A Pharmacist-Led, American Heart Association Heart360 Web-Enabled Home Blood

Pressure Monitoring Program

David J. Magid, Kari L. Olson, Sarah J. Billups, Nicole M. Wagner, Ella E. Lyons and

Beverly A. Kroner

Circ Cardiovasc Qual Outcomes published online March 5, 2013;

DOI: 10.1161/CIRCOUTCOMES.112.968172

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Original Article

A Pharmacist-Led, American Heart Association Heart360

Web-Enabled Home Blood Pressure Monitoring Program

David J. Magid, MD, MPH; Kari L. Olson, BSc(Pharm), PharmD; Sarah J. Billups, PharmD; Nicole

M. Wagner, MPH; Ella E. Lyons, MS; Beverly A. Kroner, PharmD

Background—To determine whether a pharmacist-led, Heart360-enabled, home blood pressure monitoring (HBPM) intervention

improves blood pressure (BP) control compared with usual care (UC).

Methods and Results—This randomized, controlled trial was conducted in 10 Kaiser Permanente Colorado clinics. Overall, 348

patients with BP above recommended levels were randomized to the HBPM (n=175) or UC (n=173) groups. There were no

statistically significant differences in baseline characteristics between the groups; however, there was a trend toward a higher

baseline BP for the HBPM group compared with the UC group (148.8 versus 145.5 mm Hg for systolic BP; 89.6 versus 88.0

mm Hg for diastolic BP). At 6 months, the proportion of patients achieving BP goal was significantly higher in the HBPM group

(54.1%) than in the UC group (35.4%; P<0.001). Compared with the UC group, the HBPM group experienced a −12.4-mm Hg

larger (95% confidence interval, −16.3 to −8.6) reduction in systolic BP and a −5.7-mm Hg larger (95% confidence interval,

−7.8 to −3.6) reduction in diastolic BP. The impact of the intervention on BP reduction was even larger for the subgroup of

patients with diabetes mellitus or chronic kidney disease. The HBPM group had more e-mail and telephone contacts and

greater medication regimen intensification. The proportion of patients reporting high satisfaction with hypertension care was

significantly greater in the HBPM group (58%) than in the UC group (42%), P<0.001.

Conclusions—A pharmacist-led, Heart360-supported, home BP monitoring intervention led to greater BP reductions, superior

BP control, and higher patient satisfaction than UC.

Clinical Trials Registration—URL: http://www.clinicaltrials.gov/ct2/show/NCT01162759. Unique identifier: NCT01162759.

(Circ Cardiovasc Qual Outcomes. 2013;6:0-0.)

Key Words: blood pressure ◼ home blood pressure monitoring ◼ hypertension ◼ randomized controlled trials

◼ treatment effectiveness

espite well-established evidence-based medication and

Additionally, previous studies required healthcare providers

behavioral therapies to treat hypertension, major gaps

to reach out to patients at regular intervals, to manually obtain

in blood pressure (BP) control remain.^1-3 Of the 76 million

the home BP readings of the patients, and to manually calcu-

US adults with hypertension, more than half have uncon-

late the averages before determining which patients required

trolled BP.¹ Uncontrolled hypertension is associated with an

further intervention. For HBPM and interventions to be suc-

increased risk of acute myocardial infarction, stroke, kidney

cessful at a population level, innovative methods to streamline

failure, and congestive heart failure.¹ Lowering BP to recom-

data into user-friendly reports that allow providers to focus

mended levels has been shown to reduce the occurrence of

care delivery will be important.

these events.⁴

The objective of this pragmatic, randomized, controlled

To improve BP treatment and control rates, home BP moni-

trial was to evaluate the effectiveness of a pharmacist-led,

toring (HBPM) has been suggested as an adjunct to traditional

American Heart Association Heart360 Web-enabled HBPM

outpatient hypertension care.^5-12 Previous studies involving

intervention compared with usual care

(UC) for patients

pharmacist- or nurse-led HBPM programs have demonstrated

with uncontrolled hypertension. The HBPM intervention,

improvements in BP control.^6,8,13,14 However, the applicabil-

which was delivered by regular clinical staff, used a simple

ity of these interventions to routine practice may be limited

HBPM protocol, did not require patients to make office

by reliance on complex HBPM protocols, a requirement for

visits, included high-risk patients with DM and CKD, and

patients to make prescribed office visits in addition to HBPM,

used Heart360 (www.heart360.org), a widely available and

the exclusion of high-risk patients such as those with diabetes

free Web-enabled software for HBPM. We hypothesized

mellitus (DM) or chronic kidney disease (CKD), or the use

that patients randomized to the HBPM group would achieve

of expensive, proprietary software to support telemonitoring.¹⁵

greater BP control than patients randomized to UC.

Received July 23, 2012; accepted December 31, 2012.

From the Kaiser Permanente Colorado, Denver (D.J.M., K.L.O., S.J.B., N.M.W., E.E.L., B.A.K.); University of Colorado-Denver, Denver (D.J.M.); and

University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora (K.L.O., S.J.B.,.B.A.K.).

The online-only Data Supplement is available at http://circoutcomes.ahajournals.org/lookup/suppl/doi: 10.1161/CIRCOUTCOMES.112.968172/-/DC1.

Correspondence to David Magid, 10065 E Harvard Ave, Ste 300, Denver, CO 80231. E-mail david.j.magid@kp.org

Circ Cardiovasc Qual Outcomes is available at http://circoutcomes.ahajournals.org

DOI: 10.1161/CIRCOUTCOMES.112.968172

Downloaded from circoutcomes.ahajo

rnals.org by guest on March 20, 2013

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

because aggressive BP reduction may not be appropriate for these

•

However, the applicability of previous studies to rou-

patients; (3) had a recent myocardial infarction, stroke, percutane-

tine practice may be limited by the exclusion of patients

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;

or (5) did not speak English. Patients were also excluded if they did

WHAT THE STUDY ADDS

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

mailed an invitation letter containing a description of the study along

subset of patients with diabetes mellitus or chronic

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-

line visit.

Study Design and Setting

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.¹⁶ After the patient sat for at least 5 minutes, the nurse took

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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Magid et al

Pharmacist-Led, Heart360 Home BP Program

patients, made medication adjustments as needed, and communicated

For patients who purchased their medications from a KPCO phar-

with patients via telephone or secure e-mail. Any medication chang-

macy, medication adherence was calculated from a medication pos-

es were communicated to the primary care physician of the patient

session ratio based on the total number of days supplied for each

through the EHR. Patients who neglected to upload their BP read-

filled antihypertensive medication, less the supply that would extend

ings as instructed received up to 3 reminder phone calls through an

beyond the end of the 6-month study period, divided by the period for

automated interactive voice response system. If a patient still failed to

which the medication was prescribed. For patients on multiple anti-

upload readings, he or she received a call from a clinic staff member.

hypertensive medications during this time, adherence to each medica-

tion was averaged to derive a summary adherence measure.

Six-Month Visit

Patients in both groups returned for a clinic visit at 6 months, at

Sample Size

which time they had their BP taken by a research assistant blinded

This study was designed to enroll up to 200 patients per group al-

to study group assignment using the same standardized protocol that

located equally to the HBPM and UC groups. Assuming a 15% drop-

was used at the baseline visit. In addition, all patients were asked to

out rate and a control rate of 30% in the UC group, this sample size

rate their overall satisfaction with their hypertension care and the de-

provided 80% power to detect a 14% difference in BP control rate in

gree to which they were engaged in their hypertension care during the

the HBPM group compared with the UC group.

6-month study period. Patients in the HBPM group were also asked

about how easy it was to measure their BP at home and how easy it

was to upload their BPs to Heart360 and to rate their interactions with

Statistical Analysis

the clinical pharmacy specialist.

All statistical analyses were performed on an intention-to-treat ba-

sis with SAS version 9.1 software (SAS, Cary, NC). In the primary

analyses, all patients randomized at baseline were included. Baseline

Outcome Measures

characteristics were reported as means, medians, and SDs for in-

The primary outcome was the proportion of patients who attained

terval- and ratio-level variables (eg, age) and proportions for nomi-

their goal BP at the 6-month clinic visit. BP goals were <140/90

nal- and ordinal-level data (eg, sex, comorbidities). Interval-level

mm Hg for all patients except those with DM and CKD, whose

outcome variables were assessed for normality of their distributions,

goal was <130/80 mm Hg.¹⁶ Secondary outcomes included change

and appropriate tests were used to assess differences in mean values

in SBP and DBP between the baseline and 6-month clinic visits,

between groups (eg, t test, rank-sum test). To assess differences in

change in antihypertensive medication intensity, and antihypertensive

proportions between groups on categorical variables, the Pearson χ²

medication adherence. Medication intensity was measured by

test of association was used.

comparing the proportion of patients in each group with at least 1

There were 22 people who did not complete the 6-month follow-up

antihypertensive medication added between the baseline and the

visit and were missing BP outcomes for this study. Two methods were

6-month visit and the proportion with at least 1 dose increase for an

used to include all persons randomized at baseline in these analyses.

antihypertensive medication that they were taking at baseline. Medical

For analyses of BP change, we estimated generalized linear models

service used, including all hospitalizations, emergency department

with a separate record for each time period: baseline and 6-month

visits, clinic visits, telephone encounters, and e-mail encounters, was

follow-up. Individuals missing outcome data at 6 months (n=22) have

assessed via chart review. Patients in the HBPM group were asked

only a baseline record in this model, whereas all others contributed

to measure their home BP at least 3 times per week and to upload

2 records. The intervention effect was estimated via an interaction

readings weekly. Patients were considered to be adherent to the BP

with time, assuming an unstructured covariance matrix and clustering

monitoring protocol if they measured and uploaded home BP readings

within clinic estimated as a random effect. To help account for po-

for ≥80% of the weeks during the study intervention. The mean and

tential differences in individuals missing 6-month follow-up data, the

median number of BP measurements per upload were also recorded.

models included covariates for age, sex, race, number of medications,

Figure 1. Patient flow diagram. BP indicates

blood pressure; and HBPM, home blood pressure

monitoring.

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Circ Cardiovasc Qual Outcomes

March 2013

and in the full cohort model, an indicator for DM/CKD. For analy-

relatively low in this study (6.3%), and the results were comparable

ses of BP control, similar models could not be estimated because at

in complete case analyses.

baseline all study subjects were not in control. We instead used mul-

tiple imputations to estimate BP control for the 22 people missing this

outcome. Imputation models included the covariates listed above and

Results

variables for baseline SBP and DBP. Missing data were monotonic,

Figure 1 shows the flow of patients through the initial screen-

and we used the logistic option of Proc MI (SAS 9.2) to produce 10

ing, baseline visit, randomization, and

6-month follow-up

imputations. BP control was analyzed through the use of binomial

phases of the study. Of 348 patients enrolled in the study, 326

models and generalized estimating equation methods to account for

(94%) completed the 6-month visit (162 in the HBPM group;

repeated subjects per clinic. We completed models for each imputed

164 in the UC group). The median time to follow-up was 182

data set and combined results with Proc MIanalyze. Adjusted BP con-

days for both groups. There were no significant differences

trol outcome models controlled for age, sex, race, baseline BP, and in

in the demographic and clinical characteristics of those who

the full cohort model, an indicator for DM/CKD. Missing data were

completed the 6-month visit and those who did not.

The study population had a mean age of 60 years; 40%

Table 1. Baseline Characteristics of the Study Population

were female and 83% were white. Nearly half of these

Home Blood

patients (49%) had DM and CKD. There were no statisti-

Usual Care

Pressure Monitoring

cally significant differences in baseline demographic and

Characteristics

(n=173)

(n=175)

clinical characteristics of the HBPM and the UC patients

Mean age (SD), y

59.1

(10.9)

60.0

(11.3)

(Table 1). However, there was a trend toward a higher mean

Male, n (%)

102 (59.0)

108 (61.7)

baseline BP for the HBPM group compared with the UC

Race, n (%)

group (148.8 versus 145.5 mm Hg for SBP; 89.6 versus 88.0

mm Hg for DBP).

White

146 (84.4)

143 (81.7)

After 6 months, the mean BPs were significantly lower in

Black

14 (8.1)

15 (8.6)

the HBPM group than in the UC group (128.1 versus 137.4

Asian

1 (0.6)

5 (2.9)

mm Hg, P<0.001 for SBP; 79.1 versus 83.1 mm Hg, P<0.01

Other

12 (6.9)

for DBP). The proportion of patients achieving BP goal at 6

Ethnicity, n (%)

months was significantly higher in the HBPM group (54.1%)

Hispanic

10 (5.8)

16 (9.1)

than in the UC group (35.4% adjusted risk ratio, 1.5; 95%

Current smoking, n (%)

13 (7.5)

17 (9.7)

confidence interval [CI], 1.2-1.9; Figure 2). In the subset of

Diabetes mellitus or chronic kidney

88 (50.9)

81 (46.3)

patients with DM and CKD, the proportion of patients achiev-

disease, n (%)

ing BP goal was also higher in the HBPM group (51.7% versus

Systolic blood pressure, mean

145.5

(14.5)

148.8

(16.2)

21.9%; adjusted risk ratio, 2.5; 95% CI, 1.6-3.8; Figure 2).

(SD), mm Hg

Average SBP and DBP decreased significantly in both

Diastolic blood pressure, mean

88.0

(9.9)

89.6

(10.2)

groups over the study period (Figure 3). Compared with

(SD), mm Hg

the UC group, the HBPM group experienced a 12.4-mm Hg

No medication, n (%)

19 (11.0)

24 (13.7)

larger drop in SBP (95% CI, −16.3 to −8.6) and a 5.7-mm Hg

Thiazide diuretic, n (%)

70 (40.5)

81 (46.3)

larger drop in DBP (95% CI, −7.8 to −3.6). The impact of the

intervention on BP lowering was even greater in the subset of

ACE inhibitor/ARB, n (%)

109 (63.0)

104 (59.4)

patients with DM and CKD. Within this cohort, the HBPM

β-Blocker, n (%)

53 (30.6)

43 (24.6)

group experienced a 15.4-mm Hg larger drop in SBP (95% CI,

Calcium channel blocker, n (%)

33 (19.1)

32 (18.3)

−21.0 to −9.8) and a 7.3-mm Hg larger drop in DBP (95% CI,

Other, n (%)

17 (9.8)

15 (8.6)

−10.4 to −4.1).

Medications, mean (SD), n

1.6

(0.8)

1.6

(0.7)

Of the 326 patients who completed the 6-month visit, more

Medication intensity score, mean

2.7

(1.9)

2.7

(1.8)

HBPM patients had an antihypertensive medication added to

(SD)

their regimen than UC patients (113 [70%] versus 41 [25%];

Clinic, n (%)

P<0.001; Table 2). Similarly, a greater number of HBPM

9 (5.2)

12 (6.9)

patients had the dose increased for an existing antihyperten-

11 (6.4)

9 (5.1)

sive medication (69 [43%] versus 20 [12%] in the UC group;

29 (16.8)

27 (15.4)

P<0.001). Overall, 120 of the 147 HBPM patients (82%)

using prescription antihypertensive medications and 115 of

27 (15.6)

24 (13.7)

the 158 UC patients (73%) purchased their antihypertensive

21 (12.1)

23 (13.1)

medications exclusively at KPCO pharmacies during the

1 (0.6)

12 (6.9)

study period. Among this group, there was no difference in

20 (11.6)

19 (10.9)

the mean medication possession ratio adherence score over

21 (12.1)

19 (10.9)

the 6-month study period (0.86 versus 0.87; P=0.93).

24 (13.9)

16 (9.1)

The proportion of patients at 6 months reporting that they

10 (5.8)

14 (8.0)

were very or completely satisfied with their hypertension

ACE indicates angiotensin-converting enzyme; and ARB, angiotensin receptor

care was significantly higher in the HBPM group (58%)

blocker.

than in the UC group (42%; P<0.001). More patients in

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Magid et al

Pharmacist-Led, Heart360 Home BP Program

Figure 2. Six-month rates and 95% confidence

intervals of blood pressure control for the home

blood pressure monitoring (HBPM) intervention and

the usual care groups. CKD indicates chronic kid-

ney disease; and DM, diabetes mellitus.

the HBPM group also reported paying increased attention

study intervention. The mean and median number of BP read-

to their BP (60% versus 40% in the UC group; P<0.001).

ings per upload were 7.3 (SD, 8.6) and 5 (25th-75th percen-

Finally, 68% of HBPM patients reported that the home BP

tile, 3-9), respectively.

cuff and Heart360 monitoring system were very or extremely

easy to use, and the majority of patients (52%) found their

interactions with the clinical pharmacy specialist to be very

Discussion

or extremely helpful.

This pragmatic clinical trial of a pharmacist-led, Heart360-

With regard to health care used, the mean number of out-

supported HBPM intervention led to higher rates of BP con-

patient clinic visits was similar for the HBPM and UC groups

trol and greater BP reductions than UC. The impact of the

(3.3 versus 3.1; P=0.16; Table 3). The total number of emer-

intervention on BP control and degree of BP lowering was

gency department visits (6 for HBPM and 9 for UC, P=0.44)

even greater among the subset of patients with DM and CKD.

and hospitalizations (5 for HBPM and 7 for UC P=0.57) did

Although the intervention required patients to regularly

not differ significantly between the 2 groups. However, com-

monitor home BP readings, to upload the readings into the

pared with the UC group, the HBPM group had a higher mean

Heart360 Web site, and to have regular contact with a clinical

number of e-mail encounters (6.0 versus 2.4; P<0.001) and

pharmacy specialist, most patients found the intervention easy

telephone encounters (5.3 versus 3.5; P=0.02).

to use, and HBPM patients reported higher satisfaction with

Overall, 113 of 162 HBPM patients (70%) were adherent

their hypertension care than those who received UC. Addi-

to the BP monitoring protocol, uploading their home BP read-

tionally, whereas there was no difference between groups in

ings for 80% or more of the weeks during the study interven-

clinic, emergency department, or hospital visits, patients in

tion. A total of 156 patients (96%) measured and uploaded

the HBPM group had more e-mail and telephone encounters

home BP readings for half or more of the weeks during the

than patients in the UC group.

Figure 3. Reduction in systolic and diastolic blood

pressures and 95% confidence intervals for the

home blood pressure monitoring (HBPM) interven-

tion and the usual care groups.

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Circ Cardiovasc Qual Outcomes

March 2013

Table 2. Medication Used at 6 Months

Home Blood Pressure

Characteristics

Usual Care (n=164)

Monitoring (n=162)

No medication, n (%)

15 (9.2)

6 (3.7)

0.05

Diuretic, n (%)

77 (47.0)

109 (67.3)

<0.001

ACE inhibitor/ARB, n (%)

109 (66.5)

123 (75.9)

0.06

β-Blocker, n (%)

55 (33.5)

54 (33.3)

0.97

Calcium channel blocker (%)

40 (24.4)

74 (45.7)

<0.001

Other, n (%)

11 (6.7)

16 (9.9)

0.30

Patients with ≥1 medications added, n (%)

41 (25)

113 (70)

<0.001

Patients with ≥1 medication dose increases, n (%)

20 (12)

69 (43)

<0.001

Change in medication intensity score from baseline to 6 mo, mean (SD)

0.15

(0.82)

1.35

(1.37)

<0.001

ACE indicates angiotensin-converting enzyme; and ARB, angiotensin receptor blocker.

This findings of the study are consistent with previous

antihypertensive medications, and to order laboratory tests

studies showing that pharmacist- or nurse-led HBPM inter-

to monitor for adverse effects. Second, the Heart360 Web

ventions can lead to higher rates of BP control and greater

application provided intervention patients with a simple and

BP reductions than UC.^6,8,13,14 Our study goes beyond previ-

efficient way to transmit BP measurements to their clinical

ous studies by demonstrating that improved BP control can be

pharmacy specialist while keeping patients engaged by pro-

achieved with a relatively simple home monitoring protocol

viding them with feedback on their progress toward attain-

and without requiring patients to make additional office visits.

ing BP control and easy-to-read educational information.

Previous studies have often relied on the use of expensive, pro-

Finally, the BP summary reports enabled clinical pharmacy

prietary software to support monitoring of BP measurements.

specialists to focus medication intensification efforts on

In contrast, our study used the freely available Heart360 Web

those individuals with elevated home BP readings, whereas

application for BP monitoring. An additional advancement

the remaining patients could view graphic representations of

was the use of BP summary reports that provided pharmacists

their controlled BP readings through the Heart360 Web appli-

with data on individual BP measurements and the average of

cation and required contact with the healthcare team only if

the home BP readings and categorized patients as either con-

their home BP readings increased above goal.

trolled or uncontrolled on the basis of their specific BP target

It was not possible for UC patients to access the Heart360

goal. The reports streamlined care and improved efficiency

Web application during the study period. However, because

because providers could focus their time on those patients

HBPM and UC subjects could be treated by the same pri-

with elevated home BP readings. Finally, the generalizabil-

mary care providers, it is possible that physicians caring for

ity of the study results is enhanced by the use of a pragmatic

UC patients may have been more aggressive than usual in

study design in which the intervention was delivered by regu-

addressing elevated BP. However, we would expect that the

lar clinical staff to a broadly representative patient population

impact of such contamination would be to bias the results

with uncontrolled hypertension that included participants with

toward the null, suggesting that, if anything, the benefits of the

DM and CKD, high-risk groups that have been excluded in

HBPM intervention maybe larger than what we have reported.

previous HBPM studies.⁸

Primary care physicians consulted pharmacists on the hyper-

We believe the success of the HBPM intervention can be

tension medication regimen for 22 of the UC patients (14%)

attributed to several factors. First, clinical pharmacy spe-

because this type of interaction is part of UC at KPCO. A

cialists are ideally suited to deliver the intervention because

chart review of these consultations demonstrates that in each

of their expertise in medication therapy management.

instance the pharmacist provided appropriate guideline-based

Collaborative drug therapy management protocols allow them

care that was similar to the recommendations that were made

to make necessary dose adjustments, to add or discontinue

for the patients in the HBPM group.

Table 3. Health Care Used

Home Blood Pressure

Characteristics

Usual Care (n=164), n (%)

Monitoring (n=162), n (%)

Clinic visits

3.1

(2.3)

3.3

(2.5)

0.16

ED visits

0.05

(0.23)

0.04

(0.19)

0.44

Hospitalizations

0.04

(0.20)

0.03

(0.17)

0.57

Telephone encounters

3.5

(3.8)

5.3

(4.5)

0.02

E-mail encounters

2.4

(3.2)

6.0

(5.5)

<0.01

ED indicates emergency department. Values are mean (SD).

Downloaded from circoutcomes.ahajournals.org by guest on March 20, 2013

Magid et al

Pharmacist-Led, Heart360 Home BP Program

We acknowledge several limitations. The study was con-

Physicians; American Association of Cardiovascular and Pulmonary Re-

habilitation; Preventive Cardiovascular Nurses Association. ACCF/AHA

ducted in a single healthcare system with an EHR and clinical

2009 performance measures for primary prevention of cardiovascular dis-

pharmacy specialists; therefore, the results may not be appli-

ease in adults: a report of the American College of Cardiology Foundation/

cable to all settings. To participate in the intervention, patients

American Heart Association Task Force on Performance Measures (Writ-

had to have access to a computer and the Internet, which may

ing Committee to Develop Performance Measures for Primary Prevention

of Cardiovascular Disease) developed in collaboration with the American

not be available to all patients with hypertension. Because

Academy of Family Physicians; American Association of Cardiovascu-

outcomes were assessed only at 6 months, the durability of

lar and Pulmonary Rehabilitation; and Preventive Cardiovascular Nurses

the intervention effects beyond this time frame is unknown.

Association: endorsed by the American College of Preventive Medicine,

American College of Sports Medicine, and Society for Women’s Health

Because patients ≥80 years of age were excluded, the general-

Research. J Am Coll Cardiol. 2009;54:1364-1405.

izability of the findings to this age group is unknown. Finally,

Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the

our ability to assess medication adherence was limited by the

prevention of cardiovascular disease: meta-analysis of 147 randomised tri-

relatively short 6-month time frame and the challenge in using

als in the context of expectations from prospective epidemiological stud-

ies. BMJ. 2009;338:b1665.

pharmacy refill data to assess adherence during periods when

Parati G, Omboni S, Albini F, Piantoni L, Giuliano A, Revera M, Illyes

changes to the antihypertensive medication regimen were

M, Mancia G; TeleBPCare Study Group. Home blood pressure telemoni-

frequent.

toring improves hypertension control in general practice: the TeleBPCare

study. J Hypertens. 2009;27:198-203.

Magid DJ, Ho PM, Olson KL, Brand DW, Welch LK, Snow KE, Lam-

Conclusion

bert-Kerzner AC, Plomondon ME, Havranek EP. A multimodal blood

A pharmacist-led, American Heart Association Heart360

pressure control intervention in 3 healthcare systems. Am J Manag Care.

2011;17:e96-e103.

Web-enabled home BP intervention led to higher rates of BP

Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V,

control and larger BP reductions than UC for patients with

Gentry PW, Rose C, Van Houtven C, Wang V, Goldstein MK, Oddone

uncontrolled hypertension. Patients enrolled in the interven-

EZ. Home blood pressure management and improved blood pressure

tion also reported significantly greater satisfaction with their

control: results from a randomized controlled trial. Arch Intern Med.

2011;171:1173-1180.

hypertension care than patients receiving UC. Future research

Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell

should focus on translating the intervention to other settings

D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pres-

and patient populations and to assessing the sustainability and

sure monitoring, Web communication, and pharmacist care on hyperten-

cost-effectiveness.

sion control: a randomized controlled trial. JAMA. 2008;299:2857-2867.

Agarwal R, Bills JE, Hecht TJ, Light RP. Role of home blood pressure

monitoring in overcoming therapeutic inertia and improving hyperten-

Acknowledgments

sion control: a systematic review and meta-analysis. Hypertension.

We would like to thank Heather Nuanes and Susan Shetterly for their

2011;57:29-38.

contributions to the conduct of this study. We would also like to thank

10.

Rinfret S, Lussier MT, Peirce A, Duhamel F, Cossette S, Lalonde L,

the primary care clinical pharmacy specialists for their hard work,

Tremblay C, Guertin MC, LeLorier J, Turgeon J, Hamet P; LOYAL Study

Investigators. The impact of a multidisciplinary information technology-

clinical expertise and support of this project.

supported program on blood pressure control in primary care. Circ Car-

diovasc Qual Outcomes. 2009;2:170-177.

Source of Funding

11.

Godwin M, Lam M, Birtwhistle R, Delva D, Seguin R, Casson I, Mac-

Donald S. A primary care pragmatic cluster randomized trial of the use of

The study was funded in part by the American Heart Association. The

home blood pressure monitoring on blood pressure levels in hypertensive

content is solely the responsibility of the authors and does not neces-

patients with above target blood pressure. Fam Pract. 2010;27:135-142.

sarily represent the official views of the American Heart Association.

12.

Pickering TG, Miller NH, Ogedegbe G, Krakoff LR, Artinian NT, Goff

D; American Heart Association; American Society of Hypertension; Pre-

Disclosures

ventive Cardiovascular Nurses Association. Call to action on use and re-

imbursement for home blood pressure monitoring: executive summary: a

None.

joint scientific statement from the American Heart Association, American

Society of Hypertension, and Preventive Cardiovascular Nurses Associa-

tion. Hypertension. 2008;52:1-9.

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