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.

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.

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.

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.

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.

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.