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

HealthPartners Institute

Status: Completed

Conditions: Hypertension

Treatments: Other: Telehealth Care; Other: Best Practice Clinic-Based Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02996565

HealthPartners Institute

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3,071 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,071 participants in 2 patient groups

Best Practice Clinic-Based Care

Active Comparator group

Description:

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

Treatment:

Other: Best Practice Clinic-Based Care

Telehealth Care

Active Comparator group

Description:

Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention.

Treatment:

Other: Telehealth Care