Patient Reported Outcomes for Opioid Use Disorder

Completed

• Conditions: Opioid-use Disorder; Overdose of Opiate; Patient Participation

• Registration Number: NCT03985163
• Lead Sponsor: Yale University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-07
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-13
• Primary Completion: 2020-02-16
• Study Completion: 2020-02-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Willingness to share EHR data with researchers	once: at screening and enrollment	The proportion of people who qualify for study criteria and enroll in the study
Electronic survey response	once: 3 day follow-up survey	Response rate to patient reported outcomes via electronic follow-up survey

Secondary Outcome Measures

Name	Time	Method
Lost-to-follow-up	Up to 5 months	Lost-to-follow-up rates
Treatment Effectiveness Assessment	once: 30 day follow-up survey	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
ED patients referred to substance use disorder treatment	once: 3 day follow-up survey	The proportion of participants referred for substance use disorder treatment as part of routine emergency medical care
ED patients prescribed opioid use disorder medication	once: 30 day follow-up survey	The proportion of participants prescribed opioid use disorder medication as part of routine emergency medical care
Patients enrolling in substance use disorder treatment	once: 30 day follow-up survey	The proportion of participants referred for substance use disorder treatment who enroll in substance use disorder treatment
Patients filling opioid use disorder prescriptions	once: 30 day follow-up survey	The proportion of participants prescribed opioid use disorder medication who fill the opioid use disorder prescription
Electronic survey response	once: 30 day follow-up survey	Response rate to patient reported outcomes via electronic follow-up survey

Trial Locations

Locations (1)

Yale New Haven Hospital - York Street Campus - Emergency Department; 🇺🇸 New Haven, Connecticut, United States