Northwestern University
Chicago, Illinois, 60611, United States
NCT Number: NCT04764318
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.
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Notify Me65 year–85 year
All sexes
Observational
Chicago, Illinois, 60611, United States
Only the study team can determine whether someone qualifies for participation.
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:
Inclusion criteria
primary population:
Inclusion criteria
for secondary population
Exclusion criteria
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.
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.
Time frame: 6 months
Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period <140/90 mm Hg, binary
Time frame: 3 months
Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period <140/90 mm Hg, binary
Time frame: 6 months
Systolic blood pressure at the most recent office visit (mm Hg), continuous
Time frame: 3 months
Systolic blood pressure at the most recent office visit (mm Hg), continuous
Time frame: 6 months
Antihypertensive medication intensification, count
Time frame: 3 months
Antihypertensive medication intensification, count
Time frame: 6 months
Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous
Time frame: 3 months
Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous
Time frame: 6 months
Number of RPM BP measurements in months during which any BP measurement was performed, count
Time frame: 3 months
Number of RPM BP measurements in months during which any BP measurement was performed, count
Time frame: 6 months
Any remote BP transmitted, binary
Time frame: 3 months
Any remote BP transmitted, binary
Time frame: up to 6 months
Time from BP RPM prescription to first BP RPM measurement, time-to-event
Time frame: up to 6 months
Time from first BP RPM measurement until end of first 30-day period with no RPM BP readings, time-to-event
Time frame: 6 months
Proportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period <140/90 mm Hg, binary
Time frame: 3 months
Proportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period <140/90 mm Hg, binary
Northwestern University
Other
A Pilot Study of Hypertension Management Using Remote Patient Monitoring: Study 2
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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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