Home Blood Pressure Telemonitoring and Case Management to Control Hypertension

Study Overview
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Brief Summary
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In this project we develop and implement an intervention to improve hypertension control in a primary care setting that takes advantage of new technology (home blood pressure telemonitoring) and team models of care (pharmacist case management). The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.

Detailed Description
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Blood pressure (BP) is controlled to recommended levels in only 1 in 3 people with hypertension, and there has been little improvement since the late 1980s, despite advances in evidence to support aggressive hypertension control, and availability of many new and effective antihypertensive drugs. It is clear that meaningful and sustained improvement in hypertension control will likely require fundamental changes in the current physician-centered office-visit based model of caring for hypertension. In this project we develop and implement an intervention that takes advantage of new technology and team models of care to improve BP measurement and control, solving the problems that have limited the application of case management approaches to hypertension care improvement. The study will take place in a diverse population of adults with hypertension cared for in a real-world primary care setting. The Telemonitoring Intervention (TI) integrates 2 innovative components: First, home BP measures are done using state-of-the-art modem-enabled automated equipment that internally stores and electronically transmits BP data through a simple touch-tone telephone connection to a secure web site. Second, a pharmacist case manager integrated with the primary care team through a jointly used electronic medical record (EMR) and formulary adjusts antihypertensive therapy using an approved written protocol, under a collaborative practice agreement with physicians. Treatment decisions are based on home BP data and are discussed and communicated to patients in telephone visits with the pharmacist case manager. Two-way communication between the pharmacist case manager and the patient's primary care team is assured by using a shared EMR and by additional secure messaging of the results of every pharmacist encounter to the primary care team. To assess the impact of the TI on hypertension control, patient satisfaction, and costs of care, we will conduct a cluster-randomized trial, assigning 16 primary care clinics and 450 of their nested patients with uncontrolled hypertension to either a Usual Care (UC) control group or TI. Blood pressure outcomes in both groups will be determined at baseline, 6, 12, 18 and 54 months in an identical and blinded fashion in a research clinic separate from the clinical setting where patients received their medical care. We hypothesize that guideline BP control will be achieved at 6 months and maintained at 12 months in more than 60% of patients from TI clinics, compared to < 40% in patients from UC clinics. We will compare satisfaction with care and costs in the TI and UC groups. The TI has the potential to improve hypertension control for millions of patients, and could be implemented widely in diverse and large patient populations based on performance in this randomized trial. The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.

Official Title
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Home Blood Pressure Telemonitoring and Case Management to Control Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Other: Telemonitors and pharmacy management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 years or more Linked using EMR data to a HealthPartners Medical Group primary care clinic Within the 12-month period of time prior to screening have had at least 2 primary care outpatient encounters, in the two most recent of which the blood pressure was above Joint National Committee 7 (JNC7) goal (<140/90 mmHg or <130/80 for patients with diabetes or kidney disease). Have a measured blood pressure at a research clinic screening visit above the JNC7 goal Exclusion Criteria: Acute coronary syndrome or stroke within the past 3 months Class III (marked limitation of physical activity) or IV (symptoms at rest) New York Heart Association heart failure, or known left ventricular ejection fraction (<30%) Severe renal dysfunction, with epidermal growth factor receptor (eGFR) ,30 ml/min/1.73 m2 using the abbreviated Modification of Diet in Renal Disease Study (MDRD) equation Known secondary causes of hypertension such as coarctation of the aorta, pheochromocytoma, adrenal cortical hypertension or renal vascular hypertension Unwillingness to be followed for a period of 18 months Pregnancy or unwillingness to use reliable bith control for females of child-bearing age Participation in another clinical trial Requires an interpreter to communicate with health care providers Dementia, mental illness or any condition that would limit ability to give informed consent

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics. | |
| Experimental: Telemonitors and pharmacy management<br>The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments. | Other: Telemonitors and pharmacy management<br>* Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Control | Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes) | Baseline, 6 months, 12 months, 18 months | 
| Mean Systolic Blood Pressure | Systolic blood pressure at baseline and 4 time points | Baseline, 6 months, 12 months, 18 months, 54 months | 
| Mean Diastolic Blood Pressure | Mean diastolic blood pressure at baseline and 4 time points | Baseline, 6 months, 12 months, 18 months, 54 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Telemonitoring, Pharmacy management