Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study
| Tracking Information | |||||
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| First Received Date ICMJE | November 4, 2010 | ||||
| Last Updated Date | March 13, 2013 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
prescription rates [ Time Frame: nine months ] [ Designated as safety issue: No ] rates of provider prescribing of the Cluster Designated drug at the target dose |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01235377 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study | ||||
| Official Title ICMJE | Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | July 2014 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01235377 | ||||
| Other Study ID Numbers ICMJE | VMS156 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Madeline McCarren, VA Pharmacy Benefits Management Strategic Healthcare Group | ||||
| Study Sponsor ICMJE | VA Pharmacy Benefits Management Strategic Healthcare Group | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | VA Pharmacy Benefits Management Strategic Healthcare Group | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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