eRegTime-Time Spent on Health Information Management in Primary Health Care Clinics Using a Digital Health Registry Versus Paper-Based Documentation: Cluster-Randomized Controlled Trial.

BACKGROUND: Digital health interventions have been shown to improve data quality and health services in low- and middle-income countries (LMICs). Nonetheless, in LMICs, systematic assessments of time saved with the use of digital tools are rare. We ran a set of cluster-randomized controlled trials as part of the implementation of a digital maternal and child health registry (eRegistry) in the West Bank, Palestine. OBJECTIVE: In the eRegTime study, we compared time spent on health information management in clinics that use the eRegistry versus the existing paper-based documentation system. METHODS: Intervention (eRegistry) and control (paper documentation) arms were defined by a stratified random subsample of primary health care clinics from the concurrent eRegQual trial. We used time-motion methodology to collect data on antenatal care service provision. Four observers used handheld tablets to record time-use data during one working day per clinic. We estimated relative time spent on health information management for booking and follow-up visits and on client care using mixed-effects linear regression. RESULTS: In total, 22 of the 24 included clinics (12 intervention, 10 control) contributed data; no antenatal care visits occurred in the other two clinics during the study period. A total of 123 and 118 consultations of new pregnancy registrations and follow-up antenatal care visits were observed in the intervention and control groups, respectively. Average time spent on health information management for follow-up antenatal care visits in eRegistry clinics was 5.72 minutes versus 8.10 minutes in control clinics (adjusted relative time 0.69, 95% CI 0.60-0.79; P<.001), and 15.26 minutes versus 18.91 minutes (adjusted relative time 0.96, 95% CI 0.61-1.50; P=.85) for booking visits. The average time spent on documentation, a subcategory of health information management, was 5.50 minutes in eRegistry clinics versus 8.48 minutes in control clinics (adjusted relative time 0.68, 95% CI 0.56-0.83; P<.001). While the average time spent on client care was 5.01 minutes in eRegistry clinics versus 4.91 minutes in control clinics, some uncertainty remains, and the CI was consistent with eRegistry clinics using less, the same, or more time on client care compared to those that use paper (adjusted relative time 0.85, 95% CI 0.64-1.13; P=.27). CONCLUSIONS: The eRegistry captures digital data at point of care during client consultations and generates automated routine reports based on the clinical data entered. Markedly less time (plausibly a saving of at least 18%) was spent on health information management in eRegistry clinics compared to those that use paper-based documentation. This is likely explained by the fact that the eRegistry requires lesser repetitive documentation work than paper-based systems. Adoption of eRegistry-like systems in comparable settings may save valuable and scarce health care resources. TRIAL REGISTRATION: ISRCTN registry ISRCTN18008445; https://doi.org/10.1186/ISRCTN18008445. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13653.

Comparison of a palm-based biometric solution with a name-based identification system in rural Bangladesh.

BACKGROUND: Unique identifiers are not universal in low- and middle-income countries. Biometric solutions have the potential to augment existing name-based searches used for identification in these settings. This paper describes a comparison of the searching accuracy of a palm-based biometric solution with a name-based database. OBJECTIVE: To compare the identification of individuals between a palm-based biometric solution to a name-based District Health Information Software 2 (DHIS2) Android application, in a low-resource setting. METHODS: The study was conducted in Chandpur district, Bangladesh. Trained data collectors enrolled 150 women of reproductive age into two android applications - i) a name-based DHIS2 application, and ii) a palm-based biometric solution - both run on tablets. One week after enrollment, a different research team member attempted to re-identify each enrolled woman using both systems. A single image or text-based name was used for searching at the time of re-identification. We interviewed data collectors at the end of the study. RESULTS: Significantly more women were successfully identified on the first attempt with a palm-based biometric application (84%) compared with the name-based DHIS2 application (61%). The proportion of identifications that required three or more attempts was similar between name-based (7%, CI 3.7-12.3) and palm-based biometric system (5%, CI: 1.9-9.4). However, the total number of attempts needed was significantly lower with the palm-based solution (mean 1.2 vs. 1.5, p < 0.001). In a group discussion, data collectors reported that the palm-based biometric identification system was both accurate and easy to use. CONCLUSION: A palm-based biometric identification system on mobile devices was found to be an easy-to-use and accurate technology for the unique identification of individuals compared to an existing name-based application. Our findings imply that palm-based biometrics on mobile devices may be the next step in establishing unique identifiers in remote and rural settings where they are currently absent.

A digital health registry with clinical decision support for improving quality of antenatal care in Palestine (eRegQual): a pragmatic, cluster-randomised, controlled, superiority trial.

BACKGROUND: Health worker compliance with clinical guidelines is enhanced by digital clinical decision support at the point of care. The Palestinian public health system is implementing a digital maternal and child health eRegistry with clinical decision support. We aimed to compare the quality of antenatal care between clinics using the eRegistry and those using paper-based records. METHODS: The eRegQual cluster-randomised controlled trial was done in primary health-care clinics offering routine antenatal care in the West Bank, Palestine. The intervention was the eRegistry with clinical decision support for antenatal care, implemented in District Health Information Systems 2 (DHIS2) Tracker software. 133 clinics forming 120 clusters were included and randomised; clusters were randomly assigned (1:1) to either the control (paper-based documentation) or intervention (eRegistry with clinical decision support) groups. The primary process outcomes were appropriate screening and management of anaemia, hypertension, and diabetes during pregnancy and foetal growth monitoring. The primary health outcome at delivery was a composite of moderate or severe anaemia; severe hypertension; large-for-gestational-age baby; malpresentation and small-for-gestational-age baby undetected before delivery. Data were analysed with mixed-effects logistic regression, accounting for clustering within clinics and pregnancies as appropriate. This trial is registered with the ISRCTN registry (ISRCTN18008445). FINDINGS: Between Jan 15 and Sept 15, 2017, 3219 pregnant women received care in the intervention clinics (n=60 clusters) and 3148 pregnant women received care in the control primary health-care clinics (n=59 clusters). Compared with the control group, the intervention led to higher guideline adherence for screening and management of anaemia (1535 [28·9%] of 5320 vs 2297 [44·3%] of 5182; adjusted odds ratio [OR] 1·88 [95% CI 1·52-2·32]), hypertension (7555 [94·7%] of 7982 vs 7314 [96·6%] of 7569; adjusted OR 1·62 [95% CI 1·29-2·05]), and gestational diabetes (1726 (39·7%) of 4348 vs 2189 (50·7%) of 4321; adjusted OR 1·45 [95% CI 1·14-1·83]) at eligible antenatal contacts. Only 599 (9·4%) of 6367 women attended the full antenatal care schedule, and better care provision did not translate to fewer adverse health outcomes in the intervention clusters (700 cases; 21·7%) compared to the control clusters (688 cases; 21·9%; adjusted OR 0·99; 95% CI 0·87-1·12). INTERPRETATION: Clinical decision support for antenatal care in the eRegistry was superior for most process outcomes but had no effect on the adverse health outcomes. The improvements in process outcomes strengthen the evidence for the WHO guideline for digital client tracking with clinical decision support in lower-middle-income settings. Digital health interventions to address gaps in attendance might help achieve effective coverage of antenatal care. FUNDING: European Research Council and Research Council of Norway. TRANSLATION: For the Arabic translation of the abstract see Supplementary Materials section.

Determinants of utilization of antenatal and delivery care at the community level in rural Bangladesh.

BACKGROUND: Timely utilization of antenatal care and delivery services supports the health of mothers and babies. Few studies exist on the utilization and determinants of timely ANC and use of different types of health facilities at the community level in Bangladesh. This study aims to assess the utilization, timeliness of, and socio-demographic determinants of antenatal and delivery care services in two sub-districts in Bangladesh. METHODS: This cross-sectional study used data collected through a structured questionnaire in the eRegMat cluster-randomized controlled trial, which enrolled pregnant women between October 2018-June 2020. We undertook univariate and multivariate logistic regression analysis to determine the associations of socio-demographic variables with timely first ANC, four timely ANC visits, and facility delivery. We considered the associations in the multivariate logistic regression as statistically significant if the p-value was found to be <0.05. Results are presented as adjusted odds ratios (AOR) with 95% confidence intervals (CI). RESULTS: Data were available on 3293 pregnant women. Attendance at a timely first antenatal care visit was 59%. Uptake of four timely antenatal care visits was 4.2%. About three-fourths of the women delivered in a health facility. Women from all socio-economic groups gradually shifted from using public health facilities to private hospitals as the pregnancy advanced. Timely first antenatal care visit was associated with: women over 30 years of age (AOR: 1.52, 95% CI: 1.05-2.19); nulliparity (AOR: 1.30, 95% CI: 1.04-1.62); husbands with >10 years of education (AOR: 1.40, 95% CI: 1.09-1.81) and being in the highest wealth quintile (AOR: 1.49, 95% CI: 1.18-1.89). Facility deliveries were associated with woman's age; parity; education; the husband's education, and wealth index. None of the available socio-demographic factors were associated with four timely antenatal care visits. CONCLUSIONS: The study observed socio-demographic inequalities associated with increased utilization of timely first antenatal care visit and facility delivery. The pregnant women, irrespective of wealth shifted from public to private facilities for their antenatal care visits and delivery. To increase the health service utilization and promote good health, maternal health care programs should pay particular attention to young, multiparous women, of low socio-economic status, or with poorly educated husbands. CLINICAL TRIAL REGISTRATION: ISRCTN69491836; https://www.isrctn.com/. Registered on December 06, 2018. Retrospectively registered.

FIGO good practice recommendations on the importance of registry data for monitoring rates and health systems performance in prevention and management of preterm birth.

FIGO calls for strengthening of health information systems for reproductive, maternal, newborn, and child health services, co-designed with users, to ensure the timely accessibility of actionable high-quality data for all stakeholders engaged in preventing and managing preterm birth consequences. FIGO calls for strengthening of investments and capacity for implementing digital registries and the continuity of reproductive, maternal, newborn, and child health services in line with WHO recommendations, and strengthening of the science of implementation and use of registries-from local quality improvement to big data exploration.

An Electronic Registry for Improving the Quality of Antenatal Care in Rural Bangladesh (eRegMat): Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Digital health interventions (DHIs) can alleviate several barriers to achieving better maternal and child health. The World Health Organization's guideline recommendations for DHIs emphasize the need to integrate multiple DHIs for maximizing impact. The complex health system of Bangladesh provides a unique setting for evaluating and understanding the role of an electronic registry (eRegistry) for antenatal care, with multiple integrated DHIs for strengthening the health system as well as improving the quality and utilization of the public health care system. OBJECTIVE: The aim of this study is to assess the effect of an eRegistry with DHIs compared with a simple digital data entry tool without DHIs in the community and frontline health facilities. METHODS: The eRegMat is a cluster-randomized controlled trial conducted in the Matlab North and Matlab South subdistricts in the Chandpur district, Bangladesh, where health facilities are currently using the eRegistry for digital tracking of the health status of pregnant women longitudinally. The intervention arm received 3 superimposed data-driven DHIs: health worker clinical decision support, health worker feedback dashboards with action items, and targeted client communication to pregnant women. The primary outcomes are appropriate screening as well as management of hypertension during pregnancy and timely antenatal care attendance. The secondary outcomes include morbidity and mortality in the perinatal period as well as timely first antenatal care visit; successful referrals for anemia, diabetes, or hypertension during pregnancy; and facility delivery. RESULTS: The eRegistry and DHIs were co-designed with end users between 2016 and 2018. The eRegistry was implemented in the study area in July 2018. Recruitment for the trial started in October 2018 and ended in June 2020, followed by an 8-month follow-up period to capture outcome data until February 2021. Trial results will be available for publication in June 2021. CONCLUSIONS: This trial allows the simultaneous assessment of multiple integrated DHIs for strengthening the health system and aims to provide evidence for its implementation. The study design and outcomes are geared toward informing the living review process of the guidelines for implementing DHIs. TRIAL REGISTRATION: ISRCTN Registry ISRCTN69491836; https://www.isrctn.com/ISRCTN69491836. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26918.

Development of a targeted client communication intervention for pregnant and post-partum women: a descriptive study.

BACKGROUND: Targeted client communication using text messages can inform, motivate, and remind pregnant and postpartum women to use care in a timely way. The mixed results of previous studies of the effectiveness of targeted client communication highlight the importance of theory-based co-design with users. We planned, developed, and tested a theory-based intervention tailored to pregnant and postpartum women, to be automatically distributed via an electronic maternal and child health registry in occupied Palestinian territory. METHODS: We did 26 in-depth interviews with pregnant women and health-care providers in seven purposively selected public primary health-care clinics in the West Bank and Gaza to include clinics with different profiles. An interview guide was developed using the Health Belief Model to explore women's perceptions of high-risk conditions (anaemia, hypertension, diabetes, and fetal growth restriction) and timely attendance for antenatal care, as predefined by a national expert panel. We did thematic analyses of the interview data. Based on the results, we composed messages for a targeted client communication intervention, applying concepts from the Model of Actionable Feedback, social nudging, and enhanced active choice. We assessed the acceptability and understandability of the messages through unstructured interviews with local health promotion experts, health-care providers, and pregnant women. FINDINGS: The recurring themes indicated that most women were aware of the health consequences of anaemia, hypertension, and diabetes, but that they seldom associated these conditions with pregnancy. We identified knowledge gaps and low awareness of susceptibility to and severity of these complications and the benefits of timely antenatal care. The actionable messages were iteratively improved with stakeholder and end-user feedback after presenting the initial draft, and the messages deemed were understandable and acceptable based on reflections during unstructured assessment. INTERPRETATION: Following a stepwise iterative process by a theory-based approach and co-designing the intervention with users, we revealed elements critical to an efficacious targeted client communication intervention. A potential limitation of our study is that conducting in-depth interviews on several health conditions simultaneously might have reduced the depth of information we could have obtained. The strength of our study was that we assessed for, developed, and refined the intervention following recommended theoretical frameworks and best practices. The effectiveness of this intervention is under evaluation in a cluster-randomised trial (ISRCTN10520687). FUNDING: European Research Council and Research Council of Norway.

Gestational age recorded at delivery versus estimations using antenatal care data from the Electronic Maternal and Child Health Registry in the West Bank: a comparative analysis.

BACKGROUND: Estimated dates of delivery have important consequences for clinical decisions during pregnancy and labour. The Electronic Maternal and Child Health Registry (MCH eRegistry) in Palestine includes antenatal care data and birth data from hospitals. Our objective was to compare computed best estimates of gestational age in the MCH eRegistry with the gestational ages recorded by health-care providers in hospital delivery units. METHODS: We obtained data for pregnant women in the West Bank registered in the MCH eRegistry from Jan 1, 2017 to March 31, 2017. Best estimates of gestational age in the registry are automated and based on a standard pregnancy duration of 280 days and ultrasound-based pregnancy dating before 20 weeks' gestation or the woman's last menstrual period date. Hospital recorded gestational ages are reported by care providers in delivery units and are rounded to the nearest week. We calculated proportions of gestational ages (with 95% CIs) from both sources that fell into the categories of term, very preterm (24-32 weeks' gestation), preterm (33-37 weeks), or post-term (>42 weeks). FINDINGS: 1924 women were included in the study. The median hospital recorded gestational age was 39 weeks (IQR 38-40 weeks) and according to MCH eRegistry estimates was 39 weeks and 5 days (IQR 38 weeks and 1 day to 40 weeks and 5 days). Proportions of very preterm, preterm, and post-term deliveries were higher based on MCH eRegistry estimates than on hospital recorded gestational ages (very preterm 3%, 95% CI 2-4 vs 2%, 1-2; preterm 6%, 5-7 vs 5%, 3-6 ; post-term 6%, 5-7 vs 1%, 1-2). INTERPRETATION: In addition to clinical care, the proportions of term, very preterm, preterm, and post-term births can have implications for public health monitoring. The proportion of deliveries within the normal range of term gestation was calculated to be higher by care providers in delivery units than by MCH eRegistry estimates. Extending the access of hospitals to information from antenatal care in the MCH e-Registry could improve continuity of data and better care for pregnant women. FUNDING: European Research Council, Research Council of Norway.

Developing targeted client communication messages to pregnant women in Bangladesh: a qualitative study.

BACKGROUND: Timely and appropriate evidence-based practices during antenatal care improve maternal and neonatal health. There is a lack of information on how pregnant women and families perceive antenatal care in Bangladesh. The aim of our study was to develop targeted client communication via text messages for increasing antenatal care utilization, as part of an implementation of an electronic registry for maternal and child health. METHODS: Using a phenomenological approach, we conducted this qualitative study from May to June 2017 in two sub-districts of Chandpur district, Bangladesh. We selected study participants by purposive sampling. A total of 24 in-depth interviews were conducted with pregnant women (n = 10), lactating women (n = 5), husbands (n = 5), and mothers-in-law (n = 4). The Health Belief Model (HBM) was used to guide the data collection. Thematic analysis was carried out manually according to the HBM constructs. We used behavior change techniques to inform the development of targeted client communication based on the thematic results. RESULTS: Almost no respondents mentioned antenatal care as a preventive form of care, and only perceived it as necessary if any complications developed during pregnancy. Knowledge of the content of antenatal care (ANC) and pregnancy complications was low. Women reported a variety of reasons for not attending ANC, including the lack of information on the timing of ANC; lack of decision-making power; long-distance to access care; being busy with household chores, and not being satisfied with the treatment by health care providers. Study participants recommended phone calls as their preferred communication strategy when asked to choose between the phone call and text message, but saw text messages as a feasible option. Based on the findings, we developed a library of 43 automatically customizable text messages to increase ANC utilization. CONCLUSIONS: Pregnant women and family members had limited knowledge about antenatal care and pregnancy complications. Effective health information through text messages could increase awareness of antenatal care among the pregnant women in Bangladesh. This study presents an example of designing targeted client communication to increase antenatal care utilization within formal scientific frameworks, including a taxonomy of behavior change techniques. TRIAL REGISTRATION: ISRCTN69491836 . Registered on December 06, 2018. Retrospectively registered.

The effect of a digital targeted client communication intervention on pregnant women's worries and satisfaction with antenatal care in Palestine-A cluster randomized controlled trial.

BACKGROUND: The eRegCom cluster randomized controlled trial assesses the effectiveness of targeted client communication (TCC) via short message service (SMS) to pregnant women, from a digital maternal and child health registry (eRegistry) in Palestine, on improving attendance and quality of care. In this paper, we assess whether this TCC intervention could also have unintended consequences on pregnant women's worries, and their satisfaction with antenatal care (ANC). METHODS: We interviewed a sub-sample of Arabic-speaking women attending ANC at public primary healthcare clinics, randomized to either the TCC intervention or no TCC (control) in the eRegCom trial, who were in 38 weeks of gestation and had a phone number registered in the eRegistry. Trained female data collectors interviewed women by phone from 67 intervention and 64 control clusters, after securing informed oral consent. The Arabic interview guide, pilot-tested prior to the data collection, included close-ended questions to capture the woman's socio-demographic status, agreement questions about their satisfaction with ANC services, and the 13-item Cambridge Worry Scale (CWS). We employed a non-inferiority study design and an intention-to-treat analysis approach. RESULTS: A total of 454 women, 239 from the TCC intervention and 215 from the control arm participated in this sub-study. The mean and standard deviation of the CWS were 1.8 (1.9) for the intervention and 2.0 (1.9) for the control arm. The difference in mean between the intervention and control arms was -0.16 (95% CI: -0.31 to -0.01) after adjusting for clustering, which was below the predefined non-inferiority margin of 0.3. Women in both groups were equally satisfied with the ANC services they received. CONCLUSION: The TCC intervention via SMS did not increase pregnancy-related worries among recipients. There was no difference in women's satisfaction with the ANC services between intervention and control arms.

eRegCom-Quality Improvement Dashboard for healthcare providers and Targeted Client Communication to pregnant women using data from an electronic health registry to improve attendance and quality of antenatal care: study protocol for a multi-arm cluster randomized trial.

BACKGROUND: This trial evaluates interventions that utilize data entered at point-of-care in the Palestinian maternal and child eRegistry to generate Quality Improvement Dashboards (QID) for healthcare providers and Targeted Client Communication (TCC) via short message service (SMS) to clients. The aim is to assess the effectiveness of the automated communication strategies from the eRegistry on improving attendance and quality of care for pregnant women. METHODS: This four-arm cluster randomized controlled trial will be conducted in the West Bank and the Gaza Strip, Palestine, and includes 138 clusters (primary healthcare clinics) enrolling from 45 to 3000 pregnancies per year. The intervention tools are the QID and the TCC via SMS, automated from the eRegistry built on the District Health Information Software 2 (DHIS2) Tracker. The primary outcomes are appropriate screening and management of anemia, hypertension, and diabetes during pregnancy and timely attendance to antenatal care. Primary analysis, at the individual level taking the design effect of the clustering into account, will be done as intention-to-treat. DISCUSSION: This trial, embedded in the implementation of the eRegistry in Palestine, will inform the use of digital health interventions as a health systems strengthening approach. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN10520687 . Registered on 18 October 2018.

Antenatal Uterotonics as a Risk Factor for Intrapartum Stillbirth and First-day Death in Haryana, India: A Nested Case-control Study.

BACKGROUND: Use of uterotonics like oxytocin to induce or augment labor has been shown to reduce placental perfusion and oxygen supply to the fetus, and studies indicate that it may increase the risk of stillbirth and neonatal asphyxia. Antenatal use of uterotonics, even without the required fetal monitoring and prompt access to cesarean section, is widespread, yet no study has adequately estimated the risk of intrapartum stillbirth and early neonatal deaths ascribed to such use. We conducted a case-control study to estimate this risk. METHODS: We conducted a population-based case-control study nested in a cluster-randomized trial. From 2008 to 2010, we followed pregnant women in rural Haryana, India, monthly until delivery. We visited all live-born infants on day 29 to ascertain whether they were alive. We conducted verbal autopsies for stillbirths and neonatal deaths. Cases (n = 2,076) were the intrapartum stillbirths and day-1 deaths (early deaths), and controls (n = 532) were live-born babies who died between day 8 and 28 (late deaths). RESULTS: Antenatal administration of uterotonics preceded 74% of early and 62% of late deaths, translating to an adjusted odds ratio (95% confidence interval [CI]) for early deaths of 1.7 (95% CI = 1.4, 2.1), and a population attributable risk of 31% (95% CI = 22%, 38%). CONCLUSIONS: Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death. See video abstract: http://links.lww.com/EDE/B707.

Development of a targeted client communication intervention to women using an electronic maternal and child health registry: a qualitative study.

BACKGROUND: Targeted client communication (TCC) using text messages can inform, motivate and remind pregnant and postpartum women of timely utilization of care. The mixed results of the effectiveness of TCC interventions points to the importance of theory based interventions that are co-design with users. The aim of this paper is to describe the planning, development, and evaluation of a theory led TCC intervention, tailored to pregnant and postpartum women and automated from the Palestinian electronic maternal and child health registry. METHODS: We used the Health Belief Model to develop interview guides to explore women's perceptions of antenatal care (ANC), with a focus on high-risk pregnancy conditions (anemia, hypertensive disorders in pregnancy, gestational diabetes mellitus, and fetal growth restriction), and untimely ANC attendance, issues predefined by a national expert panel as being of high interest. We performed 18 in-depth interviews with women, and eight with healthcare providers in public primary healthcare clinics in the West Bank and Gaza. Grounding on the results of the in-depth interviews, we used concepts from the Model of Actionable Feedback, social nudging and Enhanced Active Choice to compose the TCC content to be sent as text messages. We assessed the acceptability and understandability of the draft text messages through unstructured interviews with local health promotion experts, healthcare providers, and pregnant women. RESULTS: We found low awareness of the importance of timely attendance to ANC, and the benefits of ANC for pregnancy outcomes. We identified knowledge gaps and beliefs in the domains of low awareness of susceptibility to, and severity of, anemia, hypertension, and diabetes complications in pregnancy. To increase the utilization of ANC and bridge the identified gaps, we iteratively composed actionable text messages with users, using recommended message framing models. We developed algorithms to trigger tailored text messages with higher intensity for women with a higher risk profile documented in the electronic health registry. CONCLUSIONS: We developed an optimized TCC intervention underpinned by behavior change theory and concepts, and co-designed with users following an iterative process. The electronic maternal and child health registry can serve as a unique platform for TCC interventions using text messages.

eRegTime, Efficiency of Health Information Management Using an Electronic Registry for Maternal and Child Health: Protocol for a Time-Motion Study in a Cluster Randomized Trial.

BACKGROUND: Paper-based routine health information systems often require repetitive data entry. In the West Bank, the primary health care system for maternal and child health was entirely paper-based, with care providers spending considerable amounts of time maintaining multiple files and client registers. As part of the phased national implementation of an electronic health information system, some of the primary health care clinics are now using an electronic registry (eRegistry) for maternal and child health. The eRegistry consists of client-level data entered by care providers at the point-of-care and supports several digital health interventions that are triggered by the documented clinical data, including guideline-based clinical decision support and automated public health reports. OBJECTIVE: The aim of the eRegTime study is to investigate whether the use of the eRegistry leads to changes in time-efficiency in health information management by the care providers, compared with the paper-based systems. METHODS: This is a substudy in a cluster randomized controlled trial (the eRegQual study) and uses the time-motion observational study design. The primary outcome is the time spent on health information management for antenatal care, informed and defined by workflow mapping in the clinics. We performed sample size estimations to enable the detection of a 25% change in time-efficiency with a 90% power using an intracluster correlation coefficient of 0.1 and an alpha of .05. We observed care providers for full workdays in 24 randomly selected primary health care clinics-12 using the eRegistry and 12 still using paper. Linear mixed effects models will be used to compare the time spent on health information management per client per care provider. RESULTS: Although the objective of the eRegQual study is to assess the effectiveness of the eRegistry in improving quality of antenatal care, the results of the eRegTime study will contribute to process evaluation, supplementing the findings of the larger trial. CONCLUSIONS: Electronic health tools are expected to reduce workload for the care providers and thus improve efficiency of clinical work. To achieve these benefits, the implementation of such systems requires both integration with existing workflows and the creation of new workflows. Studies assessing the time-efficiency of electronic health information systems can inform policy decisions for implementations in resource-limited low- and middle-income settings. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13653.

Effective coverage of essential antenatal care interventions: A cross-sectional study of public primary healthcare clinics in the West Bank.

BACKGROUND: The proportion of women attending four or more antenatal care (ANC) visits is widely used for monitoring, but provides limited information on quality of care. Effective coverage metrics, assessing if ANC interventions are completely delivered, can identify critical gaps in healthcare service delivery. We aimed to measure coverage of at least one screening and effective coverage of ANC interventions in the public health system in the West Bank, Palestine, and to explore associations between infrastructure-related and maternal sociodemographic variables and effective coverage. METHODS: We used data from paper-based clinical records of 1369 pregnant women attending ANC in 17 primary healthcare clinics. Infrastructure-related variables were derived from a 2014 national inventory assessment of clinics. Sample size calculations were made to detect effective coverage ranging 40-60% with a 2-3% margin of error, clinics were selected by probability sampling. We calculated inverse probability weighted percentages of: effective coverage of appropriate number and timing of screenings of ANC interventions; and coverage of at least one screening. RESULTS: Coverage of one screening and effective coverage of ANC interventions were notably different for screening for: hypertension (98% vs. 10%); fetal growth abnormalities (66% vs. 6%); anemia (93% vs. 14%); gestational diabetes (93% vs. 34%), and antenatal ultrasound (74% vs. 24%). Clinics with a laboratory and ultrasound generally performed better in terms of effective coverage, and maternal sociodemographic factors had no associations with effective coverage estimates. Only 13% of the women attended ANC visits according to the recommended national schedule, driving effective coverage down. CONCLUSION: Indicators for ANC monitoring and their definitions can have important consequences for quantifying health system performance and identifying issues with care provision. To achieve more effective coverage in public primary care clinics in the West Bank, efforts should be made to improve care provision according to prescribed guidelines.

Antenatal care data sources and their policy and planning implications: a Palestinian example using the Lives Saved Tool.

BACKGROUND: Policy making in healthcare requires reliable and local data. Different sources of coverage data for health interventions can be utilized to populate the Lives Saved Tool (LiST), a commonly used policy-planning tool for women and children's health. We have evaluated four existing sources of antenatal care data in Palestine to discuss the implications of their use in LiST. METHODS: We identified all intervention coverage and health status indicators around the antenatal period that could be used to populate LiST. These indicators were calculated from 1) routine reported data, 2) a Multiple Indicator Cluster Survey (MICS), 3) paper-based antenatal records and 4) the eRegistry (an electronic health information system) for public clinics in the West Bank, Palestine for the most recent year available. We scaled coverage of each indicator to 90%, in public clinics only, and compared this to a no-change scenario for a seven-year period. RESULTS: Eight intervention coverage and health status indicators needed to populate the antenatal section of LiST could be calculated from both paper-based antenatal records and the eRegistry. Only two could be calculated from routine reports and three from a national survey. Maternal lives saved over seven years ranged from 5 to 39, with percent reduction in the maternal mortality ratio (MMR) ranging from 1 to 6%. Pre-eclampsia management accounted for 25 to 100% of these lives saved. CONCLUSIONS: The choice of data source for antenatal indicators will affect policy-based decisions when used to populate LiST. Although all data sources have their purpose, clinical data collected directly in an electronic registry during antenatal contacts may provide the most reliable and complete data to populate currently unavailable but needed indicators around specific antenatal care interventions.

Age at menarche and the risk of operative delivery.

OBJECTIVES: We sought to evaluate the impact of later menarche on the risk of operative delivery. POPULATION: We studied 38,069 eligible women (first labors at term with a singleton infant in a cephalic presentation) from the Norwegian Mothers and Child Cohort Study. The main exposures were the age at menarche and the duration of the interval between menarche and the first birth. METHODS: Poisson's regression with a robust variance estimator. MAIN OUTCOME MEASURES: Operative delivery, defined as emergency cesarean or assisted vaginal delivery (ventouse extraction or forceps). RESULTS: A 5 year increase in age at menarche was associated with a reduced risk of operative delivery (risk ratio [RR] 0.84, 95%CI 0.78, 0.89; p < .001). Adjustment for the age at first birth slightly strengthened the association (RR 0.79, 95%CI 0.74, 0.84; p < .001). However, the association was lost following adjustment for the menarche to birth interval (RR 0.99, 95%CI 0.93, 1.06; p = .81). A 5 years increase in menarche to birth interval was associated with an increased risk of operative delivery (RR 1.26, 95%CI 1.23, 1.28; p < .001). This was not materially affected by adjustment for an extensive series of maternal characteristics (RR 1.23, 95%CI 1.20, 1.25; p < .001). CONCLUSIONS: Later menarche reduces the risk of an operative first birth through shortening the menarche to birth interval. This observation is consistent with the hypothesis that the pattern and/or duration of prepregnancy exposure of the uterus to estrogen and progesterone contributes to uterine aging.

Comparing individual-level clinical data from antenatal records with routine health information systems indicators for antenatal care in the West Bank: A cross-sectional study.

BACKGROUND: In most low- and middle-income settings, national aggregate health data is the most consistently available source for policy-making and international comparisons. In the West Bank, the paper-based health information system with manual aggregations is transitioning to an individual-level data eRegistry for maternal and child health at the point-of-care. The aim of this study was to explore beforehand how routine health information systems indicators for antenatal care can change with the introduction of the eRegistry. METHODS: Data were collected from clinical antenatal paper records of pregnancy enrollments for 2015 from 17 primary healthcare clinics, selected by probability sampling from five districts in the West Bank. We used the individual-level data from clinical records to generate routinely reported health systems indicators. We weighted the data to produce population-level estimates, and compared these indicators with aggregate routine health information systems reports. RESULTS: Antenatal anemia screening at 36 weeks was 20% according to the clinical records data, compared to 52% in the routine reports. The clinical records data showed considerably higher incidences of key maternal conditions compared to the routine reports, including fundal height discrepancy (20% vs. 0.01%); Rh-negative blood group (6.8% vs. 1.4%); anemia with hemoglobin<9.5 g/dl (6% vs. 0.6%); and malpresentation at term (1.3% vs. 0.03%). Only about a sixth of cases with these conditions were referred according to guidelines to designated referral clinics. CONCLUSIONS: Differences between indicators from the clinical records data and routine health information systems reports can be attributed to human error, inconsistent denominators, and complexities of data processes. Key health systems indicators were prone to underestimations since their registration was dependent on referral of pregnant women. With a transition to individual-level data, as in the eRegistry under implementation, the public health authorities will be able to generate reliable health systems indicators reflective of the population's health status.

Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial.

BACKGROUND: 2·6 million pregnancies were estimated to have ended in stillbirth in 2015. The aim of the AFFIRM study was to test the hypothesis that introduction of a reduced fetal movement (RFM), care package for pregnant women and clinicians that increased women's awareness of the need for prompt reporting of RFM and that standardised management, including timely delivery, would alter the incidence of stillbirth. METHODS: This stepped wedge, cluster-randomised trial was done in the UK and Ireland. Participating maternity hospitals were grouped and randomised, using a computer-generated allocation scheme, to one of nine intervention implementation dates (at 3 month intervals). This date was concealed from clusters and the trial team until 3 months before the implementation date. Each participating hospital had three observation periods: a control period from Jan 1, 2014, until randomised date of intervention initiation; a washout period from the implementation date and for 2 months; and the intervention period from the end of the washout period until Dec 31, 2016. Treatment allocation was not concealed from participating women and caregivers. Data were derived from observational maternity data. The primary outcome was incidence of stillbirth. The primary analysis was done according to the intention-to-treat principle, with births analysed according to whether they took place during the control or intervention periods, irrespective of whether the intervention had been implemented as planned. This study is registered with www.ClinicalTrials.gov, number NCT01777022. FINDINGS: 37 hospitals were enrolled in the study. Four hospitals declined participation, and 33 hospitals were randomly assigned to an intervention implementation date. Between Jan 1, 2014, and Dec, 31, 2016, data were collected from 409 175 pregnancies (157 692 deliveries during the control period, 23 623 deliveries in the washout period, and 227 860 deliveries in the intervention period). The incidence of stillbirth was 4·40 per 1000 births during the control period and 4·06 per 1000 births in the intervention period (adjusted odds ratio [aOR] 0·90, 95% CI 0·75-1·07; p=0·23). INTERPRETATION: The RFM care package did not reduce the risk of stillbirths. The benefits of a policy that promotes awareness of RFM remains unproven. FUNDING: Chief Scientist Office, Scottish Government (CZH/4/882), Tommy's Centre for Maternal and Fetal Health, Sands.

eRegQual-an electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care: study protocol for a cluster randomized trial.

BACKGROUND: Health 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. METHODS: This 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. DISCUSSION: This 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 REGISTRATION: ISRCTN trial registration number, ISRCTN18008445 . Registered on 6 April 2017.