<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493866</url>
  </required_header>
  <id_info>
    <org_study_id>287762</org_study_id>
    <nct_id>NCT04493866</nct_id>
  </id_info>
  <brief_title>Quality Improvement Study on Operative Consent Forms</brief_title>
  <official_title>Delivering High Quality Documentation on Operative Consent Forms; A UK Major Trauma Centre Quality Improvement Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barts &amp; The London NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Quality Improvement Project was undertaken to improve the completion of operative consent&#xD;
      forms within a UK hospital plastic surgery department. Four weekly interventions were made&#xD;
      which were accompanied by four further data collection cycles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Royal College of Surgeons guidelines exist on the importance of full, accurate and&#xD;
      legible completion of consent forms as a key part of the process of gaining informed consent.&#xD;
      In addition to this, consent forms serve as an important medico-legal document to protect&#xD;
      clinicians and patients should problems arise. It is therefore in all parties' interests that&#xD;
      they are correctly completed.&#xD;
&#xD;
      It was noted that consent forms within the Royal London Hospital Plastic Surgery department&#xD;
      were often not correctly completed. A Quality Improvement Project was undertaken to improve&#xD;
      the completion of consent forms within the department.&#xD;
&#xD;
      Materials and Methods Common problem areas on consent forms were identified and QI&#xD;
      methodology was used to design the study including selection of appropriate outcome, process&#xD;
      and balancing measures. Baseline information on completion of: 1) patient details, 2)&#xD;
      consultant details, 3) legibility, 4) use of abbreviations in description of&#xD;
      operation/complications, and 5) patient signatures was collected. Four weekly interventions&#xD;
      were made which were accompanied by four further data collection cycles. A further re-audit&#xD;
      took place 4 months following the completion of the project to establish whether improvements&#xD;
      had been sustained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2020</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">February 3, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Legibility of consent forms</measure>
    <time_frame>4 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Full population of patient signature, writing of name and dating of operative consent form</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of operative consent forms with full population of: patient signature + patient writing of name + patient dating of operative consent form</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Omission of all abbreviations from written description of operation + risks of operation + benefits of operation on operative consent form</measure>
    <time_frame>4 weeks</time_frame>
    <description>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</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Quality Improvement</condition>
  <condition>Informed Consent</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Messages to departmental employees to improve quality of consent form completion</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The operative consent form of any adult or paediatric patient consented for an operative&#xD;
        procedure within the Royal London Hospital Plastic surgery department within the time frame&#xD;
        of the Quality Improvement Project.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Operative Consent form 1 or Consent form 2 completed within the Royal London Hospital&#xD;
             Plastic surgery department within one week of the previous intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All other consent forms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Matthew Stodell, FRCS</last_name>
    <role>Study Director</role>
    <affiliation>Barts and the Royal London NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BartsLondonNHS</name>
      <address>
        <city>London</city>
        <zip>E1 1FR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.1136/bmj.m552</url>
    <description>1. Wai Hung Yau et al. Clinical Negligence Costs: taking action to safeguard NHS sustainability. BMJ 2020; 368 doi</description>
  </link>
  <link>
    <url>https://www.rcseng.ac.uk/news-and-events/media-centre/press-releases/surgeons-warn-nhs-failing-to-implement-patient-consent-rules/</url>
    <description>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)</description>
  </link>
  <link>
    <url>https://www.rcseng.ac.uk/standards-and-research/gsp/domain-3/3-5-1-consent/</url>
    <description>5. Royal College of Surgeons Guidelines on Good Surgical Practice Sept 2014 section 3.5.1 'Consent'. (accessed 4th July 2020)</description>
  </link>
  <link>
    <url>http://www.ihi.org/resources/Pages/Tools/Quality-Improvement-Essentials-Toolkit.aspx</url>
    <description>6. Institute for Healthcare Improvement; Quality Improvement Essentials Toolkit. (accessed 4th July 2020)</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>25516950</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>No sharing of participant data will take place.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493866
org study id: 287762
nct id: NCT04493866
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Retrospective
measure: Legibility of consent forms
time frame: 4 weeks
description: 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.
measure: Full population of patient signature, writing of name and dating of operative consent form
time frame: 4 weeks
description: Number of operative consent forms with full population of: patient signature + patient writing of name + patient dating of operative consent form
measure: Omission of all abbreviations from written description of operation + risks of operation + benefits of operation on operative consent form
time frame: 4 weeks
description: 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
intervention type: Other
intervention name: Messages to departmental employees to improve quality of consent form completion
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Matthew Stodell, FRCS
role: Study Director
affiliation: Barts and the Royal London NHS Trust
facility: 
country: United Kingdom
url: https://doi.org/10.1136/bmj.m552
description: 1. Wai Hung Yau et al. Clinical Negligence Costs: taking action to safeguard NHS sustainability. BMJ 2020; 368 doi
url: https://www.rcseng.ac.uk/news-and-events/media-centre/press-releases/surgeons-warn-nhs-failing-to-implement-patient-consent-rules/
description: 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)
url: https://www.rcseng.ac.uk/standards-and-research/gsp/domain-3/3-5-1-consent/
description: 5. Royal College of Surgeons Guidelines on Good Surgical Practice Sept 2014 section 3.5.1 'Consent'. (accessed 4th July 2020)
url: http://www.ihi.org/resources/Pages/Tools/Quality-Improvement-Essentials-Toolkit.aspx
description: 6. Institute for Healthcare Improvement; Quality Improvement Essentials Toolkit. (accessed 4th July 2020)
citation: 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.
PMID: 25516950
responsible party type: Sponsor
sharing ipd: Yes
ipd description: No sharing of participant data will take place.