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

VA Pharmacy Benefits Management Strategic Healthcare Group

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Other: Favor one of two thiazides for new prescriptions & attempt target dose

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01235377

VMS156

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• VA prescribers of thiazides for hypertension

Exclusion criteria

• at non-participating VA sites

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Favor Chlorthalidone

Active Comparator group

Description:

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

Treatment:

Other: Favor one of two thiazides for new prescriptions & attempt target dose

Favor Hydrochlorothiazide

Active Comparator group

Description:

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

Treatment:

Other: Favor one of two thiazides for new prescriptions & attempt target dose