A Pilot Study of Hypertension Management Using Remote Patient Monitoring

The investigators will conduct a pragmatic pilot test of a remote patient monitoring system (RPM) for blood pressure measurement for Medicare patients with hypertension. 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.

This pilot study which we will conduct in two Northwestern Medical Group (NMG) primary care practices will: evaluate the integration of Omron's remote monitoring system into Northwestern Medicine's electronic health record (so that clinical data can flow directly from the patient's monitor to the EHR), evaluate the use of billing work flows for covered Medicare services, build and deploy clinical decision support to aid with patient identification and ordering of the remote patient monitoring system, and evaluate the uptake and clinical effects of this system in the pilot practices compared to matched patients selected from non-pilot control practices.

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

Detailed Description

Investigators at Northwestern University will partner with Omron Healthcare Co., Ltd. (hereinafter referred to as "Omron") to conduct a pragmatic pilot test of a remote patient monitoring system (RPM) for blood pressure measurement for Medicare patients with hypertension. 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. The procedures that will be evaluated are routine healthcare services that are currently reimbursable by Medicare. However, the optimal ways to: integrate these tools into primary care practice, promote clinician and patient uptake, and put this information to use in the clinical environment to best control hypertension are not fully understood. This pilot study which we will conduct in two Northwestern Medical Group (NMG) primary care practices will: evaluate the integration of Omron's remote monitoring system into Northwestern Medicine's electronic health record (so that clinical data can flow directly from the patient's monitor to the EHR), evaluate the use of billing work flows for covered Medicare services, build and deploy clinical decision support to aid with patient identification and ordering of the remote patient monitoring system, and evaluate the uptake and clinical effects of this system in the pilot practices compared to matched patients selected from non-pilot control practices.

The remote patient monitoring (RPM) system will be provided by Omron Healthcare to eligible patients at no charge. This will include a Bluetooth enabled home blood pressure monitor, a simplified smart phone connected to the Verizon network and, if requested, a Bluetooth enabled scale. Patients who are agreeable to using this RPM system will have this service ordered by their clinician will have this equipment mailed to their homes. Payments for reimbursable remote monitoring services will be billed by Northwestern Medicine to Medicare and supplemental insurance coverage in the fashion that is permitted under Medicare rules.

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

• Study Type: Observational
• Enrollment (Actual): 7068

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Division of General Internal Medicine

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

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remote patient monitoring for hypertension; RPM Integration: 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; Intervention involves practices making available remote physiologic monitoring treatment management services allowable under Medicare for blood pressure (and weight if desired) to Medicare patients in the practice when ordered by the patient's clinician.
Usual care; Matching patients from control practices will be selected from remaining Northwestern Medical Group primary care sites and be chosen to provide as sufficiently large number of eligible patients for comparison. These groups will contribute EHR data through the NM EDW 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	6 months
Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antihypertensive medication intensification	Antihypertensive medication intensification	6 months
Antihypertensive medication intensification	Antihypertensive medication intensification	3 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	3 month
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	1 month
Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg)	3 months
Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg)	1 month

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Omron Healthcare Co., Ltd.
• Investigators: Principal Investigator: Stephen D Persell, MD/MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): August 14, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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