Hypertension Management Using Remote Patient Monitoring: Study 2

Northwestern University

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Remote patient monitoring for hypertension; Behavioral: Remote patient monitoring with care management

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04764318

STU00213093 Study 2

Details and patient eligibility

About

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.

Enrollment: 17,290 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

17,290 participants in 3 patient groups

Remote patient monitoring for hypertension

Description:

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.

Treatment:

Behavioral: Remote patient monitoring for hypertension

Remote patient monitoring with care management

Description:

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. In addition, PCPs will receive lists of candidate patients. Care managers will assist with the outreach to patients to offer RPM when recommended by the PCP, will monitor and support patient use of the remote monitor, and will promote action on the part of the patient or PCP when uncontrolled hypertension is present.

Treatment:

Behavioral: Remote patient monitoring with care management

Usual care

Description:

Medicare patients from non-intervention primary care practices in Northwestern Medical Group will contribute EHR data but will not have any new procedures put in place.