Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure

Overview

This pragmatic trial will compare two team-based care models for managing hypertension, Best Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care system in Minnesota. Clinics in the study are randomized to offer one of the two treatment models to participants with uncontrolled hypertension. The investigators aim to determine a) whether one model is more effective than the other for lowering patient's blood pressure and b) which model patients prefer.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 17, 2020

Detailed Description

The objectives of the study are: Aim 1: Compare the effects of two evidence-based strategies on lowering blood pressure and other outcomes important to patients: best-practice clinic-based care and home-based telehealth care. – Hypothesis 1.1: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will have a 5 mm Hg greater change in systolic blood pressure over 12 months of follow-up. – Hypothesis 1.2: Compared with patients in clinics assigned to clinic-based care, patients in clinics assigned to telehealth care will report: a) fewer treatment side effects; b) better ratings of patient experience of hypertension care; and c) higher self-monitoring rates and confidence in self-care. Aim 2: Conduct an evaluation of the reach, adoption, implementation, and maintenance of the telehealth care and clinic-based care interventions using a mixed-methods approach supported by the RE-AIM framework and the Consolidated Framework for Implementation Research (CFIR).

Interventions

  • Other: Best Practice Clinic-Based Care
    • Relies primarily on the physician-medical assistant dyad and face-to-face visits to promote: Improved recognition of uncontrolled BP at primary care encounters, Therapeutic action to address uncontrolled BP at primary care encounters, Reliable follow-up visits to re-assess uncontrolled BP every 2-4 weeks.
  • Other: Telehealth Care
    • All elements of Clinic-Based Care are performed, plus a telemonitoring and pharmacist case management program is offered, specifically: Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device Systematic home BP telemonitoring with data transmitted into patient medical record Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email

Arms, Groups and Cohorts

  • Active Comparator: Best Practice Clinic-Based Care
    • Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention.
  • Active Comparator: Telehealth Care
    • Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Systolic Blood Pressure
    • Time Frame: Trajectory over 12 months
    • Change in systolic BP, collected from medical records

Secondary Measures

  • Self-reported side-effects of antihypertensive medications
    • Time Frame: Change between baseline and 6 months
    • Questionnaire measure
  • Self-reported patient experience/satisfaction with care
    • Time Frame: Change between baseline and 6 months
    • Questionnaire measure
  • Self-reported confidence in self-management of blood pressure
    • Time Frame: Change between baseline and 6 months
    • Questionnaire measure

Participating in This Clinical Trial

Inclusion Criteria

  • Hypertension diagnosis code in medical record, twice in last 24 months – Attends study clinic for primary care visit within study period with uncontrolled blood pressure – Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at current visit – Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at most recent previous visit Exclusion Criteria:

  • Pregnancy – End Stage Kidney Disease – Patients in hospice care and patients who permanently reside in a nursing home

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • HealthPartners Institute
  • Collaborator
    • Patient-Centered Outcomes Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Karen Margolis, MD, Principal Investigator, HealthPartners Institution

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