A Pilot Study of Hypertension Management Using Remote Patient Monitoring

NCT ID: NCT04604925

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7068 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-19
• Study Completion Date: 2022-01-31

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.

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Remote patient monitoring for hypertension

Intervention Type: BEHAVIORAL

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

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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)

• 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

• 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omron Healthcare Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Stephen Persell, MD, MPH

Professor of Medicine, Division of General Internal Medicine & Geriatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen D Persell, MD/MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University, Division of General Internal Medicine

Chicago, Illinois, United States

Countries

United States

References

Petito LC, Anthony L, Peprah YA, Lee JY, Li J, Sato H, Persell SD. Remote physiologic monitoring for hypertension in primary care: a prospective pragmatic pilot study in electronic health records using propensity score matching. JAMIA Open. 2023 Jan 31;6(1):ooac111. doi: 10.1093/jamiaopen/ooac111. eCollection 2023 Apr.

Reference Type: DERIVED

PMID: 36743315 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STU00213093

Identifier Type: -

Identifier Source: org_study_id