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Clinical Trial Summary

The overall goal of the Tools for the Management of Childhood Illness (TIMCI) project is to reduce morbidity and mortality in sick children attending primary care facilities, while supporting the rational and efficient use of diagnostics and medicines by healthcare providers. The evaluation component of the project seeks to generate evidence on the health impact, operational priorities, cost and modelled cost-effectiveness of introducing pulse oximetry, embedded into a Clinical Decision Support Algorithm (CDSA), at primary care level in LMICs, for children 0 - 59 months of age, to facilitate national and international decision-making on scale-up. For the longitudinal observational studies conducted in Kenya, Myanmar and Senegal, the health impact will be assessed through a quasi-experimental study design. It will compare the clinical care of children in a three-month pre-intervention period (Q1) with four sequential three-month periods (Q2-Q5). Additionally, mixed-method studies will be conducted to evaluate the key components of quality of care and to learn more about the implementation processes and mechanisms. Included will be a service provision assessment (SPA) which has been modified for the TIMCI study. Further a facility-based process mapping and time-flow study, as well as qualitative studies with caregivers, healthcare provediers and key stakeholders will be conducted. The study will take place in primary care level facilities in Kenya (Kakamega, Kitui and Uasin Gishu county), Myanmar (Ayeyarwady and Southern Shan) and Senegal (Thiès). In Kenya, facilities of Level 2 (dispensaries) and Level 3 (health-centres/sub-county hospitals are included; in Myanmar sub-centers and rural health centers and in Senegal health posts. The interventions that will be introduced and assessed are pulse oximetry, incorporated into Clinical Decision Support Algorithms. The criteria for pulse oximetry are a.) all children under 2 months of age, b.) Children 2-59 months of age presenting with cough/difficulty breathing, and c.) Children 2-59 months of age with IMCI signs of moderate/severe disease (yellow or red classification). The sample size for the longitudinal observational study is calculated separately for each country, based on comparison between Q1 and Q5, however the same sample size will also be collected in each of the intervening quarters (Q2, Q3 and Q4) where logistically feasible, for the purposes of secondary analysis over time. The sample size was calculated to detect a difference in referral from primary care from 3% to at least 4.5%, with 80% power. With the calculated sample size, we would expect to record a minimum detectable reduction of 18% in Kenya and Senegal and of 16% in Myanmar for the antibiotic prescription primary outcome. Service provision assessments and process mapping will be conducted in 8 - 10 longitudinal study facilities per country, stratified by rural / urban location and facility type, at 5 time points (once per quarter in each facility). At each facility at each time point, 10 - 30 children per facility will be included, resulting in an estimated sample size of 800 - 1000 clinical observations, time-flow observations and exit interviews per country over the study period.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05065320
Study type Observational [Patient Registry]
Source Swiss Tropical & Public Health Institute
Contact Fabian Schaer, PhD
Phone +41612848813
Email [email protected]
Status Recruiting
Phase
Start date August 16, 2021
Completion date June 2023

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