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

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ClinicalTrials.gov Identifier: NCT02996565
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : July 14, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hypertension Other: Best Practice Clinic-Based Care Other: Telehealth Care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3072 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : April 17, 2020
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arm Intervention/treatment
Active Comparator: Best Practice Clinic-Based Care
Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention.
Other: 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.

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




Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: Trajectory over 12 months ]
    Change in systolic BP, collected from medical records


Secondary Outcome Measures :
  1. Self-reported side-effects of antihypertensive medications [ Time Frame: Change between baseline and 6 months ]
    Questionnaire measure

  2. Self-reported patient experience/satisfaction with care [ Time Frame: Change between baseline and 6 months ]
    Questionnaire measure

  3. Self-reported confidence in self-management of blood pressure [ Time Frame: Change between baseline and 6 months ]
    Questionnaire measure


Other Outcome Measures:
  1. Diastolic Blood Pressure [ Time Frame: Trajectory, 6,12 and 24 months ]
    change in diastolic BP, collected from medical records

  2. Lipid Levels [ Time Frame: Trajectory, 12 and 24 months ]
    element of cardiovascular risk models, collected from medical records

  3. Statin Use (yes/no) [ Time Frame: Baseline and 24 months ]
    element of cardiovascular risk models, collected from medical records

  4. Smoking status (yes/no) [ Time Frame: Baseline, 6, 12, and 24 months ]
    element of cardiovascular risk models, collected from medical records

  5. 10 year cardiovascular event risk (for patients ages 40-85) [ Time Frame: Trajectory over 12 and 24 months ]
    Predictive risk model using individual elements of cardiovascular risk collected from medical records

  6. 30 year cardiovascular event risk (for patients ages 18-39) [ Time Frame: Trajectory over 12 and 24 months ]
    Predictive risk model using individual elements of cardiovascular risk collected from medical records

  7. Lab abnormalities related to hypertension and anti-hypertensive drug treatment [ Time Frame: Trajectory over 12 and 24 months ]
    Collected from medical records

  8. Hypotension or fainting diagnosis codes [ Time Frame: Any occurrence between baseline and 24 months ]
    Diagnosis codes collected from medical records



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996565


Locations
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United States, Minnesota
HealthPartners Institute
Bloomington, Minnesota, United States, 55425
Sponsors and Collaborators
HealthPartners Institute
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Karen Margolis, MD HealthPartners Institution
  Study Documents (Full-Text)

Documents provided by HealthPartners Institute:
Study Protocol  [PDF] July 25, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT02996565    
Other Study ID Numbers: HealthPartners Institute
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will provide a de-identified, individual-level dataset to PCORI if requested at the end of the study. The dataset will be made publicly available and will contain no identifying information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthPartners Institute:
Clinic care
Team-based care
Medication Therapy Management (MTM)
Telehealth
Cluster-randomized
Home blood pressure monitoring
Pharmacist
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases