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.publishedVersio

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

Abstract 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

eRegistries: governance for electronic maternal and child health registries

Background The limited availability of maternal and child health data has limited progress in reducing mortality and morbidity among pregnant women and children. Global health agencies, leaders, and funders are prioritizing strategies that focus on acquiring high quality health data. Electronic maternal and child health registries (eRegistries) offer a systematic data collection and management approach that can serve as an entry point for preventive, curative and promotive health services. Due to the highly sensitive nature of reproductive health information, careful consideration must be accorded to privacy, access, and data security. In the third paper of the eRegistries Series, we report on the current landscape of ethical and legal governance for maternal and child health registries in developing countries. Methods This research utilizes findings from two web-based surveys, completed in 2015 that targeted public health officials and health care providers in 76 countries with high global maternal and child mortality burden. A sample of 298 public health officials from 64 countries and 490 health care providers from 59 countries completed the online survey. Based on formative research in the development of the eRegistries Governance Guidance Toolkit, the surveys were designed to investigate topics related to maternal and child health registries including ethical and legal issues. Results According to survey respondents, the prevailing legal landscape is characterized by inadequate data security safeguards and weak support for core privacy principles. Respondents from the majority of countries indicated that health information from medical records is typically protected by legislation although legislation dealing specifically or comprehensively with data privacy may not be in place. Health care provider trust in the privacy of health data at their own facilities is associated with the presence of security safeguards. Conclusion Addressing legal requirements and ensuring that privacy and data security of women’s and children’s health information is protected is an ethical responsibility that must not be ignored or postponed, particularly where the need is greatest. Not only are the potential harm and unintended consequences of inaction serious for individuals, but they could impact public trust in health registries leading to decreased participation and compromised data integrity

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

Abstract 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

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

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

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

BackgroundThe 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.MethodsWe 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.ResultsCoverage 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.ConclusionIndicators 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