Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatic Diseases

Intervention / Treatment
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* Other: New e-prescribing interface


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New eRX Interface<br>Providers assigned to the intervention arm will be presented with a new eRX interface upon writing new prescriptions for hydroxychloroquine in the EHR. | Other: New e-prescribing interface<br>* 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.<br>|
| No Intervention: Standard Interface<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |