Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypertension	Other: Favor one of two thiazides for new prescriptions & attempt target dose	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Chlorthalidone

U.S. FDA Resources

Further study details as provided by VA Pharmacy Benefits Management Strategic Healthcare Group:

Primary Outcome Measures:

prescription rates [ Time Frame: nine months ] [ Designated as safety issue: No ]
rates of provider prescribing of the Cluster Designated drug at the target dose

Secondary Outcome Measures:

factors associated with prescribing patterns [ Time Frame: nine months ] [ Designated as safety issue: No ]
factors (barriers and facilitators) associated with prescribing according to the Cluster Designation

Estimated Enrollment:	100
Study Start Date:	September 2011
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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	Other: 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.
Active Comparator: 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	Other: 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.

Arms

Assigned Interventions

Active Comparator: 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

Other: 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.

Active Comparator: 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

Other: 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

VA prescribers of thiazides for hypertension

Exclusion Criteria:

at non-participating VA sites

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235377

Locations

United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141
United States, North Carolina
Charles George VAMC
Asheville, North Carolina, United States, 28805
United States, Pennsylvania
Wilkes-Barre VA Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
WJB Dorn VA Medical Center
Columbia, South Carolina, United States, 29209
WJB Dorn VAMC/Columbia Orangeburg VA Outpatient Clinic
Orangeburg, South Carolina, United States, 29118

Sponsors and Collaborators

VA Pharmacy Benefits Management Strategic Healthcare Group

Investigators

Principal Investigator:

Madeline McCarren, PhD, MPH

VA Pharmacy Benefits Management

More Information

No publications provided

Responsible Party:	Madeline McCarren, Biostatistician, VA Pharmacy Benefits Management Strategic Healthcare Group
ClinicalTrials.gov Identifier:	NCT01235377 History of Changes
Other Study ID Numbers:	VMS156
Study First Received:	November 4, 2010
Last Updated:	March 13, 2013
Health Authority:	United States: Federal Government

Keywords provided by VA Pharmacy Benefits Management Strategic Healthcare Group:

prescribing patterns
thiazide
chlorthalidone

hydrochlorothiazide
target dose
cluster randomized trial

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Chlorthalidone
Sodium Chloride Symporter Inhibitors
Hydrochlorothiazide
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013