ConsentNCT04556604
Surgical Consent During the COVID-19 Pandemic
An observational study of Consent, run by Medway Primary Care Trust at 1 site in United Kingdom.
Trial summary
Multiloop audit of consenting practice in surgical procedures during the COVID-19 pandemic Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Consent
- What is being tested?
- Educational meetings and visual prompts
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Apr 2020to 14 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults presenting with general surgical, vascular or breast surgical issues that require surgical intervention
Who may be able to join
None listed.
Who cannot join
- Children (under 18 years old)
- Participants who lack capacity and therefore cannot be consented appropriately
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consent for Surgery During the COVID-19 Pandemic
Multiloop audit of consenting practice in surgical procedures during the COVID-19 pandemic
- Conditions
- Consent
- Being tested
- Educational meetings and visual prompts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational meetings and visual promptsBehavioural
Information was disseminated to trainees via informal meeting or dedicated audit meetings with the aid of visual prompts
| Study group | Role | What they receive |
|---|---|---|
| 1 | First cycle of the audit on consenting practice pre intervention | |
| 2 | Second cycle of the audit on consenting practice to assess change following intervention Receives: Behavioral: Educational meetings and visual prompts | |
| 3 | Third cycle of the audit on consenting practice to assess long term compliance Receives: Behavioral: Educational meetings and visual prompts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to consenting practice
The number of patients being consented for COVID-19 infection in the lead up to surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start10 Apr 2020
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConsentStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medway Primary Care Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oloruntobi Rotimi, Medway Primary Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556604
- Sponsor's protocol ID
- 2021.016N
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: On request, IPD may be shared. This will include anonymised data collected during the study period
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consent for Surgery During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04556604
- Acronym / sponsor ID
- 2021.016N
- Conditions
- Consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medway Primary Care TrustOther government
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 21 Sep 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.
Multiloop audit of consenting practice in surgical procedures during the COVID-19 pandemic
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –First cycle of the audit on consenting practice pre intervention |
| 2 | – | Behavioral: Educational meetings and visual promptsSecond cycle of the audit on consenting practice to assess change following intervention |
| 3 | – | Behavioral: Educational meetings and visual promptsThird cycle of the audit on consenting practice to assess long term compliance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults presenting with general surgical, vascular or breast surgical issues that require surgical intervention
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Children (under 18 years old)
- Participants who lack capacity and therefore cannot be consented appropriately
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 |
|---|---|---|
| Educational meetings and visual promptsInformation was disseminated to trainees via informal meeting or dedicated audit meetings with the aid of visual prompts | Behavioural | 2, 3 |
Primary outcome
Compliance to consenting practice
Time frame: 3 months
The number of patients being consented for COVID-19 infection in the lead up to surgery
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 21 Sep 2020.
- Individual participant dataSharing planned: Undecided. On request, IPD may be shared. This will include anonymised data collected during the study period
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Consent, run by Medway Primary Care 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 0 inclusion and 2 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 21 Sep 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?
Compliance to consenting practice (time frame: 3 months). 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 21 Sep 2020.