The ABACus3 trial design is described in detail elsewhere (16). Briefly, the ABACus3 RCT tested a facilitated cancer awareness intervention (the Health Check) in areas of high socioeconomic deprivation (17). Participants were randomised upon recruitment (baseline) to either the intervention or control (standard care) group on a 1:1 basis. All participants completed a series of questionnaires at baseline which were repeated at 2-weeks and 6-month follow-up points. The recruitment window for the study opened in December 2017 and closed in January 2019.
The study incorporated process evaluation methods and semi-structured face-to-face interviews were conducted with the three lay advisors who randomised the particpants and delivered the intervention (two based in South Yorkshire and one based in South East Wales) before they started and after they finished the recruitment and intervention delivery. Interviews were conducted by fellow ABACus3 researchers (HQS, YM and SG) with the aid of interview topic guides revised throughout the trial. The qualitative results from this trial, including the interviews with the lay advisors, the interviews with study participants and the intervention delivery audio recordings, are presented in a separate process evaluation paper (16).
Target areas and socioeconomic deprivation
Recruitment took place in two broad geographical areas: South and West Yorkshire (Sheffield, Wakefield, Barnsley, Doncaster, Rotherham) and South East Wales (Merthyr Tydfil and Newport). All neighbourhoods of high socioeconomic deprivation (10% most deprived or 10-20% most deprived) within these areas were identified using standardised indices, namely the 2015 English Index of Multiple Deprivation for South and West Yorkshire (IMD; 19) and the 2014 Welsh Index of Multiple Deprivation for South East Wales (WIMD; 18). Indices data were displayed at neighbourhood or Lower-layer Super Output Area level, which roughly equates to postcodes. The process of identifying eligible neighbourhoods allowed targeted searches of local stakeholders, and the postcodes of prospective recruitment venues were checked using the respective IMD/WIMD tools. We sought to recruit from a range of healthcare and community settings in all identified neighbourhoods. Types of settings included GP surgeries, community pharmacies, libraries, social clubs, sheltered housing, homeless service center, community centres and churches.
Engaging local stakeholders
The ABACus3 lay advisors were trained to deliver the intervention at baseline and facilitated recruitment in the target areas of South and West Yorkshire and South East Wales. They were responsible for communication with key stakeholders, identification of eligible venues, liaising with local gatekeepers, organising recruitment days, enrolling and randomising participants and delivering the intervention. Due to previous ABACus phases recruiting exclusively from South East Wales and in keeping with the funder’s strategic focus on the Yorkshire population, emphasis was placed on recruiting participants from South and West Yorkshire. A database was kept by the lay advisors of all requests to community and healthcare venues, detailing contact attempts made by the trial team and the postcode of the venue. Eligible healthcare and community settings were contacted individually by lay advisors or were sent an Expression of Interest form (for healthcare settings) by local stakeholders supporting the trial. The lay advisors liaised with local stakeholders in healthcare settings: Pharmaceutical Committees (Yorkshire), Clinical Commissioning Groups (Yorkshire) and Welsh University Health Boards (South Wales). The lay advisors also approached local councils governing the most deprived communities intending to start a snowball effect in community settings. Individual healthcare and community venues were contacted via e-mails and phone calls by the lay advisors to introduce and invite participation in the trial as a recruitment venue.
Opening venues for recruitment
Where willingness to take part was indicated, the lay advisors would visit and meet local gatekeepers at the venues to check venue eligibility– chiefly, a private room to conduct the intervention and a reliable internet connection (needed for the online health check). The lay advisors recorded their reflections of each visit to a recruitment venue using a standardised proforma. These records included details of the day of the week, time of arrival and departure, the type of recruitment session arranged (opportunistic, pre-booked appointments or both), the total number of people recruited at the venue and an estimate of the average footfall at the venue while the advisor was present. There was no provision in the research budget for payments to centres for use of facilities in community or healthcare settings, and in many cases, community settings waived the fee to allow the research to take place. In healthcare settings in South and West Yorkshire, payment was provided by some Clinical Commissioning Groups as part of their remit to support research in primary care; however, the trial team was not involved in any payment arrangements.
Visits before recruitment were used to establish rapport with venue managers and other key staff and encourage a collaborative approach to recruiting local participants. Venue managers and key staff advised on the days when there would be maximum footfall, described the demographic profile of their visitors (e.g. age and language). Those who had capacity to support recruitment further booked provisional appointments with potential participants ahead of the advisors visiting for a recruitment day.
Discovering and reviewing new venues
The lay advisors searched and opened new healthcare and community settings regularly throughout the recruitment window in order to secure further recruitment days and avoid recruitment stagnation. Following recruitment, the suitability of the opened venue was assessed based on the eligibility of the visitors attending the venue. After eligible visitors were recruited, the English Index of Multiple Deprivation (IMD) or Welsh Index of Multiple Deprivation (WIMD) were used as appropriate to check whether the participant’s postcode was within the target socioeconomic deprivation bracket.
Sample and inclusion criteria
To adequately power the study, we aimed to recruit 246 participants which would have allowed for an attrition rate of 30% (i.e. 172 participants retained at final follow-up). Adults were considered eligible for inclusion if they were aged 40 or over, and excluded if they were a non-English speaker, unable to give written informed consent or had participated in a previous phase of ABACus.
All patient-facing study materials (participant information sheets, consent forms, questionnaires) were written with consideration to the national average literacy levels and reviewed by the trial’s Patient and Public Involvement group prior to recruitment, to ensure suitability for the target population (16) .
Recruitment of participants
Table 1 summarises the strategies employed to recruit and retain our participant sample in preparation for recruitment and after the participants were recruited.
Venue visitors could be recruited through pre-booked appointments or opportunistic recruitment. Pre-booked appointments with interested individuals were made by venue staff or the lay advisors. Opportunistic recruitment was led on site by lay advisors who approached individuals in a community or healthcare setting on set recruitment days agreed with the venue manager or other staff. Interested individuals were assessed for eligibility by the lay advisor and were given the ABACus3 participant information booklet. Once eligibility was confirmed, participants were asked to provide written informed consent before advancing to recruitment, baseline questionnaires and randomisation.
Once participants were recruited and had completed the baseline questionnaires, a series of strategies was employed to maximise participant retention at 2-weeks and 6-month follow-ups. In addition to the £10 High Street shopping voucher for completing baseline questionnaires, participants were offered a further £5 voucher for completing the final questionnaires at the 6-month follow-up. The lay advisors recorded the participant’s preferred time and method for contact and provided the participant with an approximate date for their next follow-ups. The lay advisor’s affiliation with Cardiff University (as summarised in Table 1) was emphasised to prepare the participants for receiving their follow-up calls.
Trial recruitment and retention figures were recorded centrally in a study management database, and were presented in accordance with the CONSORT guidelines (Figures 1 and 2). Descriptive statistics were used to summarise and present data relating to venue and participant recruitment, and participant characteristics. Quantitative data analyses were conducted in Microsoft Excel and SPSS version 25 (21). Interviews were transcribed verbatim and anonymised for analysis. We used thematic analysis (22) and 100% of lay advisor interviews were double coded by HQS and SG with the aid of the NVivo 11 data management software (23). The qualitative data will be reported in detail separately, as per the trial protocol (16).