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Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine

Primary Purpose

Rheumatic Diseases

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New e-prescribing interface
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatic Diseases

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

New eRX Interface

Standard Interface

Arm Description

Providers assigned to the intervention arm will be presented with a new eRX interface upon writing new prescriptions for hydroxychloroquine in the EHR.

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 Outcome Measures

Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Prevalence of dosage above 6.5 mg/kg
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Prevalence of dosage above 6.5 mg/kg
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Prevalence of dosage above 6.5 mg/kg
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Prevalence of dosage above 5.0 mg/kg
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Prevalence of dosage above 5.0 mg/kg
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Prevalence of dosage above 5.0 mg/kg

Secondary Outcome Measures

Full Information

First Posted
January 21, 2020
Last Updated
July 5, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT04310462
Brief Title
Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine
Official Title
A Quality Improvement Study to Measure the Effectiveness of an E-prescribing Interface to Reduce Dosage of Hydroxychloroquine Above Current Guidelines
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New eRX Interface
Arm Type
Experimental
Arm Description
Providers assigned to the intervention arm will be presented with a new eRX interface upon writing new prescriptions for hydroxychloroquine in the EHR.
Arm Title
Standard Interface
Arm Type
No Intervention
Arm Description
Providers assigned to the no intervention arm will be presented with the usual ordering interface when prescribing new prescriptions for hydroxychloroquine in the EHR.
Intervention Type
Other
Intervention Name(s)
New e-prescribing interface
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Description
Prevalence of dosage above 6.5 mg/kg
Time Frame
Post intervention: 1 year
Title
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Description
Prevalence of dosage above 6.5 mg/kg
Time Frame
Post intervention: 2 years
Title
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)
Description
Prevalence of dosage above 6.5 mg/kg
Time Frame
Post intervention: 3 years
Title
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Description
Prevalence of dosage above 5.0 mg/kg
Time Frame
Post intervention: 1 year
Title
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Description
Prevalence of dosage above 5.0 mg/kg
Time Frame
Post intervention: 2 years
Title
Prevalence of dosage above guidelines: 5.0 mg/kg (2016)
Description
Prevalence of dosage above 5.0 mg/kg
Time Frame
Post intervention: 3 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinoos Yazdany, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Summary level data may be provided upon request

Learn more about this trial

Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine

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