NCT02996565

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,071 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

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).

Conditions

• Hypertension

Interventions

Type	Name	Description
OTHER	Best Practice Clinic-Based Care	Relies primarily on the physician-medical assistant dyad and face-to-face visits to promote: 1. Improved recognition of uncontrolled BP at primary care encounters, 2. Therapeutic action to address uncontrolled BP at primary care encounters, 3. 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: 1. Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device 2. Systematic home BP telemonitoring with data transmitted into patient medical record 3. Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email

Timeline

• Start date: 2017-11-15
• Primary completion: 2020-04-17
• Completion: 2021-06-30
• First posted: 2016-12-19
• Last updated: 2024-09-23
• Results posted: 2024-09-23

Locations

1 site across 1 country: United States