The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method
Fenella Beynon1,2, Hélène Langet1,2, Leah F Bohle1,2
1Swiss Centre for International Health, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.
Insights
The TIMCI project introduces pulse oximetry and clinical decision support algorithms to improve child healthcare in resource-limited settings. This initiative aims to reduce severe childhood illnesses and deaths by enhancing diagnostic and treatment capabilities.
Area of Science:
- Global Health
- Pediatric Medicine
- Health Systems Strengthening
Background:
- High burden of preventable child deaths in resource-constrained settings necessitates effective interventions.
- Primary care facilities often lack tools for accurate diagnosis and management of severe childhood illnesses.
- Need for sustainable strategies integrating technology and improved clinical practices.
Purpose of the Study:
- To evaluate the health impact of introducing pulse oximetry and clinical decision support algorithms (CDSAs) in primary care.
- To assess the effectiveness of these tools in identifying and managing severe childhood illnesses in India, Kenya, Senegal, and Tanzania.
- To promote resource stewardship in managing childhood illnesses.
Main Methods:
- Pragmatic parallel group, superiority cluster randomized controlled trial (RCT) in India and Tanzania.
- Quasi-experimental pre-post study design in Kenya and Senegal.
- Data collection includes sociodemographic and clinical data, with follow-up assessments; mixed-method studies evaluate implementation and cost-effectiveness.
Main Results:
- Primary outcomes for RCT: severe complications (mortality, hospitalizations) by Day 7.
- Primary outcomes for pre-post study: referral rates and antibiotic use.
- Secondary outcomes include hypoxemia, referral adherence, follow-up rates, and antimicrobial prescribing patterns.
Conclusions:
- The TIMCI project provides evidence on the impact of pulse oximetry and CDSAs on child health outcomes in resource-limited primary care.
- Findings will inform scale-up decisions for integrated management of childhood illness strategies.
- The study emphasizes the importance of training, mentorship, and community engagement for successful implementation.
Abstract:
Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.
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