Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-30 @ 1:01 AM
Study NCT ID:
NCT04910750
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2021-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tools for the Integrated Management of Childhood Illness (TIMCI): Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care
Sponsor:
Swiss Tropical & Public Health Institute
Organization:
Study Overview
Official Title:
Tools for the Integrated Management of Childhood Illness: Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care - Pragmatic Cluster Randomised Controlled Trial, With Embedded Mixed Methods, Cost & Cost-effectiveness Studies in India and Tanzania
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMCI
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: