Quality Improvement Study on Operative Consent Forms

NCT04493866 | Completed

• 1 other identifier: 287762
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality Improvement; Informed Consent

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

Messages to departmental employees to improve quality of consent form completion OTHER

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• All other consent forms

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

BartsLondonNHS

London, E1 1FR, United Kingdom

Location

Related 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.

  PMID: 25516950 BACKGROUND

Related 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)

Study Officials

• Matthew Stodell, FRCS

  Barts and the Royal London NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 30, 2020
• Study Start: January 6, 2020
• Primary Completion: February 3, 2020
• Study Completion: June 20, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)