Patient Reported Outcomes for Opioid Use Disorder

Study Overview
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Brief Summary
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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).

Official Title
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Capturing Opioid Use Disorder Electronically & Patient Reported Outcomes

Conditions
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Opioid-use Disorder, Overdose of Opiate, Patient Participation

Intervention / Treatment
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* Other: Patient Reported Outcomes Electronic Survey


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Willingness to share EHR data with researchers | The proportion of people who qualify for study criteria and enroll in the study | once: at screening and enrollment | 
| Electronic survey response | Response rate to patient reported outcomes via electronic follow-up survey | once: 3 day follow-up survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | once: 3 day follow-up survey | 
| 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 | once: 30 day follow-up survey | 
| ED patients prescribed opioid use disorder medication | The proportion of participants prescribed opioid use disorder medication as part of routine emergency medical care | once: 3 day follow-up survey | 
| ED patients prescribed opioid use disorder medication | The proportion of participants prescribed opioid use disorder medication as part of routine emergency medical care | once: 30 day follow-up survey | 
| 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 | once: 3 day follow-up survey | 
| Patients enrolling in substance use disorder treatment | The proportion of participants referred for substance use disorder treatment who enroll in substance use disorder treatment | once: 30 day follow-up survey | 
| Patients filling opioid use disorder prescriptions | The proportion of participants prescribed opioid use disorder medication who fill the opioid use disorder prescription | once: 3 day follow-up survey | 
| Patients filling opioid use disorder prescriptions | The proportion of participants prescribed opioid use disorder medication who fill the opioid use disorder prescription | once: 30 day follow-up survey | 
| Lost-to-follow-up | Lost-to-follow-up rates | Up to 5 months | 
| Electronic survey response | Response rate to patient reported outcomes via electronic follow-up survey | once: 30 day follow-up survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Reported Outcomes, Clinical Data Research, Electronic Health Records