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| Name | Class |
|---|---|
| Omron Healthcare Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Usual care | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote patient monitoring for hypertension | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure at the most recent office visit | Systolic blood pressure at the most recent office visit (mm Hg), continuous | 6 months |
| Systolic blood pressure at the most recent office visit |
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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:
Inclusion criteria primary population:
Inclusion criteria for secondary population
Exclusion Criteria:
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This study will take place in several Northwestern Medicine Group outpatient primary care clinic settings. Patients at these practices will be eligible for inclusion in the primary study population if they have diagnosed hypertension, are 65 to 85 years old, have Medicare insurance, and have their last two prior office blood pressures ≥140 mm Hg systolic or ≥90 mm Hg diastolic. Patients at these practices will be eligible for inclusion in the secondary study population if either they meet the inclusion criteria for the primary population or they are 65 to 85 years old, have Medicare insurance and either have diagnosed hypertension but do not have their last two office blood pressures prior ≥140 mm Hg systolic or ≥90 mm Hg diastolic, or they do not have hypertension diagnosed and have their most recent prior office blood pressure ≥140 mm Hg systolic or ≥90 mm Hg diastolic.
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D Persell, MD, MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36933552 | Derived | Persell SD, Petito LC, Anthony L, Peprah Y, Lee JY, Campanella T, Campbell J, Pigott K, Kadric J, Duax CJ, Li J, Sato H. Prospective Cohort Study of Remote Patient Monitoring with and without Care Coordination for Hypertension in Primary Care. Appl Clin Inform. 2023 May;14(3):428-438. doi: 10.1055/a-2057-7277. Epub 2023 Mar 18. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Remote patient monitoring with care management | Behavioral | 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. |
|
Systolic blood pressure at the most recent office visit (mm Hg), continuous
| 3 months |
| Antihypertensive medication intensification | Antihypertensive medication intensification, count | 6 months |
| Antihypertensive medication intensification | Antihypertensive medication intensification, count | 3 months |
| Systolic blood pressure measured by home readings | Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous | 6 months |
| Systolic blood pressure measured by home readings | Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous | 3 months |
| Remote patient monitoring intensity | Number of RPM BP measurements in months during which any BP measurement was performed, count | 6 months |
| Remote patient monitoring intensity | Number of RPM BP measurements in months during which any BP measurement was performed, count | 3 months |
| RPM use | Any remote BP transmitted, binary | 6 months |
| RPM use | Any remote BP transmitted, binary | 3 months |
| RPM BP monitoring uptake | Time from BP RPM prescription to first BP RPM measurement, time-to-event | up to 6 months |
| 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 |
| 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 |
| 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 |