Implementing Evidence Based Treatment of Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

834 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-08-31

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.

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 (Pure Control Group)

Pure control (no intervention letter);

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2 (Contaminated Control Group)

Intervention control (patient does not receive intervention letter, but provider sees other patients who may bring in letter);

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 3 (Intervention Group A)

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.

Group Type EXPERIMENTAL

Patient educational letter to engage provider in hypertension rx discussion

Intervention Type BEHAVIORAL

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.

Arm 4 (Intervention Group B)

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.

Group Type EXPERIMENTAL

Patient educational letter to engage provider in hypertension rx discussion

Intervention Type BEHAVIORAL

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.

Arm 5 (Intervention Group C)

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.

Group Type EXPERIMENTAL

Patient educational letter to engage provider in hypertension rx discussion

Intervention Type BEHAVIORAL

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.

Financial incentive (Arms B and C) and health educator phone call (Arm C)

Intervention Type BEHAVIORAL

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.

Interventions

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Patient educational letter to engage provider in hypertension rx discussion

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.

Intervention Type BEHAVIORAL

Financial incentive (Arms B and C) and health educator phone call (Arm C)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No