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OpenTrials
Completed

NCT Number: NCT03985163

Patient Reported Outcomes for Opioid Use Disorder

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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Key information

Conditions

Opioid-use Disorder Behavior Chemically-Induced Disorders Drug Misuse Drug Overdose Health Behavior Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid-Related Disorders Overdose of Opiate Patient Acceptance of Health Care Patient Participation Prescription Drug Misuse Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital - York Street Campus - Emergency Department

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Reported Outcomes Electronic Survey

Other

This study does not include a drug, test, behavioral or medical procedure intervention; participants will be asked to complete three surveys

Primary outcomes

  1. 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

  2. Electronic survey response

    Time frame: once: 3 day follow-up survey

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Lost-to-follow-up

    Time frame: Up to 5 months

    Lost-to-follow-up rates

  10. Electronic survey response

    Time frame: once: 30 day follow-up survey

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Official study title

Capturing Opioid Use Disorder Electronically & Patient Reported Outcomes

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2019
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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