Status:
COMPLETED
Implementing Evidence Based Treatment of Hypertension
Lead Sponsor:
VA Office of Research and Development
Conditions:
Hypertension
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study examines the use of patient initiated discussions of blood pressure medication in the primary care setting. Additionally, this study examines different levels of patient incentive(s) to ini...
Detailed Description
Patients will be randomized to Pure control, intervention control, intervention group a, intervention group b or intervention group c. Pure control patients will not receive any study information abou...
Eligibility Criteria
Inclusion
- The eligible population includes patients less than 80 years of age enrolled in primary care clinics at the study sites that meet the following additional inclusion criteria:
- No active prescription for a thiazide diuretic (or a medication that combines a thiazide and another agent (e.g., hydrochlorothiazide and triamterene)
- Prior diagnosis of hypertension, as documented in VA outpatient administrative files
- Two or more visits to a primary care clinic in the prior 12 months;
- Blood pressure above treatment goal at the two most recent VA outpatient clinic visits Above goal is defined as a systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg. For diabetics above goal is defined as systolic pressure \>130 mmHg or diastolic pressure \>80 mmHg
- Blood pressure at goal (as defined above) during one of the last two outpatient clinic visits, but the patient is receiving a prescription for a calcium channel blocker (CCB)
Exclusion
- Patients meeting the above inclusion criteria will be excluded for the following reasons:
- Documented allergy to thiazides or to sulfa agents
- Previously documented intolerance or adverse drug reaction to thiazide diuretics
- Active prescription for a loop diuretic agent (e.g. furosemide)
- Renal insufficiency, defined by a glomerular filtration rate less than 30 ml/min
- No serum creatinine in the past year (to permit calculation of a creatinine clearance)
- Prior history of hypokalemia or serum potassium less than 3.5 meq/l in the prior year
- Diagnosis of gout or active prescription for allopurinol
- Congestive heart failure (CHF) due to systolic dysfunction with a documented left ventricular ejection fraction \< 35% by echocardiography, nuclear medicine study, or ventriculography
- Residence in a long-term care facility
- No telephone for follow-up calls
- Life-expectancy \< 6 months
- Inability to give informed consent or impaired cognitive function (defined as \> 4 errors on the 10-item Pfeiffer Portable Mental Status Questionnaire82, administered during study intake)
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT00265538
Start Date
July 1 2006
End Date
August 1 2009
Last Update
March 20 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
VA Medical Center, Iowa City
Iowa City, Iowa, United States, 52246-2208
2
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417