Pain, AcuteNCT04155229
EMR Defaults to Nudge Opioid Prescribing
A study testing Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone) in people with Pain, Acute and Opioid Use, Unspecified, run by University of California, San Francisco.
Trial summary
The investigators conducted a prospective, block-randomized study to determine whether and to what extent changes in the default settings in the electronic medical record (EMR) affect opioid prescriptions for patients discharged from emergency departments (EDs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Acute, Opioid Use, Unspecified
- What is being tested?
- Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2016to 3 Sep 2017
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Discharge prescription from emergency for study drug: hydrocodone/acetaminophen, oxycodone, or oxycodone/acetaminophen.
Who cannot join
- none
About this study
Official title: Effect of Default Electronic Health Record Settings on Clinician Opioid Prescribing Patterns in Emergency Departments
The investigators conducted a prospective, block-randomized study to determine whether and to what extent changes in the default settings in the electronic medical record (EMR) affect opioid prescriptions for patients discharged from emergency departments (EDs).
Read the detailed description
In two large, urban emergency departments, we randomly altered the pre-populated dispense quantities of discharge prescriptions for commonly-prescribed opioids over a series of five 4-week blocks. These changes were made without announcement, and providers were not informed of the study itself.
- Conditions
- Pain, Acute, Opioid Use, Unspecified
- Being tested
- Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)Other
For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.
Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.
| Study group | Role | What they receive |
|---|---|---|
| Null setting, forced entry | Experimental | Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.
This arm has a default setting for opioid quantity set at -blank-. This setting required the prescriber to enter a quantity in order to write a prescription. Receives: Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone) |
| 5 tablet default | Experimental | Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.
This arm has a default setting for opioid quantity set at 5. Receives: Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone) |
| 10 tablet default | Experimental | Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.
This arm has a default setting for opioid quantity set at 10. Receives: Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone) |
| 15 tablet default | Experimental | Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.
This arm has a default setting for opioid quantity set at 15. Receives: Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone) |
| Status quo default setting | Active comparator | Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.
This arm has a default setting for opioid quantity set at the status quo value for each site (20 for site 1, 12 for site 2). Receives: Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dispense quantity of prescribed opioids
The dispense quantity of prescribed study drugs was collected from the electronic medical record at each site. The mean and median quantities per prescription according to each study arm were compared.
Measured: Through study completion, approximately 340 days
Secondary outcomes (2)
Proportion ≤12
The dispense quantity of study drugs was collected from the electronic medical record at each site. The proportion of prescriptions at 12 or fewer tablets was compared across study arms.
Measured: Through study completion, approximately 340 days
Proportion at default setting
The dispense quantity of study drugs was collected from the electronic medical record at each site. The proportion of prescriptions written for the given default setting was compared across treatment arms.
Measured: Through study completion, approximately 340 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start3 Oct 2016
- Primary completion3 Sep 2017
- Study completion3 Sep 2017
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 Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Each of two sites underwent block randomization of four treatment assignments.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Juan Carlos Montoy, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155229
- Sponsor's protocol ID
- EMRdefaults
- Status last verified
- Nov 2019
- First submitted
- 28 Oct 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montoy JCC, Coralic Z, Herring AA, Clattenburg EJ, Raven MC. Association of Default Electronic Medical Record Settings With Health Care Professional Patterns of Opioid Prescribing in Emergency Departments: A Randomized Quality Improvement Study. JAMA Intern Med. 2020 Apr 1;180(4):487-493. doi: 10.1001/jamainternmed.2019.6544.
PubMed 31961377
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Default Electronic Health Record Settings on Clinician Opioid Prescribing Patterns in Emergency Departments
- ClinicalTrials.gov ID
- NCT04155229
- Acronym / sponsor ID
- EMRdefaults
- Conditions
- Pain, Acute, Opioid Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 3 Sep 2017 (actual)
- Study completion
- 3 Sep 2017 (actual)
- First posted
- 7 Nov 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 investigators conducted a prospective, block-randomized study to determine whether and to what extent changes in the default settings in the electronic medical record (EMR) affect opioid prescriptions for patients discharged from emergency departments (EDs).
Detailed description
In two large, urban emergency departments, we randomly altered the pre-populated dispense quantities of discharge prescriptions for commonly-prescribed opioids over a series of five 4-week blocks. These changes were made without announcement, and providers were not informed of the study itself.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Each of two sites underwent block randomization of four treatment assignments.
| Arm | Type | Receives |
|---|---|---|
| Null setting, forced entry | Experimental | Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids. This arm has a default setting for opioid quantity set at -blank-. This setting required the prescriber to enter a quantity in order to write a prescription. |
| 5 tablet default | Experimental | Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids. This arm has a default setting for opioid quantity set at 5. |
| 10 tablet default | Experimental | Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids. This arm has a default setting for opioid quantity set at 10. |
| 15 tablet default | Experimental | Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids. This arm has a default setting for opioid quantity set at 15. |
| Status quo default setting | Active comparator | Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids. This arm has a default setting for opioid quantity set at the status quo value for each site (20 for site 1, 12 for site 2). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Discharge prescription from emergency for study drug: hydrocodone/acetaminophen, oxycodone, or oxycodone/acetaminophen.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions. Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg. | Other | 10 tablet default, 15 tablet default, 5 tablet default, Null setting, forced entry, Status quo default setting |
Primary outcome
Dispense quantity of prescribed opioids
Time frame: Through study completion, approximately 340 days
The dispense quantity of prescribed study drugs was collected from the electronic medical record at each site. The mean and median quantities per prescription according to each study arm were compared.
2 secondary outcomes
Proportion ≤12
Time frame: Through study completion, approximately 340 days
Proportion at default setting
Time frame: Through study completion, approximately 340 days
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 7 Nov 2019.
- Derived from this study: PubMed 31961377Montoy JCC, Coralic Z, Herring AA, Clattenburg EJ, Raven MC. Association of Default Electronic Medical Record Settings With Health Care Professional Patterns of Opioid Prescribing in Emergency Departments: A Randomized Quality Improvement Study. JAMA Intern Med. 2020 Apr 1;180(4):487-493. doi: 10.1001/jamainternmed.2019.6544.
- Individual participant dataSharing planned: No
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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.
Juan Carlos Montoy, MD, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone) in people with Pain, Acute and Opioid Use, Unspecified, run by University of California, San Francisco.
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 1 inclusion and 1 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 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Dispense quantity of prescribed opioids (time frame: Through study completion, approximately 340 days). 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 NCT04155229, 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 7 Nov 2019.