Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-01 @ 6:43 AM
Study NCT ID:
NCT00899392
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2009-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Informed Consent in Pediatric Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'friedlan@ohsu.edu', 'phone': '503-494-1078', 'title': 'Joel A Friedlander', 'organization': "Children's Hospital of Philadelphia/OHSU/Doernbecher Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Subjects of study did not all complete secondary outcome measures hence some pilot data was included in 2ndary outcome analysis, New instrument used attempting to validate. Largely female, educated cohort. \\>60% college educated in both groups.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Electronic Assisted Consent (EAC)', 'description': 'Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.', 'otherNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Consent (FBC)', 'description': 'Form-based informed consent as performed by pediatric gastroenterologists', 'otherNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Assisted Consent (EAC)', 'description': 'Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.'}, {'id': 'OG001', 'title': 'Control Consent (FBC)', 'description': 'Form-based informed consent as performed by pediatric gastroenterologists'}], 'classes': [{'categories': [{'measurements': [{'value': '37.36', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "Student's t test", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Every 1-2 months', 'description': 'Units on a scale (score) as Measured by Consent 20 Instrument.\n\n20 questions administered on a laptop computer and answered in private. Questions 1-5: qualitative questions about recalling procedure, risks, benefits, etc. (correct or incorrectly scored 0 or 2 points), Questions 6-20: yes or no responses, measuring delivery, voluntariness, and understanding. Each scored 0 or 2 points.\n\nMeasures theoretical attainment of a minimum standard of informed consent. Worse value: Zero Best Value: 40', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Assisted Consent (EAC)', 'description': 'Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.'}, {'id': 'OG001', 'title': 'Control Consent (FBC)', 'description': 'Form-based informed consent as performed by pediatric gastroenterologists'}], 'classes': [{'categories': [{'measurements': [{'value': '41.79', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '41.46', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Mann Whitney Test-non parametric', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Every 1-2 months', 'description': 'Worse Value: 5 Best Value 45 Measures satisfaction on a scale per the mGHAA-9. 9 questions administered on a laptop in private.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '(Consent Group + some pilot participants to increase power of analysis)'}, {'type': 'SECONDARY', 'title': 'Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Assisted Consent (EAC)', 'description': 'Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.'}, {'id': 'OG001', 'title': 'Control Consent (FBC)', 'description': 'Form-based informed consent as performed by pediatric gastroenterologists'}], 'classes': [{'title': 'Day Before Procedure', 'categories': [{'measurements': [{'value': '42.17', 'spread': '14.32', 'groupId': 'OG000'}, {'value': '37.17', 'spread': '12.56', 'groupId': 'OG001'}]}]}, {'title': 'Moments after consent', 'categories': [{'measurements': [{'value': '38.77', 'spread': '12.79', 'groupId': 'OG000'}, {'value': '33.76', 'spread': '8.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'paired', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12-18 hours (Night before Endoscopy to Day of Endoscopy)', 'description': 's-STAI as a series of question administered by laptop computer in private. 20 questions answered on Likert 4 point scale that varies based on question type. Max score 80.', 'unitOfMeasure': 'Units on a Scale (STAI Score)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Matched pairs (pre consent and post consent), Pilot data included to increase power analysis'}, {'type': 'SECONDARY', 'title': 'Questions Asked by Subjects (Parents)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Electronic Assisted Consent (EAC)', 'description': 'Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.'}, {'id': 'OG001', 'title': 'Control Consent (FBC)', 'description': 'Form-based informed consent as performed by pediatric gastroenterologists'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '3.06', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.0053', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Questions written by parents during the end of consent process (48-72 hours)', 'description': 'Number of questions written down by family and asked of clinician. Question sheet given to nurse in endoscopy suite and deposited in a box.', 'unitOfMeasure': 'Questions', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'GI Suite Flow Efficiency Measured in 15 Minute Increments', 'timeFrame': 'At completion of study', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Electronic Assisted Consent (EAC)', 'description': 'Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.'}, {'id': 'FG001', 'title': 'Control Consent (FBC)', 'description': 'Form-based informed consent as performed by pediatric gastroenterologists'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subjects:PerVariableStudied Consent:47-EAC 50-FBC Anxiety:60-EAC 3-FBC Satisfaction:63-EAC 67-FBC', 'groupId': 'FG000', 'numSubjects': '47'}, {'comment': 'Subjects:PerVariableStudied Consent:47-EAC 50-FBC Anxiety:60-EAC 3-FBC Satisfaction:63-EAC 67-FBC', 'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': "Subject didn't finish/partial pilot data", 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}], 'recruitmentDetails': 'Between October 2008 and March 2009, parents of 220 children scheduled for clinically indicated upper endoscopy were prospectively and consecutively contacted. 190 subjects verbally consented to be in the study and 148 subsequently participated. 6 were withdrawn from data secondary to entering disqualifying demographic response (not in data set)', 'preAssignmentDetails': '30 subjects did not participate because they did not consent to participate. These were not enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Electronic Assisted Consent (EAC)', 'description': 'Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.'}, {'id': 'BG001', 'title': 'Control Consent (FBC)', 'description': 'Form-based informed consent as performed by pediatric gastroenterologists'}, {'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': '68', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '142', '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': '50', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'EAC population are subjects that used web based education module', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2009-05-08', 'resultsFirstSubmitDate': '2010-06-25', 'studyFirstSubmitQcDate': '2009-05-11', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-24', 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attainment of Informed Consent as Measured by Consent Instrument (Consent-20)', 'timeFrame': 'Every 1-2 months', 'description': 'Units on a scale (score) as Measured by Consent 20 Instrument.\n\n20 questions administered on a laptop computer and answered in private. Questions 1-5: qualitative questions about recalling procedure, risks, benefits, etc. (correct or incorrectly scored 0 or 2 points), Questions 6-20: yes or no responses, measuring delivery, voluntariness, and understanding. Each scored 0 or 2 points.\n\nMeasures theoretical attainment of a minimum standard of informed consent. Worse value: Zero Best Value: 40'}], 'secondaryOutcomes': [{'measure': 'Subject (Parental) Satisfaction as Measured by Modified Group Health Association of America-9 Survey (mGHAA-9)', 'timeFrame': 'Every 1-2 months', 'description': 'Worse Value: 5 Best Value 45 Measures satisfaction on a scale per the mGHAA-9. 9 questions administered on a laptop in private.'}, {'measure': 'Subject (Parental) State Anxiety as Measured by the Spielberger-State Trait Anxiety Inventory (s-STAI) (State Section)', 'timeFrame': '12-18 hours (Night before Endoscopy to Day of Endoscopy)', 'description': 's-STAI as a series of question administered by laptop computer in private. 20 questions answered on Likert 4 point scale that varies based on question type. Max score 80.'}, {'measure': 'Questions Asked by Subjects (Parents)', 'timeFrame': 'Questions written by parents during the end of consent process (48-72 hours)', 'description': 'Number of questions written down by family and asked of clinician. Question sheet given to nurse in endoscopy suite and deposited in a box.'}, {'measure': 'GI Suite Flow Efficiency Measured in 15 Minute Increments', 'timeFrame': 'At completion of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['consent', 'Anxiety', 'Satisfaction', 'Efficiency', 'Questions', 'Attainment of Informed Consent (Consent-20)', 'Procedural State Anxiety (STAI)', 'Subject Satisfaction (mGHAA-9)', 'Duration in Endoscopy Suite', 'Number of questions asked'], 'conditions': ['Informed Consent', 'Procedural State Anxiety', "Subject's Satisfaction"]}, 'referencesModule': {'references': [{'pmid': '16837805', 'type': 'BACKGROUND', 'citation': 'Woodrow SR, Jenkins AP. How thorough is the process of informed consent prior to outpatient gastroscopy? A study of practice in a United Kingdom District Hospital. Digestion. 2006;73(2-3):189-97. doi: 10.1159/000094528. Epub 2006 Jul 11.'}, {'pmid': '18085930', 'type': 'BACKGROUND', 'citation': 'Gros DF, Antony MM, Simms LJ, McCabe RE. Psychometric properties of the State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA): comparison to the State-Trait Anxiety Inventory (STAI). Psychol Assess. 2007 Dec;19(4):369-81. doi: 10.1037/1040-3590.19.4.369.'}, {'pmid': '11375575', 'type': 'BACKGROUND', 'citation': 'Yacavone RF, Locke GR 3rd, Gostout CJ, Rockwood TH, Thieling S, Zinsmeister AR. Factors influencing patient satisfaction with GI endoscopy. Gastrointest Endosc. 2001 Jun;53(7):703-10. doi: 10.1067/mge.2001.115337.'}, {'pmid': '17643691', 'type': 'BACKGROUND', 'citation': 'Standards of Practice Committee; Zuckerman MJ, Shen B, Harrison ME 3rd, Baron TH, Adler DG, Davila RE, Gan SI, Lichtenstein DR, Qureshi WA, Rajan E, Fanelli RD, Van Guilder T. Informed consent for GI endoscopy. Gastrointest Endosc. 2007 Aug;66(2):213-8. doi: 10.1016/j.gie.2007.02.029. No abstract available.'}, {'pmid': '21245476', 'type': 'DERIVED', 'citation': 'Friedlander JA, Loeben GS, Finnegan PK, Puma AE, Zhang X, de Zoeten EF, Piccoli DA, Mamula P. A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy. J Med Ethics. 2011 Apr;37(4):194-200. doi: 10.1136/jme.2010.037622. Epub 2011 Jan 18.'}], 'seeAlsoLinks': [{'url': 'http://www.pedsgiconsent.com', 'label': 'The Study Web Site'}]}, 'descriptionModule': {'briefSummary': 'Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction. In the pursuit of enhancing and studying pediatric care, the investigators propose, as pediatric gastroenterologists, assessing the current state of parental and adolescent consent/assent in upper gastrointestinal endoscopy and offering a computer based education program to improve it. The investigators will look at outcomes that include anxiety, satisfaction, attainment of informed consent, and patient flow efficiency in a GI endoscopy suite.', 'detailedDescription': 'Two hundred first-time upper endoscopy patients from The Children\'s Hospital of Philadelphia will be prospectively selected for participation in the study. One hundred subjects will then be randomized to participate in either the standard consent arm or the electronic assisted informed consent (EAIC) arm. The electronic assisted informed consent web module is a professionally designed program by Emmi Solutions, LLC. Adolescents, if present and greater than 13 years of age, will undergo the program apart from their parent as a separate subgroup not included in the 100 randomized subjects. At time of endoscopy scheduling, the scheduler will ask the subjects if they would like to participate in the study. If interest is expressed the study coordinator or PI will contact the subject to explain the study and inform them of the study parameters. At time of phone contact, consent or assent via a verbal method will be performed. Once verbal consent is given by the subject or verbal assent by the adolescent subject they will follow the protocol. No incentives will be given to the subjects. Institutional Review Board (IRB) approval will be obtained.\n\nBetween 24 and 48 hours prior to endoscopy, the participant will have the option to access the web-based module outside the hospital or through a hospital-based kiosk. The web address used is http://www.pedsgiconsent.com. Just prior to starting the module, a five-minute electronic pre-intervention test will be given and its results recorded in an electronic database. This will gather demographic and pre-intervention state anxiety without personal identifying information. After the survey is complete, the educational module will be accessed. Upon completion, the subjects will print a confirmatory document of completion and a list of questions to hand to their physician at time of endoscopy. Hand written questions will also be permitted. Non-EAIC participants will perform a non-educational web program not related to gastroenterology and also have their endoscopy questions printed to give to their physician. The questions and confirmation sheet will also be presented to their physician at time of procedure. Participants will also have space to write further questions by hand on the form. The questions collected will be used to assess number and complexity of questions asked as influenced by the education program. The web module will record time duration taken for the program. After completing the program, the participants will report to the GI suite as previously scheduled. The procedure will occur without either the practitioner or nursing staff knowing in which arm of the study the participants are enrolled. After the questions are answered and formal GI endoscopy procedural consent is obtained, the question sheet will be deposited in a lock box in the endoscopy suite for review at a later time. Total time spent in the endoscopy suite will be recorded. Prior to the patient\'s endoscopy, but after formal consent is obtained, the participant will then take a ten minute electronic post-test to ascertain satisfaction (mGHAA-modified-Group Health Association of America Survey-9), change in state anxiety \\[s-STAI-(Spielberger-State Trait Anxiety Inventory (state section)\\], and change in understanding of consent parameters achieved. Satisfaction will be measured using the validated modified Group Health Association of America-9 Survey (mGHAA-9). It is a well-validated instrument used to measure patient satisfaction in adult endoscopy. Probing questions to evaluate the attainment of consent will be based on a modified survey taken from Woodrow\'s study titled, "How Thorough is the Process of Informed Consent Prior to Outpatient Gastroscopy?"(Consent-20)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent of child undergoing 1st, elective, outpatient, sedated, upper endoscopy (EGD)\n* Subject gives consent to participate\n* Child of parent does not have a planned endoscopy intervention.\n\nExclusion Criteria:\n\n* Does not speak or understand English\n* Does not give consent to participate\n* Does not complete consent instrument at a minimum during study'}, 'identificationModule': {'nctId': 'NCT00899392', 'briefTitle': 'Improving Informed Consent in Pediatric Endoscopy', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Improving Informed Consent and Assent in Pediatric Endoscopy', 'orgStudyIdInfo': {'id': '2008-6-6053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electronic Assisted Consent', 'description': 'Standard procedural consent performed by pediatric gastroenterologist plus assistance from computerized emmi module.', 'interventionNames': ['Other: Emmi Pediatric Upper Endoscopy Patient Education Module']}, {'type': 'NO_INTERVENTION', 'label': 'Control Consent', 'description': 'Standard procedural consent as performed by pediatric gastroenterologists'}], 'interventions': [{'name': 'Emmi Pediatric Upper Endoscopy Patient Education Module', 'type': 'OTHER', 'otherNames': ['Pediatric Upper Endoscopy Patient Education Module', 'Patient Education Module', 'Upper Endoscopy Patient Education Module', 'Endoscopy Patient Education Module'], 'description': 'Emmi Pediatric Upper Endoscopy Patient Education Module as designed by EMMI SOLUTIONS, LLC', 'armGroupLabels': ['Electronic Assisted Consent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Chidren's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Petar Mamula, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}, {'name': 'Joel Friedlander, D.O., M.Be.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Phildelphia"}, {'name': 'Greg Loeben, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Midwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'Midwestern University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}