Abstract Background The evidence on what strategies can improve recruitment to clinical trials in maternity care is lacking. As trial recruiters, maternity healthcare professionals (MHCPs) perform behaviours (e.g. talking about trials with potential participants, distributing trial information) they may not ordinarily do outside of the trial. Most trial recruitment interventions do not provide any theoretical basis for the potential effect (on behaviour) or describe if stakeholders were involved during development. The study aim was to use behavioural theory in a co-design process to develop an intervention for MHCPs tasked with approaching all eligible potential participants and inviting them to join a maternity trial and to assess the acceptability and feasibility of such an intervention. Methods This study applied a step-wise sequential mixed-methods approach. Key stages were informed by the Theoretical Domains Framework and Behaviour Change Techniques (BCT) Taxonomy to map the accounts of MHCPs, with regard to challenges to trial recruitment, to theoretically informed behaviour change strategies. Our recruitment intervention was co-designed during workshops with MHCPs and maternity service users. Acceptability and feasibility of our intervention was assessed using an online questionnaire based on the Theoretical Framework of Acceptability (TFA) and involved a range of trial stakeholders. Results Two co-design workshops, with a total of nine participants (n = 7 MHCP, n = 2 maternity service users), discussed thirteen BCTs as potential solutions. Ten BCTs, broadly covering Consequences and Reframing, progressed to intervention development. Forty-five trial stakeholders (clinical midwives, research midwives/nurses, doctors, allied health professionals and trial team members) participated in the online TFA questionnaire. The intervention was perceived effective, coherent, and not burdensome to engage with. Core areas for future refinement included Anticipated opportunity and Self-efficacy. Conclusion We developed a behaviour change recruitment intervention which is based on the accounts of MHCP trial recruiters and developed in a co-design process. Overall, the intervention was deemed acceptable. Future evaluation of the intervention will establish its effectiveness in enabling MHCPs to invite all eligible people to participate in a maternity care trial, and determine whether this translates into an increase in maternity trial recruitment rates.
|Date made available||2022|