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

NCT01235377 | Completed Phase 4 Results

• 1 other identifier: VMS156
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Hypertension

Keywords

prescribing patterns; thiazide; chlorthalidone; hydrochlorothiazide; target dose; cluster randomized trial

Outcome Measures

Primary Outcomes (1)

• Prescription Rates

  rates of provider prescribing of the Cluster Designated drug

  nine months

Secondary Outcomes (1)

• Factors Associated With Prescribing Patterns

  nine months

Study Arms (2)

Favor Chlorthalidone

ACTIVE COMPARATOR

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

Favor Hydrochlorothiazide

ACTIVE COMPARATOR

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

Interventions

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.

Favor Chlorthalidone; Favor Hydrochlorothiazide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• VA prescribers of thiazides for hypertension

You may not qualify if:

• at non-participating VA sites

Sponsors & Collaborators

• VA Pharmacy Benefits Management Strategic Healthcare Group: lead

Study Sites (5)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141, United States

Location

Charles George VAMC

Asheville, North Carolina, 28805, United States

Location

Wilkes-Barre VA Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

WJB Dorn VA Medical Center

Columbia, South Carolina, 29209, United States

Location

WJB Dorn VAMC/Columbia Orangeburg VA Outpatient Clinic

Orangeburg, South Carolina, 29118, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Madeline McCarren, PhD
• Organization: Veterans Health Administration Pharmacy Benefits Management

madeline.mccarren@va.gov

7087867987

Study Officials

• Madeline McCarren, PhD, MPH

  VA Pharmacy Benefits Management

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biostatistician

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Study Start: September 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: November 25, 2014
• Results First Posted: November 25, 2014

Record last verified: 2014-11

Locations

US (5)