Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
- Conditions
- Hypertension
- Interventions
- Other: Telehealth CareOther: Best Practice Clinic-Based Care
- Registration Number
- NCT02996565
- Lead Sponsor
- HealthPartners Institute
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3072
- 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
- Pregnancy
- End Stage Kidney Disease
- Patients in hospice care and patients who permanently reside in a nursing home
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telehealth Care Telehealth Care Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention. Best Practice Clinic-Based Care Best Practice Clinic-Based Care Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention.
- Primary Outcome Measures
Name Time Method Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg) Trajectory over 12 months Change in systolic BP, collected from medical records
- Secondary Outcome Measures
Name Time Method Change in Diastolic BP Between Baseline and 12 Months (mm Hg) Trajectory over 12 months change in diastolic BP, collected from medical records
Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up Baseline to 6 months Patient report of monitoring BP at least 2 times per week
Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months. Baseline to 6 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.299.24.2857Number of Participants Who Are Current Smokers at Twelve Months Baseline to 12 months Current smoker at 12 months
Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months Baseline to 6 months Patient report that side effect is a problem
Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months Baseline to 6 months Patient report that side effect is a problem
Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months Baseline to 6 months Patient report that side effect is a problem
Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months Baseline to 6 months Patient report that side effect is a problem
Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months Baseline to 6 months Patient report that side effect is a problem
Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months Baseline to 6 months Patient report that side effect is a problem
Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months Baseline to 6 months Patient report that activity is helpful for BP self-management
Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months Baseline to 6 months Patient report that activity is helpful for BP self-management
Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months Baseline to 6 months Patient report that activity is helpful for BP self management
Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months Baseline to 6 months Patient report that activity is helpful for BP self management
Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months Baseline to 6 months Patient report that activity is helpful for BP self management
Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months Baseline to 6 months Patient report that burden is a problem
Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months Baseline to 6 months Patient report that burden is a problem
Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months Baseline to 6 months Patient report that burden is a problem
Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months Baseline to 6 months Patient report that burden is a problem
Number of Participants Reporting Measuring BP as BP Care Burden at Six Months Baseline to 6 months Patient report that burden is a problem
Number of Participants Reporting Phone Visits as BP Care Burden at Six Months Baseline to 6 months Patient report that burden is a problem
Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months Baseline to 6 months Patient report that burden is a problem
Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months Baseline to 6 months Patient report that burden is a problem
Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team Baseline to 6 months Patient reported "very" or "extremely" confident in this aspect of BP management.
Number of Participants Reporting High Confidence in Keeping BP Below Target at Six Months Baseline to 6 months Patient reported "very" or "extremely" confident in this aspect of BP management.
Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months Baseline to 6 months Patient reported "very" or "extremely" confident in this aspect of BP management
Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months Baseline to 6 months Patient reported "very" or "extremely" confident in this aspect of BP management
Number of Participants Reporting High Confidence in Taking BP Medications at Six Months Baseline to 6 months Patient reported "very" or "extremely" confident in this aspect of BP management
Number of Participants With Statin Addition at 12 Months Baseline to 12 months New statin medication current at 12 months
Trial Locations
- Locations (1)
HealthPartners Institute
🇺🇸Bloomington, Minnesota, United States