Clinical trial NCT03985163: Patient Reported Outcomes for Opioid Use Disorder
Official title: Capturing Opioid Use Disorder Electronically & Patient Reported Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Overdose of Opiate
Patient Participation
Keywords: Patient Reported Outcomes
Clinical Data Research
Electronic Health Records
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Drug Abuse Treatment Clinical Trials Network
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-06-13
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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

Primary outcomes:
measure: Willingness to share EHR data with researchers
timeFrame: once: at screening and enrollment
measure: Electronic survey response
timeFrame: once: 3 day follow-up survey
Secondary outcomes:
measure: Treatment Effectiveness Assessment
timeFrame: once: 3 day follow-up survey
measure: Treatment Effectiveness Assessment
timeFrame: once: 30 day follow-up survey
measure: ED patients prescribed opioid use disorder medication
timeFrame: once: 3 day follow-up survey
measure: ED patients prescribed opioid use disorder medication
timeFrame: once: 30 day follow-up survey
measure: ED patients referred to substance use disorder treatment
timeFrame: once: 3 day follow-up survey
measure: Patients enrolling in substance use disorder treatment
timeFrame: once: 30 day follow-up survey
measure: Patients filling opioid use disorder prescriptions
timeFrame: once: 3 day follow-up survey
measure: Patients filling opioid use disorder prescriptions
timeFrame: once: 30 day follow-up survey
measure: Lost-to-follow-up
timeFrame: Up to 5 months
measure: Electronic survey response
timeFrame: once: 30 day follow-up survey
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital - York Street Campus - Emergency Department
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine Department of Emergency Medicine
name: Kathryn Hawk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.