Hypertension Management Using Remote Patient Monitoring: Study 2
- Conditions
- Hypertension
- Interventions
- Behavioral: Remote patient monitoring for hypertensionBehavioral: Remote patient monitoring with care management
- Registration Number
- NCT04764318
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17290
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Remote patient monitoring for hypertension Remote patient monitoring for hypertension 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 with care management Remote patient monitoring with care management 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.
- Primary Outcome Measures
Name Time Method Performance measure Controlling High Blood Pressure (NQF 0018) 3 months Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period \<140/90 mm Hg, binary
- Secondary Outcome Measures
Name Time Method Systolic blood pressure measured by home readings 3 months Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous
Systolic blood pressure at the most recent office visit 3 months Systolic blood pressure at the most recent office visit (mm Hg), continuous
RPM use 3 months Any remote BP transmitted, binary
Remote patient monitoring intensity 3 months Number of RPM BP measurements in months during which any BP measurement was performed, count
Antihypertensive medication intensification 3 months Antihypertensive medication intensification, count
RPM BP monitoring uptake up to 6 months Time from BP RPM prescription to first BP RPM measurement, time-to-event
Controlling high blood pressure--office only 3 months Proportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period \<140/90 mm Hg, binary
RPM BP monitoring discontinuation up to 6 months Time from first BP RPM measurement until end of first 30-day period with no RPM BP readings, time-to-event
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Chicago, Illinois, United States