Clinical trial NCT04493866: Quality Improvement Study on Operative Consent Forms
Official title: Delivering High Quality Documentation on Operative Consent Forms; A UK Major Trauma Centre Quality Improvement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality Improvement
Informed Consent
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Operative Consent form 1 or Consent form 2 completed within the Royal London Hospital Plastic surgery department within one week of the previous intervention.

Exclusion Criteria:

* All other consent forms

Primary outcomes:
measure: Legibility of consent forms
timeFrame: 4 weeks
measure: Full population of patient signature, writing of name and dating of operative consent form
timeFrame: 4 weeks
measure: Omission of all abbreviations from written description of operation + risks of operation + benefits of operation on operative consent form
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: BartsLondonNHS
Study officials:
affiliation: Barts and the Royal London NHS Trust
name: Matthew Stodell, FRCS
role: STUDY_DIRECTOR
References:
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.