - Willingness and ability to complete electronic surveys via a smartphone or computer Exclusion Criteria: - <18 years of age - Inability to communicate in English - Inability to provide consent (for example, due to psychosis, intoxication, severe mental illness or other reason) - Transfer from the ED for psychiatric evaluation

Study Design


Intervention

Other:
Patient Reported Outcomes Electronic Survey
This study does not include a drug, test, behavioral or medical procedure intervention; participants will be asked to complete three surveys

Locations

Country Name City State
United States Yale New Haven Hospital - York Street Campus - Emergency Department New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Yale University National Drug Abuse Treatment Clinical Trials Network, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Willingness to share EHR data with researchers The proportion of people who qualify for study criteria and enroll in the study once: at screening and enrollment
Primary Electronic survey response Response rate to patient reported outcomes via electronic follow-up survey once: 3 day follow-up survey
Secondary Treatment Effectiveness Assessment Treatment Effectiveness Assessment (TEA) elicits patient responses that help the patient and the clinician quickly gauge patient progress in treatment and in recovery, according to the patients' sense of what is important within four domains (substance use, health, lifestyle, and community) established by prior research once: 3 day follow-up survey
Secondary Treatment Effectiveness Assessment Treatment Effectiveness Assessment (TEA) elicits patient responses that help the patient and the clinician quickly gauge patient progress in treatment and in recovery, according to the patients' sense of what is important within four domains (substance use, health, lifestyle, and community) established by prior research once: 30 day follow-up survey
Secondary ED patients prescribed opioid use disorder medication The proportion of participants prescribed opioid use disorder medication as part of routine emergency medical care once: 3 day follow-up survey
Secondary ED patients prescribed opioid use disorder medication The proportion of participants prescribed opioid use disorder medication as part of routine emergency medical care once: 30 day follow-up survey
Secondary ED patients referred to substance use disorder treatment The proportion of participants referred for substance use disorder treatment as part of routine emergency medical care once: 3 day follow-up survey
Secondary Patients enrolling in substance use disorder treatment The proportion of participants referred for substance use disorder treatment who enroll in substance use disorder treatment once: 30 day follow-up survey
Secondary Patients filling opioid use disorder prescriptions The proportion of participants prescribed opioid use disorder medication who fill the opioid use disorder prescription once: 3 day follow-up survey
Secondary Patients filling opioid use disorder prescriptions The proportion of participants prescribed opioid use disorder medication who fill the opioid use disorder prescription once: 30 day follow-up survey
Secondary Lost-to-follow-up Lost-to-follow-up rates Up to 5 months
Secondary Electronic survey response Response rate to patient reported outcomes via electronic follow-up survey once: 30 day follow-up survey
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