Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-12 @ 5:02 AM
Study NCT ID:
NCT03375918
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2017-12-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COmmuNity-engaged SimULation Training for Blood Pressure Control
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D063505', 'term': 'Racism'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011287', 'term': 'Prejudice'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D063508', 'term': 'Social Discrimination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.tjia@umassmed.edu', 'phone': '774-455-3538', 'title': 'Jennifer Tjia', 'organization': 'UMass Chan Medical School'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months after the intervention', 'description': 'No adverse events (defined as "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant\'s participation in the research") were expected or noted among the participating healthcare trainees who received this educational intervention Patients did not have adverse events collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthcare Trainees', 'description': "Within each academic year, trainee clusters are assigned1 of 5 start date training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.\n\nCONSULT-BP Educational Intervention: Our intervention comprised two sessions over a 5-week period. The first session focused on (1) didactic overview of healthcare disparities, social drivers of health, implicit bias and systemic racism and (2) interactive discussions and patient storytelling videos to raise awareness of the bi-directional role of racial and ethnic identity among clinicians and patients. The second session focused on skill building and included (1) bias mitigation strategies based on the RELATE bias mitigation tool proposed by Cooper (Cooper L. Why Are Health Disparities Everyone's Problem? . Baltimore: Johns Hopkins University Press; 2021.) and (2) skill practice using 2 standardized patient simulated clinical encounters focusing on hypertension management challenges. The second session lasted 4 hours. Between the two sessions, trainees were asked to complete a race/ethnicity-compliance implicit association test and were provided the results to build self-awareness of potential implicit bias.", 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patients - Control Arm', 'description': 'Patients clustered within trainees in pre-training control period', 'otherNumAtRisk': 944, 'deathsNumAtRisk': 944, 'otherNumAffected': 0, 'seriousNumAtRisk': 944, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Patients - Intervention Arm', 'description': 'Patients clustered within trainees in post-training intervention period', 'otherNumAtRisk': 1651, 'deathsNumAtRisk': 1651, 'otherNumAffected': 0, 'seriousNumAtRisk': 1651, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '944', 'groupId': 'OG000'}, {'value': '1651', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients - Pre CONSULT-BP Intervention', 'description': 'Patient BPs from prior to the CONSULT-BP Intervention taken from the Electronic Medical Record.'}, {'id': 'OG001', 'title': 'Patients - Post-Intervention', 'description': 'Patient BPs from after the CONSULT-BP Intervention taken from the Electronic Medical Record.'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '137.6', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '136.4', 'spread': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BloodPressure', 'categories': [{'measurements': [{'value': '82.1', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '81.8', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Control period is 6 months before the intervention and intervention period is up to 6 months after the intervention', 'description': 'Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood pressure data was obtained from electronic medical records of 944 patients during the control period and 1,651 period patients during the intervention period.'}, {'type': 'SECONDARY', 'title': 'RELATE Checklist, a Standardized Patient Rating Scale for Bias-Mitigating and Patient-Centered Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthcare Trainees', 'description': "Within each academic year, trainee clusters are assigned1 of 5 start date training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.\n\nCONSULT-BP Educational Intervention: Our intervention comprised two sessions over a 5-week period. The first session focused on (1) didactic overview of healthcare disparities, social drivers of health, implicit bias and systemic racism and (2) interactive discussions and patient storytelling videos to raise awareness of the bi-directional role of racial and ethnic identity among clinicians and patients. The second session focused on skill building and included (1) bias mitigation strategies based on the RELATE bias mitigation tool proposed by Cooper (Cooper L. Why Are Health Disparities Everyone's Problem? . Baltimore: Johns Hopkins University Press; 2021.) and (2) skill practice using 2 standardized patient simulated clinical encounters focusing on hypertension management challenges. The second session lasted 4 hours. Between the two sessions, trainees were asked to complete a race/ethnicity-compliance implicit association test and were provided the results to build self-awareness of potential implicit bias."}], 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '5.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During CONSULT-BP session 2 clinician training intervention (simulated standardized patient encounter)', 'description': 'The RELATE (Respect, Empathize, Listen, Ask, Talk, Engage) is a 19-item checklist completed by an informant group of "standardized" patients during a simulated standardized patient encounter to evaluate interaction with the participating clinicians. The RELATE checklist contains 4 factors: Respect (4 items), Empathetic Listening (5 items); Ask and Talk (Inquiry, 6 items), and Engagement in Partnership (4 items). The checklist scores are from 0 to 38, with higher scores reflecting better communication from the perspective of the "standardized" patient.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RELATE scores were obtained from "standardized patients" (or mock patients) during interaction with the Clinician Trainees.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Year 1: Start Time 1', 'description': '1 of 5 trainee groups to start the intervention at time point 1.'}, {'id': 'FG001', 'title': 'Year 1: Start Time 2', 'description': '1 of 5 trainee groups to start the intervention at time point 2.'}, {'id': 'FG002', 'title': 'Year 1: Start Time 3', 'description': '1 of 5 trainee groups to start the intervention at time point 3.'}, {'id': 'FG003', 'title': 'Year 1: Start Time 4', 'description': '1 of 5 trainee groups to start the intervention at time point 4.'}, {'id': 'FG004', 'title': 'Year 1: Start Time 5', 'description': '1 of 5 trainee groups to start the intervention at time point 5.'}, {'id': 'FG005', 'title': 'Year 2: Cohort 1', 'description': 'Trainees in year 2\n\nOutcomes measured at level of patients nested within trainee Control period patient BP measures are pre-intervention Intervention period patient BP measures are post-intervention'}, {'id': 'FG006', 'title': 'Year 3: Cohort 2', 'description': 'Trainees in year 3\n\nOutcomes measured at level of patients nested within trainee Control period patient BP measures are pre-intervention Intervention period patient BP measures are post-intervention'}, {'id': 'FG007', 'title': 'Year 4: Cohort 3', 'description': 'Trainees in year 4\n\nOutcomes measured at level of patients nested within trainee Control period patient BP measures are pre-intervention Intervention period patient BP measures are post-intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '600'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '527'}, {'groupId': 'FG003', 'numSubjects': '215'}, {'groupId': 'FG004', 'numSubjects': '264'}, {'groupId': 'FG005', 'numSubjects': '336'}, {'groupId': 'FG006', 'numSubjects': '256'}, {'groupId': 'FG007', 'numSubjects': '409'}]}, {'type': 'Control Patients', 'comment': 'Control Period Measurements for Patients Nested within Trainee before the Intervention Training', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '201'}, {'groupId': 'FG003', 'numSubjects': '104'}, {'groupId': 'FG004', 'numSubjects': '125'}, {'groupId': 'FG005', 'numSubjects': '150'}, {'groupId': 'FG006', 'numSubjects': '80'}, {'groupId': 'FG007', 'numSubjects': '190'}]}, {'type': 'Intervention Patients', 'comment': 'Intervention Period Measurements for Patients Nested within Trainee Post-Intervention Training', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '314'}, {'groupId': 'FG003', 'numSubjects': '98'}, {'groupId': 'FG004', 'numSubjects': '135'}, {'groupId': 'FG005', 'numSubjects': '159'}, {'groupId': 'FG006', 'numSubjects': '155'}, {'groupId': 'FG007', 'numSubjects': '196'}]}, {'type': 'Trainees', 'comment': 'Trainees Completing Intervention Outcomes measured at level of patients nested within trainee\n\nThe same trainee participants participated in, and treated patients, in both the Control and Intervention periods of the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '27'}, {'groupId': 'FG006', 'numSubjects': '21'}, {'groupId': 'FG007', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '600'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '527'}, {'groupId': 'FG003', 'numSubjects': '215'}, {'groupId': 'FG004', 'numSubjects': '264'}, {'groupId': 'FG005', 'numSubjects': '336'}, {'groupId': 'FG006', 'numSubjects': '256'}, {'groupId': 'FG007', 'numSubjects': '409'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Within each academic year, we aimed to randomize training times to 1 of 5 start dates using a stepped wedge design. However, this design was not feasible beyond the first year of our study because of the COVID emergency.', 'preAssignmentDetails': "To maintain clinical staff services in the hospital, we were not able to maintain the cluster randomization of trainees. We aimed to enroll cohorts of trainees over a 3-year period, with each academic year constituting an intervention cycle, with 3 cycles of implementation corresponding to 3 sequential academic years. Due to COVID, we extended enrollment to a 4-year period.\n\nPlease note - only trainee participants were considered enrolled. Patient participants were not considered 'enrolled'."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '944', 'groupId': 'BG001'}, {'value': '1651', 'groupId': 'BG002'}, {'value': '2713', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthcare Trainees', 'description': 'Healthcare trainee clusters assigned to 1 of 5 start dates training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.'}, {'id': 'BG001', 'title': 'Patients - Control Arm', 'description': 'Patients treated by healthcare trainees within the control period'}, {'id': 'BG002', 'title': 'Patients - Intervention Arm', 'description': 'Patients treated by healthcare trainees within the intervention period'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'spread': '2.75', 'groupId': 'BG000'}, {'value': '54.8', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '13.2', 'groupId': 'BG002'}, {'value': '54.8', 'spread': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '486', 'groupId': 'BG001'}, {'value': '894', 'groupId': 'BG002'}, {'value': '1438', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '458', 'groupId': 'BG001'}, {'value': '757', 'groupId': 'BG002'}, {'value': '1275', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}, {'value': '361', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '800', 'groupId': 'BG001'}, {'value': '1425', 'groupId': 'BG002'}, {'value': '2278', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}, {'value': '582', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}, {'value': '637', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '778', 'groupId': 'BG002'}, {'value': '1204', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '944', 'groupId': 'BG001'}, {'value': '1651', 'groupId': 'BG002'}, {'value': '2713', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline information on Healthcare Trainees, Patients--Control Arm and Patients--Intervention Arm are aggregated from all cohorts within each population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-20', 'size': 559254, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-10T10:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The primary outcome is blood pressure (BP) change as recorded in the electronic medical record (EMR) of racial/ethnic minority patients and Medicaid recipients of any race/ethnicity with controlled and uncontrolled hypertension. Secondary outcomes are standardized patient assessments of clinical trainee communication skills. Standardized patient participants are masked to the intervention status of their provider trainees.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Enrolled 4 sequential cohorts of clinical trainees \\[stratified by specialty (internal medicine (IM), family medicine (FM)\\] were to be assigned to 1 of 5 start dates within each cohort year. During the global pandemic, randomized assignment within each year was not possible due to clinical needs of the hospitals, which means that the intervention was a pre-post intervention study. Clinical outcomes will be assessed at the patient level.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2017-12-12', 'resultsFirstSubmitDate': '2024-01-18', 'studyFirstSubmitQcDate': '2017-12-14', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-29', 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'Control period is 6 months before the intervention and intervention period is up to 6 months after the intervention', 'description': 'Systolic and diastolic blood pressure of patients treated by the participating clinician trainees as reported in the Electronic Medical Record.'}], 'secondaryOutcomes': [{'measure': 'RELATE Checklist, a Standardized Patient Rating Scale for Bias-Mitigating and Patient-Centered Communication', 'timeFrame': 'During CONSULT-BP session 2 clinician training intervention (simulated standardized patient encounter)', 'description': 'The RELATE (Respect, Empathize, Listen, Ask, Talk, Engage) is a 19-item checklist completed by an informant group of "standardized" patients during a simulated standardized patient encounter to evaluate interaction with the participating clinicians. The RELATE checklist contains 4 factors: Respect (4 items), Empathetic Listening (5 items); Ask and Talk (Inquiry, 6 items), and Engagement in Partnership (4 items). The checklist scores are from 0 to 38, with higher scores reflecting better communication from the perspective of the "standardized" patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthcare disparities', 'Racial Bias'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '37324051', 'type': 'BACKGROUND', 'citation': 'Tjia J, Pugnaire M, Calista J, Eisdorfer E, Hale J, Terrien J, Valdman O, Potts S, Garcia M, Yazdani M, Puerto G, Okero M, Duodu V, Sabin J. Using Simulation-Based Learning with Standardized Patients (SP) in an Implicit Bias Mitigation Clinician Training Program. J Med Educ Curric Dev. 2023 Jun 5;10:23821205231175033. doi: 10.1177/23821205231175033. eCollection 2023 Jan-Dec.'}, {'pmid': '33592827', 'type': 'BACKGROUND', 'citation': 'Tjia J, Pugnaire M, Calista J, Esparza N, Valdman O, Garcia M, Yazdani M, Hale J, Terrien J, Eisdorfer E, Zolezzi-Wyndham V, Chiriboga G, Rappaport L, Puerto G, Dykhouse E, Potts S, Sifuentes AF, Stanhope S, Allison J, Duodo V, Sabin J. COmmuNity-engaged SimULation Training for Blood Pressure Control (CONSULT-BP): A study protocol. Medicine (Baltimore). 2021 Feb 5;100(5):e23680. doi: 10.1097/MD.0000000000023680.'}, {'pmid': '37462563', 'type': 'BACKGROUND', 'citation': "Calista J, Esparza N, Fernandez J, Beltran A, Bradshaw J, Casseres A, Duodu S, Duodu V, Fordjour C, Kuffour B, Mensah L, Negron-Cruz L, Pietri C, Pridgen C, Puerto G, Tessler LA, Tucci S, Wood K, Wright S, Zinkus P, Tjia J. Perspectives of Community Partners Involved in an Academic Training to Address Clinicians' Implicit Bias. Prog Community Health Partnersh. 2023;17(2):347-351. doi: 10.1353/cpr.2023.a900215."}]}, 'descriptionModule': {'briefSummary': "The goal of CONSULT-BP is to train early-stage healthcare providers, including residents and nurse practitioner (NP) students, to mitigate providers' bias, improve communication skills, and enhance providers' ability to develop authentic and meaningful therapeutic alliances with patients. The study setting is an academic safety net hospital that serves a large non-White and poor population. The Investigators hypothesize that patients' outcomes (blood pressure levels) will be lower after the training intervention compared with before training (control) periods.", 'detailedDescription': "CONSULT-BP is an intervention to test a theory-based, 'awareness, exposure and skill-building' approach applied in the safety of a simulation-based learning center, to improve providers' interaction skills with minority and poor patients. The study included community-based participatory research input to develop and implement CONSULT-BP in an academic medical center with a large, safety-net health system which serves minority and poor population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'For Healthcare Trainees -\n\nInclusion Criteria:\n\n1. Practice at a clinical site supported by an EMR to allow clinical data collection for outcome measurement\n2. 15-week clinical look-back period\n3. No prior completion of the CONSULT-BP intervention\n\nExclusion Criteria: 1. All 1st year trainees\n\nFor Patient Participants -\n\nInclusion Criteria:\n\n1. English-speaking\n2. Non-White racial/ethnic minority or Medicaid recipient (regardless of race/ethnicity)\n3. Hypertension identified in the EMR\n\nExclusion Criteria:\n\n1. Enrolled in hospice.\n2. Pregnancy, dementia, schizophrenia, bipolar illness, or other serious medical co-morbidity that would interfere with hypertension self-control'}, 'identificationModule': {'nctId': 'NCT03375918', 'acronym': 'CONSULT-BP', 'briefTitle': 'COmmuNity-engaged SimULation Training for Blood Pressure Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Worcester'}, 'officialTitle': 'COmmuNity-engaged SimULation Training for Blood Pressure Control', 'orgStudyIdInfo': {'id': 'H00012160'}, 'secondaryIdInfos': [{'id': '1R01MD011532', 'link': 'https://reporter.nih.gov/quickSearch/1R01MD011532', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthcare Trainees', 'description': 'Trainees were assigned to receive Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.', 'interventionNames': ['Other: CONSULT-BP Educational Intervention']}], 'interventions': [{'name': 'CONSULT-BP Educational Intervention', 'type': 'OTHER', 'description': 'CONSULT-BP is a two sessions training provided to healthcare trainees over a 5-week period. The first session focused on (1) didactic overview of healthcare disparities, social drivers of health, implicit bias and systemic racism and (2) interactive discussions and patient storytelling videos to raise awareness of the bi-directional role of racial and ethnic identity among clinicians and patients. The second session focused on skill building and included (1) bias mitigation strategies based on the RELATE bias mitigation tool and (2) skill practice using 2 standardized patient simulated clinical encounters focusing on hypertension management challenges.', 'armGroupLabels': ['Healthcare Trainees']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01005', 'city': 'Barre', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Barre Family Health Center', 'geoPoint': {'lat': 42.42287, 'lon': -72.10508}}, {'zip': '01569', 'city': 'Uxbridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tri River Family Health Center', 'geoPoint': {'lat': 42.07732, 'lon': -71.62951}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Memorial Hahnemann Family Health Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Memorial Medical Center -- Benedict Building', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Jennifer Tjia, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMass Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual level participant data includes protected health information. There is no plan to share these data with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Population and Quantitative Health Sciences', 'investigatorFullName': 'Jennifer Tjia', 'investigatorAffiliation': 'University of Massachusetts, Worcester'}}}}