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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Edward Hines, Jr. VA Hospital, Hines, Illinois, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

VA prescribers of thiazides for hypertension

Exclusion criteria

at non-participating VA sites

Treatment and study plan

Favor one of two thiazides for new prescriptions & attempt target dose

Other

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 outcomes

Prescription Rates

Time frame: nine months

rates of provider prescribing of the Cluster Designated drug

Secondary outcomes

Factors Associated With Prescribing Patterns

Time frame: nine months

factors (barriers and facilitators) associated with prescribing according to the Cluster Designation

Sponsors and collaborators

Lead sponsor

VA Pharmacy Benefits Management Strategic Healthcare Group

Fed

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2014
First posted: Nov 5, 2010
Registry last updated: Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed