Digital Data Linkage and Scheduling to Track Pregnancy With or Without Community Data Use to Increase Antenatal Clinic Uptake in Western Kenya.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: The combined "C-it DU-it" intervention: community data use for ANC.
- Кому может быть актуально
- Состояния в реестре: Health Systems, Electronic Community Health Information Systems, Antenatal Clinic Uptake, Pregnancy. Базовые параметры: Без ограничений · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Kenya
- Следующий шаг
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Официальное название
A Pragmatic Open-label, Community-based, Cluster Randomised Controlled Superiority Trial to Evaluate the Efficacy and Cost-effectiveness of Digital Data Linkage and Scheduling ('C-it') With or Without Community Data Use ('DU-it') to Increase Antenatal Clinic Uptake in Western Kenya.
Обзор
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).
Подробное описание
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.
Вмешательства
- Другое The combined "C-it DU-it" intervention: community data use for ANC
Combining data linkage ("C-it") with work improvement teams for community data use ("DU-it") to improve antenatal clinic uptake. 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)
Первичные конечные точки
- Increasing antenatal clinic uptake [Срок оценки: 14 months]
- Estimate socioeconomic impact and access to social protection [Срок оценки: 14 months]
- Estimate the costs to pregnant women and their households [Срок оценки: 14 months]
Вторичные конечные точки (11)
- The proportion of women having at least four scheduled ANC visits in the facility [Срок оценки: 14 months]
- The proportion of women having at least eight scheduled ANC visits in the facility [Срок оценки: 14 months]
- The frequency (count) of scheduled ANC visits [Срок оценки: 14 months]
- The frequency (count) of of ANC visits in the community [Срок оценки: 14 months]
- Early antenatal clinic attendance [Срок оценки: 14 months]
- Quality of antenatal care [Срок оценки: 14 months]
- Uptake of skilled birth attendance. [Срок оценки: 14 months]
- Reducing the risk of adverse pregnancy outcomes. [Срок оценки: 14 months]
- prevalence of catastrophic health expenditure (CHE) of accessing ANC care with "C-it" enhanced standard of care [Срок оценки: 14 months]
- Cost-effectiveness of "C-it" and "C-it DU-it" intervention [Срок оценки: 14 months]
- Assess equity of access to ANC and "C-it" and "C-it DU-it" intervention. [Срок оценки: 14 months]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- Currently enrolled in another interventional study targeting pregnant women
- Outside the 6-week post-partum period.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
Kenya · 1 центр
- KEMRI Centre for Global Health Research — Homa Bay
Публикации
- Ong'ayo G, Barsosio HC, Otiso L, Kamau A, Dodd J, Okoth L, Oguche M, Doyle V, Ochodo E, Okomo G, Ter Kuile F, Taegtmeyer M. Evaluating community digital data linkage with or without community data use to increase antenatal care uptake in Western Kenya: protocol for a pragmatic open-label, cluster-randomised controlled superiority trial. Front Health Serv. 2026 Jan 27;5:1697161. doi: 10.3389/frhs.2 PMID 41675597
Идентификаторы
NCT: NCT05929586 · 22-073