PS1-04: Home Blood Pressure Telemonitoring and Case Management to Control Hypertension: HyperLink Trial Design and Baseline Characteristics

摘要

>Background/Aims: Blood pressure (BP) is not controlled in the majority of people with hypertension (HTN) in the U.S. We describe a study of long-term hypertension outcomes that compares home BP telemonitoring and pharmacist case management vs. usual care.>Methods: HyperLink is a cluster-randomized trial (N=450 patients) being conducted at HealthPartners Medical Group clinics. Sixteen clinics were randomly assigned to either the Telemonitoring Intervention (TI) or Usual Care (UC). Recruitment materials are mailed to adult primary care patients in these clinics whose last 2 BP measurements were uncontrolled in the previous 12 months (>140/90, or >130/80 if diabetes or kidney disease present). To be eligible, they are required to have uncontrolled BP confirmed at a research clinic visit. Other medical exclusion criteria are minimal: pregnancy, recent cardiovascular events, symptomatic heart failure, stage 4/5 kidney disease, and dementia. Participants in the TI group receive a home BP telemonitor that stores and transmits all BP measurements to the clinic pharmacist via a modem to a secure web site. Following one intake clinic visit with the pharmacist, participants and pharmacists communicate by telephone every 2–4 weeks for 6 months. HTN treatment is adjusted based on home BP according to an approved written protocol under a collaborative practice agreement with physicians. UC participants may visit a clinic pharmacist but do not receive telemonitoring. The primary outcome is BP control measured at the research clinic visit at 6 months. Secondary outcomes are BP control maintenance at 12 and 18 months, satisfaction and costs.>Results: Recruitment began March 1, 2009, and is on track to be completed as predicted in September 2010. During the first 8 mo, 195 participants were recruited, of whom 47% were female, 17% were minority race/ethnicity and 53% were from TI clinics. Detailed baseline characteristics of participants recruited as of February 28, 2010 will be reported.>Conclusions: 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. This novel intervention could be implemented widely in diverse and large patient populations based on performance in this randomized trial.