Tools for the Integrated Management of Childhood Illness (TIMCI): Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care
Condition: Pneumonia; Primary Health Care; Child Health; Hypoxia; Referral and Consultation; Decision Support Systems, Clinical; Oxymetry
MeSH terms: Hypoxia
Study type: Interventional

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 pragmatic cluster randomised controlled trials (RCTs)
      conducted in India and Tanzania. In Kenya and Senegal, quasi-experimental pre-post studies
      are conducted (NCT05065320). 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,
      routine data review, and an economic evaluation.

      We enrol sick children 0 to 59 months of age attending government primary care facilities a
      pragmatic parallel group, superiority cluster randomised controlled trial (RCT). Primary care
      facilities randomly are 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. Interventions are
      implemented with a package of training on the use of devices and refresher IMCI, 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%. 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 and Day 28. Two primary outcomes
      are assessed for the RCT: severe complications by Day 7 (mortality and 'secondary
      hospitalisations' i.e. delayed ≥24 hours from the Day 0 consultation, or without referral);
      and 'primary' hospitalisations (within 24hrs the Day 0 consultation and with referral).
      Secondary outcomes for the RCT, relating to hypoxaemia, referral, antimicrobial prescription,
      follow-up, health status, are further detailed in the attached full protocol and statistical
      analysis plan available.

      The RCT sample size was estimated based on planned enrolment over 12 months and ability to
      detect a ≥30% decrease in severe complications (from 1.1%22) and ≥30% increase in primary
      hospitalisations (from 1.5%, based on facility estimates) for each arm compared to control
      with 80% power, 0.05 alpha per arm, and intra-cluster correlation coefficient (ICC) of
      0.00147. Anticipated feasible enrolment rates were based on DHIS2 and facility data. In
      Tanzania, 22 clusters per arm, each recruiting an average of 1680 children, were estimated to
      be needed (total 110,880). In India, 40 clusters per arm, each recruiting an average of 510
      children, were estimated to be needed (total 40,800).

      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.
    

Intervention name(s): Pulse oximetry; Clinical Decision Support Algorithm
Intervention type(s): Device; Device
Intervention description(s): Pulse oximeters are a non-invasive, accurate and easy to use method of evaluating blood oxygen saturation; Tablet-based clinical decision support algorithms, based on guidelines for the assessment and management of sick children under 5 years of age at primary care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science