Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-31 @ 5:02 AM
Study NCT ID:
NCT04002557
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2019-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Optimising Consultation Summaries to Promote Good Health
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anastassija@hotmail.com', 'phone': '07508775892', 'title': 'Ms Ann-Eneli Allas', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'Semi-structure interview on a non-sensitive topic, risk of adverse events is minimal', 'eventGroups': [{'id': 'EG000', 'title': 'Semi-structured Interview', 'description': "This is a qualitative study using semi-structured interviews with young people aged 12-18 who are receiving consultation summaries.\n\nPatients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds.\n\nInterviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant.\n\nNo intervention: Interviews contain no intervention, purely observational.", 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Completed Interviews About Consultation Summaries They Were Receiving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Semi-structured Interview', 'description': "This is a qualitative study using semi-structured interviews with young people aged 12-18 who are receiving consultation summaries.\n\nPatients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds.\n\nInterviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant.\n\nNo intervention: Interviews contain no intervention, purely observational."}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Semi-structured Interview', 'description': "This is a qualitative study using semi-structured interviews with young people aged 12-18 who are receiving consultation summaries.\n\nPatients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds.\n\nInterviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant.\n\nNo intervention: Interviews contain no intervention, purely observational."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Semi-Structured Interview', 'description': "This is a qualitative study using semi-structured interviews with young people aged 12-18 who are receiving consultation summaries.\n\nPatients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds.\n\nInterviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant.\n\nNo intervention: Interviews contain no intervention, purely observational."}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age between 15 and 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Participant's age was recorded", 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Participant's gender was collected", '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.'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-11-25', 'size': 247136, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-27T12:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2019-06-17', 'resultsFirstSubmitDate': '2021-09-27', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-10', 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Completed Interviews About Consultation Summaries They Were Receiving', 'timeFrame': '1 month', 'description': 'The aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'clinic letter', 'clinic summary', 'post-consultation letter'], 'conditions': ['Type1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '15499057', 'type': 'BACKGROUND', 'citation': 'Bartle DG, Diskin L, Finlay F. Copies of clinic letters to the family. Arch Dis Child. 2004 Nov;89(11):1032-3. doi: 10.1136/adc.2004.051938.'}, {'pmid': '18222056', 'type': 'BACKGROUND', 'citation': 'Baxter S, Farrell K, Brown C, Clarke J, Davies H. Where have all the copy letters gone? A review of current practice in professional-patient correspondence. Patient Educ Couns. 2008 May;71(2):259-64. doi: 10.1016/j.pec.2007.12.002. Epub 2008 Jan 25.'}, {'pmid': '16824259', 'type': 'BACKGROUND', 'citation': 'Harris C, Boaden R. Copying letters to patients: the view of patients and health professionals. J Health Serv Res Policy. 2006 Jul;11(3):133-40. doi: 10.1258/135581906777641712.'}, {'pmid': '12724430', 'type': 'BACKGROUND', 'citation': "Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available."}, {'pmid': '12431168', 'type': 'BACKGROUND', 'citation': 'Chan Y, Irish JC, Wood SJ, Rotstein LE, Brown DH, Gullane PJ, Lockwood GA. Patient education and informed consent in head and neck surgery. Arch Otolaryngol Head Neck Surg. 2002 Nov;128(11):1269-74. doi: 10.1001/archotol.128.11.1269.'}, {'pmid': '26054649', 'type': 'BACKGROUND', 'citation': "Lawton J, Waugh N, Noyes K, Barnard K, Harden J, Bath L, Stephen J, Rankin D. Improving communication and recall of information in paediatric diabetes consultations: a qualitative study of parents' experiences and views. BMC Pediatr. 2015 Jun 10;15:67. doi: 10.1186/s12887-015-0388-6."}, {'pmid': '10139411', 'type': 'BACKGROUND', 'citation': "Waterston T, San Lazaro C. Sending parents outpatient letters about their children: parents' and general practitioners' views. Qual Health Care. 1994 Sep;3(3):142-6. doi: 10.1136/qshc.3.3.142."}, {'type': 'BACKGROUND', 'citation': 'A new series starts: the ABC of adolescence. (2005). BMJ, 330(7486).'}], 'seeAlsoLinks': [{'url': 'http://webarchive.nationalarchives.gov.uk/+/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4007561', 'label': 'Good Practice Guidelines - Department of Health, 2004'}]}, 'descriptionModule': {'briefSummary': "Patient participation in decision making about their care promotes patient satisfaction and confidence. Further more, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding.\n\nLittle is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries.\n\nThis research aims explore the views of adolescent patients related to consultation summaries that they receive following a doctor's appointment. The investigator will use patients attending a specialist diabetes clinic as our cohort and conduct a qualitative study using focus groups.", 'detailedDescription': "Patient participation in decision making processes about their care promotes patient satisfaction and confidence. As part of this, allowing patients to see letters written about them enables trust, encourages patients to be involved in decision making process and allow patient understanding. Given this, the 2000 NHS plan made it a requirement that all medical correspondence between health professionals is shared with patients.\n\nIt is estimated that 40-80% of information discussed during a consultation is forgotten immediately. Written summaries have shown to be an effective method of improving patient recall of information by 20.8%.\n\nThe literature on the benefits/disadvantages of consultation summaries is largely focused on adult patients with little research done to explore the views of adolescent population. Where the patient is a child, the literature is only focussed on parents of children and not the children themselves. Limited research has shown that parents/care givers report clinic letters being useful in assisting with better understanding and management of their child's condition.\n\nLittle is known about how young people value these letters in the same way. Only one brief questionnaire study focused on adolescent views and found that young people wished to receive consultation summaries.\n\nAdolescence is an important time of an individual's life. This is the time when many independent health behaviours are established. During adolescence, young people start showing more interest in their own health and often wish to participate in decision making processes regarding their care. The role of health workers at this stage is to appreciate young people as individuals . Clinic summaries addressed directly to young people might play an important role in assisting with establishment of health behaviours and promoting good health in young people.\n\nThe aim of this research is to understand the views of adolescent patients on consultation summaries and identify factors can improve these summaries and subsequently their health and well-being."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young people aged 12-18 years attending a single diabetes outpatient clinic were invited to enrol. This clinic served patients from a wide geographical area across London and the South-East England with broad socio-economic status, diabetes control and ethnicity.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents aged 12-18 years attending UCLH adolescent diabetes outpatient clinic\n\nExclusion Criteria:\n\n* Young people who cannot speak English (effective communication with colleagues during the study is the major aspect of valid data collection)\n* Young people who refuse to participate in focus group discussions'}, 'identificationModule': {'nctId': 'NCT04002557', 'acronym': 'ONSET', 'briefTitle': 'Optimising Consultation Summaries to Promote Good Health', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Optimising Consultation Summaries to Promote Good Health/Views of Adolescents Attending Diabetes Clinic', 'orgStudyIdInfo': {'id': '18IC4465'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Focus group', 'description': "This is a qualitative study using focus group discussions with young people aged 12-18 who are receiving consultation summaries.\n\nPatients attending a single diabetes service will be invited to enrol. This service serves a population from a wide geographic area and socio-economic backgrounds.\n\nInterviews will be conducted by a qualitative researcher with relevant experience. They will be held on the day of a participant's clinic appointment within the same hospital or on the day agreed with the participant.", 'interventionNames': ['Other: Interview-Questionnaire']}], 'interventions': [{'name': 'Interview-Questionnaire', 'type': 'OTHER', 'description': 'Questionnaire', 'armGroupLabels': ['Focus group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'David Inwald', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}