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Pragmatic trial comparing telehealth care and optimized clinic-based care for uncontrolled high blood pressure
Investigator (PI): Margolis, Karen
Performing Organization (PO): (Current): HealthPartners Institute / (952) 967-5001
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2022
Record Source/Award ID: PCORI/IHS-1507-31146
Funding: Total Award Amount: $6,060,069
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: About one in three American adults has hypertension, also known as high blood pressure (BP). Lowering BP to recommended levels has been shown to reduce the risk of future heart attacks and strokes, but about half of people with hypertension do not have BP controlled to recommended levels. One of the most effective ways to improve BP control is to use a health care team approach, but there are different models for organizing team-based care that have not been compared. The objectives of this study are to 1) compare the effects on BP and patient-reported outcomes of two models of team-based care for uncontrolled hypertension (aim 1) and 2) study how the two models are carried out in the real-world setting of a large health system (aim 2). The study is designed as a trial in which clinics are randomly assigned, through a process like a coin flip, to one of the two care models. Clinic-based care uses recommended best practices in 10 clinics and about 1,000 patients. It relies primarily on physicians, medical assistants, and patients working closely together during clinic visits. The telehealth care approach adapts a successful research-tested model in 10 clinics and about 1,000 patients. It differs from clinic-based care through the systematic use of home BP telemonitoring and home-based telehealth care coordinated by a clinical pharmacist or nurse practitioner. The two models have not been compared directly, so we do not know whether one is more effective than the other or which approach patients prefer. The study participants (n=2,000) are drawn from patients ages 18 to 85 with uncontrolled hypertension cared for in 20 primary care clinics at HealthPartners, a large integrated health care system located in the Twin Cities metropolitan area of Minnesota and in western Wisconsin. Exclusions are few: pregnancy, advanced kidney disease, hospice care, and nursing home residence. The primary outcomes for aim 1 are (1) patient-reported outcomes, including treatment side effects, experiences with hypertension care, self-monitoring rates, and confidence in self-care over six months; and (2) change in BP over 12 months. Patients contributed extensively to the selection of the primary outcomes. We will also look at other heart- and stroke-related risk factors and safety. Outcomes are collected without research visits over 24 months: patient-reported outcomes are measured by surveys and BP and other clinical outcomes are measured using routinely collected data documented in the electronic health record. We also use routinely collected electronic data to assess how fully the two care models are carried out in practice, supplemented by data from field observations, interviews, and focus groups. The results of this trial of clinic-based care and telehealth care in a real-world health system will assist health care systems and the clinicians who work in them and help patients make the best decisions about their health.
MeSH Terms:
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Pressure
  • Clinical Trials as Topic
  • Electronic Health Records
  • Focus Groups
  • Health Promotion
  • Humans
  • Hypertension /*therapy
  • Middle Aged
  • Minnesota
  • Nurse Practitioners
  • Outcome Assessment, Health Care
  • Patient Safety
  • Patient-Centered Care
  • Pharmacists
  • Risk Factors
  • Telemedicine /*methods
  • United States
  • Wisconsin
  • Young Adult
Country: United States
State: Minnesota
Zip Code: 55440
UI: 20163088
Project Status: Ongoing
Record History: ('2017: Project extended to 2022.',)