The purpose of this research study is to see if providing patients with additional information regarding their blood pressure medications improves the management of their high blood pressure. We are also interested in how incentives to patients might influence their interactions with their doctors and improve blood pressure care.

Condition	Intervention
Hypertension	Behavior: Patient education and activation to engage provider in blood pressure treatment discussion.  Behavior: Addition of financial incentive and health educator phone call to strenghten the intervention.

Further study details as provided by Department of Veterans Affairs:

Primary Outcomes: 1) the percent of patients taking thiazide diuretics at their index visit and at 6 and 12 months; 2) the percent of patients at blood pressure treatment goal at 6 and 12 months; and 3) mean blood pressure at 6 and 12 months
Secondary Outcomes: 1) the percent of patients who initiated discussions with their providers about thiazides at the index visit; 2) cost and number of anti-hypertensive medications; 3) adverse drug events; 4) hypertension medication compliance; 5) outpatient laboratory
Expected Total Enrollment:  900

This project aims to test the efficacy of a patient-centered, "patient activation" intervention to increase the use of thiazide diuretics and improve the quality of hypertension management. The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7) and the VA/DoD have developed evidence-based guidelines, but the proportion of patients at their blood pressure goal and on guideline-concordant therapy remain suboptimal. The recent Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT) and previous studies support the use of thiazide diuretics as first-line therapy for uncomplicated hypertension.

The research objectives of the study are to:

1. Determine the effect on thiazide diuretic use of providing primary care patients with individualized risk-related information, with or without a financial incentive and a follow-up health educator telephone call.
2. Determine the effect of the patient activation intervention on blood pressure control.
3. Determine the effects of differences in patient and provider attitudes toward the physician-patient interaction ("role orientation") on the effectiveness of the intervention.

This innovative intervention will incorporate a tailored patient education mailing to activate patients to initiate a discussion of the use of thiazides with their primary care provider. The study will also test the added impact of a financial incentive and a follow-up health-educator telephone call and will examine both patient and provider characteristics that may moderate the efficacy of the intervention. Our innovative approach engages patients to act as agents of change in modifying provider behavior.

Research Design: This 3-year randomized controlled trial will be conducted at 2 VAMCs and 4 affiliated community-based outpatient clinics (CBOCs) in VISN 23. The study will enroll 900 randomly selected primary care patients with hypertension not currently taking a thiazide diuretic and either: i) Not at an appropriate treatment goal (140/90 or 130/80); or ii) At goal blood pressure, but taking a calcium channel blocker. Randomization will occur at both the provider and patient level. Control providers will have no patients enrolled in an intervention arm. Intervention providers will have patients enrolled into a control group and three intervention arms: i) mailed, customized patient-specific educational letter providing cardiovascular risk assessment based on the Framingham Heart Study, ii) the same education letter with a financial incentive if they initiate a discussion with their provider about the use of thiazides, and iii) the same educational letter and financial incentive, with a health-educator telephone call.

Significance: Based upon known clinical trial evidence, getting patients to their blood pressure goal and on thiazide diuretics will lead to improved cardiovascular outcomes. There are also potential financial savings to VA by having patients on the least costly anti-hypertensive agents. This study will complement other VA initiatives to implement evidence-based care focused at the provider and system levels. If the intervention is effective in improving hypertension management, it could be applied to other chronic diseases, such as congestive heart failure and diabetes. Finally, by understanding the modifying effect of patient and provider role-orientation, future interventions may be better tailored to the provider and patient.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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:

1. No active prescription for a thiazide diuretic (or a medication that combines a thiazide and another agent (e.g., hydrochlorothiazide and triamterene);
2. Prior diagnosis of hypertension, as documented in VA outpatient administrative files;
3. Two or more visits to a primary care clinic in the prior 12 months;
4. Blood pressure above treatment goal at the two most recent VA outpatient clinic visits Above goal is defined as a systolic pressure greater than 140 mmHg or diastolic pressure greater than 90 mmHg. For diabetics above goal is defined as systolic pressure greater than 130 mmHg or diastolic pressure greater than 80 mmHg
5. 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 Criteria:

Patients meeting the above inclusion criteria will be excluded for the following reasons:

1. Documented allergy to thiazides or to sulfa agents;
2. Previously documented intolerance or adverse drug reaction to thiazide diuretics;
3. Active prescription for a loop diuretic agent (e.g. furosemide);
4. Renal insufficiency, defined by a glomerular filtration rate less than 30 ml/min;
5. No serum creatinine in the past year (to permit calculation of a creatinine clearance);
6. Prior history of hypokalemia or serum potassium less than 3.5 meq/l in the prior year;
7. Diagnosis of gout or active prescription for allopurinol;
8. Congestive heart failure (CHF) due to systolic dysfunction with a documented left ventricular ejection fraction less than 35% by echocardiography, nuclear medicine study, or ventriculography;
9. Residence in a long-term care facility;
10. No telephone for follow-up calls
11. Life-expectancy less than 6 months; or
12. Inability to give informed consent or impaired cognitive function (defined as greater than 4 errors on the 10-item Pfeiffer Portable Mental Status Questionnaire82, administered during study intake).

Please refer to this study by ClinicalTrials.gov identifier  NCT00265538

Michael S Henderson, MA BA       michael-henderson@uiowa.edu

Iowa
      VA Medical Center, Iowa City, Iowa City,  Iowa,  52246-2208,  United States

Study chairs or principal investigators

Peter J. Kaboli, MD MS,  Principal Investigator,  VA Medical Center, Iowa City   

Study ID Numbers:  IMV 04-066
Last Updated:  December 13, 2005
Record first received:  December 12, 2005
ClinicalTrials.gov Identifier:  NCT00265538
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10