NCT04556604

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

September 18, 2020

Last Update Submit

September 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compliance to consenting practice

    The number of patients being consented for COVID-19 infection in the lead up to surgery

    3 months

Study Arms (3)

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

3

Third cycle of the audit on consenting practice to assess long term compliance

Behavioral: Educational meetings and visual prompts

Interventions

Information was disseminated to trainees via informal meeting or dedicated audit meetings with the aid of visual prompts

23

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medway NHS Foundation Trust

Gillingham, ME7 5NY, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 21, 2020

Study Start

April 10, 2020

Primary Completion

August 14, 2020

Study Completion

August 14, 2020

Last Updated

September 21, 2020

Record last verified: 2020-09

Locations