Quality Improvement Study on Operative Consent Forms

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.

Completed

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Key information

Conditions

Quality Improvement Informed Consent

Sex eligibility

All sexes

Study type

Observational

Primary location

BartsLondonNHS

London, E1 1FR, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Legibility of consent forms

Time frame: 4 weeks

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.
Full population of patient signature, writing of name and dating of operative consent form

Time frame: 4 weeks

Number of operative consent forms with full population of: patient signature + patient writing of name + patient dating of operative consent form
Omission of all abbreviations from written description of operation + risks of operation + benefits of operation on operative consent form

Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jul 30, 2020
Registry last updated: Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed