The CLARITY Trial will be jointly delivered by the West Midlands Research Collaborative (WMRC) and STARSurg. Both groups have extensive experience in conducting multicentre surgical research studies and audits through their networks. The e-learning package for the educational intervention was developed with support from Surgigogy.
The study teams at each site will consist of at least four collaborators who are staff members and one medical student, generally the STARSurg Regional Lead.
Care of the emergency general surgical patient involves a multidisciplinary team, including surgical specialties, anaesthetics, radiology, nursing and allied healthcare professionals. Many of the best practice learning points from the CLARITY educational intervention will relate to these different specialties and professionals. To best implement the educational intervention, the CLARITY team must include two consultant surgeons, at least one surgical trainee, and at least one radiologist, anaesthetist or nurse practitioner. The team can include any number of members beyond this from any profession, including students. This may include radiographers, physician associates and clinical support workers who work in surgical emergency / surgical assessment centres.
Each centre will also have a medical student Regional Lead selected through a competitive process by the STARSurg Steering Committee. The Regional Leads will be an invaluable resource in the research team, allowing for timely study progression, clarification of minor questions or issues, independent data collection and medical student collaborator recruitment. Medical students will be integral in collecting data in two phases using the REDCap software. They will be expected to fill out patient case report forms after admission, including data on presentation, investigations and management. Additionally, they will follow patients up 30 days after admission and collate this data on REDCap for data completeness. Their contributions will be recognised in future publications based on the authorship rules described in this protocol. Contact details of the Regional Leads are listed here.
All members of the CLARITY study team at each site are eligible for inclusion in co-authorship on any arising publications, provided they have materially contributed to at least one of the following:
- Gaining research and development / Caldicott guardian approvals.
- Implementing the educational intervention at the site (i.e. arranging for departmental teaching within surgical and radiology departments).
- Capturing data (entered under their login into REDCap).
- Data validation (validating the data or being an independent consultant for verifying this data).