Clinical trial NCT04310462: Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine
Official title: A Quality Improvement Study to Measure the Effectiveness of an E-prescribing Interface to Reduce Dosage of Hydroxychloroquine Above Current Guidelines
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rheumatic Diseases
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 65
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* All providers that prescribed hydroxychloroquine in the year previous to the intervention start date in rheumatology and dermatology clinics

Exclusion Criteria:

* Inactive providers in rheumatology and dermatology clinics

Primary outcomes:
measure: Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
timeFrame: Post intervention: 1 year
measure: Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
timeFrame: Post intervention: 2 years
measure: Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
timeFrame: Post intervention: 3 years
measure: Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
timeFrame: Post intervention: 1 year
measure: Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
timeFrame: Post intervention: 2 years
measure: Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
timeFrame: Post intervention: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jinoos Yazdany, MD
role: PRINCIPAL_INVESTIGATOR
References: