Hypertension Management Using Remote Patient Monitoring: Study 2

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Remote patient monitoring for hypertension; Behavioral: Remote patient monitoring with care management

• Study Type: Observational
• Enrollment (Actual): 17290

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remote patient monitoring for hypertension; All intervention practices will receive communication by email explaining RPM procedures, ordering, use, and financial implications. We will also present this information at practice meetings. Primary care clinicians at these sites will receive clinical decision support (Epic Best Practice Alert) for patients meeting primary or secondary eligibility criteria. It will be at the discretion of the primary care clinicians when to offer or refer patients to RPM.	Behavioral: Remote patient monitoring for hypertension; 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.
Remote patient monitoring with care management; All intervention practices will receive communication by email explaining RPM procedures, ordering, use, and financial implications. We will also present this information at practice meetings. Primary care clinicians at these sites will receive clinical decision support (Epic Best Practice Alert) for patients meeting primary or secondary eligibility criteria. It will be at the discretion of the primary care clinicians when to offer or refer patients to RPM. In addition, PCPs will receive lists of candidate patients. Care managers will assist with the outreach to patients to offer RPM when recommended by the PCP, will monitor and support patient use of the remote monitor, and will promote action on the part of the patient or PCP when uncontrolled hypertension is present.	Behavioral: Remote 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.
Usual care; Medicare patients from non-intervention primary care practices in Northwestern Medical Group will contribute EHR data but will not have any new procedures put in place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance measure Controlling High Blood Pressure (NQF 0018)	Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period <140/90 mm Hg, binary	6 months
Performance measure Controlling High Blood Pressure (NQF 0018)	Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period <140/90 mm Hg, binary	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg), continuous	6 months
Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg), continuous	3 months
Antihypertensive medication intensification	Antihypertensive medication intensification, count	6 months
Antihypertensive medication intensification	Antihypertensive medication intensification, count	3 months
Systolic blood pressure measured by home readings	Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous	6 months
Systolic blood pressure measured by home readings	Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous	3 months
Remote patient monitoring intensity	Number of RPM BP measurements in months during which any BP measurement was performed, count	6 months
Remote patient monitoring intensity	Number of RPM BP measurements in months during which any BP measurement was performed, count	3 months
RPM use	Any remote BP transmitted, binary	6 months
RPM use	Any remote BP transmitted, binary	3 months
RPM BP monitoring uptake	Time from BP RPM prescription to first BP RPM measurement, time-to-event	up to 6 months
RPM BP monitoring discontinuation	Time from first BP RPM measurement until end of first 30-day period with no RPM BP readings, time-to-event	up to 6 months
Controlling high blood pressure--office only	Proportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period <140/90 mm Hg, binary	6 months
Controlling high blood pressure--office only	Proportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period <140/90 mm Hg, binary	3 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Omron Healthcare Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2021
• Primary Completion (ACTUAL): August 14, 2021
• Study Completion (ACTUAL): January 14, 2022

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (ACTUAL): February 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: STU00213093 Study 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No