Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine

Not Applicable

Active, not recruiting

• Conditions: Rheumatic Diseases
• Interventions: Other: New e-prescribing interface

• Registration Number: NCT04310462
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-06
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

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Exclusion Criteria

• Inactive providers in rheumatology and dermatology clinics

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New eRX Interface	New e-prescribing interface	Providers assigned to the intervention arm will be presented with a new eRX interface upon writing new prescriptions for hydroxychloroquine in the EHR.

Primary Outcome Measures

Name	Time	Method
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)	Post intervention: 3 years	Prevalence of dosage above 6.5 mg/kg
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)	Post intervention: 3 years	Prevalence of dosage above 5.0 mg/kg

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States