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The Tommy’s Clinical Decision Tool, a device for reducing the clinical impact of placental dysfunction and preterm birth: protocol for a mixed-methods early implementation evaluation study

Research output: Contribution to journalArticlepeer-review

Jenny Carter, Dilly Anumba, Lia Brigante, Christy Burden, Tim Draycott, Siobhán Gillespie, Birte Harlev-Lam, Andrew Judge, Erik Lenguerrand, Elaine Sheehan, Basky Thilaganathan, Hannah Wilson, Cathy Winter, Maria Viner, Jane Sandall

Original languageEnglish
Article number639
JournalBMC Pregnancy and Childbirth
Volume22
Issue number1
Early online date15 Aug 2022
DOIs
Accepted/In press23 Jun 2022
E-pub ahead of print15 Aug 2022
PublishedDec 2022

Bibliographical note

Funding Information: The authors would like to sincerely thank the wider members of the Tommy’s National Centre for Maternity Improvement Programme Delivery Team for their advice, input and administrative support (Namely: Alessandra D’Angelo, Carly Edwards, Emma Gilgunn-Jones, Suzanne Gowiely, Gbenga Kayode, Victoria Komolafe, Ruta Margalete, Jo Tanner, Gemma Thurston and Dan Wolstenholme) and the Women’s Voices Involvement Group, who contributed their views and recommendations on the participant documents, focus group topic guide, interview schedule and design of the online questionnaires. Jane Sandall, at King’s College London, is an NIHR Senior Investigator and is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration South London (NIHR ARC South London) at King’s College Hospital NHS Foundation Trust. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Early findings from this study were presented at the 2022 RCM Education and Research Conference []. Funding Information: This project is funded by Tommy’s charity (Registered charity no.1060508) and conducted by the Tommy’s National Centre for Maternity Improvement: a joint initiative of the Royal College of Obstetricians & Gynaecologists and the Royal College of Midwives. Apart from funding, the funder has no role in this study. Funding Information: The authors would like to sincerely thank the wider members of the Tommy’s National Centre for Maternity Improvement Programme Delivery Team for their advice, input and administrative support (Namely: Alessandra D’Angelo, Carly Edwards, Emma Gilgunn-Jones, Suzanne Gowiely, Gbenga Kayode, Victoria Komolafe, Ruta Margalete, Jo Tanner, Gemma Thurston and Dan Wolstenholme) and the Women’s Voices Involvement Group, who contributed their views and recommendations on the participant documents, focus group topic guide, interview schedule and design of the online questionnaires. Jane Sandall, at King’s College London, is an NIHR Senior Investigator and is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration South London (NIHR ARC South London) at King’s College Hospital NHS Foundation Trust. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Early findings from this study were presented at the 2022 RCM Education and Research Conference [34]. Publisher Copyright: © 2022, The Author(s).

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Abstract

Background: Disparities in stillbirth and preterm birth persist even after correction for ethnicity and social deprivation, demonstrating that there is wide geographical variation in the quality of care. To address this inequity, Tommy’s National Centre for Maternity Improvement developed the Tommy’s Clinical Decision Tool, which aims to support the provision of “the right care at the right time”, personalising risk assessment and care according to best evidence. This web-based clinical decision tool assesses the risk of preterm birth and placental dysfunction more accurately than current methods, and recommends best evidenced-based care pathways in a format accessible to both women and healthcare professionals. It also provides links to reliable sources of pregnancy information for women. The aim of this study is to evaluate implementation of Tommy’s Clinical Decision Tool in four early-adopter UK maternity services, to inform wider scale-up. Methods: The Tommy’s Clinical Decision Tool has been developed involving maternity service users and healthcare professionals in partnership. This mixed-methods study will evaluate: maternity service user and provider acceptability and experience; 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. Data will be gathered over 25 months through interviews, focus groups, questionnaires and through the Tommy’s Clinical Decision Tool itself. The NASSS framework (Non-adoption or Abandonment of technology by individuals and difficulties achieving Scale-up, Spread and Sustainability) will inform data analysis. Discussion: This paper describes the intervention, Tommy’s Clinical Decision Tool, according to TiDIER guidelines, and the protocol for the early adopter implementation evaluation study. Findings will inform future scale up. Trial registration: This study was prospectively registered on the ISRCTN registry no. 13498237, on 31st January 2022.

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