Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials

Abstract

BackgroundRandomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts.Methods/DesignThe Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies.DiscussionSuccessful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention.Trial registrationThe START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.

Culturally-adapted Family Intervention (CaFI) for African-Caribbeans diagnosed with schizophrenia and their families: a feasibility study protocol of implementation and acceptability

“…Recruiting participants from acute wards, rehabilitation units and community settings facilitates inclusion of service users at differing levels of acuity and chronicity and examination of the feasibility of delivering CaFI across different clinical environments. Our rationale is that, given findings that African-Caribbean people reside in inpatient services for significantly longer periods of time than their White British counterparts [31, 32], working with families in acute as well as community settings might improve engagement and outcome is therefore likely to beneficial.…”

“…Details of the START programme have been published elsewhere [31, 32]. START has received full ethical approval (11/YH/0271).…”

Producing better evidence on how to improve randomised controlled trials

“…[16] [17] In addition, the Medical Research Council has funded the Systematic Techniques for Assisting Recruitment to Trials (MRC START) team to evaluate two recruitment interventions using trials within trials. [18] Nevertheless, the number of embedded trials stills needs to increase. The UK has 45 UK Clinical Research Collaboration (UKCRC) registered trials units.…”

Collaborative case management to aid return to work after long-term sickness absence: a pilot randomised controlled trial

“…Recruitment remains the major challenge to successful delivery of trials, especially in mental health, [55][56][57][58] which highlights the need for the pilot. Recruitment of patients with long-term conditions has been strongly supported by the method of screening routine records containing relevant information, followed by mass mailing of invitations to participants.…”