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Clinical Trials/NCT04764318
NCT04764318
Completed
N/A

A Pilot Study of Hypertension Management Using Remote Patient Monitoring: Study 2

Northwestern University1 site in 1 country17,290 target enrollmentFebruary 15, 2021
ConditionsHypertension

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypertension
Sponsor
Northwestern University
Enrollment
17290
Locations
1
Primary Endpoint
Performance measure Controlling High Blood Pressure (NQF 0018)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The investigators will conduct a pragmatic pilot test of a remote patient monitoring system (RPM) for blood pressure measurement for Medicare patients with hypertension with and without the support of a care management program. The primary objective is to better understand how patients' remote monitoring of blood pressure and the direct transmission of this data to a healthcare system's EHR can be used by the patient and the care team to support optimal hypertension care and whether the addition of active care management increases the use of RPM and improvements in blood pressure.

This pilot study will be conducted in four Northwestern Medical Group (NMG) primary care practices. Two practices will have RPM available for primary care physicians to order for their eligible Medicare patients and two practices will also receive the support of a care management program to assist with patient enrollment, blood pressure monitoring and taking action in the setting of uncontrolled blood pressure.

The investigators will conduct a pragmatic non-blinded, non-randomized pilot study with contemporaneous controls among NMG outpatient clinics that provide adult primary care. They will make comparisons of data obtained through the course of routine care delivery from pilot and non-pilot practices.

Registry
clinicaltrials.gov
Start Date
February 15, 2021
End Date
January 14, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen Persell, MD, MPH

Professor of Medicine

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • We will use these criteria to determine which patients will be included or excluded in the study analytic data set.
  • General inclusion criteria:
  • Adults aged 65 to 85 years at the time of the study start date
  • Receive their primary care from an eligible Northwestern Medicine clinic site
  • One or more office or telehealth visits in the year preceding the study start date
  • Inclusion criteria primary population:
  • Last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic
  • Diagnosis of hypertension in the year preceding the study start date (problem list or encounter diagnosis)
  • Inclusion criteria for secondary population
  • Meet criteria for primary population OR

Exclusion Criteria

  • Persistent atrial fibrillation as indicated in the electronic health record (EHR)
  • Stage IV or more severe kidney disease, defined as estimated glomerular filtration rate \<30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)
  • Diagnosis of dementia as indicated in the electronic health record

Outcomes

Primary Outcomes

Performance measure Controlling High Blood Pressure (NQF 0018)

Time Frame: 3 months

Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period \<140/90 mm Hg, binary

Secondary Outcomes

  • Systolic blood pressure measured by home readings(3 months)
  • Systolic blood pressure at the most recent office visit(3 months)
  • RPM use(3 months)
  • Remote patient monitoring intensity(3 months)
  • Antihypertensive medication intensification(3 months)
  • RPM BP monitoring uptake(up to 6 months)
  • Controlling high blood pressure--office only(3 months)
  • RPM BP monitoring discontinuation(up to 6 months)

Study Sites (1)

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