Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT03804918
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2019-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mobile Learning to Improve Clinician's Ability to Break Bad News
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gsoosaip@ic.ac.uk', 'phone': '+44 20 3312 6666', 'title': 'Dr Gehan Soosaipillai', 'phoneExt': '7651', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Sample numbers were small, which affects the interpretation of the quantitative measures (BAS mark sheet). Participants learned both from the app and the SPEs. Any change in the skill set must also take into consideration the learning from the SPEs.'}}, 'adverseEventsModule': {'timeFrame': "AE data was not collected due to it being an observational study and no AE's were anticipated.", 'description': "No AE's were expected and AE's were not monitored for this reason.", 'eventGroups': [{'id': 'EG000', 'title': 'Interventional Group: All Participants', 'description': 'Given access to a selected breaking bad news mobile learning resource (VitalTips application).\n\nVitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Group: All Participants', 'description': 'Given access to a selected breaking bad news mobile learning resource (VitalTips application).\n\nVitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.'}], 'classes': [{'title': 'Pre-intervention: Not very confident at all', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Not very confident at all', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pre-intervention: Not very confident', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Not very confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pre-intervention: Somewhat confident', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Somewhat confident', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Pre-intervention: Very confident', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Very confident', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pre-intervention: Extremely confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Extremely confident', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)', 'description': "Baseline and post-intervention questionnaires utilise a five-point Likert scale ranking of the user's confidence and agreeability with statements (Scale: Not very confident at all; Not very confident; Somewhat confident; Very confident; Extremely confident). With each participant acting as their own control, comparisons were made from their own baseline and post-intervention Likert scale ratings.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants (n=16) completed both the pre- and post-intervention questionnaires and there was no missing data.'}, {'type': 'PRIMARY', 'title': 'Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Group: All Participants', 'description': 'Given access to a selected breaking bad news mobile learning resource (VitalTips application).\n\nVitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.'}], 'classes': [{'title': 'Pre-intervention: Setting the scene', 'categories': [{'measurements': [{'value': '10.15', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Setting the scene', 'categories': [{'measurements': [{'value': '12.25', 'spread': '1.51', 'groupId': 'OG000'}]}]}, {'title': 'Pre-intervention: Breaking the news', 'categories': [{'measurements': [{'value': '13.31', 'spread': '5.06', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Breaking the news', 'categories': [{'measurements': [{'value': '20.85', 'spread': '2.66', 'groupId': 'OG000'}]}]}, {'title': 'Pre-intervention: Eliciting concerns', 'categories': [{'measurements': [{'value': '7.71', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Eliciting concerns', 'categories': [{'measurements': [{'value': '10.77', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Pre-intervention: Information giving', 'categories': [{'measurements': [{'value': '13.23', 'spread': '2.92', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Information giving', 'categories': [{'measurements': [{'value': '17.46', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Pre-intervention: General considerations', 'categories': [{'measurements': [{'value': '26.54', 'spread': '6.08', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: General considerations', 'categories': [{'measurements': [{'value': '33.58', 'spread': '3.72', 'groupId': 'OG000'}]}]}, {'title': 'Pre-intervention: Overall', 'categories': [{'measurements': [{'value': '71.15', 'spread': '17.19', 'groupId': 'OG000'}]}]}, {'title': 'Post-intervention: Overall', 'categories': [{'measurements': [{'value': '94.92', 'spread': '9.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)', 'description': 'The simulated patient encounter (SPE) was marked by three assessors using the validated Breaking bad news Assessment Schedule (BAS). The BAS comprises of five sections which group a set of skills relating to BBN. Each skill was marked on a Likert scale in the form of a numerical scale: definitely (positive) 5 \\_ 4 \\_ 3 \\_ 2 \\_ 1 not at all (negative). The five sections were: A. Setting the scene (minimum score 3; maximum score 15); B. Breaking the news (minimum score 5; maximum score 25); C. Eliciting concerns (minimum score 3; maximum score 15); D. Information giving (minimum score 4; maximum score 20); E. General considerations (minimum score 8; maximum score 40). Overall score (minimum score 23; maximum score 115). Scores from three markers were summed and a mean average was taken pre- and post-intervention for each section and overall. Paired sample t-test were used for analysis of aggregated scores s they enabled the comparison of means between pre- and post-intervention mean scores.', 'unitOfMeasure': 'score on the BAS scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants (n=16) completed both the pre- and post-intervention SPEs and there was no missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interventional Group: All Participants', 'description': 'Given access to a selected breaking bad news mobile learning resource (VitalTips application).\n\nVitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Participant did not use the app', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Interventional Group: All Participants', 'description': 'Given access to a selected breaking bad news mobile learning resource (VitalTips application).\n\nVitalTips mobile application: VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time does not impact on their clinical and academic commitments.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Specialty', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Intensive care', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Medicine', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Oncology', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Paediatrics', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Surgery', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-18', 'size': 435507, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-07-31T06:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A pre-post mixed methods pilot educational study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2019-01-07', 'resultsFirstSubmitDate': '2020-07-31', 'studyFirstSubmitQcDate': '2019-01-11', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-05', 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Self-assessed Likert Scale Relating to Confidence in Breaking Bad News at Baseline and Post-intervention.', 'timeFrame': 'Baseline questionnaire (week 0) followed by post-intervention questionnaire (weeks 4 to 6)', 'description': "Baseline and post-intervention questionnaires utilise a five-point Likert scale ranking of the user's confidence and agreeability with statements (Scale: Not very confident at all; Not very confident; Somewhat confident; Very confident; Extremely confident). With each participant acting as their own control, comparisons were made from their own baseline and post-intervention Likert scale ratings."}, {'measure': 'Change in Simulated Patient Encounter Marking Scores Related to Breaking Bad News at Baseline and Post-intervention.', 'timeFrame': 'Baseline SPE (week 0) followed by post-intervention SPE (weeks 4 to 6)', 'description': 'The simulated patient encounter (SPE) was marked by three assessors using the validated Breaking bad news Assessment Schedule (BAS). The BAS comprises of five sections which group a set of skills relating to BBN. Each skill was marked on a Likert scale in the form of a numerical scale: definitely (positive) 5 \\_ 4 \\_ 3 \\_ 2 \\_ 1 not at all (negative). The five sections were: A. Setting the scene (minimum score 3; maximum score 15); B. Breaking the news (minimum score 5; maximum score 25); C. Eliciting concerns (minimum score 3; maximum score 15); D. Information giving (minimum score 4; maximum score 20); E. General considerations (minimum score 8; maximum score 40). Overall score (minimum score 23; maximum score 115). Scores from three markers were summed and a mean average was taken pre- and post-intervention for each section and overall. Paired sample t-test were used for analysis of aggregated scores s they enabled the comparison of means between pre- and post-intervention mean scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthcare education', 'Breaking bad news', 'Digital learning'], 'conditions': ['Education']}, 'descriptionModule': {'briefSummary': 'Design:\n\nA pre-post mixed methods pilot study. All participants granted access to a breaking bad news mobile learning resource (VitalTips).\n\nBaseline and post-intervention questionnaires, pre- and post-intervention simulated patient encounters, and post-intervention semi-structured interviews.\n\nObjective:\n\nTo assess if a selected breaking bad news mobile learning resource can improve the ability of clinicians to break bad news.\n\nPopulation/Eligibility:\n\n15-20 junior doctors and nurses working within two NHS hospitals trusts and one private hospital in England.\n\nDuration:\n\n25th February 2019 to 8th July 2019.', 'detailedDescription': "Purpose:\n\nDigital and mobile learning is at the forefront of healthcare education. Though there is evidence for the use of digital learning for practical skills acquisition, there is little evidence of the use of digital learning for breaking bad news training. This pre-post mixed methods pilot study aimed to address this gap in knowledge by assessing how a mobile learning resource may impact the ability of clinicians to break bad news.\n\nHypothesis:\n\nThe addition of a breaking bad news mobile learning resource to clinical practice improves the confidence and ability of junior doctors and nurses to break bad news.\n\nStudy objective:\n\nTo assess if a breaking bad news mobile learning resource can improve the confidence and ability of clinicians to break bad news.\n\nMethodology:\n\nPotential participants were sent an invitation and participant information sheet (PIS) via e-mail. Potential participants were given up to two weeks to decide if they wanted to participate, with a reminder sent after one week. Each potential participant was referenced by a participant ID number for confidentiality purposes.\n\nOnce potential participants read the PIS and given consent, they were asked to complete a baseline questionnaire to understand their demographics, their previous exposure to breaking bad news (through formal or informal training) and their engagement with digital resources.\n\nFollowing this, participants were asked to complete a baseline simulated patient encounter (SPE) with a simulated patient (SP) (role-played by an actor) to assess their baseline ability to break bad news. Participants were given a task sheet with a brief history of the SP and what news they needed to deliver. The details and history of the SP was documented on a character sheet for the actor's reference. Each participant was given 15 minutes to complete the SPE which was video-recorded. The SPEs were evaluated against the validated Breaking bad news Assessment Schedule (BAS) mark sheet completed by the chief investigator, actor and an independent assessor (by watching the video footage).\n\nAccess to the mobile learning resource was granted following the baseline SPE. The mobile learning resource was the freely available VitalTips mobile application, provided by VitalTalks. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that this time did not impact on their clinical and academic commitments.\n\nFour to six weeks later, participants were asked to complete a second videoed SPE, which was marked as described above. The participants were asked to complete a post-intervention questionnaire to gauge the impact on their clinical practice and their engagement with the mobile resources.\n\nThe questionnaires utilised a five-point Likert scale ranking of the user's confidence and agreeability with statements. The questionnaires are novel to this study and were developed using the principles of Kirkpatrick's Model of Learning Evaluation, the Theory of Planned Behaviour and the Technology Acceptance Model, whilst also drawing on the most important curricula competencies derived from the content analysis of a sample of medical and nursing curricula followed by an expert consensus.\n\nSoon after the completion of the post-intervention questionnaire, the participants were asked to participate in a 15-30 minutes semi-structured interview with the chief investigator. The participant was asked about their general impressions of the mobile learning resource, their use of the resource in and outside of the clinical environment, their perception of their ability to break bad news before and after the intervention, their perception of their performance in the SPE and any impact on their practice.\n\nData handling and confidentiality:\n\nFollowing consent, participants were referenced by their participant ID number (e.g. MLR001). Their e-mail address was recorded next to their participant ID number, gender, role (i.e. doctor or nurse) and training grade, on an Excel spreadsheet for the purpose of contacting participants as the study progressed. Once their commitment to the study had ended, the e-mail addresses were deleted.\n\nVideo recordings from the SPEs were transferred from the recording device to a password protected USB stick referenced by the participant ID followed by SPE1 (baseline) or SPE2 (post-intervention), e.g. MLR001\\_SPE1. Once the independent reviewer had viewed the video and marked the participant, the video file was destroyed.\n\nAudio files from the interviews was transferred from the recording device onto a password protected computer using a USB stick. Once the transfer was completed, the files were deleted from the USB stick. The transferred files were stored on the password protected computer till the returned transcriptions were checked by the chief investigator. Once the files had been checked, the recordings were deleted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Working and training within NHS England and a private healthcare hospital.\n* Junior doctor, pre-certificate of completion of training (of any specialty).\n* Junior nurse band 5 to 6 (or equivalent) from any specialty.\n* Over the age of 18.\n* Able to communicate and write in English.\n* Willing to engage with mobile learning resources as an additional task to their clinical role, ensuring their learning does not take time out of their clinical commitments.\n\nExclusion Criteria:\n\n* Medical and nursing students.\n* Clinicians who have completed their training programmes i.e. medical or nursing consultants, matrons.\n* Retired clinicians.'}, 'identificationModule': {'nctId': 'NCT03804918', 'briefTitle': "Mobile Learning to Improve Clinician's Ability to Break Bad News", 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': "Mobile Learning Resources as a Tool for Improving Clinician's Ability to Break Bad News: A Pre-post Mixed Methods Pilot Study", 'orgStudyIdInfo': {'id': '18SM4947'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group: All participants', 'description': 'Given access to a selected breaking bad news mobile learning resource (VitalTips application).', 'interventionNames': ['Other: VitalTips mobile application']}], 'interventions': [{'name': 'VitalTips mobile application', 'type': 'OTHER', 'description': 'VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that the time did not impact on their clinical and academic commitments.', 'armGroupLabels': ['Interventional group: All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 2EF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW5 0TU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Bupa Cromwell Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Gehan B Soosaipillai, BM BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD was only be available on a password protected computer with sole access to the chief investigator. Only anonymised data was sent to the academic supervisor and other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}