Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-29 @ 4:25 AM
Study NCT ID:
NCT04599166
Status:
COMPLETED
Last Update Posted:
2025-05-20
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Choosing an Effective Healthcare Spokesperson: An Interactive Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BHLevi@psu.edu', 'phone': '717-531-8778', 'title': 'Dr. Benjamin Levi', 'organization': 'Penn State College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1. At several game events, we experienced technology failures when participants tried to connect to the intervention app. This resulted in several events being cancelled, with no data collection from them.\n2. We were unable to retrieve audio-recordings for one-on-one telephone interviews from the digital recording device, and are unable to report those qualitative data. This is why we only had results from 8 participants for the primary outcome of the study.'}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Participant Arm', 'description': 'Participants were recruited to complete the WWYC intervention.\n\nWho Would You Choose: Serious Fun: "Who Would You Choose: Serious Fun" is a conversation activity that prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. At the end of the activity, players identify a real-life spokesperson based on the qualities considered during gameplay.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 0, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Changed Their Choice of Spokesperson', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participant Arm', 'description': 'This was a 1-armed study in which all participants were asked to identify a real-life spokesperson after completing the intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'This measure involved a verbal response (during a follow-up telephone interview) to the question as to whether they have changed their choice for who should be their healthcare spokesperson in the event that someone else needed to make medical decisions for them.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participation Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participant Arm', 'description': 'Participants were recruited to complete the WWYC intervention.\n\nWho Would You Choose: Serious Fun: "Who Would You Choose: Serious Fun" is a conversation activity that prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. At the end of the activity, players identify a real-life spokesperson based on the qualities considered during gameplay.'}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Aug 2021 - Dec 2022', 'description': 'Participation rate was defined as the number of participants who completed the study. This number excludes the number of participants who were enrolled but could not complete the intervention due to problems with technology (n=80).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spokesperson Response (Percentage)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participant Arm', 'description': 'Participants were recruited to complete the WWYC intervention.\n\nWho Would You Choose: Serious Fun: "Who Would You Choose: Serious Fun" is a conversation activity that prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. At the end of the activity, players identify a real-life spokesperson based on the qualities considered during gameplay.'}], 'classes': [{'categories': [{'title': 'Spokespersons who responded to invitation', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Spokespersons who did not respond to invitation', 'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Percentage of spokespersons who responded to participant request following intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Endorsement of the WWYC Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participant Arm', 'description': 'Participants will be recruited to complete the WWYC intervention.\n\nWho Would You Choose: Serious Fun: "Who Would You Choose: Serious Fun" is a conversation activity that prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. At the end of the activity, players identify a real-life spokesperson based on the qualities considered during gameplay.'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': '\\>75% of WWYC participants endorse WWYC, as measured by the Net Promoter Score', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participant Arm', 'description': 'Participants were recruited to complete the WWYC intervention.\n\nWho Would You Choose: Serious Fun: "Who Would You Choose: Serious Fun" is a conversation activity that prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. At the end of the activity, players identify a real-life spokesperson based on the qualities considered during gameplay.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}], 'dropWithdraws': [{'type': 'Technological failure connecting to study app', 'reasons': [{'groupId': 'FG000', 'numSubjects': '80'}]}]}], 'recruitmentDetails': 'Flier, emails, and public service announcements were used to recruit community members for participation in study game events. Respondents were contacted via email and phone. A total of 207 individuals expressed interest and showed up to game events. The period of study recruitment was from 7-1-2020 - 11-1-2022.', 'preAssignmentDetails': 'Not applicable as there was only one arm to the study, and no participants were excluded after enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participant Arm', 'description': 'Participants were recruited to complete the WWYC intervention.\n\nWho Would You Choose: Serious Fun: "Who Would You Choose: Serious Fun" is a conversation activity that prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. At the end of the activity, players identify a real-life spokesperson based on the qualities considered during gameplay.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Middle Eastern or North African', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Single', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}, {'title': 'Married', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'Divorced', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Widowed', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Civil Union/Domestic Partnership', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Prefer not to answer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest Level of Education', 'classes': [{'title': 'High school graduate', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Trade or professional degree', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Some college', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': "Associate's degree", 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': "Bachelor's degree", 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': "Master's degree", 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'Doctoral degree', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Healthcare worker status', 'classes': [{'title': 'Work in healthcare field', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Do not work in healthcare field', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior experience with surrogate decision-making', 'classes': [{'title': 'Has made surrogate decision for another', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Has not made surrogate decision for another', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Importance of religion or spirituality', 'classes': [{'title': 'Not at all important', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'Not very important', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Somewhat important', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Very important', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Extremely important', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Health status', 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Very good', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-17', 'size': 898551, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-14T14:49', 'hasProtocol': True}, {'date': '2021-07-12', 'size': 93942, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-14T14:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2020-10-06', 'resultsFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-05', 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Changed Their Choice of Spokesperson', 'timeFrame': '4 weeks', 'description': 'This measure involved a verbal response (during a follow-up telephone interview) to the question as to whether they have changed their choice for who should be their healthcare spokesperson in the event that someone else needed to make medical decisions for them.'}], 'secondaryOutcomes': [{'measure': 'Participation Rate', 'timeFrame': 'Aug 2021 - Dec 2022', 'description': 'Participation rate was defined as the number of participants who completed the study. This number excludes the number of participants who were enrolled but could not complete the intervention due to problems with technology (n=80).'}, {'measure': 'Spokesperson Response (Percentage)', 'timeFrame': '8 weeks', 'description': 'Percentage of spokespersons who responded to participant request following intervention'}, {'measure': 'Endorsement of the WWYC Intervention', 'timeFrame': '4 weeks', 'description': '\\>75% of WWYC participants endorse WWYC, as measured by the Net Promoter Score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surrogate decision-making', 'Healthcare spokesperson', 'Advance care planning', 'Feasibility'], 'conditions': ['Surrogate Decision-making', 'Healthcare Spokesperson', 'Advance Care Planning']}, 'descriptionModule': {'briefSummary': 'The investigators developed a "serious game" intervention called "Who Would You Choose: Serious Fun" (WWYC) to help people consider the key qualities healthcare spokespersons should have. The intervention uses a spinner, cards, and dice, along with a smart-phone App to prompt players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. Friendly competition is encouraged by having players receive points for correct answers, and additional points for good explanations of their choices. At the end of the game, players identify a real-life spokesperson based on the qualities considered during game-play. Then, using an associated smart-phone App, the intervention will help spark communication between the player and their chosen spokesperson.', 'detailedDescription': 'Advance care planning (ACP) is the process of thinking through and articulating in advance one\'s preferences for future medical care. It has long been promoted as a way for people to receive medical treatment consistent with their values, goals, and preferences. While ACP typically involves decision-making about specific life-sustaining treatments, choosing who will make medical decisions when the patient cannot is considered by many to be the single most important ACP action a person can take. When patients fail to designate a healthcare spokesperson (henceforth spokesperson), it leads to uncertainty about who will make medical decisions, what treatments are to be accepted or declined, and on what basis-which can lead to familial conflict, unwanted and costly medical care, and avoidable patient suffering. So, too, when patients choose the "wrong" person to represent them, the patient\'s wishes are less likely to be known or respected. The investigation team\'s own research suggests that when patients prefer fewer aggressive medical treatments, there is significantly lower concordance between spokespersons\' decisions and patients\' wishes.\n\nPatients, families, and ACP experts have identified several qualities as being especially important for spokespersons to have. Ideally, spokespersons should know the patient\'s values, be available when needed, be trustworthy and caring, have good judgment, and be able to stand up under pressure. That said, many individuals (and state laws) assign spokespersons on the basis of relationship (spouse, parent, etc.) rather than personal qualities. Surprisingly, no interventions (to the team\'s knowledge) are explicitly designed to help people consider the actual qualities of the person chosen as spokesperson, much less engage this individual to confirm that this person can fully represent the patient\'s wishes should the need arise.\n\nTo address these gaps, the investigative team has developed a novel intervention that includes a "serious game" to help people consider the qualities desired in a spokesperson, then engage the person they choose for this role. Combining a serious topic with an enjoyable activity ("gamification") has been effective at changing health-related behaviors in multiple settings with the target population ("sandwich generation" and older adults). The game element of the intervention, "Who Would You Choose: Serious Fun" (WWYC), prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. At the end of the game, players identify a real-life spokesperson based on the qualities considered during gameplay. Then, using an online interface, WWYC will spark communication between the player and their chosen spokesperson.\n\nThe long-term goal of this project is to help people make more thoughtful and informed choices when selecting a spokesperson, and to help these spokespersons be better prepared for the role of surrogate decision-maker. The current mixed methods study proposed here is designed to learn whether and how WWYC helps individuals select an appropriate spokesperson for healthcare decisions, as assessed via three specific aims:\n\nAim 1. To explore how playing the novel game Who Would You Choose affects people\'s choice of a spokesperson. Using qualitative methods including focus groups and one-on-one interviews, the investigative team will explore how WWYC affects individual players\' thought process for choosing a spokesperson, and whether the player\'s choice changes as a result of game-play.\n\nAim 2. To establish that WWYC is a feasible way to help individuals choose and engage a spokesperson. The investigative team will judge it feasible if: 1) 100 individuals are recruited to play the game; 2) \\>75% of game players report that playing the game is helpful for choosing a spokesperson; 3) \\>75% of game players endorse the game; 4) \\>75% of spokespersons engage with WWYC (using its online interface) following player request.\n\nAim 3. To integrate qualitative and quantitative data to explain how the experience of playing the game relates to their spokesperson\'s willingness to engage. The investigative team hypothesizes that a positive player experience with WWYC will be associated with successful engagement with their spokesperson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read and write in English\n* 18 years or older\n* Have a working smart phone\n\nExclusion Criteria:\n\n* NOT able to read and write in English\n* Younger than 18 years old\n* Does NOT have a working smart phone'}, 'identificationModule': {'nctId': 'NCT04599166', 'briefTitle': 'Choosing an Effective Healthcare Spokesperson: An Interactive Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Choosing an Effective Healthcare Spokesperson: An Interactive Intervention', 'orgStudyIdInfo': {'id': 'IR-16274'}, 'secondaryIdInfos': [{'id': 'R21NR019363', 'link': 'https://reporter.nih.gov/quickSearch/R21NR019363', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participant arm', 'description': 'Participants will be recruited to complete the WWYC intervention.', 'interventionNames': ['Behavioral: Who Would You Choose: Serious Fun']}], 'interventions': [{'name': 'Who Would You Choose: Serious Fun', 'type': 'BEHAVIORAL', 'description': '"Who Would You Choose: Serious Fun" is a conversation activity that prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. At the end of the activity, players identify a real-life spokesperson based on the qualities considered during gameplay.', 'armGroupLabels': ['Participant arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Benjamin H Levi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'At close of study in 2022.', 'ipdSharing': 'YES', 'description': 'We will present our findings at conferences and in peer-reviewed publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Benjamin H. Levi', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}