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.
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.
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DOI：
10.1186/s12884-022-05249-y
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发表时间：
2023-01-26
影响因子：
3.1
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中科院分区：
文献类型：
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印度占全球孕产妇死亡总负担的15%。这些死亡中越来越多的比例是由于妊娠高血压（PIH）、妊娠糖尿病（GDM）和贫血。本研究旨在评价基于平板电脑的电子决策支持系统（EDSS）在印度特兰加纳初级医疗机构中加强常规产前护理（ANC）和改善妊娠期妊高征、GDM和贫血筛查和管理的有效性。EDSS将在两级初级卫生设施中运作，并针对三种保健提供者骨干-助产士助理护士、护士和医生（医务人员）-进行定制。这将是一项随机分组对照试验，涉及66个分组，干预组和对照组共1320名女性。每个集群将包括三个保健设施-一个初级保健中心和两个相连的分中心。在干预组的设施中，ANM、护士和医务人员将使用EDSS，同时为所有孕妇提供ANC。控制部门的设施将继续使用特兰加纳现有的护理标准提供产前护理服务。主要结局是ANC质量，测量为医疗保健提供者每次访视提供的四种选定ANC组分（测量血压、血糖、血红蛋白水平和进行尿试纸测试）的复合物，观察两次访视。经过培训的实地研究人员将通过观察清单收集结果数据。据我们所知，这是印度第一次评估EDSS的试验，旨在提高ANC的质量，改善PIH，GDM和贫血的筛查和管理，适用于多个级别的卫生设施和几个医疗保健提供者的干部。如果有效，从试验中获得的关于实施EDSS的可行性和成本的见解可以为潜在的国家规模扩大提供信息。从这项试验中吸取的经验教训也将为在其他低收入和中等收入国家设计和扩大类似的移动健康干预措施提供建议。试验注册。ClinicalTrials.gov，NCT 03700034，2018年10月9日注册，https://www.clinicaltrials.gov/ct2/show/NCT03700034 CTRI，CTRI/2019/01/016857，2019年3月3日注册，http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php? trialid=28627&EncHid=&modid=&compid=%27，%2728627det%27在线版本包含补充材料，可通过10.1186/s12884-022-05249-y获得。
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). 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. 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 The online version contains supplementary material available at 10.1186/s12884-022-05249-y.
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DOI：
10.1136/bmj.h1258
发表时间：
2015-03-19
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Moore GF;Audrey S;Barker M;Bond L;Bonell C;Hardeman W;Moore L;O'Cathain A;Tinati T;Wight D;Baird J
通讯作者：
Baird J
影响因子：
7.4
作者：
Amoakoh-Coleman M;Borgstein AB;Sondaal SF;Grobbee DE;Miltenburg AS;Verwijs M;Ansah EK;Browne JL;Klipstein-Grobusch K
通讯作者：
Klipstein-Grobusch K
影响因子：
5
作者：
Benski, Anne Caroline;Schmidt, Nicole C.;Reich, Michael R.
通讯作者：
Reich, Michael R.
影响因子：
7.2
作者：
Adams, G;Gulliford, MC;Campbell, MJ
通讯作者：
Campbell, MJ
影响因子：
0.9
作者：
Chudasama, Rajesh K.;Kadri, A. M.;Kamariya, Chandrakant P.
通讯作者：
Kamariya, Chandrakant P.