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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: 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. gov, NCT03700034, registered 9 Oct 2018, https://www. 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.

SUBMITTER: Mohan S

PROVIDER: S-EPMC9878774 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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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.

Mohan Sailesh S Chaudhry Monica M McCarthy Ona O Jarhyan Prashant P Calvert Clara C Jindal Devraj D Shakya Rajani R Radovich Emma E Kondal Dimple D Penn-Kekana Loveday L Basany Kalpana K Roy Ambuj A Tandon Nikhil N Shrestha Abha A Shrestha Abha A Karmacharya Biraj B Cairns John J Perel Pablo P Campbell Oona M R OMR Prabhakaran Dorairaj D

BMC pregnancy and childbirth 20230126 1

<h4>Background</h4>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, ...[more]

PMID: 36703109

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Project description:BackgroundAntenatal care coverage has dramatically increased in many low-and middle-income settings, including in the state of Telangana, India. However, there is increasing evidence of shortfalls in the quality of care women receive during their pregnancies. This study aims to examine dimensions of antenatal care quality in Telangana, India using four primary and secondary data sources.MethodsData from two secondary statewide data sources (National Family Health Survey (NFHS-5), 2019-21; Health Management Information System (HMIS), 2019-20) and two primary data sources (a facility survey in 19 primary health centres and sub-centres in selected districts of Telangana; and observations of 36 antenatal care consultations at these facilities) were descriptively analysed.ResultsNFHS-5 data showed about 73% of women in Telangana received all six assessed antenatal care components during pregnancy. HMIS data showed high coverage of antenatal care visits but differences in levels of screening, with high coverage of haemoglobin tests for anaemia but low coverage of testing for gestational diabetes and syphilis. The facility survey found missing equipment for several key antenatal care services. Antenatal care observations found blood pressure measurement and physical examinations had high coverage and were generally performed correctly. There were substantial deficiencies in symptom checking and communication between the woman and provider. Women were asked if they had any questions in 22% of consultations. Only one woman was asked about her mental health. Counselling of women on at least one of the ten items relating to birth preparedness and on at least one of six danger signs occurred in 58% and 36% of consultations, respectively.ConclusionDespite high coverage of antenatal care services and some essential maternal and foetal assessments, substantial quality gaps remained, particularly in communication between healthcare providers and pregnant women and in availability of key services. Progress towards achieving high quality in both content and experience of antenatal care requires addressing service gaps and developing better measures to capture and improve women's experiences of care.

Project description:BackgroundHealth worker compliance with established best-practice clinical and public health guidelines may be enhanced by customized checklists of care and clinical decision support driven by point-of-care data entry into an electronic health registry. The public health system of Palestine is currently implementing a national electronic registry (eRegistry) for maternal and child health. This trial is embedded in the national implementation and aims to assess the effectiveness of the eRegistry's interactive checklists and clinical decision support, compared with the existing paper based records, on improving the quality of care for pregnant women.MethodsThis two-arm cluster randomized controlled trial is conducted in the West Bank, Palestine, and includes 120 clusters (primary healthcare clinics) with an average annual enrollment of 60 pregnancies. The intervention tool is the eRegistry's interactive checklists and clinical decision support implemented within the District Health Information System 2 (DHIS2) Tracker software, developed and customized for the Palestinian context. The primary outcomes reflect the processes of essential interventions, namely timely and appropriate screening and management of: 1) anemia in pregnancy; 2) hypertension in pregnancy; 3) abnormal fetal growth; 4) and diabetes mellitus in pregnancy. The composite primary health outcome encompasses five conditions representing risk for the mother or baby that could have been detected or prevented by high-quality antenatal care: moderate or severe anemia at admission for labor; severe hypertension at admission for labor; malpresentation at delivery undetected during pregnancy; small for gestational age baby at delivery undetected during pregnancy; and large for gestational age baby at delivery. Primary analysis at the individual level taking the design effect of the clustering into account will be performed as intention-to-treat.DiscussionThis trial, embedded in the national implementation of the eRegistry in Palestine, allows the assessment of process and health outcomes in a large-scale pragmatic setting. Findings will inform the use of interactive checklists and clinical decision support driven by point-of-care data entry into an eRegistry as a health systems-strengthening approach.Trial registrationISRCTN trial registration number, ISRCTN18008445 . Registered on 6 April 2017.

Project description:BackgroundGaps in maternal and child health services can slow progress towards achieving the Sustainable Development Goals. The Management and Optimization of Nutrition, Antenatal, Reproductive, Child Health & HIV Care (MONARCH) study will evaluate a Continuous Quality Improvement (CQI) intervention targeted at improving antenatal and postnatal health service outcomes in rural South Africa where HIV prevalence among pregnant women is extremely high. Specifically, it will establish the effectiveness of CQI on viral load (VL) testing in pregnant women who are HIV-positive and repeat HIV testing in pregnant women who are HIV-negative.MethodsThis is a stepped-wedge cluster-randomised controlled trial (RCT) of 7 nurse-led primary healthcare clinics to establish the effect of CQI on selected routine antenatal and postnatal services. Each clinic was a cluster, with the exception of the two smallest clinics, which jointly formed one cluster. The intervention was applied at the cluster level, where staff received training on CQI methodology and additional mentoring as required. In the control exposure state, the clusters received the South African Department of Health standard of care. After a baseline data collection period of 2 months, the first cluster crossed over from control to intervention exposure state; subsequently, one additional cluster crossed over every 2 months. The six clusters were divided into 3 groups by patient volume (low, medium and high). We randomised the six clusters to the sequences of crossing over, such that both the first three and the last three sequences included one cluster with low, one with medium, and one with high patient volume. The primary outcome measures were (i) viral load testing among pregnant women who were HIV-positive, and (ii) repeat HIV testing among pregnant women who were HIV-negative. Consenting women ≥18 years attending antenatal and postnatal care during the data collection period completed outcome measures at delivery, and postpartum at three to 6 days, and 6 weeks. Data collection started on 15 July 2015. The total study duration, including pre- and post-exposure phases, was 19 months. Data will be analyzed by intention-to-treat based on first booked clinic of study participants.DiscussionThe results of the MONARCH trial will establish the effectiveness of CQI in improving antenatal and postnatal clinic processes in primary care in sub-Saharan Africa. More generally, the results will contribute to our knowledge on quality improvement interventions in resource-poor settings.Trial registrationThis trial was registered on 10 December 2015: www.clinicaltrials.gov, identifier NCT02626351 .

Project description:BackgroundAcute diarrhoeal disease management often requires rehydration alone without antibiotics. However, non-indicated antibiotics are frequently ordered and this is an important driver of antimicrobial resistance. The mHealth Diarrhoea Management (mHDM) trial aimed to establish whether electronic decision support improves rehydration and antibiotic guideline adherence in resource-limited settings.MethodsA cluster randomised controlled trial was done at ten district hospitals in Bangladesh. Inclusion criteria were patients aged 2 months or older with uncomplicated acute diarrhoea. Admission orders were observed without intervention in the pre-intervention period, followed by randomisation to electronic (rehydration calculator) or paper formatted WHO guidelines for the intervention period. The primary outcome was rate of intravenous fluid ordered as a binary variable. Generalised linear mixed-effect models, accounting for hospital clustering, served as the analytical framework; the analysis was intention to treat. The trial is registered with ClinicalTrials.gov (NCT03154229) and is completed.FindingsFrom March 11 to Sept 10, 2018, 4975 patients (75·6%) of 6577 screened patients were enrolled. The intervention effect for the primary outcome showed no significant differences in rates of intravenous fluids ordered as a function of decision-support type. Intravenous fluid orders decreased by 0·9 percentage points for paper electronic decision support and 4·2 percentage points for electronic decision support, with a 4·2-point difference between decision-support types in the intervention period (paper 98·7% [95% CI 91·8-99·8] vs electronic 94·5% [72·2-99·1]; pinteraction=0·31). Adverse events such as complications and mortality events were uncommon and could not be statistically estimated.InterpretationAlthough intravenous fluid orders did not change, electronic decision support was associated with increases in the volume of intravenous fluid ordered and decreases in antibiotics ordered, which are consistent with WHO guidelines.FundingUS National Institutes of Health.

Project description:Healthcare accessibility and site suitability analysis is an elongated and complex task that requires evaluation of different decision factors. The main objective of the present study was to develop a hybrid decision-making approach with geographic information systems to integrate spatial and non-spatial data to form a weighted result. This study involved three-tier analyses for assessing accessibility and selecting suitable sites for healthcare facilities, and analysing shortest-path network. The first tier of analysis stressed the spatial distance, density and proximity from existing healthcare to find more deprived and inaccessible areas in term of healthcare facilities. The result revealed that spatial discrepancy exists in the study area in term of access to healthcare facilities and for achieving equal healthcare access, it is essential to propose new plans. Thus, require finding suitable sites for put forward new healthcare service, which was highlighted in the second tier of analysis based on land use land cover, distancing to road and rail, proximity to residential areas, and weighted overlay of accessibility as decision factors. Finally, in the third tier of analysis, the most suitable site among the proposed healthcare was identified using the technique for order of preference by similarity to ideal solution. The road network analysis was also performed in this study to determine the shortest and fastest route from these healthcare facilities to connect with district medical hospital. The present study found some suitable sites throughout the district on inaccessible zones where people are deprived from better healthcare facilities. This attempt will highly helpful for preparing a spatial decision support system which assists the health authorities regarding the healthcare services in inaccessible, underprivileged, and rural areas. Electronic supplementary material The online version of this article (10.1007/s41324-020-00330-0) contains supplementary material, which is available to authorized users.

Project description:Large gaps exist in the implementation of guideline recommendations for cardiovascular disease (CVD) risk management. Electronic decision support (EDS) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia. We have developed HealthTracker, a multifaceted EDS and quality improvement intervention to improve the management of CVD risk. It is hypothesised that the use of HealthTracker over a 12-month period will result in: (1) an increased proportion of patients receiving guideline-indicated measurements of CVD risk factors and (2) an increased proportion of patients at high risk will receive guideline-indicated prescriptions for lowering their CVD risk. Sixty health services (40 general practices and 20 Aboriginal Community Controlled Health Services (ACCHSs) will be randomised in a 1:1 allocation to receive either the intervention package or continue with usual care, stratified by service type, size and participation in existing quality improvement initiatives. The intervention consists of point-of-care decision support; a risk communication interface; a clinical audit tool to assess performance on CVD-related indicators; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance. The control arm will continue with usual care without access to these intervention components. Quantitative data will be derived from cross-sectional samples at baseline and end of study via automated data extraction. Detailed process and economic evaluations will also be conducted. The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee (HREC) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC. Formal agreements with each of the participating sites have been signed. In addition to the usual scientific forums, results will be disseminated via newsletters, study websites, face-to-face feedback forums and workshops. The trial is registered with the Australian Clinical Trials Registry ACTRN 12611000478910.

Project description:ObjectivesWe undertook assessment of quality of antenatal care (ANC) services in public sector facilities in the Indian state of Bihar state delivered under the national ANC programme (Pradhan Mantri Surakshit Matritva Abhiyan, PMSMA).SettingThree community health centres and one subdistrict hospital each in two randomly selected districts of Bihar.ParticipantsPregnant women who sought ANC services under PMSMA irrespective of the pregnancy trimester.Primary and secondary measuresQuality ANC services were considered if a woman received all of these services in that visit-weight, blood pressure and abdomen check, urine and blood sample taken, and were given iron and folic acid and calcium tablets. The process of ANC service provision was documented.ResultsEight hundred and fourteen (94.5% participation) women participated. Coverage of quality ANC services was 30.4% (95% CI 27.3% to 33.7%) irrespective of pregnancy trimester, and was similar in both districts and ranged 3%-83.1% across the facilities. Quality ANC service coverage was significantly lower for women in the first trimester of pregnancy (6.8%, 95% CI 3.3% to 13.6%) as compared with those in the second (34.4%, 95% CI 29.9% to 39.1%) and third (32.9%, 95% CI 27.9% to 38.3%) trimester of pregnancy. Individually, the coverage of weight and blood pressure check-up, receipt of iron folic acid (IFA) and calcium tablets, and blood sample collection was >85%. The coverage of urine sample collection was 46.3% (95% CI 42.9% to 49.7%) and of abdomen check-up was 62% (95% CI 58.6% to 65.3%). Poor information sharing post check-up was done with the pregnant women. Varied implementation of ANC service provision was seen in the facilities as compared with the PMSMA guidelines, in particular with laboratory diagnostics and doctor consultation. Task shifting from doctors to ANMs was observed in all facilities.ConclusionsGrossly inadequate quality ANC services under the PMSMA needs urgent attention to improve maternal and neonatal health outcomes.

Project description:BackgroundIn 2021, over one million children developed tuberculosis, resulting in 214 000 deaths, largely due to inadequate diagnosis and treatment. The diagnosis and treatment of tuberculosis is limited in most high-burden countries because services are highly centralised at secondary/tertiary levels and are managed in a vertical, non-integrated way. To improve case detection and treatment among children, the World Health Organisation (WHO) recommends decentralised and integrated tuberculosis care models. The Integrating Paediatric TB Services Into Child Healthcare Services in Africa (INPUT) stepped-wedge cluster-randomised trial evaluated the impact of integrating tuberculosis services into healthcare for children under five in Cameroon and Kenya, compared with usual care, finding a 10-fold increase in tuberculosis case detection in Cameroon but no effect in Kenya.MethodsWe estimated intervention impact on healthcare outcomes, resource use, health system costs and cost-effectiveness relative to the standard of care (SoC) using a decision tree analytical approach and data from the INPUT trial. INPUT trial data on cascades, resource use and intervention diagnostic rate ratios were used to parametrise the decision tree model. Health outcomes following tuberculosis treatment were modelled in terms of mortality and disability-adjusted life-years (DALYs).FindingsFor every 100 children starting antituberculosis treatment under SoC, an additional 876 (95% uncertainty interval (UI) -76 to 5518) in Cameroon and -6 (95% UI -61 to 96) in Kenya would start treatment under the intervention. Treatment success would increase by 5% in Cameroon and 9% in Kenya under the intervention compared with SoC. An estimated 350 (95% UI -31 to 2204) and 3 (95% UI -22 to 48) deaths would be prevented in Cameroon and Kenya, respectively. The incremental cost-effectiveness ratio for the intervention compared with SoC was US$506 and US$1299 per DALY averted in Cameroon and Kenya, respectively.InterpretationAlthough likely to be effective, the cost-effectiveness of integrating tuberculosis services into child healthcare services depends on baseline service coverage, tuberculosis detection and treatment outcomes.

Dataset Information

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.

Publications

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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