Surgical Consent During the COVID-19 Pandemic

September 18, 2020 updated by: Oloruntobi Rotimi, Medway Primary Care Trust

Consent for Surgery During the COVID-19 Pandemic

Multiloop audit of consenting practice in surgical procedures during the COVID-19 pandemic

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Gillingham, United Kingdom, ME7 5NY
        • Medway NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adults presenting with general surgical, vascular or breast surgical issues that require surgical intervention

Description

Exclusion Criteria:

  • Children (under 18 years old)
  • Participants who lack capacity and therefore cannot be consented appropriately

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Behavioral: Educational meetings and visual prompts
Information was disseminated to trainees via informal meeting or dedicated audit meetings with the aid of visual prompts
3
Third cycle of the audit on consenting practice to assess long term compliance
Behavioral: Educational meetings and visual prompts
Information was disseminated to trainees via informal meeting or dedicated audit meetings with the aid of visual prompts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance to consenting practice
Time Frame: 3 months
The number of patients being consented for COVID-19 infection in the lead up to surgery
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medway Primary Care Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2020

Primary Completion (Actual)

August 14, 2020

Study Completion (Actual)

August 14, 2020

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021.016N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

On request, IPD may be shared. This will include anonymised data collected during the study period

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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