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OpenTrials
Completed

NCT Number: NCT04764318

Hypertension Management Using Remote Patient Monitoring: Study 2

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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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Performance measure Controlling High Blood Pressure (NQF 0018)

    Time frame: 6 months

    Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period <140/90 mm Hg, binary

  2. Performance measure Controlling High Blood Pressure (NQF 0018)

    Time frame: 3 months

    Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period <140/90 mm Hg, binary

Secondary outcomes

  1. Systolic blood pressure at the most recent office visit

    Time frame: 6 months

    Systolic blood pressure at the most recent office visit (mm Hg), continuous

  2. Systolic blood pressure at the most recent office visit

    Time frame: 3 months

    Systolic blood pressure at the most recent office visit (mm Hg), continuous

  3. Antihypertensive medication intensification

    Time frame: 6 months

    Antihypertensive medication intensification, count

  4. Antihypertensive medication intensification

    Time frame: 3 months

    Antihypertensive medication intensification, count

  5. Systolic blood pressure measured by home readings

    Time frame: 6 months

    Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous

  6. Systolic blood pressure measured by home readings

    Time frame: 3 months

    Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous

  7. Remote patient monitoring intensity

    Time frame: 6 months

    Number of RPM BP measurements in months during which any BP measurement was performed, count

  8. Remote patient monitoring intensity

    Time frame: 3 months

    Number of RPM BP measurements in months during which any BP measurement was performed, count

  9. RPM use

    Time frame: 6 months

    Any remote BP transmitted, binary

  10. RPM use

    Time frame: 3 months

    Any remote BP transmitted, binary

  11. RPM BP monitoring uptake

    Time frame: up to 6 months

    Time from BP RPM prescription to first BP RPM measurement, time-to-event

  12. RPM BP monitoring discontinuation

    Time frame: 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

  13. Controlling high blood pressure--office only

    Time frame: 6 months

    Proportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period <140/90 mm Hg, binary

  14. Controlling high blood pressure--office only

    Time frame: 3 months

    Proportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period <140/90 mm Hg, binary

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Omron Healthcare Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 21, 2021
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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