Abstract P373: Design for a Pragmatic Trial Comparing Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure

Abstract

The 2017 ACC/AHA hypertension guideline strongly recommends systematic follow-up and monitoring of treatment using team-based care and telehealth, based on Level A evidence. However, different models for organizing team-based care and telehealth have not been compared. We describe the design of a PCORI-funded pragmatic trial with the following objectives: Aim 1) compare the effects on BP and patient-reported outcomes of two models of team-based care for uncontrolled hypertension, and Aim 2) study how the two models are carried out in the real-world setting of a large health system. The study is a 5-year cluster-randomized trial in 2000 patients age 18-85 with uncontrolled hypertension cared for in 21 primary care clinics at HealthPartners, a large integrated healthcare system in the Twin Cities area of Minnesota and western Wisconsin. Clinic-based care uses recommended best practices and face-to-face visits primarily with physicians, nurses and medical assistants. The telehealth care approach adapts a research-tested model with systematic use of home BP telemonitoring and home-based telehealth care coordinated by a clinical pharmacist or nurse practitioner. Patients in both groups are recruited directly from primary care clinics using electronic health record (EHR) prompts. Exclusions are few: pregnancy, advanced kidney disease, hospice care, and nursing home residence. The primary outcomes for Aim 1 are:1) change in BP over 12 months, and 2) change in patient-reported outcomes over six months, including treatment side effects, experiences with hypertension care, self-monitoring rates, and confidence in self-care. Secondary outcomes include other heart- and stroke-related risk factors and safety. Patients contributed extensively to the selection of the outcomes. Outcomes are collected over 24 months without reliance on research visits: patient-reported outcomes are measured by surveys and BP and other clinical outcomes are measured using routinely collected data documented in the EHR. We also use EHR data supplemented by qualitative data to assess how the two care models are carried out in practice. The results of this comparative effectiveness trial will assess pragmatic methods for implementing hypertension guideline recommendations.