Trial Design
This CRCT is a superiority trial with four parallel arms (TCC, QID, TCC & QID and control). The unit of randomization is an individual PHC, with the exception of two clusters that include two PHCs served by the same healthcare provider.
Study setting
The most common organizational structure in the public maternal and child healthcare system in Palestine includes two healthcare providers per clinic, mainly midwifes, nurses and/or community health workers, in addition to a doctor serving several clinics. Each user in the governmental eRegistry has a unique username and password, which enable access to records and specific system features according to their assigned role. The woman’s personal ID number is used to create an electronic ANC record for her pregnancy. The sociodemographic, obstetric and medical information including clinical tests, laboratory, and ultrasound measurement results, are entered into the eRegistry at point-of-care. The data trigger different digital health interventions such as the guideline-based clinical decision support and automated public health reports. Women identified with certain risk factors are referred for additional management, and their records are available in the so called high-risk clinics after referral [31].
Eligibility criteria
All public PHCs offering ANC and PPC services using the eRegistry were eligible for the study. PHCs that enrolled less than 45 or more than 3000 new pregnancies in 2016 were excluded. No exclusion criteria were made based on individual healthcare provider’s or pregnant women’s characteristics (Fig. 1).
A total of 138 clusters (individual PHC and a combination of two PHCs served by the same healthcare provider for two clusters) were eligible for randomization. They enrolled a mean of 344 and a median of 131 new pregnant women in 2016 (Additional file 1). Data from all ANC visits occurring in the included PHCs during the study period will be used to assess our outcomes.
Intervention
The interventions are at the cluster level targeting nurses, midwifes and community health workers, referred to as healthcare providers, and their clients.
The Quality Improvement Dashboard intervention
The QID intervention is the provision of access to the QID within their routine eRegistry, as well as training of healthcare providers on how to use it.
As part of the QID intervention development process, public healthcare providers, supervisors and health system administrators were interviewed to map the existing supervision and feedback system [27]. We found that healthcare providers received irregular supervision visits with limited focus on performance improvement at the clinical level. Findings and recommendations regarding benchmarking [32], the use of SMART (Specific, Measurable, Achievable, Relevant and Timely) criteria, concepts from social nudging and Enhanced active choice [33], and the Model of Actionable Feedback [13], informed the design of the QID. eRegistry users’, nursing and medical directors’, and PNIPH and MoH staff’s reviews informed the revisions. The final version was translated to the local Arabic language.
The training curriculum is founded on quality improvement theories and models such as the Plan, Do, Study, Act (PDSA) cycles [34]. Healthcare providers learn how they can use the QID, which presents indicators of quality gaps in their clinic, as a tool to improve the quality of the care they provide.
The QID includes four tabs for each focus area, namely anemia, hypertension, diabetes and attendance. Healthcare providers are given a new focus area every week through a message in the eRegistry that congratulates a good performing PHC or presents an evidence-based statement on the week’s focus area. Each tab contains performance indicators calculated from data entered at point-of-care. The indicators are presented as an average over the last three months, in both tables and graphs, and benchmarked with clinics within the district. The clinic’s performance level—defined as an index of the absolute and relative values of an overall screening and an overall management indicator–drives the appropriate action items for each focus area. Two screening and two management action items that include recommendations for improvement, are presented in colors (green = good performance, yellow = room for improvement, red = large room for improvement) with monthly updates (Fig. 2). The healthcare providers can score the action items via a thumbs up/down icon, and add written comments.
(Figure legend) Top left: Individualized on clinic level; Top right: Reminders of the week’s focus area, namely anemia, hypertension, diabetes or attendance; Tables: Indicators with benchmarks; Graphs: Percentage average over last three months; Right: Action items presented in colors (green = good performance, yellow = room for improvement, red = large room for improvement)
The Targeted Client Communication intervention
The TCC intervention is automated text messages sent via SMS from the eRegistry to pregnant women, and training of healthcare providers on how to enroll women in the program.
The TCC intervention development process, including the full text message library is described in detail elsewhere [35]. In short, pregnant women and healthcare providers were interviewed to identify how pregnant women perceive their risks of getting anemia, hypertension and diabetes during pregnancy and susceptibility to fetal growth restriction, in addition to benefits and barriers of attending ANC, using the Health Belief Model (43). The findings, concepts from social nudging and Enhanced active choice [33] and the Model of Actionable Feedback [13] informed the content, medium, timing and frequency of the TCC intervention.
The training includes how to register and withdraw women, and the timing and the content of the text messages. Healthcare providers register women that consent to receive text messages by ticking a box in the eRegistry. This can be done at any time in gestation, preferably at the first visit.
The tailored text messages include the woman’s name and her clinic’s name, and may also include the date of her next appointment (Fig. 3). Those that include information about one or more of the high priority areas (anemia, hypertension and diabetes during pregnancy, and fetal growth restriction) will be sent at the time these conditions are screened for, namely at the 16, 18–22, 24–28, 32 or 36 weeks’ gestation routine ANC visit. However, women with documented anemia, hypertension, diabetes or fetal growth restriction, will not receive the information about routine screening for that condition, e.g. women with diabetes will not receive a text message about the routine screening for diabetes at 24–28 weeks’ gestation. The text messages will be sent to the mobile number registered on the woman after working hours during ANC at the following time points:
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At registration, a welcome message including information about how to un-enroll
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One week prior to a timely scheduled routine visit
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Three days prior to a timely scheduled routine visit to women with risk factors for anemia, hypertension, diabetes or fetal growth restriction
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24 hours prior to a visit
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24 hours after a missed timely scheduled routine visit
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Recapture message 24 hours prior to the start of the appropriate time window for a routine visit to women without any timely scheduled routine visit in the future
Welcome | One week prior to a visit | Three days prior to a | 24 hours prior to a visit | 24 h after a missed visit | 24 h prior to a missing visit |
Dear Abi, Most women attend antenatal care for their own and baby's health. The healthcare provider will measure your blood pressure, hemoglobin and blood glucose level. You will receive text message appointment reminders. Please let us know if you do not want these messages. Tamoon clinic | Dear Abi, The date of your upcoming appointment is 2020.04.20. One in 20 develop high blood pressure in pregnancy, and this may affect your health and the growth of your baby. The healthcare provider will measure your blood pressure and the amount of protein in urine as they may be a sign of high blood pressure. Tamoon clinic | Dear Abi, 2020.04.20 is your next appointment, as agreed. High body weight before pregnancy, may increase the risk of developing high blood pressure. The healthcare provider will measure your blood pressure and the amount of protein in urine at your next visit. Tamoon clinic | Dear Abi, This is a reminder that you have an appointment tomorrow, 2020.04.20, as agreed. Tamoon clinic | Dear Abi, Sorry to have missed you at yesterday’s appointment. We hope to see you back with us for antenatal care as soon as possible. Tamoon clinic | Dear Abi, You haven’t scheduled your next appointment, which is coming up soon. Timely attendance to every antenatal care visit may ensure you and your baby's safety, through early detection and treatment of complications. Please contact us to schedule your next visit. We are ready to provide you with care, and hope to see you soon. Tamoon clinic |
Adherence, training, Concomitant care
The TCC and QID interventions in the eRegistry are available to healthcare providers working in PHCs randomized to trial arms receiving one or both of the digital health interventions. The research team trained the trainers, whom were eRegistry staff at PNIPH and nursing directors, each representing a governorate. Healthcare providers from TCC and QID intervention PHCs were trained separately, and healthcare providers working in PHCs randomized to both interventions received both trainings. The trainings were conducted in the first quarter of 2019, and each session lasted for half a day. A follow-up training session was conducted in September 2019. Healthcare providers in QID intervention PHCs received a video presenting new functionalities in the QID at the start of the trial. New employees in intervention PHCs will receive on-site training from one of the trainers.
MCH supervisors will carry out similar periodic supervision visits to all PHCs in all arms of this CRCT. Women will not receive any concomitant care across intervention and control PHCs.
Outcomes
The outcomes represent key areas of quality concerns in Palestine, and are in line with our previous eRegQual CRCT, a study assessing the effect of using an eRegistry versus paper-based ANC records [25]. The Palestinian ANC guidelines for the recommended gestational week (Table 1) for screening and management of anemia, hypertension and diabetes, have defined our outcomes. For routine visits recommended for one specific week, we have made the time window for the outcome measures two weeks wider than the guideline, to allow some flexibility for maternal choice and time for e.g. laboratory results to be received and documented in the eRegistry.
Table 1
Time windows for the outcome measures and routine ANC visits including the primary screening test
| First visit | Routine visits |
Recommended occurrence of ANC visits, GW | Any week | 16 | 18–22 | 24–28 | 32 | 36 |
Included in outcome measures, GW | Any week ± 7 days | 15–17 | 18–22 | 24–28 | 31–33 | 35–37 |
Primary screening tests for priority conditions* | Blood pressure, Hemoglobin, Urine glucose | Blood pressure, Fetal growth | Blood pressure | Blood pressure, Hemoglobin, Blood glucose | Blood pressure, Fetal growth | Blood pressure, Hemoglobin, Fetal growth |
ANC = Antenatal care, GW = weeks of gestation, * Anemia, hypertension, diabetes and fetal growth restriction according to the Palestinian guidelines. |
Primary outcomes:
Comparison I: QID arm vs control arm
The primary outcome in comparison 1 is the proportion of women who receive appropriate screening and management of anemia, hypertension and diabetes (Figs. 4–6). For example for anemia, the proportion is calculated by identifying the number of ANC visits where anemia should have been screened for and/or managed (denominator), and among them where anemia was appropriately screened for and/or managed (numerator). Only the first step in the management algorithm will be included (Figs. 4–6). Pregnant women with documented ongoing anemia, hypertension or diabetes prior to the timely routine visit, will not be included in the denominator for appropriate screening and management of anemia, hypertension and diabetes respectively.
Hemoglobin test at first visit, 24–28 and 36 weeks gestation |
Hb ≥ 11 g/dL | Hb 10.9–7 g/dL | Hb < 7 g/dL |
No further action | Hb after 1 month | Refer to hospital |
Blood pressure prior to 20 weeks gestation, test at first visit and at 16, 18–22 weeks gestation |
SBP < 140 & DBP < 90 mmHg | SBP ≥ 140 mmHg, DBP ≥ 90 |
No further action | Refer to high risk clinic |
SBP = Systolic blood pressure, DBP = Diastolic blood pressure |
Blood pressure at or after 20 weeks gestation, test at 18–22, 24–28 and 36 weeks gestation |
SBP < 140 & DBP < 90 mmHg | DBP 90–99, SBP 140–149 mmHg | DBP ≥ 100 SBP ≥ 150 mmHg |
No further action | New BP within 4 days | Refer to hospital |
SBP = Systolic blood pressure, DBP = Diastolic blood pressure |
Urine glucose test at booking prior to 24 weeks gestation |
Negative | Positive |
No further action | Blood glucose test |
Blood glucose test at 24–28 weeks gestation |
RBG < 105, FBG < 95 mg/dL | RBG 105–140, FBG 95–126 mg/dL | RBG ≥140, FBG ≥126 mg/dL |
No further action | New blood test within 3 weeks | Refer to diabetes clinic |
RBG = Random blood glucose, FBG = Fasting blood glucose |
Comparison II: TCC arm vs control arm:
The primary outcome in comparison 2 is the proportion of all timely routine ANC visits that a woman was eligible for, where the woman attended (Table 1). The first ANC booking visit is excluded, and each timely routine visit will be counted separately as a singular opportunity to succeed or fail in attendance.
Comparison III: QID + TCC arm vs control arm
The primary outcome in comparison 3 is the product of the quality of care (comparison 1) and the utilization of care (comparison 2) to assess the effective coverage. For example for anemia, it is the proportion of all timely routine ANC visits where anemia should have been screened for and/or managed, where the woman attended and anemia was appropriately screened for and/or managed.
Effect on healthcare equity
We will assess the effects of the interventions on the primary outcomes across equity measures used in routine statistics in Palestine. The data points include: average monthly household incomes (less than 200; 200–900; 901–1824; 1825–3054; and > 3055 Israeli new Shekel), mother’s years of education (< 10; 10–13 years; >13 years), age at marriage (less than 20; 21–25; 26–30; 31–35; 36–40; greater than 40 years) and age at first pregnancy (less than 20; 20–25; 26–30; 31–35; 36–40; greater than 40 years).
Other outcomes
We will assess the proportion of women receiving appropriate screening and appropriate management separately at each visit for anemia, hypertension and diabetes. We will also measure the retention rate from ANC to PPC and timely screening and management of fetal growth. The data collection in the eRegistry is continuous and the randomization permanent, which enable analyzes of overall health outcomes in a continuous and longitudinal manner for each individual woman. We might assess other outcomes if the intervention(s) shows an effect.
Timeline
Care providers in PHCs randomized to the TCC intervention have had the opportunity to register pregnant women to the text message service since June 2019. Care providers in PHC randomized to the QiD intervention, received access to the QiD December 2019. We expect to reach the target sample size after approximately 6 months (Fig. 7).
Sample size
Sample size calculations for the primary outcomes were performed in STATA “clustersampsi” (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP). We estimated the minimum detectable difference for comparison of each intervention arm with the control arm without assuming the effect of multiple comparison (using a single control to each intervention arms). The control prevalence for the primary outcome, using data from the eRegQual CRCT, ranged from 30–85% for comparison I (QID vs Control) and from 34–53% for comparison II (TCC vs Control) (unpublished results). The 138 eligible clusters have an average of 172 new pregnancies per six months (ranging from 23-1500) and a 1.69 coefficient of variation of cluster size (2016 data). We assumed a priori intra-cluster correlation coefficient (ICC) of 0.05, and set the statistical significance level to 5%. Not accounting for the clustering within women, we are 90% powered to detect an estimated relative 26% increase for the outcomes with the smallest control prevalence (e.g. improving anemia screening and management at 24–28 weeks gestation from 30–38%).
Recruitment
PHCs that fulfilled the recruitment criteria were randomized to one of the four arms. Healthcare providers working in PHCs randomized to one or both of the interventions received training as described (intervention section).
No financial or non-financial incentives are or will be provided to the woman, public health officers or healthcare providers at the PHCs included in the trial.
Allocation
Statisticians at the Center for Intervention Science in Maternal and Child Health (CISMAC), University of Bergen, Norway, performed the randomization independently without any influence from the research team.
PHCs were randomized to the TCC intervention, QID intervention, TCC and QID intervention or control group with a 1:1:1:1 allocation. The randomization was stratified by the implementation phase of the eRegistry, and constrained on laboratory availability, ultrasound availability and the size of the PHC.
In total, 10,000 randomization allocations were generated. The 10% best and balanced allocations with the least differences between the arms for the given covariates were identified, and one of these allocations were randomly selected for the trial [36].
Blinding
Healthcare providers and women attending care at PHCs included in the trial are blinded to the outcome measures. Women are expected to be blinded to the allocation of the QID intervention, but not to the TCC intervention due to the nature of the intervention. Healthcare providers are not blinded to the allocation of any intervention.
Data will be extracted from the eRegistry and transformed to anonymous datasets by blinded data analysts at PNIPH. Allocation codes will be generated for each primary outcome separately (e.g. A, B, C and D; E, F, G and H; I, J, K, L and M). CISMAC will keep the codes, which will be provided as allocation groups (intervention TCC, intervention QID, intervention TCC & QID vs control) for each set of outcomes after the completion of analyses.
Data extraction methods
Healthcare providers will routinely and continuously enter data in the eRegistry during patient care, and all outcomes are informed by secondary data. Anonymous data will be extracted from the eRegistry in accordance with the standard operating procedure (SOP) of the Palestinian maternal and child health eRegistry for routine registry operations and use of data for research purposes.
Data management
The data in the eRegistry will be managed in accordance with the governance structure approved by the Palestinian MoH. Only pre-defined anonymous data needed for the outcomes will be extracted from the eRegistry by PNIPH staff for this trial.
Statistical methods
Intention-to-treat analysis will be performed for the primary outcomes to compare each independent intervention arms (QID, TCC and QID & TCC) with the control, using individual level data taking the design effect of the clustering into account. Descriptive statistics will be reported, and appropriate tests will be used to compare variables between the groups. Statistical significance will be set at p < 0.05. Appropriate bivariate and multivariate regression analyses will be performed. The regression analyses will take the design effect of the clustering into account and enable adjustment for any relevant variables not accounted for during randomization. We will do complete case analyses and consider appropriate imputations for missing data. We will present cluster-wise effects of the intervention to explore whether a disproportionately large part of the effect can be ascribed to extreme effects in a few large clusters. The interaction effect of the two interventions will be performed as secondary analysis. We will conduct per protocol analyses in cases of protocol violations, including withdrawal of the eRegistry, and data from these clusters will be excluded from the time of violation when appropriate. Data will be analyzed using the latest version of STATA (StataCorp. 2016. Stata Statistical Software: College Station, TX: StataCorp LP).
Data monitoring
Data management and monitoring will be done in accordance with the SOP of the Palestinian maternal and child health eRegistry for routine registry operations. A Data and Safety Monitoring Committee will not be established due to the lack of potential significant harm.
Harms
This CRCT only utilizes the moment of opportunity of an ongoing implementation to study new digital interventions in a health systems approach. No potential for clinically significant harm has been identified during the development and implementation of this trial. Potential discomfort from worries may occur among women attending ANC in clusters receiving the TCC intervention, and this will be examined in a sub-sample (Frame 1).
Confidentiality
Data confidentiality will be handled in accordance with the Palestinian MoH’s legal framework for maternal and child health electronic registries. This CRCT will only utilize anonymous data to enable the assessment of the effectiveness of the interventions. We will publish only aggregate data, and no data on individual clients, care providers, or identifiable clusters will be published.
Access to data
The data in the eRegistry belong to the Palestinian MoH and the researchers will not have access to the entire registry or identifiable data of any kind. We will not publish the full data set as our legal rights to the data is limited to this analysis, and the richness of data would allow for several other analyses for which there is no ethics approval or approval from the Palestinian MoH. We will however, publish syntaxes needed to recreate the data set from the eRegistry.
Dissemination plan
This protocol follows the Standard Protocol Items: Recommendations for Intervention trials (SPIRIT) guidelines. We will inform all users and stakeholders, and publish the results of the CRCT in peer-reviewed open-access journals according to the Consolidating Standards of Reporting Trials (CONSORT) guidelines and the mHealth Evidence Reporting and Assessment (mERA) checklist. Results will also be presented at scientific meetings and congresses, and to the Palestinian MoH directly. With permission from the MoH, we will inform all participating PHC and their staff directly. We will acknowledge any change in the study outcomes, study design, sample sizes or significant administrative aspects that will impact the study’s nature when disseminating the findings. Authorship will be in line with the recommendations of International Committee of Medical Journal Editors. Summaries of the results and other relevant information will be published on the eRegistries website.