Rheumatic DiseasesNCT04310462
Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine
A study testing New e-prescribing interface in people with Rheumatic Diseases, run by University of California, San Francisco at 1 site in United States.
Trial summary
Hydroxychloroquine (HCQ) is a disease-modifying, anti-rheumatic drug that regulates immune system activity and is typically prescribed to treat rheumatoid arthritis and systemic lupus erythematosus, as well as other immune conditions. Read more about this study
- Who is it for?
- Ages Up to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- New e-prescribing interface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 28 Feb 2024
- 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 Up to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All providers that prescribed hydroxychloroquine in the year previous to the intervention start date in rheumatology and dermatology clinics
Who cannot join
- Inactive providers in rheumatology and dermatology clinics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Quality Improvement Study to Measure the Effectiveness of an E-prescribing Interface to Reduce Dosage of Hydroxychloroquine Above Current Guidelines
Hydroxychloroquine (HCQ) is a disease-modifying, anti-rheumatic drug that regulates immune system activity and is typically prescribed to treat rheumatoid arthritis and systemic lupus erythematosus, as well as other immune conditions. Although generally well tolerated, study data have demonstrated that long-term use of HCQ may lead to irreversible and potentially vision-threatening retinal toxicity. The American Academy of Ophthalmology (AAO) issued guidelines in 2011, and again in 2016 that recommended dosing of HCQ be based on an individual's body weight, and also outlined how and when to screen for retinal toxicity. While clinicians have been aware of the potential side effects of HCQ for decades, studies have shown that many patients continue to receive higher than recommended doses.
The goal of this study is to conduct a pragmatic trial to assess the utility of a new e-prescribing (eRX) interface for prescriptions of hydroxychloroquine (HCQ). The investigators will measure the effectiveness of the system in reducing the number of individuals prescribed HCQ over current guidelines by randomizing clinicians to the new interface. Ideally, the eRX interface will result in a lower number of potential adverse events (i.e. retinal toxicity) associated with high-dose, long-term use of HCQ.
- Conditions
- Rheumatic Diseases
- Being tested
- New e-prescribing interface
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New e-prescribing interfaceOther
The goal of this study is to conduct a pragmatic trial to assess the utility of a new e-prescribing (eRX) interface for prescriptions of hydroxychloroquine (HCQ). Through randomization of clinicians to the new interface, the investigators will measure the effectiveness of the system in reducing the number of individuals prescribed HCQ over current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| New eRX Interface | Experimental | Providers assigned to the intervention arm will be presented with a new eRX interface upon writing new prescriptions for hydroxychloroquine in the EHR. Receives: Other: New e-prescribing interface |
| Standard Interface | No intervention | Providers assigned to the no intervention arm will be presented with the usual ordering interface when prescribing new prescriptions for hydroxychloroquine in the EHR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Prevalence of dosage above 6.5 mg/kg
Measured: Post intervention: 1 year
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Prevalence of dosage above 6.5 mg/kg
Measured: Post intervention: 2 years
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Prevalence of dosage above 6.5 mg/kg
Measured: Post intervention: 3 years
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Prevalence of dosage above 5.0 mg/kg
Measured: Post intervention: 1 year
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Prevalence of dosage above 5.0 mg/kg
Measured: Post intervention: 2 years
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Prevalence of dosage above 5.0 mg/kg
Measured: Post intervention: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Feb 2017
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Why it stopped: Study investigators became aware of an internal error that overrode randomization of providers; therefore, the study randomization for this study was no longer present.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinoos Yazdany, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310462
- Sponsor's protocol ID
- UCSF-16-21347
- Status last verified
- Sep 2024
- First submitted
- 21 Jan 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Summary level data may be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality Improvement Study to Measure the Effectiveness of an E-prescribing Interface to Reduce Dosage of Hydroxychloroquine Above Current Guidelines
- ClinicalTrials.gov ID
- NCT04310462
- Acronym / sponsor ID
- UCSF-16-21347
- Conditions
- Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study investigators became aware of an internal error that overrode randomization of providers; therefore, the study randomization for this study was no longer present.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 17 Mar 2020 (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.
Hydroxychloroquine (HCQ) is a disease-modifying, anti-rheumatic drug that regulates immune system activity and is typically prescribed to treat rheumatoid arthritis and systemic lupus erythematosus, as well as other immune conditions. Although generally well tolerated, study data have demonstrated that long-term use of HCQ may lead to irreversible and potentially vision-threatening retinal toxicity. The American Academy of Ophthalmology (AAO) issued guidelines in 2011, and again in 2016 that recommended dosing of HCQ be based on an individual's body weight, and also outlined how and when to screen for retinal toxicity. While clinicians have been aware of the potential side effects of HCQ for decades, studies have shown that many patients continue to receive higher than recommended doses.
The goal of this study is to conduct a pragmatic trial to assess the utility of a new e-prescribing (eRX) interface for prescriptions of hydroxychloroquine (HCQ). The investigators will measure the effectiveness of the system in reducing the number of individuals prescribed HCQ over current guidelines by randomizing clinicians to the new interface. Ideally, the eRX interface will result in a lower number of potential adverse events (i.e. retinal toxicity) associated with high-dose, long-term use of HCQ.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New eRX Interface | Experimental | Other: New e-prescribing interfaceProviders assigned to the intervention arm will be presented with a new eRX interface upon writing new prescriptions for hydroxychloroquine in the EHR. |
| Standard Interface | No intervention | –Providers assigned to the no intervention arm will be presented with the usual ordering interface when prescribing new prescriptions for hydroxychloroquine in the EHR. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All providers that prescribed hydroxychloroquine in the year previous to the intervention start date in rheumatology and dermatology clinics
Key exclusion criteria (1 listed)
- Inactive providers in rheumatology and dermatology clinics
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 |
|---|---|---|
| New e-prescribing interfaceThe goal of this study is to conduct a pragmatic trial to assess the utility of a new e-prescribing (eRX) interface for prescriptions of hydroxychloroquine (HCQ). Through randomization of clinicians to the new interface, the investigators will measure the effectiveness of the system in reducing the number of individuals prescribed HCQ over current guidelines. | Other | New eRX Interface |
Primary outcome
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Time frame: Post intervention: 1 year
Prevalence of dosage above 6.5 mg/kg
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Time frame: Post intervention: 2 years
Prevalence of dosage above 6.5 mg/kg
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Time frame: Post intervention: 3 years
Prevalence of dosage above 6.5 mg/kg
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Time frame: Post intervention: 1 year
Prevalence of dosage above 5.0 mg/kg
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Time frame: Post intervention: 2 years
Prevalence of dosage above 5.0 mg/kg
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Time frame: Post intervention: 3 years
Prevalence of dosage above 5.0 mg/kg
Results and safety
The study was stopped early (reason given: Study investigators became aware of an internal error that overrode randomization of providers; therefore, the study randomization for this study was no longer present.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Summary level data may be provided upon request
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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.
Jinoos Yazdany, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New e-prescribing interface in people with Rheumatic Diseases, run by University of California, San Francisco 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 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: stopped early, as of the sponsor's last update on 19 Sep 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 was stopped early (reason given: Study investigators became aware of an internal error that overrode randomization of providers; therefore, the study randomization for this study was no longer present.). Results are not available in the source record.
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?
Prevalence of dosage above guidelines: 6.5 mg/kg (2011) (time frame: Post intervention: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.