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Patient Reported Outcomes for Opioid Use Disorder

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ClinicalTrials.gov Identifier: NCT03985163
Recruitment Status : Enrolling by invitation
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
National Drug Abuse Treatment Clinical Trials Network
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief 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).

Condition or disease Intervention/treatment
Opioid-use Disorder Overdose of Opiate Patient Participation Other: Patient Reported Outcomes Electronic Survey

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Capturing Opioid Use Disorder Electronically & Patient Reported Outcomes
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Intervention Details:
  • 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


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985163


Locations
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United States, Connecticut
Yale New Haven Hospital - York Street Campus - Emergency Department
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Drug Abuse Treatment Clinical Trials Network
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kathryn Hawk, MD Yale University School of Medicine Department of Emergency Medicine

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03985163     History of Changes
Other Study ID Numbers: 2000024667
3UG1DA015831-17S1 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
Patient Reported Outcomes
Clinical Data Research
Electronic Health Records

Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders