Tools for the Integrated Management of Childhood Illness: Cross-country Quasi-experimental Pre-post Study in Kenya and Senegal
Condition: Childhood Severe Illness; Pneumonia; Primary Health Care; Hypoxia; Referreal and Consultation; Decision Support Systems, Clinical; Oxymetry
MeSH terms: Hypoxia
Study type: Observational [Patient Registry]

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.
    

Detailed 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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children 0 - 59 months, for whom caregivers provide consent, will be eligible if attending
        any study facility with an illness, excluding those admitted as inpatients within the
        facility, or attending for a consultation related to trauma only.