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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3071 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2021-06-30

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.

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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).

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Best Practice Clinic-Based Care

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

Group Type ACTIVE_COMPARATOR

Best Practice Clinic-Based Care

Intervention Type OTHER

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.

Telehealth Care

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

Group Type ACTIVE_COMPARATOR

Telehealth Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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

Intervention Type OTHER

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