Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): A cluster randomized trial

Abstract

Background Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. Objectives The Home Blood Pressure Telemonitoring and Case Management to Control Hypertension study (HyperLink) is a clinic-randomized trial designed to determine whether an intervention that combines home BP telemonitoring with pharmacist case management improves BP control compared to usual care at 6 and 12 months in patients with uncontrolled hypertension. Secondary outcomes are maintenance of BP control at 18 months, patient satisfaction with their health care, and costs of care. Methods HyperLink enrolled 450 hypertensive patients with uncontrolled BP from 16 primary care clinics. Eight clinics were randomized to provide usual care (UC) to their patients (n = 222) and 8 were randomized to provide the telemonitoring intervention (TI) (n = 228). TI patients received home BP telemonitors that internally store and electronically transmit BP data to a secure database. Pharmacist case managers adjust antihypertensive therapy based on the home BP data under a collaborative practice agreement with the clinics’ primary care teams. The length of the intervention is 12 months, with follow-up to 18 months to determine the durability of the intervention. Conclusions We will test in a real primary care setting whether combining BP telemonitoring and pharmacist case management can achieve and maintain high rates of BP control compared to usual care.

Effect of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Control

“…The trial's rationale and design have been described in detail. 17 The study protocol was approved by the HealthPartners Institutional Review Board.…”

A Successful Multifaceted Trial to Improve Hypertension Control in Primary Care: Why Did it Work?

“…They assessed and adjusted antihypertensive drug therapy based on an algorithm using the percentage of home BP readings meeting goal. 12 Generally, if at least 75 % of readings since the last visit met the BP goal, no medication changes were suggested. If fewer than 75 % of readings met goal, the algorithm recommended treatment intensification.…”

“…12 All participants provided informed consent, and the study protocol was approved by the HealthPartners Institutional Review Board.…”

“…Study participants were further required to have uncontrolled BP (>140/90 mmHg or >130/ 80 mmHg if diabetes or kidney disease was present) 13 based on the average of three automated measurements taken in the research clinic using a standardized protocol. 12 Medical exclusion criteria included stage 4 or 5 kidney disease or an albumin-to-creatinine ratio >700 mg/g creatinine; acute coronary syndrome, coronary revascularization, or stroke within the past 3 months; known secondary causes of hypertension; pregnancy; and New York Heart Association class III or IV heart failure or known left ventricular ejection fraction <30 %. Of 2020 patients who were screened for the study, 450 were eligible and agreed to participate.…”

“…We speculate that this may have occurred because our intervention algorithm emphasized adding a new BP medication class over dose escalation for uncontrolled BP. 12 Improved medication adherence was an important intended component of the intervention, but self-reported adherence was already high at baseline. Preliminary analyses among the participants for whom pharmacy claims data were available at baseline showed that the proportion of days covered measure of adherence was >90 % in both the intervention and control groups (unpublished data).…”