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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.
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.
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.
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.
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.
DERR1-10.2196/13653
Robust health information systems play a central role in the strengthening of health systems and achieving universal health coverage [
In the West Bank, Palestine, an electronic health information system—the eRegistry for maternal and child health—is currently being rolled out on a national scale throughout primary health care. The eRegistry consists of electronic health (eHealth) records for antenatal, postpartum, and newborn care for use at the point of care by the care providers. The eRegistry supports automated clinical decision support, workflow management support, and referral functionalities. [
An ongoing cluster randomized controlled trial (CRCT), the eRegQual study, is embedded in the national implementation of the eRegistry, where clinics using the eRegistry were included in the intervention arm and compared with the control arm that used paper-based records [
The time-motion method is one of the more robust study designs for the collection and quantification of time data [
The aim of the eRegTime study is to evaluate whether the use of an eRegistry changes the time-efficiency of care providers in primary health care clinics for antenatal care. Time-efficiency will be assessed by measuring the time spent by the care providers on health information management.
In this protocol, we have followed the Suggested Time and Motion Procedures checklist for standardized reporting of studies using the time-motion design (see
In the West Bank, Palestine, primary health care clinics provide antenatal, postpartum, and newborn care.
The different cadres of health care providers that work in maternal and child health in primary health care clinics include midwives, nurses, general practitioners trained in maternal and child health care, and specialist obstetricians. Smaller clinics (less than 50 new enrollments of pregnancies a year) typically have a nurse or a midwife working throughout the week, whereas the doctor visits the clinic once every 2 weeks. Larger clinics (more than 50 new enrollments of pregnancies a year) and referral clinics have specialist obstetricians, in addition. The nurse or midwife in the clinics does the majority of the antenatal care consultation and after-consultation work that involves health information management and were the only groups of care providers observed in this study.
The phased national implementation of the eRegistry was undertaken in tandem with the eRegQual study; the intervention clusters of the eRegQual study were the clinics that received the eRegistry as part of phase 1 of implementation, whereas control clusters continued to use paper-based clinical records and were scheduled to receive the eRegistry after the end of the eRegQual study. Although 68 primary health care clinics started using the eRegistry in phase 1 of implementation, and 59 clinics continued to use paper-based clinical records, some of the smaller clinics were clubbed to form clusters before randomization for the eRegQual study. Larger clinics were considered as clusters of their own. In total, there were 60 clusters in each arm of the eRegQual study. Details of enrollment and randomization for the eRegQual study can be found in the published trial protocol [
The intervention evaluated in the eRegQual study—the eRegistry—is used as a point-of-care electronic data entry tool in primary health care clinics in the West Bank [
Pregnant women visit primary health care clinics for their first antenatal (booking) visit on specific workdays (clinics may work 1-4 days a week). The nurse or midwife in the clinics receives the pregnant women for the booking visit and documents a set of demographic data (eg, name, national identification number, address, phone number, and date of birth), and medical, surgical, and obstetric history. Afterward, the nurse or midwife measures and documents the woman’s height and weight, blood pressure, and fundal height and orders and fills out routine laboratory results appropriate for each antenatal visit. As part of the booking visit, the doctor examines women on the same workday or a few workdays later in some clinics. The nurse or midwife assists the doctor in medical and ultrasound examinations. For pregnant women identified with risk factors that warrant a referral, the nurse or midwife makes necessary arrangements for transfer to the referral health facility. There is a flexible appointment system for all subsequent antenatal visits. For uncomplicated pregnancies, the nurse or midwife documents blood pressure and fundal height, checks for fetal presentation, and orders laboratory investigations during the subsequent antenatal visits. Nurses and midwives typically do client care for pregnant and postpartum women as well as newborns in the first part of the workday. Following this, the nurse or midwife usually completes registers for antenatal care, referrals, ultrasounds, vaccines, and laboratory investigations. The nurse or midwife also compiles the data in the registers for public health reporting to the Palestinian Ministry of Health, typically concentrating this task in 1 or 2 workdays monthly. Event counts of number of pregnancies registered in the clinic, number of ultrasound examinations and laboratory tests that are performed, and number of pregnancies with risk conditions that are referred are some examples of the data that are part of standardized monthly reports submitted by care providers [
All clinical tasks, as described for the control clusters, are identical in case of the intervention clusters. Only the health information management differs. The eRegistry is used by care providers to document real-time clinical data during client consultation. On the basis of the data entered at the point of care, the eRegistry generates automated decision support and workflow assistance [
The time-motion study design was employed to collect data in the eRegTime study [
The primary outcome measure is the time spent on health information management per consultation. We defined health information management as the preparations and executions of collection, aggregation, analysis, and dissemination of clinical data, both at the individual and aggregate levels [
A total of 2 additional analysis categories were defined: (1) “client care” that includes all activities in which the care provider is fully focused on the client without any writing and (2) “client-related care” that refers to all tasks that are imperative for care of individual pregnant women undertaken between 2 antenatal care consultations (see
Activities unrelated to care of clients, including personal activities of the care providers, and tidying and preparing the consultation room for new clients, were categorized as “miscellaneous” (see
Analysis categories including the primary outcome measure, corresponding task, and task category as defined for data collection (adapted from the study by Pizziferri et al [
Analysis category | Task category in data collection tool | Name of task in data collection tool |
Client care | Outside | Assisting doctor |
Client care | Outside | Examination in other room |
Client care | Procedures | Clinical and medical examination |
Client care | Procedures | Injections and bloodtake |
Client care | Procedures | Giving tablets |
Client care | Procedures | Other |
Client care | Talking | Education and counseling |
Client care | Talking | Talking to family |
Client care | Talking | History: demographic and medical |
Client care or client-related carea | Talking | Clinical support |
Client care or client-related carea | Talking | Call client or family |
Client care or client-related carea | Talking | Referrals |
Client care or client-related carea | Talking | Other |
Health information management | Between or after consultations | Writing in statistics book |
Health information management | Computer-Find | Client file |
Health information management | Computer-Find | Lab or ultrasound results |
Health information management | Computer-Writing | Client file (including history) |
Health information management | Computer-Writing | Lab or ultrasound form |
Health information management | Computer-Writing | Schedule appointment |
Health information management | Computer-Writing | Text message in eRegistry |
Health information management | Paper-Find | Client file |
Health information management | Paper-Find | Lab or ultrasound results |
Health information management | Paper-Writing | MCH (Maternal and Child Health) Handbook (including history) |
Health information management | Paper-Writing | Client file (including history) |
Health information management | Paper-Writing | Register book |
Health information management | Paper-Writing | MCH Handbook or register book |
Health information management | Paper-Writing | Register book or client file |
Health information management | Paper-Writing | Client file or MCH handbook |
Health information management | Paper-Writing | Lab, ultrasound, prescriptions, and referrals |
Health information management | Paper-Writing | Schedule appointment |
Health information management | Paper-Writing | Writing on other paper |
Health information management | Talking | Explaining test results |
Health information management | Talking | Technical support |
Health information management or client-related careb | Computer-Read | Appointment list |
Health information management or client-related careb | Computer-Read | Client file |
Health information management or client-related careb | Computer-Read | Lab or ultrasound results |
Health information management or client-related careb | Computer-Read | Guidelines, treatment |
Health information management or client-related careb | Computer-Read | Other info |
Health information management or client-related careb | Paper-Read | Appointment list |
Health information management or client-related careb | Paper-Read | MCH handbook |
Health information management or client-related careb | Paper-Read | Client file |
Health information management or client-related careb | Paper-Read | Lab or ultrasound results |
Health information management or client-related careb | Paper-Read | Treatment guidelines |
Health information management or client-related careb | Paper-Read | Other info |
Miscellaneous | Between or after consultations | Cleaning, arranging files |
Miscellaneous | Between or after consultations | Phone and computer (personal) |
Miscellaneous | Between or after consultations | Other: praying, eating, toilet |
Miscellaneous | Between or after consultations | Eating, praying, toilet |
Miscellaneous | Between or after consultations | Group education |
Miscellaneous | Postpartum care | Postpartum care |
aTask classified as client-related care if done outside of a consultation. If done within an antenatal care consultation, it is classified as client care.
bTask classified as client-related care if done outside of a consultation. If done within an antenatal care consultation, it is classified as health information management.
Clusters (primary health care clinics) that are part of the eRegQual CRCT that fulfil the following criteria were eligible for inclusion in the eRegTime study: (1) Have 1 nurse or 1 midwife providing antenatal care services on a given workday (to maintain a 1:1 subject-to-observer ratio) and (2) Have, on average, at least 1 booking visit per workday (to ensure capturing a sufficient number of antenatal booking visits). After applying these inclusion criteria to the 120 clusters that are part of the eRegQual CRCT, 41 clusters were eligible for the time-motion study observations (20 intervention clusters and 21 control clusters;
Selection of clusters in primary health care clinics for observations.
For sample size estimations, we assumed that clinics using paper-based systems spend an average of 10 min on health information management per client. We also assumed unequal and higher SD around the mean health information management time (in minutes) for clinics that use the eRegistry (SD=5) compared with clinics that use paper-based systems (SD=2) because of an expected variance in computer literacy and confidence of use. Sample size calculations were made using the Stata command “clustersampsi” to detect a 25% difference at a 90% power and 5% significance using an a priori intracluster correlation coefficient of .1 [
We designed the data collection tool based on a Microsoft Access database template made available online by the US Agency for Healthcare Research and Quality [
The observers were trained to first determine the nature of the observed task and then click on the corresponding task on the data collection tool (
The database stored the observation times for each task with an activity code linked to the tasks. In accordance with ethical approvals for the study, no personal or other demographic data related to the client or the care provider were collected, and clinic names were only being stored as computer-generated codes in the database.
A total of 4 trained observers completed the data collection. Observers were trained with simulation videos on the time-motion methodology and the task categories and in using the data collection tool (see
The field coordinators of the study received the data after each day of data collection and checked that the sample size for each clinic is reached with a sufficient number of documented observations.
Although neither the observers nor the care providers in the primary health care clinics can be blinded to the intervention, they both will be blinded to the outcomes of the eRegTime study and have only been informed of the overarching objective of the eRegQual CRCT (including the eRegTime study) of assessing effects of the eRegistry on the quality of care. To ensure blinding of the observers to the outcome, the data collection tool included an exhaustive list of tasks, beyond the primary outcome of the eRegTime study (see
Data collection tool (data entry form) used for recording time-motion data.
The unit of measurement of the primary outcome is the time spent on health information management per client per care provider, where time will be analyzed in minutes. Statistical analyses will be performed using Stata version 15 or later (StataCorp LLC, 2017,
We assume that the nurse or midwife spends, on average, an equal amount of time on after-consultation documentation work per client. The after-consultation time spent on client-related documentation and public health reporting will be averaged over the number of observed antenatal consultations and added to the time spent per consultation. Differences in the health information management time between the clinics with and without the eRegistry will be tested for significance using the linear mixed effects model to account for clustering [
Accompanying the results of the outcomes of the study, interobserver reliability assessments will be reported using kappa coefficients for the total number of clinical tasks and activity types recorded and intraclass correlation coefficients for the recorded mean times for the tasks and analysis categories (see
The eRegTime study was approved by the Palestinian Health Research Council (PHRC/HC/208/17) and the Regional Committee for Medical and Health Research Ethics in Norway (2017/400). Permissions to conduct observations in the clinics have been obtained from the Palestinian Ministry of Health. Care providers and supervisors of the primary health care clinics will be informed of the data collection for this study. Considering the local sensitivity and hesitance related to signing documents in our study context, pregnant women will be asked for oral consent to allow the observers to be present in the rooms during consultations, and the ethics committees were notified of this. No data will be recorded on personal or individual characteristics of pregnant women, care providers, or primary health care clinics. Only completely anonymous data will be available to the researchers for analysis.
Ethical approvals for conduct of the study were obtained in April 2017. The data collection tool was designed, tested, and adjusted over 2017 and 2018, followed by which the sample was selected for the main study. Clinics included in the sample were informed about the study before start of observations, and the data collection for the eRegTime study was completed between August and December 2018. Data will be analyzed for outcomes in July and August 2019; the results are expected to be published in the second half of 2019.
The eRegTime study is one of the few studies that assesses the impact of an eHealth intervention on clinical workflow and time-efficiency in a middle-income context, where the impact of using digital tools routinely during clinical care is probably much bigger given the manpower and resource constraints than high-income settings.
Most studies that have assessed the time-efficiency using the time-motion design find no statistical differences in the workload of care providers following the introduction of eHealth tools [
Other methods such as work sampling and self-reported questionnaires were considered during the planning phase of this study. However, with work sampling, in which activities are recorded only at certain time intervals, there is a risk of missing certain activities. In addition, this method requires an enormously large sample size, which was not feasible in our setting [
We acknowledge that it may not be possible to completely eliminate the risk of care providers behaving differently because they know they are being observed [
Suggested Time and Motion Procedures (STAMP) checklist.
SPIRIT protocol checklist.
Training manual.
cluster randomized controlled trial
District Health Information System 2
electronic health
electronic registry
low- and middle-income country
The first author MHL, with supervision from Knut Reidar Wangen, conducted formative research for this study as part of a master thesis at the University of Oslo, sections of which also informed this protocol. The eRegTime study is conducted in cooperation with the Ministry of Health, Palestine and the Palestinian National Institute of Public Health, who will facilitate the training of the observers and the implementation of the study.
The eRegQual CRCT and the eRegTime study are funded by the European Research Council (grant agreement number: 617639; project title: A New Paradigm for Public Health Surveillance: Unlocking the Potential of Data to Empower Woman and Health Systems; project acronym: HEALTMPOWR) and the Research Council of Norway (grant agreement number: 234376; project title: Harmonized Reproductive Health Registry Communication Strategies: Using Health Data to Empower Women and Health Systems). This study is also supported by the Centre for Intervention Science in Maternal and Child Health (CISMAC), a Centre of Excellence funded by the Research Council of Norway and the University of Bergen (grant agreement number: 223269). The funding agencies have no role in the study design, data collection, and analyses of data or publication of results.
MHL designed the data collection tool, conducted formative research including mapping clinical workflows, and defining task categories. MHL and MV contributed to the study design, sample size estimations, and formulation of outcomes and the writing of this study. KM contributed to the study design and formulation of the outcomes and the formative research. BG, TA, KAK, and TH participated in the design of the data collection tool. TA, KAK, and TH conducted pilot observations in the clinics. JFF is the principal investigator of the eRegQual CRCT and contributed to the study design, objectives, outcomes, and the writing of this study. All authors have read and approved of this version of the manuscript.
None declared.