BMC Pregnancy and Childbirth | |
A cluster randomized controlled trial of an electronic decision-support system to enhance antenatal care services in pregnancy at primary healthcare level in Telangana, India: trial protocol | |
Study Protocol | |
Nikhil Tandon1  Ambuj Roy1  Devraj Jindal2  Biraj Karmacharya3  Rajani Shakya3  Abha Shrestha3  John Cairns4  Oona M. R. Campbell4  Emma Radovich4  Pablo Perel4  Loveday Penn-Kekana4  Ona McCarthy4  Clara Calvert5  Monica Chaudhry6  Prashant Jarhyan6  Dimple Kondal6  Sailesh Mohan7  Dorairaj Prabhakaran8  Kalpana Basany9  | |
[1] All India Institute of Medical Sciences, Sri Aurobindo Marg, 110029, Ansari Nagar, New Delhi, Delhi, India;Centre for Chronic Disease Control (CCDC), Safdarjung Development Area, C-1/52, Second Floor, 110016, Delhi, India;Dhulikhel Hospital, Kathmandu University, JG8X+P54, 45200, Dhulikhel, Nepal;London School of Hygiene & Tropical Medicine, Keppel St, WC1E 7HT, London, UK;London School of Hygiene & Tropical Medicine, Keppel St, WC1E 7HT, London, UK;Old Medical School, Usher Institute, University of Edinburgh, Teviot Place, EH8 9AG, Edinburgh, UK;Public Health Foundation of India (PHFI), Plot 47, Sector 44, 122002, Gurugram, Haryana, India;Public Health Foundation of India (PHFI), Plot 47, Sector 44, 122002, Gurugram, Haryana, India;Centre for Chronic Disease Control (CCDC), Safdarjung Development Area, C-1/52, Second Floor, 110016, Delhi, India;Public Health Foundation of India (PHFI), Plot 47, Sector 44, 122002, Gurugram, Haryana, India;Centre for Chronic Disease Control (CCDC), Safdarjung Development Area, C-1/52, Second Floor, 110016, Delhi, India;London School of Hygiene & Tropical Medicine, Keppel St, WC1E 7HT, London, UK;SHARE (Sci Health Allied Res Education), MediCiti Institute of Medical Sciences Campus, Medchal-Malkajgiri, 501401, Hyderabad, Telangana, India; | |
关键词: Mobile health; Digital health; Electronic decision-support system; Clinical decision-support system; Antenatal care; Maternal health services; Health system redesign; Pregnancy Induced Hypertension; Gestational Diabetes Mellitus; Anaemia in pregnancy; Cluster randomized trial; | |
DOI : 10.1186/s12884-022-05249-y | |
received in 2022-10-03, accepted in 2022-11-24, 发布年份 2022 | |
来源: Springer | |
【 摘 要 】
BackgroundIndia contributes 15% of the total global maternal mortality burden. An increasing proportion of these deaths are due to Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anaemia. This study aims to evaluate the effectiveness of a tablet-based electronic decision-support system (EDSS) to enhance routine antenatal care (ANC) and improve the screening and management of PIH, GDM, and anaemia in pregnancy in primary healthcare facilities of Telangana, India. The EDSS will work at two levels of primary health facilities and is customized for three cadres of healthcare providers – Auxiliary Nurse Midwifes (ANMs), staff nurses, and physicians (Medical Officers).MethodsThis will be a cluster randomized controlled trial involving 66 clusters with a total of 1320 women in both the intervention and control arms. Each cluster will include three health facilities—one Primary Health Centre (PHC) and two linked sub-centers (SC). In the facilities under the intervention arm, ANMs, staff nurses, and Medical Officers will use the EDSS while providing ANC for all pregnant women. Facilities in the control arm will continue to provide ANC services using the existing standard of care in Telangana. The primary outcome is ANC quality, measured as provision of a composite of four selected ANC components (measurement of blood pressure, blood glucose, hemoglobin levels, and conducting a urinary dipstick test) by the healthcare providers per visit, observed over two visits. Trained field research staff will collect outcome data via an observation checklist.DiscussionTo our knowledge, this is the first trial in India to evaluate an EDSS, targeted to enhance the quality of ANC and improve the screening and management of PIH, GDM, and anaemia, for multiple levels of health facilities and several cadres of healthcare providers. If effective, insights from the trial on the feasibility and cost of implementing the EDSS can inform potential national scale-up. Lessons learned from this trial will also inform recommendations for designing and upscaling similar mHealth interventions in other low and middle-income countries.Trial Registration.ClinicalTrials.gov, NCT03700034, registered 9 Oct 2018, https://www.clinicaltrials.gov/ct2/show/NCT03700034CTRI, CTRI/2019/01/016857, registered on 3 Mar 2019, http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=28627&EncHid=&modid=&compid=%27,%2728627det%27
【 授权许可】
CC BY
© The Author(s) 2023
【 预 览 】
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