Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 9:00 PM
Study NCT ID:
NCT05088603
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2021-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Clear Masks on Patient Satisfaction With Communication
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kfargen@wakehealth.edu', 'phone': '336-716-6702', 'title': 'Dr. Kyle Fargen', 'organization': 'Atrium Health Wake Forest Baptist Health Department of Neurosurgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 1 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.106', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question #1 of the CG-CAHPS is "Did this provider explain things in a way that was easy to understand?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who were not excluded due to a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 2 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 2 "Did this provider listen carefully to you?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who were not excluded due to a protocol deviation'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 3 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 3 "Did this provider seem to know the important information about your medical history?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing one participant response to this question'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 4 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 4 "Did this provider show respect for what you had to say?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 5 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.529', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 5 "Did this provider spend enough time with you?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 6 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 6 "Did this provider demonstrate empathy?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 7 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.502', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 7 "How comfortable do you feel trusting the provider\'s decisions?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 8 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.431', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 8 "Did you understand what you were being asked to do?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 9 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.434', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 9 "How satisfied are you with the procedure thus far overall?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response Score of 4 to Question 10 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.159', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Participants were asked "What was your impression of the doctor\'s mask" with 1 meaning "Strongly Disliked" and 4 meaning "Strongly Liked". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Positive Response to Question 11 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'OG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.051', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Participants were asked "What comments do you have about the doctor\'s mask." The free text responses were categorized as positive/negative/neutral. Outcome is count of positive responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'FG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.\n\nClear Mask: The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.'}, {'id': 'BG001', 'title': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'BG000', 'lowerLimit': '55.0', 'upperLimit': '72.0'}, {'value': '68.5', 'groupId': 'BG001', 'lowerLimit': '63.0', 'upperLimit': '75.0'}, {'value': '69.0', 'groupId': 'BG002', 'lowerLimit': '60.0', 'upperLimit': '73.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White, non-Hispanic', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Unknown/Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Indication for DBS', 'classes': [{'categories': [{'title': 'Dystonia', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Essential Tremor', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': "Parkinson's Disease", 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HHIE -S Overall Score', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '14.5'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'description': 'Hearing Handicap Inventory - Screening Version. Total score was sum of points across 10 questions. Responses were "No" (0 points), "Sometimes" (2 points) or "Yes" (4 points). Interpretation of Total Score: 0-8 = no handicap; 10-24 = mild to moderate handicap; 26-40 = severe handicap', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-08', 'size': 340295, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-24T16:02', 'hasProtocol': True}, {'date': '2023-07-11', 'size': 179461, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-10-05T14:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The neurologist will wear the mask type assigned by randomization for the duration of involvement in the surgery. At the conclusion of the neurologist's interaction with the participant, the participant will be asked a series of questions to evaluate the communication experience. This step will be performed by another member of the study team (not the participating neurologist) who will read from the questionnaire and record the participant's responses. During questioning, the neurologist will step out of the operating room to reduce potential bias from the participants answering subjective questions in front of the neurologist."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-19', 'studyFirstSubmitDate': '2021-10-13', 'resultsFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-25', 'studyFirstPostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Positive Response Score of 4 to Question 1 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question #1 of the CG-CAHPS is "Did this provider explain things in a way that was easy to understand?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Positive Response Score of 4 to Question 2 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 2 "Did this provider listen carefully to you?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}, {'measure': 'Number of Participants With a Positive Response Score of 4 to Question 3 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 3 "Did this provider seem to know the important information about your medical history?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}, {'measure': 'Number of Participants With a Positive Response Score of 4 to Question 4 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 4 "Did this provider show respect for what you had to say?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}, {'measure': 'Number of Participants With a Positive Response Score of 4 to Question 5 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 5 "Did this provider spend enough time with you?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}, {'measure': 'Number of Participants With a Positive Response Score of 4 to Question 6 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 6 "Did this provider demonstrate empathy?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}, {'measure': 'Number of Participants With a Positive Response Score of 4 to Question 7 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 7 "How comfortable do you feel trusting the provider\'s decisions?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}, {'measure': 'Number of Participants With a Positive Response Score of 4 to Question 8 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 8 "Did you understand what you were being asked to do?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}, {'measure': 'Number of Participants With a Positive Response Score of 4 to Question 9 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Questionnaire measures the subject\'s satisfaction and experience with his or her physician and/or physician practice. Question 9 "How satisfied are you with the procedure thus far overall?" with 1 meaning "not at all" and 4 meaning "completely". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}, {'measure': 'Number of Participants With a Positive Response Score of 4 to Question 10 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Participants were asked "What was your impression of the doctor\'s mask" with 1 meaning "Strongly Disliked" and 4 meaning "Strongly Liked". Responses 1-3 were considered negative and response 4 considered positive. Outcome is count of positive responses.'}, {'measure': 'Number of Participants With a Positive Response to Question 11 on the Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Questionnaire', 'timeFrame': 'Day 1 Post Surgery', 'description': 'Participants were asked "What comments do you have about the doctor\'s mask." The free text responses were categorized as positive/negative/neutral. Outcome is count of positive responses.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['clear mask', 'neurological condition', 'deep brain stimulation', 'brain surgery', 'neurology'], 'conditions': ['Communication', 'Patient Satisfaction']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to evaluate participants' experience and satisfaction during the awake deep brain stimulation (DBS) procedure. Normally, the neurologist will ask the participant questions and also ask the participant to perform tasks during surgery. During this time, the neurologist will be talking to the participant and the participant will be responding by answering questions or participating with the tasks.\n\nFor some study participants, there will be one small change made to the typical way the neurologist conducts this evaluation. The study staff will then ask the study participants about their experience with the neurologist's evaluation. The subject will not be told what part of the evaluation is changed for the study, until after they have responded to the questionnaire.", 'detailedDescription': 'All participants scheduled for a DBS phase I surgery will be contacted via telephone in the days prior to their scheduled surgery to discuss the possibility of study participation. This will be done to give the participant time to consider study participation in order to avoid delays the morning of surgery. The morning of surgery the participant will be approached in pre-operative holding room to discuss participation in the study and if amenable sign consent for participation. This discussion will inform the participant that minor changes are being made in an attempt to improve the participant experience, but limited information will be shared to reduce potential bias that might result from the participant knowing what is being studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients electing to undergo deep brain stimulator placement\n* Patient in whom general anesthesia is not planned for stimulator target localization\n\nExclusion Criteria:\n\n* Patients who do not give consent\n* Patients who do not undergo DBS placement\n* Patients who are blind or have a severe visual impairment\n* Non-English speaking patients (i.e., patients for whom an interpreter would be needed to conduct the intra-operative assessment)'}, 'identificationModule': {'nctId': 'NCT05088603', 'briefTitle': 'Effect of Clear Masks on Patient Satisfaction With Communication', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The Effect of Clear Masks on Patient Satisfaction With Physician Communication During Awake Brain Surgery', 'orgStudyIdInfo': {'id': 'IRB00077199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clear Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a clear mask during their procedure and during their interaction with the subject.', 'interventionNames': ['Device: Clear Mask']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Mask', 'description': 'Subjects randomized to this group will have a neurologist who wears a standard mask during their procedure and during their interaction with the subject.'}], 'interventions': [{'name': 'Clear Mask', 'type': 'DEVICE', 'description': 'The clear mask has a 4.75 x 1.35 inch clear window that allows for clear visibility of the mouth.', 'armGroupLabels': ['Clear Mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health Wake Forest Baptist', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Wesley Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}