Study 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.
Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine
A Quality Improvement Study to Measure the Effectiveness of an E-prescribing Interface to Reduce Dosage of Hydroxychloroquine Above Current Guidelines
1 other identifier
interventional
65
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
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
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 21, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedSeptember 19, 2024
September 1, 2024
7.1 years
January 21, 2020
September 9, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Prevalence of dosage above 6.5 mg/kg
Post intervention: 1 year
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Prevalence of dosage above 6.5 mg/kg
Post intervention: 2 years
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Prevalence of dosage above 6.5 mg/kg
Post intervention: 3 years
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Prevalence of dosage above 5.0 mg/kg
Post intervention: 1 year
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Prevalence of dosage above 5.0 mg/kg
Post intervention: 2 years
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Prevalence of dosage above 5.0 mg/kg
Post intervention: 3 years
Study Arms (2)
New eRX Interface
EXPERIMENTALProviders 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 INTERVENTIONProviders assigned to the no intervention arm will be presented with the usual ordering interface when prescribing new prescriptions for hydroxychloroquine in the EHR.
Interventions
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.
Eligibility Criteria
You may qualify if:
- All providers that prescribed hydroxychloroquine in the year previous to the intervention start date in rheumatology and dermatology clinics
You may not qualify if:
- Inactive providers in rheumatology and dermatology clinics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinoos Yazdany, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2020
First Posted
March 17, 2020
Study Start
February 1, 2017
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share
Summary level data may be provided upon request