Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04764318
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypertension Management Using Remote Patient Monitoring: Study 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098465', 'term': 'Remote Patient Monitoring'}], 'ancestors': [{'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-09', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance measure Controlling High Blood Pressure (NQF 0018)', 'timeFrame': '6 months', 'description': 'Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period \\<140/90 mm Hg, binary'}, {'measure': 'Performance measure Controlling High Blood Pressure (NQF 0018)', 'timeFrame': '3 months', 'description': 'Proportion of eligible hypertension patients with most recent eligible blood pressure in the measurement period \\<140/90 mm Hg, binary'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure at the most recent office visit', 'timeFrame': '6 months', 'description': 'Systolic blood pressure at the most recent office visit (mm Hg), continuous'}, {'measure': 'Systolic blood pressure at the most recent office visit', 'timeFrame': '3 months', 'description': 'Systolic blood pressure at the most recent office visit (mm Hg), continuous'}, {'measure': 'Antihypertensive medication intensification', 'timeFrame': '6 months', 'description': 'Antihypertensive medication intensification, count'}, {'measure': 'Antihypertensive medication intensification', 'timeFrame': '3 months', 'description': 'Antihypertensive medication intensification, count'}, {'measure': 'Systolic blood pressure measured by home readings', 'timeFrame': '6 months', 'description': 'Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous'}, {'measure': 'Systolic blood pressure measured by home readings', 'timeFrame': '3 months', 'description': 'Systolic blood pressure measured by home (mm Hg) measured using RPM, continuous'}, {'measure': 'Remote patient monitoring intensity', 'timeFrame': '6 months', 'description': 'Number of RPM BP measurements in months during which any BP measurement was performed, count'}, {'measure': 'Remote patient monitoring intensity', 'timeFrame': '3 months', 'description': 'Number of RPM BP measurements in months during which any BP measurement was performed, count'}, {'measure': 'RPM use', 'timeFrame': '6 months', 'description': 'Any remote BP transmitted, binary'}, {'measure': 'RPM use', 'timeFrame': '3 months', 'description': 'Any remote BP transmitted, binary'}, {'measure': 'RPM BP monitoring uptake', 'timeFrame': 'up to 6 months', 'description': 'Time from BP RPM prescription to first BP RPM measurement, time-to-event'}, {'measure': 'RPM BP monitoring discontinuation', 'timeFrame': 'up to 6 months', 'description': 'Time from first BP RPM measurement until end of first 30-day period with no RPM BP readings, time-to-event'}, {'measure': 'Controlling high blood pressure--office only', 'timeFrame': '6 months', 'description': 'Proportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period \\<140/90 mm Hg, binary'}, {'measure': 'Controlling high blood pressure--office only', 'timeFrame': '3 months', 'description': 'Proportion of eligible hypertension patients with most recent eligible office blood pressure in the measurement period \\<140/90 mm Hg, binary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '36933552', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:We will use these criteria to determine which patients will be included or excluded in the study analytic data set.\n\nGeneral inclusion criteria:\n\n* Adults aged 65 to 85 years at the time of the study start date\n* Receive their primary care from an eligible Northwestern Medicine clinic site\n* One or more office or telehealth visits in the year preceding the study start date\n\nInclusion criteria primary population:\n\n* Last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic\n* Diagnosis of hypertension in the year preceding the study start date (problem list or encounter diagnosis)\n\nInclusion criteria for secondary population\n\n* Meet criteria for primary population OR\n* Diagnosed hypertension but did not have the last two office blood pressures ≥140 mm Hg systolic or ≥90 mmHg diastolic OR\n* No diagnosis of hypertension in the past year but did have the last office blood pressure ≥140 mm Hg systolic or ≥90 mmHg diastolic\n\nExclusion Criteria:\n\n* Persistent atrial fibrillation as indicated in the electronic health record (EHR)\n* 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)\n* Diagnosis of dementia as indicated in the electronic health record'}, 'identificationModule': {'nctId': 'NCT04764318', 'briefTitle': 'Hypertension Management Using Remote Patient Monitoring: Study 2', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Pilot Study of Hypertension Management Using Remote Patient Monitoring: Study 2', 'orgStudyIdInfo': {'id': 'STU00213093 Study 2'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Behavioral: Remote patient monitoring for hypertension']}, {'label': '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.', 'interventionNames': ['Behavioral: Remote patient monitoring with care management']}, {'label': '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.'}], 'interventions': [{'name': 'Remote patient monitoring for hypertension', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Remote patient monitoring for hypertension']}, {'name': 'Remote patient monitoring with care management', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Remote patient monitoring with care management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Stephen D Persell, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Omron Healthcare Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Stephen Persell, MD, MPH', 'investigatorAffiliation': 'Northwestern University'}}}}