Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT03468920
Status:
COMPLETED
Last Update Posted:
2019-05-14
First Post:
2018-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Preoperative IV Versus Oral Acetaminophen
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Rachel_Baker2@trihealth.com', 'phone': '513-569-6191', 'title': 'Nurse Researcher', 'organization': 'TriHealth'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 months', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: IV Acetaminophen Group', 'description': 'Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively\n\nIV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively\n\nPO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: PO Acetaminophen Group', 'description': 'Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively\n\nPO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively\n\nIV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Reported Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: IV Acetaminophen Group', 'description': 'Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively\n\nIV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively\n\nPO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule'}, {'id': 'OG001', 'title': 'Arm 2: PO Acetaminophen Group', 'description': 'Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively\n\nPO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively\n\nIV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'spread': '3.092', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '3.226', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study visit, less than 24 hours', 'description': 'Pain measured from 0 (no pain) to 10 (worst pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Received Opioid Administration in PACU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: IV Acetaminophen Group', 'description': 'Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively\n\nIV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively\n\nPO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule'}, {'id': 'OG001', 'title': 'Arm 2: PO Acetaminophen Group', 'description': 'Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively\n\nPO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively\n\nIV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study visit, less than 24 hours', 'description': 'Number of Participants who Received Opioid Administration in PACU', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced Postoperative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: IV Acetaminophen Group', 'description': 'Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively\n\nIV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively\n\nPO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule'}, {'id': 'OG001', 'title': 'Arm 2: PO Acetaminophen Group', 'description': 'Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively\n\nPO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively\n\nIV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study visit, less than 24 hours', 'description': 'Did patient experience negative effects of pain medication (postoperative nausea and vomiting)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: IV Acetaminophen Group', 'description': 'Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively\n\nIV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively\n\nPO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule'}, {'id': 'OG001', 'title': 'Arm 2: PO Acetaminophen Group', 'description': 'Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively\n\nPO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively\n\nIV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '88.25', 'spread': '26.651', 'groupId': 'OG000'}, {'value': '92.88', 'spread': '29.911', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study visit, less than 24 hours', 'description': 'Minutes from entering PACU to end of Phase II', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: IV Acetaminophen Group', 'description': 'Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively\n\nIV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively\n\nPO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule'}, {'id': 'OG001', 'title': 'Arm 2: PO Acetaminophen Group', 'description': 'Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively\n\nPO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively\n\nIV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '9.45', 'spread': '0.950', 'groupId': 'OG000'}, {'value': '9.77', 'spread': '0.528', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 2 days after surgery', 'description': 'Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: IV Acetaminophen Group', 'description': 'Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively\n\nIV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively\n\nPO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule'}, {'id': 'FG001', 'title': 'Arm 2: PO Acetaminophen Group', 'description': 'Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively\n\nPO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively\n\nIV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: IV Acetaminophen Group', 'description': 'Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively\n\nIV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively\n\nPO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule'}, {'id': 'BG001', 'title': 'Arm 2: PO Acetaminophen Group', 'description': 'Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively\n\nPO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively\n\nIV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.37', 'spread': '15.82', 'groupId': 'BG000'}, {'value': '46.28', 'spread': '16.84', 'groupId': 'BG001'}, {'value': '45.83', 'spread': '16.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-01', 'size': 293760, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-12T13:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only pharmacy staff will have randomization scheme and be aware of whether patient received oral Acetaminophen with IV placebo OR if the patient received IV Acetaminophen with oral placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will use a randomized, double-blind, placebo controlled design with two arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2018-03-01', 'resultsFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-12', 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Reported Pain', 'timeFrame': 'through study visit, less than 24 hours', 'description': 'Pain measured from 0 (no pain) to 10 (worst pain)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Received Opioid Administration in PACU', 'timeFrame': 'through study visit, less than 24 hours', 'description': 'Number of Participants who Received Opioid Administration in PACU'}, {'measure': 'Number of Participants Who Experienced Postoperative Nausea and Vomiting', 'timeFrame': 'through study visit, less than 24 hours', 'description': 'Did patient experience negative effects of pain medication (postoperative nausea and vomiting)'}, {'measure': 'Length of Stay', 'timeFrame': 'through study visit, less than 24 hours', 'description': 'Minutes from entering PACU to end of Phase II'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'up to 2 days after surgery', 'description': 'Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.', 'detailedDescription': 'This study will use a randomized, double-blind, controlled design with two arms:\n\nArm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively\n\n120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia\n\nExclusion Criteria:\n\n* Allergy to Acetaminophen\n* Lactose intolerance or lactose allergy (placebo capsules contain lactose)\n* Hepatic disease\n* Having taken a product containing acetaminophen within 6 hours of scheduled surgery time\n* Pregnant\n* Weight less than 50kg\n* Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse\n* Emergent or on-call procedures\n* Inpatient surgery'}, 'identificationModule': {'nctId': 'NCT03468920', 'briefTitle': 'Preoperative IV Versus Oral Acetaminophen', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen', 'orgStudyIdInfo': {'id': '17-114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: IV Acetaminophen group', 'description': 'Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively', 'interventionNames': ['Drug: IV Acetaminophen', 'Drug: PO Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: PO Acetaminophen group', 'description': 'Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively', 'interventionNames': ['Drug: PO Acetaminophen', 'Drug: IV Solution Placebo']}], 'interventions': [{'name': 'IV Acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively', 'armGroupLabels': ['Arm 1: IV Acetaminophen group']}, {'name': 'PO Acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'Acetaminophen PO 1000mg once pre-operatively', 'armGroupLabels': ['Arm 2: PO Acetaminophen group']}, {'name': 'PO Placebo', 'type': 'DRUG', 'description': 'PO placebo capsule compounded to match PO Acetaminophen capsule', 'armGroupLabels': ['Arm 1: IV Acetaminophen group']}, {'name': 'IV Solution Placebo', 'type': 'DRUG', 'otherNames': ['IV Normal Saline'], 'description': 'This will serve as the placebo for the IV Acetaminophen intervention', 'armGroupLabels': ['Arm 2: PO Acetaminophen group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45011', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'TriHealth, Bethesda Butler Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse Researcher', 'investigatorFullName': 'Rachel Baker', 'investigatorAffiliation': 'TriHealth Inc.'}}}}