Patient SatisfactionNCT04024189
Patient Experience of Consent for Cancer Surgery in Light of Recent Changes to UK Law- a Questionnaire Study
An observational study of Patient Satisfaction, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Since the 2015 Montgomery vs Lanarkshire Health Board ruling, the consent process in the UK has had to change. In practice, this means that doctors must ask themselves whether the patient knows about the material risks of the treatment being proposed, alternatives to the treatment, and whether reasonable care has been… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Survey
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2018to 10 Aug 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing surgery during a 6 week period at The Christie NHS Foundation Trust
Who may be able to join
- All patients who have been admitted and undergone surgery within a 6 week period between April - June 2018.
Who cannot join
- Any patient who could not complete the survey questionnaire i.e. English was not their first language or to unwell to complete.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Audit of Informed Consent of Patients Undergoing Surgery
Since the 2015 Montgomery vs Lanarkshire Health Board ruling, the consent process in the UK has had to change. In practice, this means that doctors must ask themselves whether the patient knows about the material risks of the treatment being proposed, alternatives to the treatment, and whether reasonable care has been taken to ensure the patient actually knows this. This study aims to determine patients' perspectives of consent for major cancer surgery in light of the Lanarkshire ruling.
Read the detailed description
A patient satisfaction survey was administered to patients who had undergone urological, gynaecological, colorectal, and plastic surgical procedures at a specialised cancer centre where changes to consent processes in light of the Lanarkshire ruling had been implemented.
- Conditions
- Patient Satisfaction
- Being tested
- Survey
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Patients were given a questionnaire/survey to complete in respect of their satisfaction of the consent process for their surgical procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients understanding of the risks associated with the procedure they will be having and the alternatives available to them was assessed using a study specific questionnaire.
Was the patient made aware by the clinical care team of the risks associated with their procedure and the alternatives available to them. Were they able to make an informed choice. This will be measured using a patient questionnaire
Measured: 6 weeks
Patients views and feelings regarding their experiences in relation to support from healthcare professionals was assessed using a study specific patient questionnaire.
Did patients feel that healthcare professionals provided them with sufficient information and support to make an informed decision in respect of their procedure. This will be measured using a questionnaire completed by patients.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Apr 2018
- Primary completion30 Jun 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omer Aziz, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024189
- Sponsor's protocol ID
- 18/2117
- Status last verified
- Jul 2019
- First submitted
- 14 Jun 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audit of Informed Consent of Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT04024189
- Acronym / sponsor ID
- 18/2117
- Conditions
- Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 18 Jul 2019 (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.
Since the 2015 Montgomery vs Lanarkshire Health Board ruling, the consent process in the UK has had to change. In practice, this means that doctors must ask themselves whether the patient knows about the material risks of the treatment being proposed, alternatives to the treatment, and whether reasonable care has been taken to ensure the patient actually knows this. This study aims to determine patients' perspectives of consent for major cancer surgery in light of the Lanarkshire ruling.
Detailed description
A patient satisfaction survey was administered to patients who had undergone urological, gynaecological, colorectal, and plastic surgical procedures at a specialised cancer centre where changes to consent processes in light of the Lanarkshire ruling had been implemented.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery during a 6 week period at The Christie NHS Foundation Trust
Key inclusion criteria (1 listed)
- All patients who have been admitted and undergone surgery within a 6 week period between April - June 2018.
Key exclusion criteria (1 listed)
- Any patient who could not complete the survey questionnaire i.e. English was not their first language or to unwell to complete.
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 |
|---|---|---|
| SurveyPatients were given a questionnaire/survey to complete in respect of their satisfaction of the consent process for their surgical procedure | Other | – |
Primary outcome
Patients understanding of the risks associated with the procedure they will be having and the alternatives available to them was assessed using a study specific questionnaire.
Time frame: 6 weeks
Was the patient made aware by the clinical care team of the risks associated with their procedure and the alternatives available to them. Were they able to make an informed choice. This will be measured using a patient questionnaire
Patients views and feelings regarding their experiences in relation to support from healthcare professionals was assessed using a study specific patient questionnaire.
Time frame: 6 week
Did patients feel that healthcare professionals provided them with sufficient information and support to make an informed decision in respect of their procedure. This will be measured using a questionnaire completed by patients.
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 18 Jul 2019.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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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.
Omer Aziz principal investigator
The Christie NHS Foundation 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 Patient Satisfaction, run by The Christie NHS Foundation 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 18 Jul 2019. 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?
Patients understanding of the risks associated with the procedure they will be having and the alternatives available to them was assessed using a study specific questionnaire. (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2019.