Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05386069
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'patti.parker@prismahealth.org', 'phone': '864-455-1510', 'title': 'Manager OBGYN Research', 'organization': 'Prisma Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '7 days', 'eventGroups': [{'id': 'EG000', 'title': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail\n\nNOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Morphine Milligram Equivalents Used During Inpatient Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA'}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail\n\nNOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from immediately postoperative through discharge or 4 weeks, whichever comes first', 'description': 'Total morphine milligram equivalents calculated for each patient during their stay.', 'unitOfMeasure': 'morhpine milligram equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing urogynecologic procedure.'}, {'type': 'SECONDARY', 'title': 'Passage of Voiding Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA'}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail\n\nNOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from immediately postoperative through discharge or 4 weeks, whichever comes first', 'description': 'percentage of patients who pass voiding trial on POD#1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anti-emetic Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA'}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail\n\nNOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1', 'description': 'Did the patient require anti-emetics in the post-operative period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA'}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail\n\nNOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'postoperative day 7', 'description': 'Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prescription for Opioid at Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA'}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail\n\nNOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'postoperative day 2 through postoperative day 7', 'description': 'Did the patient require a narcotic prescription', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA'}, {'id': 'OG001', 'title': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail\n\nNOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'postoperative day 1 through discharge or 4 weeks, whichever comes first', 'description': 'The average number of days patients were admitted as inpatient.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients included - all patients stayed in hospital for 2 days.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA'}, {'id': 'FG001', 'title': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail\n\nNOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA'}, {'id': 'BG001', 'title': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail\n\nNOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Brief Pain Inventory (Short Form)', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '2.4', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '3.6', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-21', 'size': 220865, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-29T10:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Control Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2020-04-06', 'resultsFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2022-05-17', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-22', 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine Milligram Equivalents Used During Inpatient Stay', 'timeFrame': 'from immediately postoperative through discharge or 4 weeks, whichever comes first', 'description': 'Total morphine milligram equivalents calculated for each patient during their stay.'}], 'secondaryOutcomes': [{'measure': 'Passage of Voiding Trial', 'timeFrame': 'from immediately postoperative through discharge or 4 weeks, whichever comes first', 'description': 'percentage of patients who pass voiding trial on POD#1'}, {'measure': 'Anti-emetic Use', 'timeFrame': 'postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1', 'description': 'Did the patient require anti-emetics in the post-operative period'}, {'measure': 'Patient Pain Score', 'timeFrame': 'postoperative day 7', 'description': 'Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst'}, {'measure': 'Prescription for Opioid at Discharge', 'timeFrame': 'postoperative day 2 through postoperative day 7', 'description': 'Did the patient require a narcotic prescription'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'postoperative day 1 through discharge or 4 weeks, whichever comes first', 'description': 'The average number of days patients were admitted as inpatient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use']}, 'referencesModule': {'references': [{'pmid': '28551445', 'type': 'RESULT', 'citation': "Reagan KML, O'Sullivan DM, Gannon R, Steinberg AC. Decreasing postoperative narcotics in reconstructive pelvic surgery: a randomized controlled trial. Am J Obstet Gynecol. 2017 Sep;217(3):325.e1-325.e10. doi: 10.1016/j.ajog.2017.05.041. Epub 2017 May 25."}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.', 'detailedDescription': 'The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. NOMO protocols seek to reduce the opioid usage for patients in the postoperative period. Patients will receive multiple pain medications (usually referred to as a "pain cocktail") that work on various pain receptors throughout the body. These medications are approved for pain control; but they have few side effects and less addictive properties. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females undergoing Urogynecology procedure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking females\n* greater than or equal to 18 years old\n* scheduled for a urogynecologic procedure at GHS requiring inpatient stay or extended observation.\n\nExclusion Criteria:\n\n* less than 18 years of age\n* non-English speaking patients\n* unscheduled urogynecologic surgeries\n* patients expected to undergo a simple reconstructive surgery with same-day discharge,\n* history of chronic pain\n* chronic Lyrica or Celebrex use\n* psychiatric disorder, narcotic dependence or narcotic prescription in the past six weeks\n* current liver disease\n* kidney disease (defined as GFR \\<60)\n* malignancy\n* sulfa allergy'}, 'identificationModule': {'nctId': 'NCT05386069', 'briefTitle': 'Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use', 'organization': {'class': 'OTHER', 'fullName': 'Prisma Health-Upstate'}, 'officialTitle': 'The Effect of a Non-Opioid Multimodal Pain (NOMO) Protocol in Decreasing Narcotic Use After Urogynecologic Surgery', 'orgStudyIdInfo': {'id': 'NOMO Protocol'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Routine Care per Anesthiologist/cRNA'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Arm', 'description': 'Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail', 'interventionNames': ['Drug: NOMO Protocol']}], 'interventions': [{'name': 'NOMO Protocol', 'type': 'DRUG', 'otherNames': ['Standard Care'], 'description': 'Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health - Upstate', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Hema Brazell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prisma Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prisma Health-Upstate', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}