Quality Improvement Study on Operative Consent Forms

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Quality Improvement, Informed Consent

Intervention / Treatment
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* Other: Messages to departmental employees to improve quality of consent form completion


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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 |