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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Madeline McCarren, VA Pharmacy Benefits Management Strategic Healthcare Group
ClinicalTrials.gov Identifier:
NCT01235377
First received: November 4, 2010
Last updated: September 26, 2014
Last verified: September 2014
  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:


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


Enrollment: 20
Study Start Date: September 2011
Study Completion Date: February 2014
Primary Completion Date: October 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 26, 2014
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
Cardiovascular Diseases
Vascular Diseases
Chlorthalidone
Hydrochlorothiazide
Sodium Chloride Symporter Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Diuretics
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014