Improving diversity in clinical research for patients undergoing surgery (PROTECT-DIVERSITY)

Diversity in perioperative research

Registry ID
ISRCTN14173025
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Queen Mary University of London
Enrollment
532
Start date
2026-03-06
Completion date
2028-08-01
Last update
2026-08-17

Conditions

Summary

Adult patients undergoing elective surgery

Detailed description

Current interventions, as of 05/08/2026: The master protocol is registered at https://www.isrctn.com/ISRCTN14639555 The method of informed consent will use either an electronic or paper method, which is consistent with the master protocol. For this comparison, the language of the consent form materials will be determined at random before approaching the patient, which includes consent for entry into the platform. Since the intervention in question is the process of consent, it will not be possible to obtain consent before the ‘intervention’ i.e. the consent process. In this case, there will be a waiver of consent to randomise to intervention or usual care (multi-lingual consent materials vs. english consent materials ). After randomisation, the patient will complete the consent process using either multi-lingual consent documents or consent documents in English, according to group allocation. This process supersedes the procedure for timing of informed consent detailed in the master protocol section nine, which will apply to consent for inclusion in the platform (master protocol) and this comparison. Electronic consent materials will be translated into Polish, Romania, Panjabi, Urdu, Portuguese and Bengali. Translations will be undertaken by an approved/certified provider _____ Previous interventions: The master protocol is registered at https://www.isrctn.com/ISRCTN14639555 The method of informed consent will use either an electronic or paper method, which is consistent with the master protocol. For this comparison, the mode of consent (electronic or paper) will be determined at random before approaching the patient, which includes consent for entry into the platform. Since the intervention in question is the process of consent, it will not be possible to obtain consent before the ‘intervention’ i.e. the consent process. In this case, there will be a waiver of consent to randomise to intervention or usual care (electronic consent or paper consent). After ran

Interventions

Inclusion criteria

1. Patients aged 18 years and over undergoing elective surgery

Exclusion criteria

1. Inability to provide informed consent 2. Co-enrolment in PROTECT CTIMP comparisons 3. Previous enrolment to the PROTECT-DIVERSITY comparison

Locations

Related clinical trials

View on source registry