Home Blood Pressure Telemonitoring and Case Management to Control Hypertension

Not Applicable

Completed

Conditions: Hypertension

Interventions: Other: Telemonitors and pharmacy management

Registration Number: NCT00781365

Lead Sponsor: HealthPartners Institute

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 450

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitors and pharmacy management	Telemonitors and pharmacy management	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.

Primary Outcome Measures

Name	Time	Method
Blood Pressure Control	Baseline, 6 months, 12 months, 18 months	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)
Mean Systolic Blood Pressure	Baseline, 6 months, 12 months, 18 months, 54 months	Systolic blood pressure at baseline and 4 time points
Mean Diastolic Blood Pressure	Baseline, 6 months, 12 months, 18 months, 54 months	Mean diastolic blood pressure at baseline and 4 time points