Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 17, 2014
Last verified: November 2014
Results First Received: November 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Hypertension
Intervention: Other: Favor one of two thiazides for new prescriptions & attempt target dose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Favor Chlorthalidone Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
Favor Hydrochlorothiazide Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients

Participant Flow:   Overall Study
    Favor Chlorthalidone     Favor Hydrochlorothiazide  
STARTED     11     9  
COMPLETED     10     8  
NOT COMPLETED     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
patients of the 18 providers

Reporting Groups
  Description
Favor Chlorthalidone Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
Favor Hydrochlorothiazide Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
Total Total of all reporting groups

Baseline Measures
    Favor Chlorthalidone     Favor Hydrochlorothiazide     Total  
Number of Participants  
[units: participants]
  77     61     138  
Age  
[units: years]
Mean ± Standard Deviation
  60.9  ± 10.8     60.4  ± 13.1     60.7  ± 11.8  
Gender  
[units: patients]
     
Female     1     1     2  
Male     76     60     136  



  Outcome Measures

1.  Primary:   Prescription Rates   [ Time Frame: nine months ]

2.  Secondary:   Factors Associated With Prescribing Patterns   [ Time Frame: nine months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Madeline McCarren, PhD
Organization: Veterans Health Administration Pharmacy Benefits Management
phone: 7087867987
e-mail: madeline.mccarren@va.gov


No publications provided


Responsible Party: Madeline McCarren, VA Pharmacy Benefits Management Strategic Healthcare Group
ClinicalTrials.gov Identifier: NCT01235377     History of Changes
Other Study ID Numbers: VMS156
Study First Received: November 4, 2010
Results First Received: November 17, 2014
Last Updated: November 17, 2014
Health Authority: United States: Federal Government