Page 3 CirculationCardiovascularQualityandOutcomes

2 Circ Cardiovasc Qual Outcomes March 2013

for those with DM or CKD, SBP ≥130 mm Hg or DBP ≥80 mm Hg);
(2) were prescribed ≤3 antihypertensive medications; (3) had a primary
WHAT IS KNOWN care provider who worked at 1 of the 10 participating clinics; and (4)
were registered on the KPCO My Chart Web site (which suggested that
• Previous studies involving pharmacist- or nurse-led they had access to a computer and the Internet).
home blood pressure (BP) monitoring programs have Patients were excluded if they (1) had a limited life expectancy
demonstrated improvements in BP control. (eg, patients in hospice or palliative care); (2) were ≥80 years of age
• However, the applicability of previous studies to rou- because aggressive BP reduction may not be appropriate for these
tine practice may be limited by the exclusion of patients patients; (3) had a recent myocardial infarction, stroke, percutane-
ous coronary intervention, or coronary artery bypass graft surgery
with diabetes mellitus or chronic kidney disease, com- because KPCO patients receive enhanced hypertension care as part
plex monitoring protocols, or the use of expensive, of intensive cardiac rehabilitation in the year after the event; (4) had
proprietary software to support telemonitoring. end-stage renal disease because hypertension care for these patients is
provided by nephrology specialists instead of primary care providers;
WHAT THE STUDY ADDS or (5) did not speak English. Patients were also excluded if they did
not have access to the Internet and a computer with a USB port and
• This pragmatic, randomized, controlled trial found Internet Explorer 6.0 or higher, if their BP measured at the baseline
that a pharmacist-led, Heart360-supported, home BP enrollment visit (described below) was already at goal, or if the home
monitoring intervention delivered by regular clinical BP cuff could not be validated (eg, the home BP reading was not
staff to a broadly representative patient population within 5 mm Hg of the baseline BP).
led to greater BP reductions, superior BP control, and
higher patient satisfaction than usual care. Recruitment and Enrollment
• The impact of the intervention on BP control and Potentially eligible patients were identified by screening BP mea-
degree of BP lowering was even greater among the surements and other clinical data recorded in the EHR. Patients were
subset of patients with diabetes mellitus or chronic mailed an invitation letter containing a description of the study along
with an opt-out postcard. Patients who did not return the opt-out post-
kidney disease. card were contacted by telephone by research staff to describe the
• The proportions of patients with a dose increase for an study and to determine eligibility. Patients who expressed interest in
antihypertensive medication or the addition of at least 1 participating in the study were invited to a baseline clinic visit.
antihypertensive medication were greater for the home Eligible patients were randomly allocated to the HBPM or UC
BP monitoring group than for the usual care group. groups. A random allocation sequence was computer generated us-
ing stratified randomization with an allocation ratio of 1:1. We used
commercially available statistical software (SAS RANUNI function;
SAS Institute Inc, Cary, NC) to generate the assignment list for each
Methods stratum. The sequence was concealed from the patient until the base-
Study Design and Setting line visit.
Baseline study visits were conducted between October 2008 and
This was a pragmatic, randomized, controlled trial comparing HBPM December 2009. At these visits, patients provided written informed
intervention with UC for patients with diagnosed hypertension consent and had their BP taken by a clinic nurse using a standardized
whose BP was higher than recommended levels. The American Heart protocol. After the patient sat for at least 5 minutes, the nurse took
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Association Heart360 Web application (www.heart360.org) was used the BP of the patient 3 times 2 minutes apart using an electronic BP
by patients in the HBPM group to transmit their home BP measure- cuff (VSM MedTech BPM-100 Professional Blood Pressure Monitor:
ments to study staff. Heart360 is a free Web application for managing A/A grade from the British Hypertension Society). Patients whose
cardiovascular risk. With Heart360, patients can enter and store their mean BP was above their goal were eligible for study participation.
BP readings (and other cardiovascular risk factor data), track progress
toward attaining risk factor control, and receive educational informa-
tion on cardiovascular risk. Heart360.org enables users to automati- UC and HBPM Intervention
cally upload data stored on home BP machines that have a USB port. Patients assigned to the UC group were advised that their BP was
The study was conducted at Kaiser Permanente Colorado (KPCO), elevated; received written educational materials on managing high
a group-model, closed-panel, nonprofit managed care organization BP, diet, and physical activity; and were instructed to follow up with
that cares for >500 000 members in the Denver-Boulder metropoli- their primary care physician. In addition, the patient's physician was
tan area. Outpatient medical services are provided at 18 primary notified of the patient's elevated BP via a note sent to the EHR in-box
care clinics spread geographically across the metropolitan area. This of the physicians.
study was conducted at 10 of these primary care clinics. Each clinic is In addition to receiving the same educational materials as the UC
staffed with ≥1 clinical pharmacy specialists who assist primary care group, patients assigned to the HBPM intervention group were pro-
providers with drug therapy management. With regard to hypertension vided a properly fitted home BP cuff (Omron HEM-790IT) and were
management, clinical pharmacy specialists work under preapproved trained on how to use it. Patients were assisted in establishing an ac-
collaborative drug therapy management protocols that permit them to count at the Heart360 Web site and were shown how to automatically
initiate or change antihypertensive medications, to adjust medication upload BPs stored on their home BP device into their Heart360 ac-
doses, and to order laboratory tests related to medication monitoring. count. Patients in the HBPM group also met with a clinical phar-
KPCO clinicians use a commercially available EpicCare electronic macy specialist who reviewed their current BP medication regimen,
health record (EHR) as part of routine care delivery. The KPCO EHR provided counseling on lifestyle changes, and adjusted or changed
has a feature called My Chart that allows patients and their providers antihypertensive medications as needed.
to communicate through a password-protected Web site. The study Patients were asked to measure their BP at least 3 times per week
was approved by the KPCO Institutional Review Board. and to upload their BPs to their Heart360 account weekly. From the
Heart360 account, BPs were automatically uploaded nightly to KPCO
and organized into BP summary reports that were viewed by the clini-
Patient Population cal pharmacy specialists managing their care. The reports summa-
Adults 18 to 79 years of age were eligible if they (1) had a diagnosis of rized weekly BP averages and flagged patients with averages above
hypertension and their 2 most recent clinic BP readings were above goal their goal. The clinical pharmacy specialist reviewed the home BP
(systolic BP [SBP] ≥140 mm Hg or diastolic BP [DBP] ≥90 mm Hg or, measurements and adherence to antihypertensive medications of the

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