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

NCT ID: NCT01235377

Last Updated: 2014-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Favor Chlorthalidone

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Providers will be randomized to either Favor Chlorthalidone or Favor Hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. Providers will have agreed to adhere to their assignment for patients for whom there is equipoise, but they are free to deviate if medically indicated for individual patients. There is no requirement to maintain the initial thiazide therapy; it is expected that the regimen may require adjustment over time. The cluster assignment is simply to favor a particular thiazide on initiation of thiazide therapy and attempt to reach the target dose.

Favor Hydrochlorothiazide

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Providers will be randomized to either Favor Chlorthalidone or Favor Hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. Providers will have agreed to adhere to their assignment for patients for whom there is equipoise, but they are free to deviate if medically indicated for individual patients. There is no requirement to maintain the initial thiazide therapy; it is expected that the regimen may require adjustment over time. The cluster assignment is simply to favor a particular thiazide on initiation of thiazide therapy and attempt to reach the target dose.

Interventions

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

Providers will be randomized to either Favor Chlorthalidone or Favor Hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. Providers will have agreed to adhere to their assignment for patients for whom there is equipoise, but they are free to deviate if medically indicated for individual patients. There is no requirement to maintain the initial thiazide therapy; it is expected that the regimen may require adjustment over time. The cluster assignment is simply to favor a particular thiazide on initiation of thiazide therapy and attempt to reach the target dose.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* VA prescribers of thiazides for hypertension

Exclusion Criteria

* at non-participating VA sites
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Pharmacy Benefits Management Strategic Healthcare Group

FED

Sponsor Role lead

Responsible Party

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Madeline McCarren

Biostatistician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madeline McCarren, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

VA Pharmacy Benefits Management

Locations

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Edward Hines, Jr. VA Hospital

Hines, Illinois, United States

Site Status

Charles George VAMC

Asheville, North Carolina, United States

Site Status

Wilkes-Barre VA Medical Center

Wilkes-Barre, Pennsylvania, United States

Site Status

WJB Dorn VA Medical Center

Columbia, South Carolina, United States

Site Status

WJB Dorn VAMC/Columbia Orangeburg VA Outpatient Clinic

Orangeburg, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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VMS156

Identifier Type: -

Identifier Source: org_study_id