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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,071
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.
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
HealthPartners Institute
Bloomington, Minnesota, United States
Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)
Change in systolic BP, collected from medical records
Time frame: Trajectory over 12 months
Change in Diastolic BP Between Baseline and 12 Months (mm Hg)
change in diastolic BP, collected from medical records
Time frame: Trajectory over 12 months
Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up
Patient report of monitoring BP at least 2 times per week
Time frame: Baseline to 6 months
Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.
Patient rating of 9-10 vs. 0-8 on a scale of 0 (low satisfaction) to 10 (high satisfaction). Developed from a scale used by Green, et al (2008). Citation: Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D,Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008;299:2857-2867. doi:10.1001/jama.299.24.2857
Time frame: Baseline to 6 months
Number of Participants Who Are Current Smokers at Twelve Months
Current smoker at 12 months
Time frame: Baseline to 12 months
Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months
Patient report that side effect is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months
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Patient report that side effect is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months
Patient report that side effect is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months
Patient report that side effect is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months
Patient report that side effect is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months
Patient report that side effect is a problem
Time frame: Baseline to 6 months
Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self-management
Time frame: Baseline to 6 months
Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self-management
Time frame: Baseline to 6 months
Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self management
Time frame: Baseline to 6 months
Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self management
Time frame: Baseline to 6 months
Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months
Patient report that activity is helpful for BP self management
Time frame: Baseline to 6 months
Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months
Patient report that burden is a problem
Time frame: Baseline to 6 months
Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months
Patient report that burden is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months
Patient report that burden is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months
Patient report that burden is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Measuring BP as BP Care Burden at Six Months
Patient report that burden is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Phone Visits as BP Care Burden at Six Months
Patient report that burden is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months
Patient report that burden is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months
Patient report that burden is a problem
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team
Patient reported "very" or "extremely" confident in this aspect of BP management.
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Keeping BP Below Target at Six Months
Patient reported "very" or "extremely" confident in this aspect of BP management.
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months
Patient reported "very" or "extremely" confident in this aspect of BP management
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months
Patient reported "very" or "extremely" confident in this aspect of BP management
Time frame: Baseline to 6 months
Number of Participants Reporting High Confidence in Taking BP Medications at Six Months
Patient reported "very" or "extremely" confident in this aspect of BP management
Time frame: Baseline to 6 months
Number of Participants With Statin Addition at 12 Months
New statin medication current at 12 months
Time frame: Baseline to 12 months