Comparing two methods of site initiation for centres recruiting patients into a surgical trial

Plain English summary of protocol

Background and study aims
Randomised controlled trials (RCTs) can be problematic and complicated to set up, and often suffer from problems with slow recruitment; limiting the potential for meaningful conclusions to be drawn from studies. A key problem that has been identified in the setting up phase of RCTs relates to the delays that can occur prior to submission for R&D approval.
Preliminary contact with trial sites prior to R&D application provides the opportunity to discuss the trial rationale and design, finalise local arrangements and obtain any additional information that may be necessary for R&D approval. Two methods of preliminary site initiation have been adopted in surgical trials to date (on-site visits and remote initiation), however the effectiveness of these methods is unclear as similarly long time delays to R&D approval and patient recruitment have been reported across studies despite variations in
approach.
This study aims to investigate the cost-effectiveness of these two approaches to preliminary initiation of sites being set up to recruit patients into a multi-centre randomised controlled trial in orthopaedic surgery.

Who can participate?
Sites being set-up to recruit patients into an orthopaedic surgery trial will be included and blinded to their involvement in order to prevent any change in attitudes towards site set up and recruitment. The hospital site of the Chief Investigator and trial sponsor will be excluded from this study as this site is not only involved in recruitment but is substantially involved in setting up the trial in general.

What does the study involve?
At first point of contact, sites will be randomised to receive either on-site initiation visits or remote initiation via email and telephone correspondence. Sites will be randomly allocated on a 1:1 ratio and minimisation will be used to ensure the groups are balanced in terms of important characteristics that may impact on a site’s ability to get set up and recruit: 1) whether the principal investigator has previous experience of working on a multi-centre surgical RCT, 2) whether the site has a research nurse in place, 3) the size of the hospital catchment area.
Initiation contact with sites will be standardised using a detailed site initiation checklist to ensure comparability of discussions across trial arms. A detailed record of costs associated with each trial arm will be kept using the main trial database (e.g. number of
telephone calls, emails, visit costs and time).
A range of outcomes will be measured to assess the effectiveness of on-site versus remote initiation, such as time to R&D submission and approval, recruitment and screening activity at sites, and subsequent data collection for recruited patients. The costs associated with each approach will also be examined using information about the researcher’s time use and travel costs of each trial arm. Research nurse’s and local PI’s opinions and satisfaction with set up processes, recruitment and data collection will also be explored using a follow-up survey.

What are the possible benefits and risks of participating?
Both approaches are commonly used to set up sites in RCTs and we do not anticipate any negative implications for patients as all sites will receive the same amount of training in trial procedures when setting up the site after R&D approval.
Should sites be randomised to the ‘remote initiation group’ and subsequently the local site Principal Investigator feel that they would benefit from face to face contact to discuss the trial, this will take place and the site will remain in the study and be analysed under the
assumptions of intention to treat.
Recruitment at sites will be monitored on an on-going basis by the trial co-ordinators and at regular Trial Management Group meetings. If the trial is not meeting recruitment targets and monitoring indicates substantial differences in recruitment rates at sites in either trial arm, a decision may be taken to end the study so as not to jeopardise patient recruitment in the main trial.

Where is the study from?
Hospital sites from across the UK will be included.

When is the study starting and how long is it expected to run for?
May 2013 until March 2017

Who is funding the study?
The NIHR Health Technology Assessment Programme (HTA), UK.

Who is the main contact?
Laura Jefferson (Trial Co-ordinator)
laura.jefferson@york.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

Leicester General Hospital
Leicester
LE5 4PW
England
United Kingdom

Website	http://www.leicestershospitals.nhs.uk/
"ROR"	https://ror.org/02fha3693

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

19/10/2018: Publication reference added.
30/11/2017: this is a nested sub-study to the SWIFFT trial (ISRCTN67901257).