TY - JOUR
T1 - A cluster randomized control trial of an Electronic Decision-Support System to enhance antenatal care services in pregnancy at primary healthcare level in Telangana, India
T2 - Trial protocol
AU - Mohan, Sailesh
AU - Chaudhry, Monica
AU - McCarthy, Ona
AU - Jarhyan, Prashant
AU - Calvert, Clara
AU - Jindal, Devraj
AU - Shakya, Rajani
AU - Radovich, Emma
AU - Basany, Kalpana
AU - Roy, Ambuj
AU - Tandon, Nikhil
AU - Shrestha, Abha
AU - Shrestha, Abha
AU - Karmacharya, Biraj M
AU - Cairns, John
AU - Perel, Pablo
AU - Campbell, Oona M. R.
AU - Prabhakaran, Dorairaj
N1 - Funding Information:
This study has been funded by the Newton fund joint call from the Department of Biotechnology (DBT) (Grant Ref: BT/IN/DBT-MRC/DIFD/DP/14/2018–19), India and Medical Research Council (MRC), UK (Grant Ref: MR/R022127/1) under the UK-India Global Research Programme (GRP) 2017. The funders had no role in the study design; collection, management, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication.
Funding Information:
We are grateful to our subject expert committee members, Dr. Yashdeep Gupta (Department of Endocrinology and Metabolism, All India Institute of Medical Sciences (AIIMS), Delhi), Prof. Sandosh Padmanabhan (Cardiovascular Genomics and Therapeutics, University of Glasgow, Scotland), Prof. Poonam Verma Shivkumar (Department of Obstetrics & Gynecology, Mahatma Gandhi Institute of Medical Sciences, Wardha, Maharashtra, India), Prof. Vinita Das (Department of Obstetrics &Gynecology, King George's Medical University, Lucknow, Uttar Pradesh, India) for their clinical inputs and feedback. We are very thankful for the overall guidance provided by our Trial Steering Committee members, Prof. Neerja Bhatla, (Department of Obstetrics & Gynecology, AIIMS, Delhi), Prof. P Von Dadelszen (Global Women's Health, King’s College London), Prof. Chanda Karki (Department of Obstetrics & Gynecology, Kathmandu Medical College, Nepal), and our Independent Data Monitoring Committee members, Prof. Laura Magee (Women's Health, King’s College London); Dr. Archana Amatya (USAID's Strengthening Systems for Better Health), and Dr. Howard Chang (Biostatistics & Bioinformatics, Rollins School of Public Health, Emory University, USA). We thank the Commissionerate of Health and Family Welfare (CHFW) for providing their feedback for co-designing the intervention and for extending support during the formative research activities. We thank Quad One Technologies Pvt Ltd., Telangana, the software company that developed the intervention. We are very grateful to our mIRA research team members (Mr. Kanchanapally Radha Krishnam Raju, Ms. Ramya Vallabhuni, and Ms. Aparajita Mishra from India, and Ms. Sulata and Ms Seema from Nepal), who worked tirelessly to collect formative research data, and undertook the testing of the intervention. Dr. Dorairaj Prabhakaran, Lead Principal Investigator (PI), Distinguished Professor of Public Health Public Health Foundation of India (PHFI), Plot 47, Sector 44, Gurugram, Haryana – 122002, India ([email protected]). As study sponsor, the PI participated in study design, management, analysis, data interpretation, and manuscript development.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/1/26
Y1 - 2023/1/26
N2 - 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.
AB - 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.
KW - Anaemia in pregnancy
KW - Antenatal care
KW - Clinical decision-support system
KW - Cluster randomized trial
KW - Digital health
KW - Electronic decision-support system
KW - Gestational Diabetes Mellitus
KW - Health system redesign
KW - Maternal health services
KW - Mobile health
KW - Pregnancy Induced Hypertension
U2 - 10.1186/s12884-022-05249-y
DO - 10.1186/s12884-022-05249-y
M3 - Article
C2 - 36703109
SN - 1471-2393
VL - 23
JO - BMC pregnancy and childbirth
JF - BMC pregnancy and childbirth
IS - 1
M1 - 72
ER -