Hypertension Management Using Remote Patient Monitoring: Study 2

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764318
• Other study ID #: STU00213093 Study 2
• Status: Completed
• Start date: February 15, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: February 2023
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17290
• Est. completion date: January 14, 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
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
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.

Locations

Country	Name	City	State
United States	Northwestern University	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, binary	6 months
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, binary	3 months
Secondary	Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg), continuous	6 months
Secondary	Systolic blood pressure at the most recent office visit	Systolic blood pressure at the most recent office visit (mm Hg), continuous	3 months
Secondary	Antihypertensive medication intensification	Antihypertensive medication intensification, count	6 months
Secondary	Antihypertensive medication intensification	Antihypertensive medication intensification, count	3 months
Secondary	Systolic blood pressure measured by home readings	Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous	6 months
Secondary	Systolic blood pressure measured by home readings	Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous	3 months
Secondary	Remote patient monitoring intensity	Number of RPM BP measurements in months during which any BP measurement was performed, count	6 months
Secondary	Remote patient monitoring intensity	Number of RPM BP measurements in months during which any BP measurement was performed, count	3 months
Secondary	RPM use	Any remote BP transmitted, binary	6 months
Secondary	RPM use	Any remote BP transmitted, binary	3 months
Secondary	RPM BP monitoring uptake	Time from BP RPM prescription to first BP RPM measurement, time-to-event	up to 6 months
Secondary	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
Secondary	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
Secondary	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