This longitudinal observational study, with embedded mixed methods studies, is a global effort led by PATH to accelerate availability, adoption and scale-up of tools to identify severe illness and decrease mortality in children under five years of age.

It is funded by UNITAID. PATH (Seattle) is the primary recipient of the funds and manages the project including strategic direction and decision-making, project oversight and compliance, global communications, risk monitoring and mitigation, quality/change management, as well as serving as liaison with UNITAID, the International Advisory Group and other relevant global partners, such as WHO and UNICEF.

As a research partner, Burnet Institute is responsible for operational research of pox and electronic decision support tool intervention, and a cost-effectiveness evaluation of pox and electronic decision support tools. Swiss TPH will lead on development and design of the research. Burnet Institute’s in-country research partner is responsible for the adaption of the design to the country specific context, in close collaboration with Swiss TPH and PATH.

Two primary outcomes, and important secondary outcomes, will be assessed between the pre-intervention and the last intervention period.

Primary outcomes

• 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 zero consultation

• Proportion of children prescribed an antibiotic at day zero primary care consultation.

Important secondary outcomes include:

• Proportion of children with a severe complication (death or secondary hospitalisation) by day seven

• Proportion of children admitted to hospital within 24 hours of the day zero primary care consultation and as a result of a referral (used as a proxy for ‘appropriate referral’)

• Proportion of children completing referral to a higher level of care within 24 hours, of all children referred at day zero consultation

• Proportion of children cured (defined as caregiver reported recovery from illness) by day seven

• Proportion of children with hypoxemia (according to differing cut-offs) with severe complication.

Study design

The health impact will be assessed through a quasi-experimental longitudinal study, comparing clinical care of children in a three-month pre-intervention period (Q1) with four sequential three-month periods over the following year (Q2-Q5). The intervention package will be piloted and refined in parallel with the pre-intervention period of the longitudinal study.

This will be complemented by embedded mixed methods sub-studies to evaluate key components of quality of care and gain a deeper understanding of the implementation processes, mechanisms and context following a realist approach.

These studies include modified Service Provision Assessments (SPAs), a facility-based process mapping and time-flow study, qualitative studies with caregivers, healthcare providers and key stakeholders, a survey sent to selected key stakeholders on a quarterly basis, a desk-based project document and monitoring and evaluation (M&E) review, and a costed and modelled cost-effectiveness study.

Beneficiaries:

• Children 0 – 59 months of age attending at primary health care clinic

• Health facilities at the study site (health facilities will be excluded if they use pulse oximetry as a routine part of outpatient consultations of children prior to the start of the intervention)

• Caregivers of enrolled children, and healthcare providers at study sites involved in the care of children 0 – 59 months of age

• Stakeholders involved in or affected by the intervention, who will be eligible for inclusion in the applicable studies.

First enrolment is anticipated to be in January 2021, with completion of data collection in March 2022.

Timeline

• January 2020, with completion of data collection in March 2022.