Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine

NCT ID: NCT04310462

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2024-02-28

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.

Conditions

Rheumatic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

New e-prescribing interface

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinoos Yazdany, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

UCSF-16-21347

Identifier Type: -

Identifier Source: org_study_id