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Contemp Clin Trials. 2020 Jan 22:105939. doi: 10.1016/j.cct.2020.105939. [Epub ahead of print]

Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure.

Author information

1
HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America. Electronic address: Karen.L.Margolis@Healthpartners.com.
2
HealthPartners Institute, Mailstop 23301A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.
3
Kaiser Permanente Washington Health Research Institute, 1730 Minor Av, Seattle, WA 98101, United States of America.
4
HealthPartners, Mailstop 31100A, PO Box 1524, Minneapolis, MN 55440-1524, United States of America.
5
Rutgers Robert Wood Johnson Medical School, Department of Family Medicine and Community Health, New Brunswick, NJ 08901, United States of America.

Abstract

BACKGROUND:

Uncontrolled hypertension is the largest single contributor to all-cause and cardiovascular mortality in the U.S.

POPULATION:

Nurse- and pharmacist-led team-based care and telehealth care interventions have been shown to result in large and lasting improvements in blood pressure (BP); however, it is unclear how successfully these can be implemented at scale in real-world settings. It is also uncertain how telehealth interventions impact patient experience compared to traditional clinic-based care.

AIMS/OBJECTIVES:

To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist. To evaluate implementation using mixed-methods supported by the RE-AIM framework and Consolidated Framework for Implementation Research.

METHODS:

The design is a cluster-randomized comparative effectiveness pragmatic trial in 21 primary care clinics (9 clinic-based care, 12 telehealth care). Adult patients (age 18-85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95 mmHg at two consecutive visits. The primary outcome is change in systolic BP over 12 months as extracted from the EHR. Secondary outcomes are change in key patient-reported outcomes over 6 months as measured by surveys. Qualitative data are collected at various time points to investigate implementation barriers and help explain intervention effects.

CONCLUSION:

This pragmatic trial aims to inform health systems about the benefits, strengths, and limitations of implementing home BP telemonitoring with pharmacist management for uncontrolled hypertension in real-world primary care settings.

PMID:
31981712
DOI:
10.1016/j.cct.2020.105939

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