Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine

Rheumatic Diseases Clinical Trial

Official title:

A Quality Improvement Study to Measure the Effectiveness of an E-prescribing Interface to Reduce Dosage of Hydroxychloroquine Above Current Guidelines

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04310462
• Other study ID #: UCSF-16-21347
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: February 2025

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Rheumatic Diseases

Intervention

Other:
• New e-prescribing interface
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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of dosage above guidelines: 6.5 mg/kg (2011)	Prevalence of dosage above 6.5 mg/kg	Post intervention: 1 year
Primary	Prevalence of dosage above guidelines: 6.5 mg/kg (2011)	Prevalence of dosage above 6.5 mg/kg	Post intervention: 2 years
Primary	Prevalence of dosage above guidelines: 6.5 mg/kg (2011)	Prevalence of dosage above 6.5 mg/kg	Post intervention: 3 years
Primary	Prevalence of dosage above guidelines: 5.0 mg/kg (2016)	Prevalence of dosage above 5.0 mg/kg	Post intervention: 1 year
Primary	Prevalence of dosage above guidelines: 5.0 mg/kg (2016)	Prevalence of dosage above 5.0 mg/kg	Post intervention: 2 years
Primary	Prevalence of dosage above guidelines: 5.0 mg/kg (2016)	Prevalence of dosage above 5.0 mg/kg	Post intervention: 3 years