Designing a Single Online Screening and eConsenting System to Maximise Recruitment for Three Concurrent Randomised Controlled Trials of Complex Interventions for Improving Student Mental Health

Abstract

The aim of the NURTURE-U study is to develop and evaluate an acceptable, effective, cohesive system of whole-university and stepped care student wellbeing and mental health support. This study comprises three concurrent randomised controlled trials (RCTs) which will evaluate different approaches of support. Participants will be allocated to a trial based on their screening assessment. Screening, consenting and data collection is to be conducted online in the form of surveys. A key requirement of the solution is participants’ user experience of the enrolment process (screening and consenting). The participants’ journey, from screening to baseline completion, should be perceived as a single survey whilst accommodating segregation of trial data. A system or integrated systems to facilitate this had to be developed. The defined process allows individuals to enter the screening survey, consent and complete screening before being, automatically, evaluated for trial eligibility. There are four possible outcomes from the study screening. If an individual consents to participate in a trial, they then continue to complete the baseline survey for their allocated trial. REDCap Academic (RCA) was selected as the solution system, due to its versatility as an EDC system with survey capabilities and extensive API. Desired features include RCA’s ability to prepopulate (pipe) data from one survey to another, allowing participants to be seamlessly transferred into an alternative project within RCA whilst completing a survey. Four RCA validated projects were created: one screening and one for each of the three trials. Once participants complete enrolment for a trial, they are automatically transferred to the trial’s baseline survey without any break in survey flow. This transfer includes piped data, such as screening ID, linking the screening record to the trial record. User Acceptance Testing by the study team and students will conclude in August 2022, providing feedback on student engagement of the system design and user experience, prior to deployment in Autumn 2022. A single, unified, online screening and consenting system to determine eligibility against multiple trials is an efficient trial enrolment solution. By negating the need for potential participants to complete multiple screening surveys for different concurrent trials, it is anticipated that the system will aid recruitment, as well as reducing burden on both potential participants and trial teams.