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

Pneumonia Clinical Trial

Official title: Tools for the Integrated Management of Childhood Illness: Evaluation of Pulse Oximetry and Clinical Decision Support Algorithms in Primary Care. Cross-country Quasi-experimental Pre-post Study, With Embedded Mixed Methods Studies, Cost and Modelled Cost-effectiveness in Kenya and Senegal

Status Completed

Clinical Trial 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.

Clinical Trial Description

This registry entry describes the quasi-experimental pre-post studies conducted in Kenya and Senegal. In India and Tanzania, pragmatic cluster randomised controlled trials (RCTs) are conducted (NCT04910750). These studies evaluating health, clinical and quality of care impact are complemented by embedded multi-method studies in all countries, including modified Service Provision Assessments, facility-based process mapping and time-flow studies, in-depth interviews (IDIs) with caregivers and healthcare providers, online key stakeholder surveys and key informant interviews, routine data review, and an economic evaluation.

We enrol sick children 0 to 59 months of age attending government primary care facilities in before and after implementation of pulse oximetry and CDSA. Interventions are implemented with a package of training on the use of devices and refresher IMCI, supportive supervision, operational support and community engagement.

As part of the intervention, facilities are provided with handheld, UNICEF-approved, pulse oximeters along with guidance and training for healthcare providers. In Senegal, 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 Kenya, healthcare providers are advised to measure oxygen saturation for all sick children. Providers are advised to urgently refer children with SpO2 <90% in Kenya and <92% in Senegal. 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.

Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children at study facilities, with phone follow-up on Day 7. Two primary outcomes are assessed for the quasi-experimental pre-post study: referrals to a higher level of care at Day 0 consultation; and antibiotic prescriptions on Day 0. These reflect the aim that the intervention increases detection of severe disease, and therefore increasing referral, whilst promoting antimicrobial stewardship, and therefore reducing antibiotic prescription. Secondary outcomes, relating to hypoxaemia, hospitalisation, referral, antimicrobial prescription, follow-up, health status are further detailed in the attached full protocol and statistical analysis plan available.

The pre-post study sample size was originally estimated for a planned 15 month study, with 3 months pre- (Q1) and 12 months post-intervention (Q2-5), with comparison of Q1 and Q5 for the primary outcome. Calculations were based on detecting a ≥50% increase in Day 0 referrals (from 3%, based on DHIS2, SPA and facility estimates), with 80% power, 0.05 alpha and ICC of 0.00547. A relatively large detectable difference was chosen given that a relatively high proportion of referrals may not be completed.5 46 Day 0 referrals, rather than antibiotic prescriptions (with baseline estimated at 60% with ICC 0.05), drove the sample size calculation. We estimated needing 17 facilities, recruiting an average of 690 children per facility per 3-month period in Kenya, and 18 facilities recruiting 510 children per facility per period in Senegal.

Following lower than anticipated recruitment in the baseline of the pre-post study, sample size was re-evaluated resulting in a decision to add two facilities per country, extend the baseline (to 6-7 months), and reduce the post-intervention period (to 9-10 months). A minimum of 7429 and 6760 children were estimated to be needed in each period in Kenya and Senegal respectively, with recruitment continuing after meeting the minimum sample size in order to allow for description of changes over time and with overlapping seasonal periods, in line with the intention of the original design.

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. ;

Related Conditions & MeSH terms

• Decision Support Systems, Clinical
• Hypoxia
• Pneumonia
• Primary Health Care

• NCT number: NCT05065320
• Study type: Observational [Patient Registry]
• Source: Swiss Tropical & Public Health Institute
• Status: Completed
• Start date: August 16, 2021
• Completion date: March 31, 2023