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Clinical Trials/NCT04310462
NCT04310462TerminatedNot Applicable

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

University of California, San Francisco1 site in 1 country65 target enrollmentStarted: February 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
65
Locations
1
Primary Endpoint
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
— to 120 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: New e-prescribing interface (Other)

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.

Outcomes

Primary Outcomes

Prevalence of dosage above guidelines: 6.5 mg/kg (2011)

Time Frame: Post intervention: 3 years

Prevalence of dosage above 6.5 mg/kg

Prevalence of dosage above guidelines: 5.0 mg/kg (2016)

Time Frame: Post intervention: 3 years

Prevalence of dosage above 5.0 mg/kg

Prevalence of dosage above guidelines: 6.5 mg/kg (2011)

Time Frame: Post intervention: 1 year

Prevalence of dosage above 6.5 mg/kg

Prevalence of dosage above guidelines: 6.5 mg/kg (2011)

Time Frame: Post intervention: 2 years

Prevalence of dosage above 6.5 mg/kg

Prevalence of dosage above guidelines: 5.0 mg/kg (2016)

Time Frame: Post intervention: 1 year

Prevalence of dosage above 5.0 mg/kg

Prevalence of dosage above guidelines: 5.0 mg/kg (2016)

Time Frame: Post intervention: 2 years

Prevalence of dosage above 5.0 mg/kg

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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