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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prescription Rates | rates of provider prescribing of the Cluster Designated drug | nine months |
| Measure | Description | Time Frame |
|---|---|---|
| Factors Associated With Prescribing Patterns | factors (barriers and facilitators) associated with prescribing according to the Cluster Designation | nine months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madeline McCarren, PhD, MPH | VA Pharmacy Benefits Management | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines, Jr. VA Hospital | Hines | Illinois | 60141 | United States | ||
| Charles George VAMC |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Asheville |
| North Carolina |
| 28805 |
| United States |
| Wilkes-Barre VA Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| WJB Dorn VA Medical Center | Columbia | South Carolina | 29209 | United States |
| WJB Dorn VAMC/Columbia Orangeburg VA Outpatient Clinic | Orangeburg | South Carolina | 29118 | United States |
| FG001 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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patients of the 18 providers
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prescription Rates | rates of provider prescribing of the Cluster Designated drug | providers prescribing a thiazide at least once in the study period | Posted | Median | Inter-Quartile Range | % new thiazide prescriptions | nine months |
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| Secondary | Factors Associated With Prescribing Patterns | factors (barriers and facilitators) associated with prescribing according to the Cluster Designation | Not Posted | nine months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 77 | 2 | 77 | ||
| EG001 | 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 | 0 | 61 | 0 | 61 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| other abnormal glucose | Endocrine disorders | Systematic Assessment | from analysis of select International Classification of Diseases (ICD9) terms in an administrative database |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madeline McCarren, PhD | Veterans Health Administration Pharmacy Benefits Management | 7087867987 | madeline.mccarren@va.gov |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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