Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Other: Favor one of two thiazides for new prescriptions & attempt target dose

• Registration Number: NCT01235377
• Lead Sponsor: VA Pharmacy Benefits Management Strategic Healthcare Group

Brief Summary

This is a pilot study of a method to compare common, FDA-approved drugs in a clinic. Instead of putting single patients into one of two drug groups, the investigators will assign the doctors who prescribe these drugs for high blood pressure into two groups. One group of doctors has agreed to prescribe mostly ("favor") one drug, chlorthalidone, if that drug would be a good choice for a patient. The other group has agreed to prescribe mostly hydrochlorothiazide. For both groups, they will try to use the doses that were shown to be protective in other trials. If the doctors mostly prescribe the drug they agreed to favor, the investigators will be able to compare outcomes, like heart attacks, in the two groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Study Start: 2011-09
• Primary Completion: 2013-10
• Study Completion: 2014-02
• Status Verified: 2014-11
• Results First Submitted: 2014-11-17
• Results First Submitted QC: 2014-11-17
• Last Update Submitted: 2014-11-17
• Results First Posted: 2014-11-25
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• VA prescribers of thiazides for hypertension

Exclusion Criteria

• at non-participating VA sites

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Favor Hydrochlorothiazide	Favor one of two thiazides for new prescriptions & attempt target dose	Providers randomized to Favor Hydrochlorothiazide will have agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
Favor Chlorthalidone	Favor one of two thiazides for new prescriptions & attempt target dose	Providers randomized to Favor Chlorthalidone will have agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients

Primary Outcome Measures

Name	Time	Method
Prescription Rates	nine months	rates of provider prescribing of the Cluster Designated drug

Secondary Outcome Measures

Name	Time	Method
Factors Associated With Prescribing Patterns	nine months	factors (barriers and facilitators) associated with prescribing according to the Cluster Designation

Trial Locations

Locations (5)

WJB Dorn VA Medical Center; 🇺🇸 Columbia, South Carolina, United States

Charles George VAMC; 🇺🇸 Asheville, North Carolina, United States

Wilkes-Barre VA Medical Center; 🇺🇸 Wilkes-Barre, Pennsylvania, United States

Edward Hines, Jr. VA Hospital; 🇺🇸 Hines, Illinois, United States

WJB Dorn VAMC/Columbia Orangeburg VA Outpatient Clinic; 🇺🇸 Orangeburg, South Carolina, United States