A Pilot Study of Hypertension Management Using Remote Patient Monitoring

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Remote patient monitoring for hypertension

• Registration Number: NCT04604925
• Lead Sponsor: Northwestern University

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. 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-27
• Study Start: 2020-11-19
• Primary Completion: 2021-08-14
• Study Completion: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7068

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remote patient monitoring for hypertension	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.

Primary Outcome Measures

Name	Time	Method
Performance measure Controlling High Blood Pressure (NQF 0018)	6 months	Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period \<140/90 mm Hg
Systolic blood pressure at the most recent office visit	6 months	Systolic blood pressure at the most recent office visit (mm Hg)

Secondary Outcome Measures

Name	Time	Method
Antihypertensive medication intensification	3 months	Antihypertensive medication intensification
Systolic blood pressure at the most recent office visit	1 month	Systolic blood pressure at the most recent office visit (mm Hg)
Performance measure Controlling High Blood Pressure (NQF 0018)	1 month	Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period \<140/90 mm Hg

Trial Locations

Locations (1)

Northwestern University, Division of General Internal Medicine; 🇺🇸 Chicago, Illinois, United States