Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 8/1/2018 |
| Start Date: | November 15, 2017 |
| End Date: | April 15, 2021 |
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.
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.
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).
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).
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
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