Patient Reported Outcomes for Opioid Use Disorder

Opioid-use Disorder Clinical Trial

Official title:

Capturing Opioid Use Disorder Electronically & Patient Reported Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985163
• Other study ID #: 2000024667
• Secondary ID: 3UG1DA015831-17S
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Opiate Overdose
• Opioid-Related Disorders
• Opioid-use Disorder
• Overdose of Opiate
• Patient Participation
• Substance-Related Disorders

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