Opioid-use DisorderNCT03985163
Patient Reported Outcomes for Opioid Use Disorder
An observational study of Opioid-use Disorder and Overdose of Opiate, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Overdose of Opiate, Patient Participation
- What is being tested?
- Patient Reported Outcomes Electronic Survey
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2019to 16 Feb 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital - York Street Campus - Emergency Department
New Haven, Connecticut, 06510
About this study
Official title: Capturing Opioid Use Disorder Electronically & Patient Reported Outcomes
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).
- Being tested
- Patient Reported Outcomes Electronic Survey
- Keywords
- Patient Reported Outcomes, Clinical Data Research, Electronic Health Records
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to share EHR data with researchers
The proportion of people who qualify for study criteria and enroll in the study
Measured: once: at screening and enrollment
Electronic survey response
Response rate to patient reported outcomes via electronic follow-up survey
Measured: once: 3 day follow-up survey
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: once: 30 day follow-up survey
Lost-to-follow-up
Lost-to-follow-up rates
Measured: Up to 5 months
Electronic survey response
Response rate to patient reported outcomes via electronic follow-up survey
Measured: once: 30 day follow-up survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start7 Jun 2019
- Primary completion16 Feb 2020
- Study completion16 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Drug Abuse Treatment Clinical Trials Network, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kathryn Hawk, MD, Principal investigator, Yale University School of Medicine Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985163
- Sponsor's protocol ID
- 2000024667
- Other IDs
- 3UG1DA015831-17S1
- Status last verified
- Feb 2024
- First submitted
- 10 Jun 2019
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34758881
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capturing Opioid Use Disorder Electronically & Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT03985163
- Acronym / sponsor ID
- 2000024667
- Keywords
- Patient Reported Outcomes, Clinical Data Research, Electronic Health Records
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Drug Abuse Treatment Clinical Trials Network, National Institute on Drug Abuse (NIDA)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 16 Feb 2020 (actual)
- Study completion
- 16 Feb 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Reported Outcomes Electronic SurveyThis study does not include a drug, test, behavioral or medical procedure intervention; participants will be asked to complete three surveys | Other | – |
Primary outcome
Willingness to share EHR data with researchers
Time frame: once: at screening and enrollment
The proportion of people who qualify for study criteria and enroll in the study
Electronic survey response
Time frame: once: 3 day follow-up survey
Response rate to patient reported outcomes via electronic follow-up survey
10 secondary outcomes
Treatment Effectiveness Assessment
Time frame: once: 3 day follow-up survey
Treatment Effectiveness Assessment
Time frame: once: 30 day follow-up survey
ED patients prescribed opioid use disorder medication
Time frame: once: 3 day follow-up survey
ED patients prescribed opioid use disorder medication
Time frame: once: 30 day follow-up survey
ED patients referred to substance use disorder treatment
Time frame: once: 3 day follow-up survey
Patients enrolling in substance use disorder treatment
Time frame: once: 30 day follow-up survey
Patients filling opioid use disorder prescriptions
Time frame: once: 3 day follow-up survey
Patients filling opioid use disorder prescriptions
Time frame: once: 30 day follow-up survey
Lost-to-follow-up
Time frame: Up to 5 months
Electronic survey response
Time frame: once: 30 day follow-up survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Derived from this study: PubMed 34758881Hawk 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Hawk, MD principal investigator
Yale University School of Medicine Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder and Overdose of Opiate, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to share EHR data with researchers (time frame: once: at screening and enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.