Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-05 @ 5:35 PM
Study NCT ID:
NCT04493866
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2020-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality Improvement Study on Operative Consent Forms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Legibility of consent forms', 'timeFrame': '4 weeks', 'description': 'Number of operative consent forms that are overall legible (rather than illegible) as assessed by 2 members of the quality improvement team. In cases of differing of opinion on legibility a third member the team to assess.'}, {'measure': 'Full population of patient signature, writing of name and dating of operative consent form', 'timeFrame': '4 weeks', 'description': 'Number of operative consent forms with full population of: patient signature + patient writing of name + patient dating of operative consent form'}, {'measure': 'Omission of all abbreviations from written description of operation + risks of operation + benefits of operation on operative consent form', 'timeFrame': '4 weeks', 'description': 'Number of operative consent forms with: omission of all abbreviations from written description of operation / risks of operation / benefits of operation fields on operative consent form'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality Improvement', 'Informed Consent']}, 'referencesModule': {'references': [{'pmid': '25516950', 'type': 'BACKGROUND', 'citation': 'Gillon R. Defending the four principles approach as a good basis for good medical practice and therefore for good medical ethics. J Med Ethics. 2015 Jan;41(1):111-6. doi: 10.1136/medethics-2014-102282.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1136/bmj.m552', 'label': '1\\. Wai Hung Yau et al. Clinical Negligence Costs: taking action to safeguard NHS sustainability. BMJ 2020; 368 doi'}, {'url': 'https://publications.parliament.uk/pa/cm201719/cmselect/cmpubacc/397/397.pdf', 'label': '2\\. House of Commons Committee of public accounts. Managing the costs of clinical negligence in hospital trusts. Fifth report of session 2017-2019. (accessed 4th July 2020)'}, {'url': 'https://www.rcseng.ac.uk/news-and-events/media-centre/press-releases/surgeons-warn-nhs-failing-to-implement-patient-consent-rules/', 'label': '2\\. House of Commons Committee of public accounts. Managing the costs of clinical negligence in hospital trusts. Fifth report of session 2017-2019. (accessed 4th July 2020)'}, {'url': 'https://www.rcseng.ac.uk/standards-and-research/gsp/domain-3/3-5-1-consent/', 'label': "5\\. Royal College of Surgeons Guidelines on Good Surgical Practice Sept 2014 section 3.5.1 'Consent'. (accessed 4th July 2020)"}, {'url': 'http://www.ihi.org/resources/Pages/Tools/Quality-Improvement-Essentials-Toolkit.aspx', 'label': '6\\. Institute for Healthcare Improvement; Quality Improvement Essentials Toolkit. (accessed 4th July 2020)'}]}, 'descriptionModule': {'briefSummary': 'A Quality Improvement Project was undertaken to improve the completion of operative consent forms within a UK hospital plastic surgery department. Four weekly interventions were made which were accompanied by four further data collection cycles.', 'detailedDescription': "Background Royal College of Surgeons guidelines exist on the importance of full, accurate and legible completion of consent forms as a key part of the process of gaining informed consent. In addition to this, consent forms serve as an important medico-legal document to protect clinicians and patients should problems arise. It is therefore in all parties' interests that they are correctly completed.\n\nIt was noted that consent forms within the Royal London Hospital Plastic Surgery department were often not correctly completed. A Quality Improvement Project was undertaken to improve the completion of consent forms within the department.\n\nMaterials and Methods Common problem areas on consent forms were identified and QI methodology was used to design the study including selection of appropriate outcome, process and balancing measures. Baseline information on completion of: 1) patient details, 2) consultant details, 3) legibility, 4) use of abbreviations in description of operation/complications, and 5) patient signatures was collected. Four weekly interventions were made which were accompanied by four further data collection cycles. A further re-audit took place 4 months following the completion of the project to establish whether improvements had been sustained."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The operative consent form of any adult or paediatric patient consented for an operative procedure within the Royal London Hospital Plastic surgery department within the time frame of the Quality Improvement Project.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operative Consent form 1 or Consent form 2 completed within the Royal London Hospital Plastic surgery department within one week of the previous intervention.\n\nExclusion Criteria:\n\n* All other consent forms'}, 'identificationModule': {'nctId': 'NCT04493866', 'briefTitle': 'Quality Improvement Study on Operative Consent Forms', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'Delivering High Quality Documentation on Operative Consent Forms; A UK Major Trauma Centre Quality Improvement Study', 'orgStudyIdInfo': {'id': '287762'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Messages to departmental employees to improve quality of consent form completion', 'type': 'OTHER', 'description': 'All interventions directed to members of the plastic surgery department: Intervention 1: Poster illustration common mistakes on consent forms. Intervention 2: Group message explaining Quality Improvement Project to the department. Intervention 3: Email from Consultant lead in support of project. Intervention 4: Further group message illustrating gains and ongoing goals of the project.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 1FR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'BartsLondonNHS', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Matthew Stodell, FRCS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Barts and the Royal London NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'No sharing of participant data will take place.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}