Implementing Evidence Based Treatment of Hypertension

Study Overview
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Brief Summary
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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 initiate discussions with providers including information only, information plus a financial incentive and reimbursement for 6 months of copay, and information/monetary incentive plus a reminder call prior to the index visit. Patient opinions about doctor/patient relationships will be assessed. Provider attitudes and prescribing behaviors will be analyzed as well.

Detailed Description
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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 about diuretics and their providers will not see any patients who receive our study intervention letter. Patients in the intervention control group will not receive the intervention but will see providers who have other patients in the intervention groups. Patients in intervention group a will receive a customized letter prior to their next primary care appointment with information regarding the patient's specific blood pressure, current blood pressure medication and recommendation for switching or adding a thiazide. Patients in group b will receive the customized intervention letter as well as a financial incentive for discussing the information with their provider and a copay reimbursement for 6 months if a prescription is written for a thiazide. Patients in group c will receive the intervention letter, financial discussion incentive, copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care visit.

Official Title
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Implementing Evidence-based Treatment of Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Patient educational letter to engage provider in hypertension rx discussion
* Behavioral: Financial incentive (Arms B and C) and health educator phone call (Arm C)


Participation Criteria
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Eligibility Criteria
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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: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1 (Pure Control Group)<br>Pure control (no intervention letter); | |
| No Intervention: Arm 2 (Contaminated Control Group)<br>Intervention control (patient does not receive intervention letter, but provider sees other patients who may bring in letter); | |
| Experimental: Arm 3 (Intervention Group A)<br>Intervention group A (the intervention is a letter only mailed to the subject); This intervention group receives an educational letter, which is the intervention. It is an educational intervention only. | Behavioral: Patient educational letter to engage provider in hypertension rx discussion<br>* Patients will receive a customized/tailored letter (education) including most recent clinic blood pressure, current blood pressure medications and suggested htn medication(s). All the intervention arms (A, B and C) receive the letter.<br>|
| Experimental: Arm 4 (Intervention Group B)<br>Intervention group B (intervention letter A + financial incentive for discussion w/ provider and 6 month copay reimbursement); This group receives the same educational intervention as Group A, but also receives the Financial incentive, which is an added intervention. | Behavioral: Patient educational letter to engage provider in hypertension rx discussion<br>* Patients will receive a customized/tailored letter (education) including most recent clinic blood pressure, current blood pressure medications and suggested htn medication(s). All the intervention arms (A, B and C) receive the letter.<br>|
| Experimental: Arm 5 (Intervention Group C)<br>Intervention group C (intervention letter A, financial incentive for discussion w/ provider + copay reimbursement, PLUS reminder phone call 1-3 days prior to primary care visit). This group receives the same intervention as Group B, but with the added intervention of a reminder phone call to test whether additional prompting is needed to make the intervention more effective. | Behavioral: Patient educational letter to engage provider in hypertension rx discussion<br>* Patients will receive a customized/tailored letter (education) including most recent clinic blood pressure, current blood pressure medications and suggested htn medication(s). All the intervention arms (A, B and C) receive the letter.<br>Behavioral: Financial incentive (Arms B and C) and health educator phone call (Arm C)<br>* Patients may receive a financial incentive for discussing the intervention letter with their provider and 6 months copay reimbursement and/or the financial incentive discussion incentive, 6 months copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care appt. The Financial incentive is part of both Arms B and C. The health educator phone call is only in Arm C.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Taking Thiazide Diuretics and at BP Goal at Index Visit and 6 Months | Reported in 2 sub-groups: Subgroup 1 not at BP goal; Subgroup 2 at BP goal but taking a calcium channel blocker (see pre-specified sub group analysis below). | index visit and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Diuretics, Drug Therapy, Anti-Hypertensive Agents, Patient Intervention