shows the flow of participants through the study. Letters were mailed to 9298 patients with an ICD-9 diagnosis of hypertension. Of those answering the telephone survey questions, 78.2% (1574/7279) were “computer able” (based on the percent answering these questions). Of those who had a screening appointment and had their BP measured, 60.9% (1567/2573) had controlled hypertension, making them ineligible. Of the total sample contacted who remained eligible, 20.4% (778/3810) consented to participate. A total of 778 computer-able patients with uncontrolled essential hypertension were enrolled from 10 medical centers, of whom 730 (94%) completed the 12-month follow-up visit. Completion rates did not differ significantly by study group and were higher than the assumed 80% follow-up rate in the sample size determination.
Flow of e-BP Trial Patients Through Recruitment, Intervention, and Blinded Follow-up Assessments
Demographic characteristics of the study groups were comparable at baseline (P >.10), except for sex and already having a home BP monitor (). To account for these differences, we adjusted for these variables in the primary analyses. Overall, racial minorities were better represented than is typical for Group Health and the surrounding Puget Sound area. By definition, all patients had uncontrolled hypertension: 44.6% had elevated systolic BP only, 7.6% had elevated diastolic BP only, and 47.8% had combined systolic and diastolic BP elevation, with a group mean of 151.9 mm Hg systolic and 89.1 mm Hg diastolic BP. Baseline BPs were similar in all three groups. For the pre-specified subgroup with baseline systolic BP ≥160 mm Hg, mean systolic BP was 167.6 mm Hg and mean diastolic BP was 90.7 mm Hg at baseline.
Compared to patients receiving usual care (UC), the BP control (<140/90 mm Hg) of those receiving home BP monitoring, Web training, and encouragement to send BP numbers to their physician (BPM-Web) did not improve; however, they had a nonsignificant trend in that direction and a modest reduction in systolic BP (net change −2.9 mm Hg [95% CI −5.4 to −0.4], P =.02) (). The addition of Web-based pharmacy care (BPM-Web-Pharm) resulted in 25% more patients with controlled BP compared to UC and 20% more patients with controlled BP compared to BPM-Web (UC 31% [95% CI, 25% to 37%]; BPM-Web 36% [95% CI, 30% to 42%], P <.001; and BPM-Web-Pharm 56% [95% CI, 49% to 62%], P <.001). Adjusted analyses found a 1.8 times increase in BP control for BPM-Web-Pharm (RR 1.8 [95% CI, 1.5 to 2.3] P <.001) and a 1.2 times increase for BPM-Web (RR 1.2 [95% CI, 0.95 to1.6] P <.001) compared to UC. BPM-Web-Pharm resulted in greater reductions in systolic BP compared to UC (mean net change −8.9 mm Hg ([95% CI, −11.4 to −6.3] P <.001) and BPM-Web (mean net change −6.0 mm Hg [95% CI −8.5 to −3.5], P <.001). BPM-Web-Pharm also led to significant decreases to diastolic BP compared to UC (net change −3.5 mm Hg [95% CI −4.9 to −2.1] P <.001). For the subgroup with baseline systolic BP ≥160 mm Hg, BPM-Web-Pharm had 3.3 times more patients in BP control (RR 3.3 [95% CI, 1.9 to 5.9], P <.001), −13.2 mm Hg lower systolic BP (95% CI, −19.2 to −7.1, P <.001), and −4.6 mm Hg lower diastolic BP (95% CI, −8.0 to −1.2, P <.001) compared to UC.
Primary Outcomes at 12 Months for All Patients Completing Follow-up in e-BP Trial by Intervention Group, Then Stratified by Elevated Blood Pressure
At baseline, patients took a mean of 1.6 antihypertensive medication classes. At 12 months, there was a stepped increase in mean number of antihypertensive medications classes filled, with BPM-Web (1.9, SD 0.9) significantly greater than UC (1.7, SD 0.9) (P <.01) and BPM-Web-Pharm (2.2, SD 0.9) significantly greater than both UC (P <.001) and BPM-Web (P <.01) (). Aspirin use for BPM-Web-Pharm significantly increased by 1.3 times and 1.2 times compared to UC and BPM-Web, respectively (RR 1.3 [95% CI, 1.1 to 1.5]; 1.2 [95% CI, 1.1 to 1.4]). Aspirin use did not significantly change for BPM-Web compared to UC. BMI, physical activity, health-related quality of life, and satisfaction with the health plan did not differ among the three groups.
Secondary Outcomes at 12 Months for All Patients Completing Follow-up in e-BP Trial by Intervention Group
Secure Messages and Other Healthcare Utilization
In the 12 months after randomization, mean number of message threads (a secure message and subsequent responses) was higher in the BPM-Web-Pharm group (22.3, SD 10.2) than in the UC (2.4, SD 4.6) and BPM-Web (3.3 , SD 7.4) groups, because the pharmacists regularly initiated these threads. Patient-initiated threads increased significantly in the BPM-Web group compared to UC (P = .01) and in the BPM-Web-Pharm group compared to both UC (P <.01) and BPM-Web (P <.01) (mean number of patient initiated message threads: UC 1.8, SD 4.2; BPM-Web 2.7, SD 7.1; BPM-Web-Pharm 4.2, SD 6.0). At 12 months, with the one planned phone encounter excluded, phone encounters were also higher in the BPM-Web-Pharm (mean 7.5, SD 9.3) compared to the BPM-Web (3.8, SD 5.0) (P <.001) and UC groups (4.0, SD 4.8) (P <.001). Primary care visits did not differ between patients in the UC, BPM-Web, and BPM-Web-Pharm groups (with 3.2, 3.0, and 3.2 visits, respectively, over 12 months). There were also no significant differences among patients in any arm with respect to inpatient and urgent care/emergency use at 12 months. There was a modest but significant decrease in the percentage of patients in the BPM-Web-Pharm group with office visits to a specialist in 12 months (P = .04 ) relative to baseline and to patients in the other arms.
Serious Adverse Events
Three people died during the study: two in the BPM-Web group from cancer-related complications and a third in the BPM-Web-Pharm group from a cardiac arrest. Seven patients had non-fatal cardiovascular events: two in the UC, four in the BPM-Web, and three in the BPM-Web-Pharm group. The DSMB and investigators attributed none of the deaths, cardiovascular events, or other hospitalizations to study participation.