Quality Improvement Study on Operative Consent Forms

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

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.

Study Overview

• Status: Completed
• Conditions: Quality Improvement; Informed Consent
• Intervention / Treatment: Other: Messages to departmental employees to improve quality of consent form completion

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 1FR
    • BartsLondonNHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Investigators: Study Director: Matthew Stodell, FRCS, Barts and the Royal London NHS Trust

Publications and helpful links

General Publications

• 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.

Helpful 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)
• 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 record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2020
• Primary Completion (ACTUAL): February 3, 2020
• Study Completion (ACTUAL): June 20, 2020

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 287762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: No sharing of participant data will take place.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No