TIMCI: Tools for the Integrated Management of Childhood Illness: Evaluation of Pulse Oximetry and Clinical Decision Support Algorithms in Primary Care. Longitudinal Observational Study, With Embedded Mixed Methods Studies, Cost and Modelled Cost-effectiveness in Kenya, Myanmar and Senegal
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- 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 0 consultation [24 hours]
- Proportion of children prescribed an antibiotic at Day 0 primary care consultation [24 hours]
Secondary Outcome Measures
- Proportion of children with a severe complication (death or secondary hospitalisation) by Day 7 [7 Days]
Secondary hospitalisation refers to any delayed hospitalisation (occurring at any point greater than 24 hours after Day 0 consultation) and any hospitalisation occurring without referral. The denominator is all enrolled children
- Proportion of children admitted to hospital within 24 hours of the Day 0 primary care consultation and as a result of a referral [24 hours]
This is used as a proxy for 'appropriate referral' of children, as those with severe disease should generally be admitted to hospital. The denominator for this outcome is also all children enrolled in the study, rather than only referred children. This is because the proportion of referred children that are admitted may be high in routine care, in the context of an inappropriately low referral rate. The aim of the intervention is therefore to increase the overall referral rate of children with severe disease. Hospital admission is chosen as the proxy of severe disease rather than using primary care classification of severe disease, as there are inadequacies in the classification of severe disease in routine practice
- Proportion of children completing referral to a higher level of care within 24 hours, of all children referred at Day 0 consultation [24 hours]
- Proportion of children cured (defined as caregiver reported recovery from illness) by Day 7 [7 Days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Children 0-59 months of age for whom caregivers provide consent
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Consulting for an illness, or reported to be unwell when attending for a routine visit (e.g. vaccination, growth or chronic disease monitoring)
Exclusion Criteria:
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Children in the immediate post-natal period or first day of life
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Attending for a consultation related to trauma only (including new and follow-up presentations for burns, injuries, wounds)
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Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother)
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Enrolled in the study within the preceding 28 days at any study facility
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nairobi | Nairobi | Kenya | ||
| 2 | UCAD | Dakar | Senegal |
Sponsors and Collaborators
- Swiss Tropical & Public Health Institute
- PATH
- University of Nairobi
- Cheikh Anta Diop University, Senegal
- Burnet Institute
Investigators
- Principal Investigator: Kaspar Wyss, Prof, PhD, Swiss Tropical & Public Health Institute
- Principal Investigator: Valérie D'Acremont, MD, PhD, Swiss Tropical & Public Health Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ERC.0003406