ArticlePilot and feasibility studies2026
Tommy's Clinical Decision Support Tool: an intervention development and feasibility study to inform a future randomised controlled trial.
Article in Pilot and feasibility studies, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
16 authors.
Funding
Abstract
backgroundThe Tommy's Clinical Decision Support Tool is a web-based application that is used to assess risk of preterm birth and placental dysfunction. Utilising validated algorithms and rule engines, which are more accurate than current checklist methods, the Tool instantly recommends best evidenced-based care pathways. This personalisation of assessment and decision support could reduce preterm birth and stillbirth, whilst also addressing variation in care. This study aimed to develop the intervention and assess feasibility of implementation in four NHS maternity services to inform a planned cluster randomised controlled trial. We aimed to investigate barriers and facilitators to implementation; reach (whether particular groups are excluded and why), fidelity (degree to which the intervention is delivered as intended), and unintended consequences.
methodsThe NASSS framework (Non-adoption or Abandonment of technology by individuals and difficulties achieving Scale-up, Spread and Sustainability) informed analysis. We used online surveys, semi-structured interviews and focus groups to investigate maternity service user and healthcare professional (HCP) experience.
resultsOne thousand one hundred eighty-one maternity service users and 112 HCPs participated, completing 1260 online surveys, 8 focus groups and 29 semi-structured interviews (women: n = 24; HCPs: n = 23). Overall, the Tool appears acceptable and easy-to-use for both pregnant and HCP users, although the burden of introducing a novel intervention within an already overstretched service was identified as a potential barrier to successful implementation. Findings influenced developments of the device and implementation strategy ahead of the trial. Lessons learned highlighted the importance of: availability of the Tool to guide care for all, including pregnant users unable, or choosing not to engage with it; top-level and multidisciplinary buy-in; dedicated resources; preparation for transitional period; local champions across professions and settings; clarity in purpose, scope, potential benefits and evidence-base; mitigation of double data entry; IT infrastructure optimisation; flexibility in training and accessibility of implementation resources. Further refinements will include non-English translation of the pregnant user interface.
conclusionsTommy's Tool has the potential to make providing optimal maternity care easier for health professionals, which could reduce variation in care and ultimately improve outcomes. This study gave us the opportunity to evaluate implementation processes and identify potential barriers to successful implementation. By addressing these barriers, ahead of the trial, we have maximised the chance of the trial results being conclusive.
trial registrationthis study was prospectively registered on ISRCTN:ID13498237, on 31/01/2022.
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