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

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.

Keywords: Hypoxaemia; IMCI; cluster randomized controlled trial; primary care; quality of care.

Figure 1.

Overview of the multi-country, multi-method TIMCI evaluation – study design and main outcomes. Abbreviations: CDSA: clinical decision support algorithm; RCT: randomised controlled trial; KII: key informant interviews; HMIS: health management information system; DALY: disease-adjusted life years.

Figure 2.

Pulse oximetry criteria for Senegal and Tanzania. In India and Kenya, Ministries opted to recommend pulse oximetry for all sick young infants and children.

Figure 3.

Study flowcharts of the pragmatic cluster RCT and quasi-experimental pre-post study, with interconnections with the embedded mixed-methods studies involving caregivers and children. (1) Location refers to urban/rural for Tanzania and to districts in India. (2) Data collected after consultations include caregiver responses at consultation exit and clinical records. (3) In all countries other than Kenya, data are collected from hospital (or primary care admission area) records for all children reported to have attended a hospital/admission facility (4) If children return to their enrolment facility (or attend any other study facility) during the follow-up period, data about the visit is collected, which includes the same information as gathered on Day 0.