Clinical trial NCT04764318: Hypertension Management Using Remote Patient Monitoring: Study 2
Official title: A Pilot Study of Hypertension Management Using Remote Patient Monitoring: Study 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Omron Healthcare Co., Ltd.
First posted: 2021-02-21
Enrollment: 17290
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will take place in several Northwestern Medicine Group outpatient primary care clinic settings. Patients at these practices will be eligible for inclusion in the primary study population if they have diagnosed hypertension, are 65 to 85 years old, have Medicare insurance, and have their last two prior office blood pressures ≥140 mm Hg systolic or ≥90 mm Hg diastolic. Patients at these practices will be eligible for inclusion in the secondary study population if either they meet the inclusion criteria for the primary population or they are 65 to 85 years old, have Medicare insurance and either have diagnosed hypertension but do not have their last two office blood pressures prior ≥140 mm Hg systolic or ≥90 mm Hg diastolic, or they do not have hypertension diagnosed and have their most recent prior office blood pressure ≥140 mm Hg systolic or ≥90 mm Hg diastolic.

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.


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
* 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

Primary outcomes:
measure: Performance measure Controlling High Blood Pressure (NQF 0018)
timeFrame: 6 months
measure: Performance measure Controlling High Blood Pressure (NQF 0018)
timeFrame: 3 months
Secondary outcomes:
measure: Systolic blood pressure at the most recent office visit
timeFrame: 6 months
measure: Systolic blood pressure at the most recent office visit
timeFrame: 3 months
measure: Antihypertensive medication intensification
timeFrame: 6 months
measure: Antihypertensive medication intensification
timeFrame: 3 months
measure: Systolic blood pressure measured by home readings
timeFrame: 6 months
measure: Systolic blood pressure measured by home readings
timeFrame: 3 months
measure: Remote patient monitoring intensity
timeFrame: 6 months
measure: Remote patient monitoring intensity
timeFrame: 3 months
measure: RPM use
timeFrame: 6 months
measure: RPM use
timeFrame: 3 months
measure: RPM BP monitoring uptake
timeFrame: up to 6 months
measure: RPM BP monitoring discontinuation
timeFrame: up to 6 months
measure: Controlling high blood pressure--office only
timeFrame: 6 months
measure: Controlling high blood pressure--office only
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephen D Persell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: