Tools for the Integrated Management of Childhood Illness: Cross-country Quasi-experimental Pre-post Study in Kenya and Senegal

NCT05065320 | Completed

• 1 other identifier: ERC.0003406
• Study Type: observational
• Target: 51,590
• Locations: 2 countries
• Sites: 2

Brief Summary

By introducing pulse oximetry, with or without clinical decision support algorithms, to primary care facilities in India, Kenya, Senegal and Tanzania, the Tools for Integrated Management of Childhood Illness (TIMCI) project aims to contribute to reducing morbidity and mortality for sick children under-five while supporting the rational and efficient use of diagnostics and medicines by healthcare providers. The multi-country, multi-method evaluation aims to generate evidence on the health and quality of care impact, operational priorities, cost and cost-effectiveness of introducing these tools to facilitate national and international decision-making on scale-up.

Conditions

Childhood Severe Illness; Pneumonia; Primary Health Care; Hypoxia; Referreal and Consultation; Decision Support Systems, Clinical; Oxymetry

Outcome Measures

Primary Outcomes (2)

• Proportion of children referred by a primary care healthcare provider to a higher level of care (either to a hospital or to an inpatient part of a larger primary healthcare facility) at Day 0 consultation

  The denominator will be all children recruited. Only urgent referrals will be considered.

  At time of enrolment

• Proportion of children prescribed an antibiotic at Day 0

  Only antibacterials for systemic use will be taken into account for the definition of antibiotics. All children recruited will be counted in the denominator.

  At time of enrolment

Secondary Outcomes (17)

• Proportion of children with a severe complication (death or secondary hospitalisation) by Day 7

  From enrolment up to 7 days after

• Proportion of children admitted to hospital within 24 hours of the Day 0 primary care consultation and as a result of a referral

  From enrolment up to 1 day after

• Proportion of children who completed referral, as reported at day 7 follow-up

  From enrolment up to 10 days after

• Proportion of children cured (defined as caregiver reported recovery from illness) by Day 7

  From enrolment up to 10 days after

• Proportion of children with non-severe disease referred to a higher level of care on Day 0

  At time of enrolment

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children 0 - 59 months, for whom caregivers provide consent, will be eligible if attending any study facility with an illness, excluding those admitted as inpatients within the facility, or attending for a consultation related to trauma only.

You may qualify if:

• Children 0-59 months of age for whom caregivers provide consent
• Consulting for an illness, or reported to be unwell when attending for a routine visit (e.g. vaccination, growth or chronic disease monitoring)

You may not qualify if:

• Children in the immediate post-natal period or first day of life
• Attending for a consultation related to trauma only (including new and follow-up presentations for burns, injuries, wounds)
• Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother)
• Enrolled in the study within the preceding 28 days at any study facility

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• PATH: collaborator
• University of Nairobi: collaborator
• Cheikh Anta Diop University, Senegal: collaborator
• Burnet Institute: collaborator

Study Sites (2)

University of Nairobi

Nairobi, Kenya

Location

UCAD

Dakar, Senegal

Location

Related Publications (2)

• Langet H, Faye PM, Njiri F, Cicconi S, Levine GA, Glass TR, Kosgei RJ, Ngari K, Schaer F, Thiongane A, Tine JAD, Ba M, Bohle LF, Emmanuel-Fabula M, Faye MM, Horton S, Miheso A, Mugo M, Ngutu M, Ruffo M, Shauri J, Sougou NM, D'Acremont V, Wyss K, Ndiaye O, Beynon F; TIMCI Collaborator Group. Effectiveness of introducing pulse oximetry and clinical decision support algorithms for the management of sick children in primary care in Kenya and Senegal on referral and antibiotic prescription: the TIMCI quasi-experimental pre-post study. EClinicalMedicine. 2025 May 12;83:103196. doi: 10.1016/j.eclinm.2025.103196. eCollection 2025 May.

  PMID: 40474998 DERIVED

• Beynon F, Langet H, Bohle LF, Awasthi S, Ndiaye O, Machoki M'Imunya J, Masanja H, Horton S, Ba M, Cicconi S, Emmanuel-Fabula M, Faye PM, Glass TR, Keitel K, Kumar D, Kumar G, Levine GA, Matata L, Mhalu G, Miheso A, Mjungu D, Njiri F, Reus E, Ruffo M, Schar F, Sharma K, Storey HL, Masanja I, Wyss K, D'Acremont V; TIMCI Collaborator Group. The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms. Glob Health Action. 2024 Dec 31;17(1):2326253. doi: 10.1080/16549716.2024.2326253. Epub 2024 Apr 29.

  PMID: 38683158 DERIVED

MeSH Terms

Conditions

Pneumonia; Hypoxia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaspar Wyss, Prof, PhD

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

• Valérie D'Acremont, MD, PhD

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 4, 2021
• Study Start: August 16, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 31, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Individual participant data will be available immediately following the cross-country publication of the quasi-experimental pre-post study outcomes. No end date.
• Access Criteria: Anyone who wishes to access the data. Data will be available indefinitely on the TIMCI project space on Zenodo.

Locations

KE (1); SE (1)