Patient Reported Outcomes for Opioid Use Disorder

NCT ID: NCT03985163

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-07

Study Completion Date

2020-02-16

Brief Summary

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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

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Conditions

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Opioid-use Disorder Overdose of Opiate Patient Participation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Drug Abuse Treatment Clinical Trials Network

NETWORK

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn Hawk, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Medicine Department of Emergency Medicine

Locations

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Yale New Haven Hospital - York Street Campus - Emergency Department

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Hawk K, Malicki C, Kinsman J, D'Onofrio G, Taylor A, Venkatesh A. Feasibility and acceptability of electronic administration of patient reported outcomes using mHealth platform in emergency department patients with non-medical opioid use. Addict Sci Clin Pract. 2021 Nov 10;16(1):66. doi: 10.1186/s13722-021-00276-0.

Reference Type DERIVED
PMID: 34758881 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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3UG1DA015831-17S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000024667

Identifier Type: -

Identifier Source: org_study_id

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