Quality ImprovementNCT04493866
Quality Improvement Study on Operative Consent Forms
An observational study of Quality Improvement and Informed Consent, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality Improvement, Informed Consent
- What is being tested?
- Messages to departmental employees to improve quality of consent form completion
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2020to 20 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Operative Consent form 1 or Consent form 2 completed within the Royal London Hospital Plastic surgery department within one week of the previous intervention.
Who cannot join
- All other consent forms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality Improvement, Informed Consent
- Being tested
- Messages to departmental employees to improve quality of consent form completion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Messages to departmental employees to improve quality of consent form completionOther
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start6 Jan 2020
- Primary completion3 Feb 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality ImprovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Stodell, FRCS, Study director, Barts and the Royal London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493866
- Sponsor's protocol ID
- 287762
- Status last verified
- May 2020
- First submitted
- 22 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No sharing of participant data will take place.
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.
PubMed 25516950
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering High Quality Documentation on Operative Consent Forms; A UK Major Trauma Centre Quality Improvement Study
- ClinicalTrials.gov ID
- NCT04493866
- Acronym / sponsor ID
- 287762
- Conditions
- Quality Improvement, Informed Consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Operative Consent form 1 or Consent form 2 completed within the Royal London Hospital Plastic surgery department within one week of the previous intervention.
Key exclusion criteria (1 listed)
- All other consent forms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Messages to departmental employees to improve quality of consent form completionAll 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background: PubMed 25516950Gillon 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.
- 1\. Wai Hung Yau et al. Clinical Negligence Costs: taking action to safeguard NHS sustainability. BMJ 2020; 368 doiLink provided by the sponsor.
- 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)Link provided by the sponsor.
- 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)Link provided by the sponsor.
- 5\. Royal College of Surgeons Guidelines on Good Surgical Practice Sept 2014 section 3.5.1 'Consent'. (accessed 4th July 2020)Link provided by the sponsor.
- 6\. Institute for Healthcare Improvement; Quality Improvement Essentials Toolkit. (accessed 4th July 2020)Link provided by the sponsor.
- 7\. General Medical Council: Consent: patients and doctors making decisions together. June 2008. Sections 44-49. (accessed 3rd July 2020)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. No sharing of participant data will take place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Stodell, FRCS study director
Barts and the Royal London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality Improvement and Informed Consent, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Legibility of consent forms (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04493866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.