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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hypertension

Intervention / Treatment
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* Other: Best Practice Clinic-Based Care
* Other: Telehealth Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Best Practice Clinic-Based Care<br>Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention. | Other: Best Practice Clinic-Based Care<br>* 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.<br>|
| Active Comparator: Telehealth Care<br>Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention. | Other: Telehealth Care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | Change in systolic BP, collected from medical records | Trajectory over 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Clinic care, Team-based care, Medication Therapy Management (MTM), Cluster-randomized, Home blood pressure monitoring, Pharmacist