Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine

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

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 Overview

• Status: Active, not recruiting
• Conditions: Rheumatic Diseases
• Intervention / Treatment: Other: New e-prescribing interface

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New eRX Interface; 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; 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.
No Intervention: Standard Interface; 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?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Jinoos Yazdany, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: UCSF-16-21347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Summary level data may be provided upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No