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

This study aims to evaluate the impact of introducing pulse oximeters and clinical decision support algorithms (CDSAs) to primary care on health outcomes of children under 5 years of age. We will enrol sick children 0 to 59 months of age attending government primary care facilities in India and Tanzania to a three-arm parallel group, superiority pragmatic cluster-randomized controlled trial.

In India, 120 facilities (Primary Health Centres (PHCs), Community Health Centres (CHCs)) in three districts of Uttar Pradesh (Deoria, Sitapur and Unnao) are included; in Tanzania, 66 facilities (dispensaries and health centres) in Mwanza, Tabora and Tanga are included.

Facilities are randomised 1:1:1 to i) pulse oximetry and tablet-based CDSA ii) pulse oximetry and paper job aid, or iii) routine care. Interventions are implemented with a package of training, supportive supervision, operational support and community engagement. IMCI refresher training is provided to all arms.

Providers at intervention facilities are provided with handheld, UNICEF-approved, pulse oximeters along with guidance and training in line with government-approved criteria. In Tanzania, healthcare providers are advised to measure oxygen saturation (SpO2) on all children under 2 months of age, all children 2 to 59 months of age with cough or difficulty breathing or with signs of moderate or severe disease based on Integrated Management of Childhood Illness (IMCI); in India, healthcare providers are advised to measure oxygen saturation for all sick children. Providers are advised to urgently refer children with SpO2 <90% (and also <94% in India if SARS-CoV-2 is suspected).

The tablet-based CDSA provides step-by-step support to healthcare providers through consultations, providing national guideline-based recommendations on assessment, diagnosis and treatment based tailored to the individual child based on information entered by the provider. Following training, providers are advised to use CDSA for all consultations with sick children under 5 years of age.

The comparison between arms will be assessed through two main primary outcomes: a.) the proportion of children with severe complication (death or secondary hospitalization i.e. delayed beyond 24 hours of primary care consultation, or without referral) by Day 7; and b.) the proportion of children appropriately hospitalised (admitted to hospital within 24 hours of primary care consultation and as a result of referral).

The sample size for the trial is calculated separately for each country, taking the following assumptions into account: a.) a power of 80%, b.) alpha level of 0.05 per arm, c.) intracluster correlation coefficient (ICC) of 0.001, d.) control arm severe complication of 1.1%, e.) control arm appropriate hospitalization of 1.5% and f.) a recruitment period of 12 months. Based on these assumptions, to be able to detect a 30% or greater decrease in severe complication and 30% or greater increase in appropriate hospitalization for each arm compared to the control, 120 and 66 facilities will be required in India and in Tanzania respectively. The estimated average recruitment over the 12-months period is 61,200 children in India (510 per cluster) and 110,880 children in Tanzania (1680 per cluster).

The main trial is is complemented by embedded mixed-method, cost & cost-effectiveness studies, including periodic service provision assessments, process mapping and time-flow studies, in-depth interviews with caregivers, and healthcare providers, key informant interviews and online surveys with stakeholders, and document routine data review. The main is preceded by a 3-month pilot phase, in which sub-studies are also conducted.