NCT03985163

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2020

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

June 10, 2019

Last Update Submit

February 13, 2024

Conditions

Opioid-use DisorderOverdose of OpiatePatient Participation

Keywords

Patient Reported OutcomesClinical Data ResearchElectronic Health Records

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Treatment Effectiveness Assessment

    once: 3 day follow-up survey

  • Treatment Effectiveness Assessment

    once: 30 day follow-up survey

  • ED patients prescribed opioid use disorder medication

    once: 3 day follow-up survey

  • ED patients prescribed opioid use disorder medication

    once: 30 day follow-up survey

  • ED patients referred to substance use disorder treatment

    once: 3 day follow-up survey

  • +5 more secondary outcomes

Interventions

Patient Reported Outcomes Electronic SurveyOTHER

This study does not include a drug, test, behavioral or medical procedure intervention; participants will be asked to complete three surveys

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital - York Street Campus - Emergency Department

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 34758881DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersOpiate OverdosePatient Participation

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrug OverdosePrescription Drug MisuseDrug MisusePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Kathryn Hawk, MD

    Yale University School of Medicine Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 13, 2019

Study Start

June 7, 2019

Primary Completion

February 16, 2020

Study Completion

February 16, 2020

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

US(1)