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

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Favor one of two thiazides for new prescriptions & attempt target dose
Sponsored by
VA Pharmacy Benefits Management Strategic Healthcare Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring prescribing patterns, thiazide, chlorthalidone, hydrochlorothiazide, target dose, cluster randomized trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • VA prescribers of thiazides for hypertension

Exclusion Criteria:

  • at non-participating VA sites

Sites / Locations

  • Edward Hines, Jr. VA Hospital
  • Charles George VAMC
  • Wilkes-Barre VA Medical Center
  • WJB Dorn VA Medical Center
  • WJB Dorn VAMC/Columbia Orangeburg VA Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Favor Chlorthalidone

Favor Hydrochlorothiazide

Arm Description

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

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

Outcomes

Primary Outcome Measures

Prescription Rates
rates of provider prescribing of the Cluster Designated drug

Secondary Outcome Measures

Factors Associated With Prescribing Patterns
factors (barriers and facilitators) associated with prescribing according to the Cluster Designation

Full Information

First Posted
November 4, 2010
Last Updated
November 17, 2014
Sponsor
VA Pharmacy Benefits Management Strategic Healthcare Group
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1. Study Identification

Unique Protocol Identification Number
NCT01235377
Brief Title
Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study
Official Title
Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Pharmacy Benefits Management Strategic Healthcare Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
prescribing patterns, thiazide, chlorthalidone, hydrochlorothiazide, target dose, cluster randomized trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Favor Chlorthalidone
Arm Type
Active Comparator
Arm Description
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
Arm Title
Favor Hydrochlorothiazide
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Favor one of two thiazides for new prescriptions & attempt target dose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prescription Rates
Description
rates of provider prescribing of the Cluster Designated drug
Time Frame
nine months
Secondary Outcome Measure Information:
Title
Factors Associated With Prescribing Patterns
Description
factors (barriers and facilitators) associated with prescribing according to the Cluster Designation
Time Frame
nine months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: VA prescribers of thiazides for hypertension Exclusion Criteria: at non-participating VA sites
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeline McCarren, PhD, MPH
Organizational Affiliation
VA Pharmacy Benefits Management
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Charles George VAMC
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28805
Country
United States
Facility Name
Wilkes-Barre VA Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
WJB Dorn VA Medical Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
Facility Name
WJB Dorn VAMC/Columbia Orangeburg VA Outpatient Clinic
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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