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Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine

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ClinicalTrials.gov Identifier: NCT04310462
Recruitment Status : Active, not recruiting
First Posted : March 17, 2020
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Rheumatic Diseases Other: New e-prescribing interface Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Quality Improvement Study to Measure the Effectiveness of an E-prescribing Interface to Reduce Dosage of Hydroxychloroquine Above Current Guidelines
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Prevalence of dosage above guidelines: 6.5 mg/kg (2011) [ Time Frame: Post intervention: 1 year ]
    Prevalence of dosage above 6.5 mg/kg

  2. Prevalence of dosage above guidelines: 6.5 mg/kg (2011) [ Time Frame: Post intervention: 2 years ]
    Prevalence of dosage above 6.5 mg/kg

  3. Prevalence of dosage above guidelines: 6.5 mg/kg (2011) [ Time Frame: Post intervention: 3 years ]
    Prevalence of dosage above 6.5 mg/kg

  4. Prevalence of dosage above guidelines: 5.0 mg/kg (2016) [ Time Frame: Post intervention: 1 year ]
    Prevalence of dosage above 5.0 mg/kg

  5. Prevalence of dosage above guidelines: 5.0 mg/kg (2016) [ Time Frame: Post intervention: 2 years ]
    Prevalence of dosage above 5.0 mg/kg

  6. Prevalence of dosage above guidelines: 5.0 mg/kg (2016) [ Time Frame: Post intervention: 3 years ]
    Prevalence of dosage above 5.0 mg/kg



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310462


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Jinoos Yazdany, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04310462    
Other Study ID Numbers: UCSF-16-21347
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Summary level data may be provided upon request

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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
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases