Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT05030467
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2021-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nkchoudhry@bwh.harvard.edu', 'phone': '617-278-0930', 'title': 'Niteesh Choudhry', 'organization': "Brigham and Women's Hospial"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'Deaths and adverse events are reported for intervention clinic patients who were included in the analyses for the trial; information was not collected on control clinic patients. We used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. For deaths, we identified patient deaths through a retrospective review within the EHR based on reports.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Arm', 'description': "Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.\n\nREDUCE-BP Intervention: Pre-visit:\n\nProviders in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.\n\nDuring visit:\n\nProviders will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.\n\nProviders will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.\n\nPost-visit:\n\nPatient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits.", 'otherNumAtRisk': 24747, 'deathsNumAtRisk': 24747, 'otherNumAffected': 17, 'seriousNumAtRisk': 24747, 'deathsNumAffected': 3, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Control Arm - Not Collected for the Adverse Event Reporting', 'description': 'Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.\n\nInformation on control clinic patients was not collected as part of the adverse event reporting.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Unrelated AE', 'notes': 'All AEs were deemed unrelated to the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24747, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Unrelated SAE', 'notes': 'All SAEs were deemed unrelated to the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24747, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.01'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24747', 'groupId': 'OG000'}, {'value': '24463', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.\n\nREDUCE-BP Intervention: Pre-visit:\n\nProviders in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.\n\nDuring visit:\n\nProviders will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.\n\nProviders will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.\n\nPost-visit:\n\nPatient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits."}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.0', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.31', 'groupDescription': 'We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Change in systolic blood pressure from identification to the end of the 12-month follow-up, using values in the EHR from ambulatory care encounters', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients identified as eligible were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Well-controlled Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24747', 'groupId': 'OG000'}, {'value': '24463', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.\n\nREDUCE-BP Intervention: Pre-visit:\n\nProviders in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.\n\nDuring visit:\n\nProviders will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.\n\nProviders will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.\n\nPost-visit:\n\nPatient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits."}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '16910', 'groupId': 'OG000'}, {'value': '16441', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.03', 'groupDescription': 'Outcomes were evaluated using generalized estimating equations with a log link and Poisson-distributed errors, adjusting for clinic-level clustering.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Percentage of patients with well-controlled blood pressure (\\<140/90mmHg) in the 12-month follow-up period, using values in the EHR from ambulatory care encounters', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients identified as eligible were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Intensification of Medication', 'timeFrame': '12 months', 'description': 'Percentage of patients with intensification of medication in the 12-month follow-up period, defined by addition of therapy or increasing dose.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Guideline-concordant Medications', 'timeFrame': '12 months', 'description': 'Percentage of patients with guideline-concordant medications ordered in the follow-up period', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24747', 'groupId': 'OG000'}, {'value': '24463', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': "Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.\n\nREDUCE-BP Intervention: Pre-visit:\n\nProviders in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.\n\nDuring visit:\n\nProviders will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.\n\nProviders will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.\n\nPost-visit:\n\nPatient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits."}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.4', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '10.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.383', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.15', 'groupDescription': 'We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Change in diastolic blood pressure from identification to 12-month follow-up, measured using values in the EHR', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient identified as eligible for analysis'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure Differences', 'timeFrame': '12 months', 'description': 'Change in the gap in systolic blood pressure (SBP) between Black and White patients and Hispanic/Latino and Non-Hispanic/Latino patients from identification to the end of the 12-month follow-up, measured using values in the EHR from ambulatory care encounters', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm', 'description': "Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.\n\nREDUCE-BP Intervention: Pre-visit:\n\nProviders in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.\n\nDuring visit:\n\nProviders will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.\n\nProviders will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.\n\nPost-visit:\n\nPatient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits."}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '24747'}, {'groupId': 'FG001', 'numUnits': '12', 'numSubjects': '24463'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '24747'}, {'groupId': 'FG001', 'numUnits': '12', 'numSubjects': '24463'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Clinics', 'preAssignmentDetails': '24 clinics were randomized to intervention and control (1:1). Patients were identified from EHR data on the basis of their meeting eligibility criteria at the randomized clinics. Providers from these clinics were not directly enrolled in the study. Outcomes were measured at the patient level.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24747', 'groupId': 'BG000'}, {'value': '24463', 'groupId': 'BG001'}, {'value': '49210', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm', 'description': "Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.\n\nREDUCE-BP Intervention: Pre-visit:\n\nProviders in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.\n\nDuring visit:\n\nProviders will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.\n\nProviders will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.\n\nPost-visit:\n\nPatient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits."}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '64.6', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14977', 'groupId': 'BG000'}, {'value': '14143', 'groupId': 'BG001'}, {'value': '29120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9770', 'groupId': 'BG000'}, {'value': '10320', 'groupId': 'BG001'}, {'value': '20090', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2922', 'groupId': 'BG000'}, {'value': '1929', 'groupId': 'BG001'}, {'value': '4851', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21079', 'groupId': 'BG000'}, {'value': '21890', 'groupId': 'BG001'}, {'value': '42969', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '746', 'groupId': 'BG000'}, {'value': '644', 'groupId': 'BG001'}, {'value': '1390', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1093', 'groupId': 'BG000'}, {'value': '1458', 'groupId': 'BG001'}, {'value': '2551', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13997', 'groupId': 'BG000'}, {'value': '10803', 'groupId': 'BG001'}, {'value': '24800', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8291', 'groupId': 'BG000'}, {'value': '11137', 'groupId': 'BG001'}, {'value': '19428', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '905', 'groupId': 'BG000'}, {'value': '598', 'groupId': 'BG001'}, {'value': '1503', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '145.4', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '145.3', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '145.4', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '80.4', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '80.6', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '80.5', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'This is the number of patients who met eligibility criteria.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-04', 'size': 501725, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-29T17:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2021-08-26', 'resultsFirstSubmitDate': '2025-05-02', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-20', 'studyFirstPostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Systolic Blood Pressure', 'timeFrame': '12 months', 'description': 'Change in systolic blood pressure from identification to the end of the 12-month follow-up, using values in the EHR from ambulatory care encounters'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Well-controlled Blood Pressure', 'timeFrame': '12 months', 'description': 'Percentage of patients with well-controlled blood pressure (\\<140/90mmHg) in the 12-month follow-up period, using values in the EHR from ambulatory care encounters'}, {'measure': 'Percentage of Patients With Intensification of Medication', 'timeFrame': '12 months', 'description': 'Percentage of patients with intensification of medication in the 12-month follow-up period, defined by addition of therapy or increasing dose.'}, {'measure': 'Percentage of Patients With Guideline-concordant Medications', 'timeFrame': '12 months', 'description': 'Percentage of patients with guideline-concordant medications ordered in the follow-up period'}, {'measure': 'Change in Diastolic Blood Pressure', 'timeFrame': '12 months', 'description': 'Change in diastolic blood pressure from identification to 12-month follow-up, measured using values in the EHR'}, {'measure': 'Systolic Blood Pressure Differences', 'timeFrame': '12 months', 'description': 'Change in the gap in systolic blood pressure (SBP) between Black and White patients and Hispanic/Latino and Non-Hispanic/Latino patients from identification to the end of the 12-month follow-up, measured using values in the EHR from ambulatory care encounters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'A two-arm cluster randomized controlled trial targeting primary care providers will be conducted to evaluate the impact of a multicomponent electronic health record (EHR) intervention on hypertension management. Given the cluster trial design, randomization will be conducted at the site level, and in the intervention sites, all eligible providers will receive the intervention. The intervention consists of enhancing tools already available to primary care providers in the EHR system, including developing and implementing provider disparities dashboards, enhancing electronic decision support, and simplifying self-monitoring orders and communication materials. The intervention aims to improve blood pressure control and reduce health disparities in racial and ethnic minorities. Findings from this trial will provide important insight into whether a multicomponent intervention targeting providers and leveraging health information technology can reduce health disparities.', 'detailedDescription': 'The goal of this project is to improve existing decision support for hypertension control and to reduce disparities in treatment, consistent with Advocate-specific professional guidelines and quality metrics. To achieve this, a cluster randomized trial will be conducted and evaluated to determine whether health IT tools targeted to providers improve blood pressure control for patients with uncontrolled hypertension.\n\nThe primary hypothesis is that a health IT intervention will improve systolic blood pressure (primary outcome), concordance with hypertension guidelines (secondary outcome), diastolic blood pressure (secondary outcome), treatment intensification (secondary outcome), controlled blood pressure (secondary outcome) and systolic blood pressure disparities (secondary outcome) compared with usual care.\n\nParticipating clinics will be randomly assigned to one of 2 arms: (a) Arm 1: multicomponent, intervention and (b) Arm 2: usual care (i.e. no intervention). Providers and in each arm will receive the same intervention for up to 24 months after randomization, which will demonstrate the relative effectiveness of each approach as well as its long-term impact on clinical outcomes. Primary care providers in the intervention clinics will receive electronic decision support tools to guide their care of eligible patients. Providers in usual care clinics will receive usual care at Advocate Aurora Health (AAH). Patients will not receive any intervention or outreach independent of their provider or care team. EHR data will be used to implement the EHR tools, identify study subjects, track study progress, and evaluate the effect of the interventions. Patients will only be included in the analysis and will not be directly enrolled or contacted by investigators; we expect at least 2000 patients to be included in the analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '24 practices will be randomized to either Intervention or Control. We will include in the analysis patients who meet the following Inclusion Criteria:\n\n1. Medical Group Medical Home Population: 1 visit with Primary Care Physician (PCP) in past 2 years (rolling 24 months) and Patient has a medical group PCP as their EPIC General PCP\n2. Current age 18-85 years\n3. Hypertension diagnosis on EPIC Problem list OR at least 2 visits (office/telehealth/telephonic) with an encounter diagnosis of hypertension on different dates, with any during the last 24 months (rolling dates) performing provider\n4. Latest outpatient/ambulatory (exclude urgent care) systolic blood pressure ≥140 or diastolic blood pressure ≥90 (12 months rolling) (lowest measure if more than one taken at the same time)\n\nExclusion Criteria:\n\n* Patients not meeting the inclusion criteria above will not be included in the analysis of the study. No other exclusion criteria will be used.\n\nAmong these eligible patients, patients included in the primary analysis will be those that had an in-person visit at one of the trial clinics.'}, 'identificationModule': {'nctId': 'NCT05030467', 'acronym': 'REDUCE-BP', 'briefTitle': 'Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension', 'orgStudyIdInfo': {'id': '2021P002479'}, 'secondaryIdInfos': [{'id': 'R01MD014874', 'link': 'https://reporter.nih.gov/quickSearch/R01MD014874', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.', 'interventionNames': ['Behavioral: REDUCE-BP Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.'}], 'interventions': [{'name': 'REDUCE-BP Intervention', 'type': 'BEHAVIORAL', 'description': "Pre-visit:\n\nProviders in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.\n\nDuring visit:\n\nProviders will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.\n\nProviders will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.\n\nPost-visit:\n\nPatient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits.", 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60515', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Health Care', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Niteesh K Choudhry, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Niteesh K. Choudhry, MD, PhD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}