A Pilot Study of Hypertension Management Using Remote Patient Monitoring

Hypertension Clinical Trial

Official title:

A Pilot Study of Hypertension Management Using Remote Patient Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604925
• Other study ID #: STU00213093
• Status: Completed
• Start date: November 19, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7068
• Est. completion date: January 31, 2022
• Est. primary completion date: August 14, 2021
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University, Division of General Internal Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Omron Healthcare Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg)	6 months
Secondary	Antihypertensive medication intensification	Antihypertensive medication intensification	6 months
Secondary	Antihypertensive medication intensification	Antihypertensive medication intensification	3 months
Secondary	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
Secondary	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
Secondary	Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg)	3 months
Secondary	Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg)	1 month