Digital Data Linkage and Scheduling to Track Pregnancy With or Without Community Data Use to Increase Antenatal Clinic Uptake in Western Kenya.
- Conditions
- Electronic Community Health Information SystemsAntenatal Clinic UptakePregnancyHealth Systems
- Registration Number
- NCT05929586
- Lead Sponsor
- Liverpool School of Tropical Medicine
- Brief Summary
The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. Our short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The trial design is a 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm).
- Detailed Description
Facility and community health data is being rapidly digitised using multiple parallel systems across the 47 devolved counties in Kenya, but data do not link. Setting up community-based antenatal care (ANC) to complement facility-based ANC and data systems that link these platforms is essential to support Kenya in adopting WHO's ambitious target of 8 ANC contacts. As of February 2023, national scale up of the national electronic community health information systems (eCHIS) for standard of care is ongoing, and there are increased efforts to scale-up use of the nationally approved Kenya Electronic Medical Records (KenyaEMR) Maternal and Child Health Module (MNH) to capture ANC, delivery and postnatal (PNC) data at health facilities. Data between eCHIS and Kenya EMR do not link. There are plans within the Community Health Division at national level to link eCHIS to facility EMRs, but this has yet to be developed. The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. The short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The overarching research question the investigators will seek to answer is "what is the effect of 'C-it DU it' on community health systems strengthening and what is required for effective transfer and scale-up?" The investigators will use mixed methods implementation research to evaluate this in 4 counties in Western Kenya (Homa Bay, Migori, Kisumu, Kakamega) over a period of four years. The proposed methods include: (a) Realist evaluation to generate, empirically test and refine a transferrable programme theory to understand the causal relationship between context, participant response and outcomes; (b) A 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm); (c) Health economic evaluation and equity analysis to compare costs and catastrophic health expenditure of women accessing and engaging with ANC care and determine costs and cost-effectiveness of C-it Du-it from a health systems perspective; and (d) Qualitative interviews will assess transferability and iterative scale-up of C-it DU-it across the three remaining counties using toolkits developed in Homa Bay. This protocol describes the pragmatic cluster randomised trial and health economic evaluation. The realist evaluation and scale up will be addressed in a separate sister protocol.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 1440
- Pregnant women of all ages willing to participate
- Written informed consent
- A resident of the study area (catchment area) for the duration of the pregnancy
- Delivered and still within the 6-week post-partum period.
- Currently enrolled in another interventional study targeting pregnant women
- Outside the 6-week post-partum period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Increasing antenatal clinic uptake 14 months The proportion of women having at least eight ANC contacts during the antenatal period, defined as either a scheduled ANC visit in the facility or a scheduled ANC contact with a CHV in the community assessed at birth (or within the first 6-8 weeks for home births) using the ANC cards.
Estimate socioeconomic impact and access to social protection 14 months Defined as the proportion of women using financial coping strategies and their frequency and distribution
Estimate the costs to pregnant women and their households 14 months Absolute costs to the pregnant woman and their household and the costs as a proportion of the pregnant woman and their household's monthly income or expenditure/consumption will be calculated for the following variables:
* Out-of-pocket medical costs
* Out-of-pocket non-medical costs
* Lost income, time, and productivity
- Secondary Outcome Measures
Name Time Method The proportion of women having at least four scheduled ANC visits in the facility 14 months assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.
The proportion of women having at least eight scheduled ANC visits in the facility 14 months assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.
The frequency (count) of scheduled ANC visits 14 months assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.
Early antenatal clinic attendance 14 months The proportion of women with a first ANC contact before 16 weeks gestation.
Cost-effectiveness of "C-it" and "C-it DU-it" intervention 14 months Incremental cost-effectiveness ratios (ICERs) compared across trial arms
Uptake of skilled birth attendance. 14 months The proportion of women who had a skilled birth attendance.
Reducing the risk of adverse pregnancy outcomes. 14 months The proportion of women with adverse pregnancy outcomes- defined as a composite of foetal loss (stillbirth or spontaneous miscarriage), low birth weight or neonatal mortality)
Assess equity of access to ANC and "C-it" and "C-it DU-it" intervention. 14 months Equity of access to ANC and the interventions will be evaluated by exploratory distributional (or "extended") cost-effectiveness analysis of the intervention across the following sub-groups: poverty quintiles, age groups including adolescents vs adults, study sites, HIV status, and by eligibility for health insurance including NHIF and Linda Mama.
The frequency (count) of of ANC visits in the community 14 months assessed at birth (or within the first 6-8 weeks after birth for home births) using the ANC cards.
prevalence of catastrophic health expenditure (CHE) of accessing ANC care with "C-it" enhanced standard of care 14 months CHE prevalence at two World Health Organization-defined thresholds: out-of-pocket medical costs of more than 10% of a patient household's total monthly expenditure/consumption (10%-threshold); and out-of-pocket medical costs of more than 40% of a patient household's monthly capacity to pay (non-food/housing/utilities expenditure/consumption)
• A sensitivity analysis of the proportion of women's households incurring CHE due to pregnancy and ANC visits using varying additional recognised calculations and thresholds including, as per WHO Tuberculosis Patient Cost Survey methodology, the addition of non-medical out-of-pocket costs and lost income in the numeratorQuality of antenatal care 14 months * The proportion of women with at least three courses of IPTp
* The proportion of women who received iron and folate for 90 days.
* The proportion of women receiving testing and management for HIV.
* The proportion of women receiving testing and management for malaria.
* The proportion of women receiving testing and management for syphilis.
* The proportion of women receiving testing and management for anaemia.