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Completed

NCT Number: NCT02996565

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

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Institute

Bloomington, Minnesota, 55425, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice Clinic-Based Care

Other

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.

Telehealth Care

Other

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

Primary outcomes

  1. Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)

    Time frame: Trajectory over 12 months

    Change in systolic BP, collected from medical records

Secondary outcomes

  1. Change in Diastolic BP Between Baseline and 12 Months (mm Hg)

    Time frame: Trajectory over 12 months

    change in diastolic BP, collected from medical records

  2. Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up

    Time frame: Baseline to 6 months

    Patient report of monitoring BP at least 2 times per week

  3. Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.

    Time frame: 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.299.24.2857

  4. Number of Participants Who Are Current Smokers at Twelve Months

    Time frame: Baseline to 12 months

    Current smoker at 12 months

  5. Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months

    Time frame: Baseline to 6 months

    Patient report that side effect is a problem

  6. Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months

    Time frame: Baseline to 6 months

    Patient report that side effect is a problem

  7. Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months

    Time frame: Baseline to 6 months

    Patient report that side effect is a problem

  8. Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months

    Time frame: Baseline to 6 months

    Patient report that side effect is a problem

  9. Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months

    Time frame: Baseline to 6 months

    Patient report that side effect is a problem

  10. Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months

    Time frame: Baseline to 6 months

    Patient report that side effect is a problem

  11. Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months

    Time frame: Baseline to 6 months

    Patient report that activity is helpful for BP self-management

  12. Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months

    Time frame: Baseline to 6 months

    Patient report that activity is helpful for BP self-management

  13. Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months

    Time frame: Baseline to 6 months

    Patient report that activity is helpful for BP self management

  14. Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months

    Time frame: Baseline to 6 months

    Patient report that activity is helpful for BP self management

  15. Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months

    Time frame: Baseline to 6 months

    Patient report that activity is helpful for BP self management

  16. Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months

    Time frame: Baseline to 6 months

    Patient report that burden is a problem

  17. Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months

    Time frame: Baseline to 6 months

    Patient report that burden is a problem

  18. Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months

    Time frame: Baseline to 6 months

    Patient report that burden is a problem

  19. Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months

    Time frame: Baseline to 6 months

    Patient report that burden is a problem

  20. Number of Participants Reporting Measuring BP as BP Care Burden at Six Months

    Time frame: Baseline to 6 months

    Patient report that burden is a problem

  21. Number of Participants Reporting Phone Visits as BP Care Burden at Six Months

    Time frame: Baseline to 6 months

    Patient report that burden is a problem

  22. Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months

    Time frame: Baseline to 6 months

    Patient report that burden is a problem

  23. Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months

    Time frame: Baseline to 6 months

    Patient report that burden is a problem

  24. Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team

    Time frame: Baseline to 6 months

    Patient reported "very" or "extremely" confident in this aspect of BP management.

  25. Number of Participants Reporting High Confidence in Keeping BP Below Target at Six Months

    Time frame: Baseline to 6 months

    Patient reported "very" or "extremely" confident in this aspect of BP management.

  26. Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months

    Time frame: Baseline to 6 months

    Patient reported "very" or "extremely" confident in this aspect of BP management

  27. Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months

    Time frame: Baseline to 6 months

    Patient reported "very" or "extremely" confident in this aspect of BP management

  28. Number of Participants Reporting High Confidence in Taking BP Medications at Six Months

    Time frame: Baseline to 6 months

    Patient reported "very" or "extremely" confident in this aspect of BP management

  29. Number of Participants With Statin Addition at 12 Months

    Time frame: Baseline to 12 months

    New statin medication current at 12 months

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Dec 19, 2016
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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