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| ID | Type | Description | Link |
|---|---|---|---|
| 3UG1DA015831-17S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Drug Abuse Treatment Clinical Trials Network | NETWORK |
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of adult ED patients with OUD or non-medical opioid use, or those who are being treated for opioid overdose.
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Hawk, MD | Yale University School of Medicine Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital - York Street Campus - Emergency Department | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34758881 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2019 | Feb 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000083682 | Opiate Overdose |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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 |
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |