HypertensionNCT04764318
Hypertension Management Using Remote Patient Monitoring: Study 2
An observational study of Hypertension, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Remote patient monitoring for hypertension and Remote patient monitoring with care management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17,290 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 14 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Older adult
Study population: 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.
Who may be able to join
- 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)
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of 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.
- Conditions
- Hypertension
- Being tested
- Remote patient monitoring for hypertension, Remote patient monitoring with care management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote patient monitoring for hypertensionBehavioural
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 managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Remote patient monitoring for hypertension | |
| 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. Receives: Behavioral: Remote patient monitoring with care management | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (14)
Systolic blood pressure at the most recent office visit
Systolic blood pressure at the most recent office visit (mm Hg), continuous
Measured: 6 months
Systolic blood pressure at the most recent office visit
Systolic blood pressure at the most recent office visit (mm Hg), continuous
Measured: 3 months
Antihypertensive medication intensification
Antihypertensive medication intensification, count
Measured: 6 months
Antihypertensive medication intensification
Antihypertensive medication intensification, count
Measured: 3 months
Systolic blood pressure measured by home readings
Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous
Measured: 6 months
Systolic blood pressure measured by home readings
Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous
Measured: 3 months
Remote patient monitoring intensity
Number of RPM BP measurements in months during which any BP measurement was performed, count
Measured: 6 months
Remote patient monitoring intensity
Number of RPM BP measurements in months during which any BP measurement was performed, count
Measured: 3 months
RPM use
Any remote BP transmitted, binary
Measured: 6 months
RPM use
Any remote BP transmitted, binary
Measured: 3 months
RPM BP monitoring uptake
Time from BP RPM prescription to first BP RPM measurement, time-to-event
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Feb 2021
- Primary completion14 Aug 2021
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Omron Healthcare Co., Ltd.
- Responsible party
- Principal investigator, Stephen Persell, MD, MPH, Northwestern University
- Investigators
- Stephen D Persell, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764318
- Sponsor's protocol ID
- STU00213093 Study 2
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36933552
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Hypertension Management Using Remote Patient Monitoring: Study 2
- ClinicalTrials.gov ID
- NCT04764318
- Acronym / sponsor ID
- STU00213093 Study 2
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,290 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Omron Healthcare Co., Ltd.
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 14 Aug 2021 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote patient monitoring for hypertension | – | Behavioral: Remote patient monitoring for hypertensionAll 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 | – | Behavioral: Remote patient monitoring with care managementAll 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. |
| 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote patient monitoring for hypertensionThe 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. | Behavioural | Remote patient monitoring for hypertension |
| Remote patient monitoring with care managementThe 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. | Behavioural | Remote patient monitoring with care management |
Primary outcome
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
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
14 secondary outcomes
Systolic blood pressure at the most recent office visit
Time frame: 6 months
Systolic blood pressure at the most recent office visit
Time frame: 3 months
Antihypertensive medication intensification
Time frame: 6 months
Antihypertensive medication intensification
Time frame: 3 months
Systolic blood pressure measured by home readings
Time frame: 6 months
Systolic blood pressure measured by home readings
Time frame: 3 months
Remote patient monitoring intensity
Time frame: 6 months
Remote patient monitoring intensity
Time frame: 3 months
RPM use
Time frame: 6 months
RPM use
Time frame: 3 months
RPM BP monitoring uptake
Time frame: up to 6 months
RPM BP monitoring discontinuation
Time frame: up to 6 months
Controlling high blood pressure--office only
Time frame: 6 months
Controlling high blood pressure--office only
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Derived from this study: PubMed 36933552Persell 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D Persell, MD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance measure Controlling High Blood Pressure (NQF 0018) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04764318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.