Patient Reported Outcomes for Opioid Use Disorder

February 13, 2024 updated by: Yale University

Capturing Opioid Use Disorder Electronically & Patient Reported Outcomes

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101

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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital - York Street Campus - Emergency Department

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult ED patients with OUD or non-medical opioid use, or those who are being treated for opioid overdose.

Description

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 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)
National Drug Abuse Treatment Clinical Trials Network

Investigators

  • Principal Investigator: Kathryn Hawk, MD, Yale University School of Medicine Department of Emergency Medicine

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.

General Publications

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)

June 7, 2019

Primary Completion (Actual)

February 16, 2020

Study Completion (Actual)

February 16, 2020

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 13, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000024667
  • 3UG1DA015831-17S1 (U.S. NIH Grant/Contract)

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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