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

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ClinicalTrials.gov Identifier: NCT01235377
Recruitment Status : Completed
First Posted : November 5, 2010
Results First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Madeline McCarren, VA Pharmacy Benefits Management Strategic Healthcare Group

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study
Study Start Date : September 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Prescription Rates [ Time Frame: nine months ]
    rates of provider prescribing of the Cluster Designated drug


Secondary Outcome Measures :
  1. Factors Associated With Prescribing Patterns [ Time Frame: nine months ]
    factors (barriers and facilitators) associated with prescribing according to the Cluster Designation


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • VA prescribers of thiazides for hypertension

Exclusion Criteria:

  • at non-participating VA sites
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235377


Locations
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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
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Principal Investigator: Madeline McCarren, PhD, MPH VA Pharmacy Benefits Management
More Information
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Responsible Party: Madeline McCarren, Biostatistician, VA Pharmacy Benefits Management Strategic Healthcare Group
ClinicalTrials.gov Identifier: NCT01235377    
Other Study ID Numbers: VMS156
First Posted: November 5, 2010    Key Record Dates
Results First Posted: November 25, 2014
Last Update Posted: November 25, 2014
Last Verified: November 2014
Keywords provided by Madeline McCarren, VA Pharmacy Benefits Management Strategic Healthcare Group:
prescribing patterns
thiazide
chlorthalidone
 hydrochlorothiazide
target dose
cluster randomized trial
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases