Tommy’s Clinical Decision Tool Phase II Evaluation Study v.1
Research type
Research Study
Full title
Tommy’s Clinical Decision Tool Phase II Implementation Evaluation Study
IRAS ID
294819
Contact name
Jane Sandall
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Research summary\nTommy’s National Centre for Maternity Improvement wants to make it easier for midwives and obstetricians to provide the best possible care, without adding to already busy workloads. With this in mind, they have developed a digital tool that will process data already gathered at antenatal appointments, as well as information directly entered by women themselves, to more accurately assess a woman’s risk of preterm birth and of developing pregnancy complications which can lead to preeclampsia, growth restriction of the unborn baby and stillbirth.\n\nCurrent risk assessments involve a simple checklist and results can be unreliable. The Tommy’s Centre Tool will provide healthcare professionals with personalised care recommendations for each woman to ensure she receives the right care at the right time. By raising the standard of antenatal care in all UK regions to the level of the top performing 20%, up to 12,000 preterm births and 600 stillbirths every year could be prevented.\n\nThis study is evaluating the second phase of the implementation programme, where the tool will be used in four early adopter NHS Trusts. We will identify factors that may help or hinder its successful roll-out in the future. We will assess this through interviews and focus groups with maternity service users (n=104) and healthcare providers (n=84), and through postnatal online questionnaires completed by approximately 3,244 women. We will also use aggregate data collected through the Tool itself to assess whether it is being used as intended (fidelity) and by women who are representative of the whole maternity population (reach).\n\nSummary of results\nWho sponsored this study?\nKing’s College London sponsored this study. Research Governance Office email address: rgo@kcl.ac.uk\n\nGeneral information about the study.\nThe Tommy’s Clinical Decision Support Tool helps midwives and doctors to know what pregnancy care should be offered to those who are more likely to have their baby early (preterm birth) or more likely to have problems with their placenta. Placental problems can lead to a pregnancy condition called pre-eclampsia, and to babies not growing as well as they should, or even dying before birth (stillbirth). Changing the way things are done in hospitals is always difficult, so the purpose of this study was to find out what could be done to make the introduction of the Tommy’s Tool (implementation) as easy as possible. Four NHS hospitals started using the Tool (early adopters) in the autumn of 2021. This study was carried out between 4th February 2022 and 31st August 2023. We asked the people using the Tool (midwives, doctors and those receiving pregnancy care) what they thought about it, and about any problems they had with it. We planned to use this information to make improvements to the Tool, and to advise other hospitals how best to introduce it into their maternity care (implementation strategy) before a larger study started in 2024. We also wanted to make sure people were using it correctly, and that it was used in providing care for everyone.\n\nWhat patients/people were included in this study?\nAll maternity service users (women and birthing people) and providers (midwives, doctors and other healthcare staff) who used the Tool were eligible to take part. In total, 1181 maternity service users and 117 healthcare professionals completed 1265 online surveys, and 24 women and 23 healthcare professionals took part in interviews and focus groups.\n\nWhat were the overall results of the study?\nOverall, users found the Tool acceptable and easy-to-use. Suggestions for improvements were used to make changes to the Tool and implementation strategies. This included a new function that allows midwives and doctors to create user profiles for those who were unable or unwilling to use the Tool themselves. After this, the proportion of those booked for maternity care with user profiles increased from 7 out of 10 to 9 out of 10. We could not judge whether the Tool had always been used correctly because we were unable to get all the information we needed within the time period of the study.\n\nHow has this study helped patients and researchers?\nFindings from this study have been used to improve the Tool and implementation strategy before a larger study is carried out.\n\nAre there plans for further studies?\nA larger study, called the PARTNER Trial, will compare the rates of pre-eclampsia, preterm birth and other pregnancy problems, between 13 hospitals who use the Tommy’s Tool with 13 hospitals who don’t. This new study will also evaluate whether introducing the Tool saves money, or costs more money for the NHS.\n\nWhere can I find more information about this study?\nMore information can be found about this study, the Tommy’s National Centre for Maternity Improvement and the Tommy’s Clinical Decision Support Tool here:\nhttps://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.isrctn.com%252FISRCTN13498237%2FNBTI%2FkKq3AQ%2FAQ%2F1fc40540-5ece-4f61-ab1d-0f62fb7c9715%2F2%2FlvCA-yQJWV&data=05%7C02%7Cbromley.rec%40hra.nhs.uk%7C5ffbc988c80441f6f43808dcc84a4376%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638605468482752231%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=lJ3NfobdcDHy7UOewIO4N1jUefMaQLC1S5%2F4%2B4vo%2F2I%3D&reserved=0\nhttps://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.tommys.org%252Fresearch%252Fresearch-centres%252Ftommys-national-centre-maternity-improvement%2FNBTI%2FkKq3AQ%2FAQ%2F1fc40540-5ece-4f61-ab1d-0f62fb7c9715%2F3%2FSG4DtYH3Gq&data=05%7C02%7Cbromley.rec%40hra.nhs.uk%7C5ffbc988c80441f6f43808dcc84a4376%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638605468482759419%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=m%2B7saAfmiWTdp7WH4tHH7DiRlPrbKqaOqxeW8FH5h0s%3D&reserved=0\n\n
REC name
London - Bromley Research Ethics Committee
REC reference
21/PR/1029
Date of REC Opinion
18 Oct 2021
REC opinion
Further Information Favourable Opinion