Opioid-use Disorder, Overdose of Opiate, Patient Participation
Conditions
Keywords
Patient Reported Outcomes, Clinical Data Research, Electronic Health Records
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).
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
Sponsors
National Drug Abuse Treatment Clinical Trials Network
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Willingness to share EHR data with researchers | once: at screening and enrollment | The proportion of people who qualify for study criteria and enroll in the study |
| Electronic survey response | once: 3 day follow-up survey | Response rate to patient reported outcomes via electronic follow-up survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ED patients referred to substance use disorder treatment | once: 3 day follow-up survey | The proportion of participants referred for substance use disorder treatment as part of routine emergency medical care |
| Patients enrolling in substance use disorder treatment | once: 30 day follow-up survey | The proportion of participants referred for substance use disorder treatment who enroll in substance use disorder treatment |
| Treatment Effectiveness Assessment | 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 |
| Lost-to-follow-up | Up to 5 months | Lost-to-follow-up rates |
| Electronic survey response | once: 30 day follow-up survey | Response rate to patient reported outcomes via electronic follow-up survey |
| Patients filling opioid use disorder prescriptions | once: 3 day follow-up survey | The proportion of participants prescribed opioid use disorder medication who fill the opioid use disorder prescription |
| ED patients prescribed opioid use disorder medication | once: 3 day follow-up survey | The proportion of participants prescribed opioid use disorder medication as part of routine emergency medical care |
Countries
United States
Outcome results
None listed