Tools for the Integrated Management of Childhood Illness (TIMCI): Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care

NCT04910750 | Completed DMC FDA Device

• 1 other identifier: ERC.0003405
• Study Type: interventional
• Target: 167,517
• Locations: 1 country
• Sites: 27

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

Pneumonia; Primary Health Care; Child Health; Hypoxia; Referral and Consultation; Decision Support Systems, Clinical; Oxymetry

Outcome Measures

Primary Outcomes (2)

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

  Secondary hospitalisation refers to any delayed hospitalisation (occurring at any point greater than 24 hours after Day 0 consultation) and any hospitalisation occurring without referral. The denominator is all enrolled children.

  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

  This is used as a proxy for 'appropriate referral' of children, as those with severe disease should generally be admitted to hospital. The denominator for this outcomes is all children enrolled in the study, rather than only referred children. This is because the proportion of referred children that are admitted may be high in routine care, in the context of an inappropriately low referral rate. The aim of the intervention is therefore to increase the overall referral rate of children with severe disease. Hospital admission is chosen as the proxy of severe disease rather than using primary care classification of severe disease, as there are inadequacies in the classification of severe disease in routine practice. A child will be considered admitted to hospital 24hrs of Day0 consultation if the date of hospitalization is the same as Day0 date or is one day after Day0 date.

  From enrolment up to 1 day after

Secondary Outcomes (18)

• Proportion of children with severe complication (death or secondary hospitalisation) by Day 28

  From enrolment up to 28 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 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

  At time of enrolment

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

  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

Study Arms (3)

Intervention Arm 1 - Pulse oximetry and Clinical Decision Support Algorithm

ACTIVE COMPARATOR

Facilities in intervention arm 1 will be provided with handheld pulse oximeters and tablet-based clinical decision support algorithms, with pulse oximetry, CDSA and IMCI refresher training

Device: Pulse oximetry; Device: Clinical Decision Support Algorithm

Intervention Arm 2 - Pulse oximetry alone

ACTIVE COMPARATOR

Facilities in intervention arm 2 will be provided with handheld pulse oximeters and paper-based guidance (pulse oximetry job aid and IMCI chart booklet integrating pulse oximetry), with pulse oximetry and IMCI refresher training

Device: Pulse oximetry

Control Arm - Routine Primary Health Care

NO INTERVENTION

Facilities in the control arm will be provided with IMCI refresher training

Interventions

Pulse oximetry DEVICE

Pulse oximeters are a non-invasive, accurate and easy to use method of evaluating blood oxygen saturation

Intervention Arm 1 - Pulse oximetry and Clinical Decision Support Algorithm; Intervention Arm 2 - Pulse oximetry alone

Clinical Decision Support Algorithm DEVICE

Tablet-based clinical decision support algorithms, based on guidelines for the assessment and management of sick children under 5 years of age at primary care

Intervention Arm 1 - Pulse oximetry and Clinical Decision Support Algorithm

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 0 - 59 months 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
• Ifakara Health Institute: collaborator
• King George's Medical University: collaborator
• University of Waterloo: collaborator
• PATH: collaborator

Study Sites (27)

Bukemba

Kaliua, Tanzania

Location

Igombe 60

Kaliua, Tanzania

Location

Imalamihayo

Kaliua, Tanzania

Location

Kazaroho

Kaliua, Tanzania

Location

Seleli

Kaliua, Tanzania

Location

Ulyankulu

Kaliua, Tanzania

Location

Uyowa

Kaliua, Tanzania

Location

Igalagalilo

Sengerema, Tanzania

Location

Kagunga

Sengerema, Tanzania

Location

Kamanga

Sengerema, Tanzania

Location

Kasungamile

Sengerema, Tanzania

Location

Mulaga

Sengerema, Tanzania

Location

Mwabaluhi

Sengerema, Tanzania

Location

Nyamazugo

Sengerema, Tanzania

Location

Sengerema Secondary

Sengerema, Tanzania

Location

Sengerema

Sengerema, Tanzania

Location

Duga

Tanga, Tanzania

Location

Kange

Tanga, Tanzania

Location

Kisosora

Tanga, Tanzania

Location

Kwanjekanyota

Tanga, Tanzania

Location

Machui

Tanga, Tanzania

Location

Mafuriko

Tanga, Tanzania

Location

Magaoni

Tanga, Tanzania

Location

Mpirani

Tanga, Tanzania

Location

Mwakidila

Tanga, Tanzania

Location

Ngamiani

Tanga, Tanzania

Location

Nguvumali

Tanga, Tanzania

Location

Related Publications (2)

• Beynon F, Mhalu G, Kumar D, Cicconi S, Langet H, Levine GA, Agarwal G, Festo C, Glass TR, Jacob A, Kumar G, Lwambura S, Matata L, Mkopi A, Moshiro R, Schaer F, Bandi V, Bohle LF, Emmanuel-Fabula M, Horlacher M, Horton S, Maiba J, Makawia S, Masanja N, Mjungu D, Mtebene IE, Odek O, Oliveira V, Pantjushenko E, Reus E, Ruffo M, Sharma K, Storey H, Tyagi M, D'Acremont V, Masanja H, Awasthi S, Wyss K; TIMCI Collaborator Group. Effectiveness of introducing pulse oximetry and clinical decision support algorithms for the management of sick children in primary care in India and Tanzania on hospitalisation and mortality: the TIMCI pragmatic cluster randomised controlled trial. EClinicalMedicine. 2025 Jul 3;85:103306. doi: 10.1016/j.eclinm.2025.103306. eCollection 2025 Jul.

  PMID: 40686675 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

Interventions

Oximetry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: July 5, 2021
• Primary Completion: April 21, 2023
• Study Completion: April 21, 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 RCT 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

TA (27)