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
Abstract Background India 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 electro...
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| Format: | Article |
| Language: | English |
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BMC
2023-01-01
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| Series: | BMC Pregnancy and Childbirth |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12884-022-05249-y |
| _version_ | 1811175715688677376 |
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| author | Sailesh Mohan Monica Chaudhry Ona McCarthy Prashant Jarhyan Clara Calvert Devraj Jindal Rajani Shakya Emma Radovich Dimple Kondal Loveday Penn-Kekana Kalpana Basany Ambuj Roy Nikhil Tandon Abha Shrestha Abha Shrestha Biraj Karmacharya John Cairns Pablo Perel Oona M. R. Campbell Dorairaj Prabhakaran |
| author_facet | Sailesh Mohan Monica Chaudhry Ona McCarthy Prashant Jarhyan Clara Calvert Devraj Jindal Rajani Shakya Emma Radovich Dimple Kondal Loveday Penn-Kekana Kalpana Basany Ambuj Roy Nikhil Tandon Abha Shrestha Abha Shrestha Biraj Karmacharya John Cairns Pablo Perel Oona M. R. Campbell Dorairaj Prabhakaran |
| author_sort | Sailesh Mohan |
| collection | DOAJ |
| description | Abstract Background India 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). Methods This 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. Discussion To 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/NCT03700034 CTRI, 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 |
| first_indexed | 2024-04-10T19:40:15Z |
| format | Article |
| id | doaj.art-d2a9a6b45a9d47169340c2d3ab16b367 |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-04-10T19:40:15Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-d2a9a6b45a9d47169340c2d3ab16b3672023-01-29T12:24:11ZengBMCBMC Pregnancy and Childbirth1471-23932023-01-0123111610.1186/s12884-022-05249-yA 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 protocolSailesh Mohan0Monica Chaudhry1Ona McCarthy2Prashant Jarhyan3Clara Calvert4Devraj Jindal5Rajani Shakya6Emma Radovich7Dimple Kondal8Loveday Penn-Kekana9Kalpana Basany10Ambuj Roy11Nikhil Tandon12Abha Shrestha13Abha Shrestha14Biraj Karmacharya15John Cairns16Pablo Perel17Oona M. R. Campbell18Dorairaj Prabhakaran19Public Health Foundation of India (PHFI)Public Health Foundation of India (PHFI)London School of Hygiene & Tropical MedicinePublic Health Foundation of India (PHFI)London School of Hygiene & Tropical MedicineCentre for Chronic Disease Control (CCDC), Safdarjung Development AreaDhulikhel Hospital, Kathmandu UniversityLondon School of Hygiene & Tropical MedicinePublic Health Foundation of India (PHFI)London School of Hygiene & Tropical MedicineSHARE (Sci Health Allied Res Education), MediCiti Institute of Medical Sciences Campus, Medchal-MalkajgiriAll India Institute of Medical SciencesAll India Institute of Medical SciencesDhulikhel Hospital, Kathmandu UniversityDhulikhel Hospital, Kathmandu UniversityDhulikhel Hospital, Kathmandu UniversityLondon School of Hygiene & Tropical MedicineLondon School of Hygiene & Tropical MedicineLondon School of Hygiene & Tropical MedicinePublic Health Foundation of India (PHFI)Abstract Background India 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). Methods This 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. Discussion To 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/NCT03700034 CTRI, 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%27https://doi.org/10.1186/s12884-022-05249-yMobile healthDigital healthElectronic decision-support systemClinical decision-support systemAntenatal careMaternal health services |
| spellingShingle | Sailesh Mohan Monica Chaudhry Ona McCarthy Prashant Jarhyan Clara Calvert Devraj Jindal Rajani Shakya Emma Radovich Dimple Kondal Loveday Penn-Kekana Kalpana Basany Ambuj Roy Nikhil Tandon Abha Shrestha Abha Shrestha Biraj Karmacharya John Cairns Pablo Perel Oona M. R. Campbell Dorairaj Prabhakaran 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 BMC Pregnancy and Childbirth Mobile health Digital health Electronic decision-support system Clinical decision-support system Antenatal care Maternal health services |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Mobile health Digital health Electronic decision-support system Clinical decision-support system Antenatal care Maternal health services |
| url | https://doi.org/10.1186/s12884-022-05249-y |
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