Hypertension
Conditions
Keywords
prescribing patterns, thiazide, chlorthalidone, hydrochlorothiazide, target dose, cluster randomized trial
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.
Interventions
OTHERFavor 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.
Sponsors
VA Pharmacy Benefits Management Strategic Healthcare Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* VA prescribers of thiazides for hypertension
Exclusion criteria
* at non-participating VA sites
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prescription Rates | nine months | rates of provider prescribing of the Cluster Designated drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Factors Associated With Prescribing Patterns | nine months | factors (barriers and facilitators) associated with prescribing according to the Cluster Designation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 77 |
| 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 | 61 |
| Total | 138 |
Baseline characteristics
| Characteristic | Favor Chlorthalidone | Favor Hydrochlorothiazide | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 10.8 | 60.4 years STANDARD_DEVIATION 13.1 | 60.7 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 76 Participants | 60 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 77 | 0 / 61 |
| serious Total, serious adverse events | 0 / 77 | 0 / 61 |
Outcome results
Primary
Prescription Rates
rates of provider prescribing of the Cluster Designated drug
Time frame: nine months
Population: providers prescribing a thiazide at least once in the study period
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Favor Chlorthalidone | Prescription Rates | 80 % new thiazide prescriptions |
| Favor Hydrochlorothiazide | Prescription Rates | 100 % new thiazide prescriptions |
Secondary
Factors Associated With Prescribing Patterns
factors (barriers and facilitators) associated with prescribing according to the Cluster Designation
Time frame: nine months