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Hypertension Management Using Remote Patient Monitoring: Study 2

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04764318
Enrollment
17290
Registered
2021-02-21
Start date
2021-02-15
Completion date
2022-01-14
Last updated
2023-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

The intervention involves making available remote physiologic monitoring services for hypertension patients allowable under Medicare for blood pressure (and weight if desired) when ordered by a patient's clinician.

BEHAVIORALRemote patient monitoring with care management

The intervention involves making available remote physiologic monitoring services for hypertension patients allowable under Medicare for blood pressure (and weight if desired) when ordered by a patient's clinician and providing care management services to support the enrollment and active use of this service.

Sponsors

Omron Healthcare Co., Ltd.
CollaboratorINDUSTRY
Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years

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 * Diagnosed hypertension but did not have the last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic OR * No diagnosis of hypertension in the past year but did have the last office blood pressure ≥140 mm Hg systolic or ≥90 mmHg diastolic

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

Design outcomes

Primary

MeasureTime frameDescription
Performance measure Controlling High Blood Pressure (NQF 0018)6 monthsProportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period \<140/90 mm Hg, binary

Secondary

MeasureTime frameDescription
Antihypertensive medication intensification6 monthsAntihypertensive medication intensification, count
Systolic blood pressure measured by home readings6 monthsSystolic blood pressure measured by home (mm Hg) measured using RPM, continuous
Remote patient monitoring intensity6 monthsNumber of RPM BP measurements in months during which any BP measurement was performed, count
Systolic blood pressure at the most recent office visit6 monthsSystolic blood pressure at the most recent office visit (mm Hg), continuous
RPM BP monitoring uptakeup to 6 monthsTime from BP RPM prescription to first BP RPM measurement, time-to-event
RPM BP monitoring discontinuationup to 6 monthsTime from first BP RPM measurement until end of first 30-day period with no RPM BP readings, time-to-event
Controlling high blood pressure--office only6 monthsProportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period \<140/90 mm Hg, binary
RPM use6 monthsAny remote BP transmitted, binary

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026