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CompletedNCT03985163Updated Feb 16, 2024

Patient Reported Outcomes for Opioid Use Disorder

An observational study in Opioid-use Disorder, Overdose of Opiate and Patient Participation, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by Yale University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
101
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Opioid-use Disorder
  • Overdose of Opiate
  • Patient Participation

Keywords

  • Patient Reported Outcomes
  • Clinical Data Research
  • Electronic Health Records
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In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 101 is below the median of 129 across 184 observational studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Observational model
Other
Time perspective
Prospective
Enrollment
101 participants (actual)
Target follow-up
30 Days
Patient registry
Yes

Interventions

  • OtherPatient 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

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What researchers measure

Primary outcomes

  1. Willingness to share EHR data with researchers

    The proportion of people who qualify for study criteria and enroll in the study

    Time frame: once: at screening and enrollment

  2. Electronic survey response

    Response rate to patient reported outcomes via electronic follow-up survey

    Time frame: once: 3 day follow-up survey

Secondary outcomes

  1. 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

    Time frame: once: 3 day follow-up survey

  2. 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

    Time frame: once: 30 day follow-up survey

  3. ED patients prescribed opioid use disorder medication

    The proportion of participants prescribed opioid use disorder medication as part of routine emergency medical care

    Time frame: once: 3 day follow-up survey

  4. ED patients prescribed opioid use disorder medication

    The proportion of participants prescribed opioid use disorder medication as part of routine emergency medical care

    Time frame: once: 30 day follow-up survey

  5. 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

    Time frame: once: 3 day follow-up survey

  6. Patients enrolling in substance use disorder treatment

    The proportion of participants referred for substance use disorder treatment who enroll in substance use disorder treatment

    Time frame: once: 30 day follow-up survey

  7. Patients filling opioid use disorder prescriptions

    The proportion of participants prescribed opioid use disorder medication who fill the opioid use disorder prescription

    Time frame: once: 3 day follow-up survey

  8. Patients filling opioid use disorder prescriptions

    The proportion of participants prescribed opioid use disorder medication who fill the opioid use disorder prescription

    Time frame: once: 30 day follow-up survey

  9. Lost-to-follow-up

    Lost-to-follow-up rates

    Time frame: Up to 5 months

  10. Electronic survey response

    Response rate to patient reported outcomes via electronic follow-up survey

    Time frame: once: 30 day follow-up survey

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Study locations

1 site
  • Yale New Haven Hospital - York Street Campus - Emergency Department
    New Haven, Connecticut 06510, United States
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References and documents

Publications

  • 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. PubMed 34758881 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03985163
Lead sponsor
Yale University
Collaborators
National Drug Abuse Treatment Clinical Trials Network, National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Jun 13, 2019
Start date
Jun 7, 2019
Primary completion
Feb 16, 2020
Completion
Feb 16, 2020
Last update
Feb 16, 2024

Study contacts

Kathryn Hawk, MD
principal investigator · Yale University School of Medicine Department of Emergency Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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