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Study investigators became aware of an internal error that overrode randomization of providers; therefore, the study randomization for this study was no longer present.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New eRX Interface | Experimental | Providers assigned to the intervention arm will be presented with a new eRX interface upon writing new prescriptions for hydroxychloroquine in the EHR. |
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| Standard Interface | No Intervention | Providers assigned to the no intervention arm will be presented with the usual ordering interface when prescribing new prescriptions for hydroxychloroquine in the EHR. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New e-prescribing interface | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinoos Yazdany, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
Summary level data may be provided upon request
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| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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