Quality Improvement Study on Operative Consent Forms

Quality Improvement Clinical Trial

Official title:

Delivering High Quality Documentation on Operative Consent Forms; A UK Major Trauma Centre Quality Improvement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04493866
• Other study ID #: 287762
• Status: Completed
• Start date: January 6, 2020
• Est. completion date: June 20, 2020

Study information

• Verified date: May 2020
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 20, 2020
• Est. primary completion date: February 3, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Informed Consent
• Quality Improvement

Intervention

Other:
• Messages to departmental employees to improve quality of consent form completion
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.

Locations

Country	Name	City	State
United Kingdom	BartsLondonNHS	London

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. Erratum in: J Med Ethics. 2015 Jun;41(6):446. J Med Ethics. 2015 Oct;41(10):829. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	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	4 weeks
Primary	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	4 weeks

External Links

•   1. Wai Hung Yau et al. Clinical Negligence Costs: taking action to safeguard NHS sustainability. BMJ 2020; 368 doi
•   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)
•   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)
•   5. Royal College of Surgeons Guidelines on Good Surgical Practice Sept 2014 section 3.5.1 'Consent'. (accessed 4th July 2020)
•   6. Institute for Healthcare Improvement; Quality Improvement Essentials Toolkit. (accessed 4th July 2020)