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

November 4, 2010
September 26, 2014
September 2011
October 2013   (final data collection date for primary outcome measure)
prescription rates [ Time Frame: nine months ] [ Designated as safety issue: No ]
rates of provider prescribing of the Cluster Designated drug at the target dose
Same as current
Complete list of historical versions of study NCT01235377 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study
Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Hypertension
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 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
    Intervention: Other: Favor one of two thiazides for new prescriptions & attempt 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
    Intervention: Other: Favor one of two thiazides for new prescriptions & attempt target dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • VA prescribers of thiazides for hypertension

Exclusion Criteria:

  • at non-participating VA sites
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01235377
VMS156
No
Madeline McCarren, VA Pharmacy Benefits Management Strategic Healthcare Group
VA Pharmacy Benefits Management Strategic Healthcare Group
Not Provided
Principal Investigator: Madeline McCarren, PhD, MPH VA Pharmacy Benefits Management
VA Pharmacy Benefits Management Strategic Healthcare Group
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP