An observational study in Quality Improvement and Informed Consent, sponsored by Barts & The London NHS Trust. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2020-07-30.
Sponsored by Barts & The London NHS Trust · Observational
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.
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.
It 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.
Materials 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.
Barts & The London NHS Trust is the lead sponsor of 149 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Legibility of consent forms
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.
Time frame: 4 weeks
Full population of patient signature, writing of name and dating of operative consent form
Number of operative consent forms with full population of: patient signature + patient writing of name + patient dating of operative consent form
Time frame: 4 weeks
Omission of all abbreviations from written description of operation + risks of operation + benefits of operation on operative consent form
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
Time frame: 4 weeks
Plan to share: Yes — No sharing of participant data will take place.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Barts & The London NHS Trust