Tools for the Integrated Management of Childhood Illness (TIMCI): Evaluation of Pulse Oximetry & Clinical Decision Support Algorithms in Primary Care (TIMCI)
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| ClinicalTrials.gov Identifier: NCT04910750 |
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Recruitment Status :
Recruiting
First Posted : June 2, 2021
Last Update Posted : December 6, 2022
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This study aims to evaluate the impact of introducing pulse oximeters and clinical decision support algorithms (CDSAs) to primary care on health outcomes of children under 5 years of age. We will enrol sick children 0 to 59 months of age attending government primary care facilities in India and Tanzania to a three-arm parallel group, superiority pragmatic cluster-randomized controlled trial.
In India, 120 facilities (Primary Health Centres (PHCs), Community Health Centres (CHCs)) in three districts of Uttar Pradesh (Deoria, Sitapur and Unnao) are included; in Tanzania, 66 facilities (dispensaries and health centres) in Mwanza, Tabora and Tanga are included.
Facilities are randomised 1:1:1 to i) pulse oximetry and tablet-based CDSA ii) pulse oximetry and paper job aid, or iii) routine care. Interventions are implemented with a package of training, 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% (and also <94% in India if SARS-CoV-2 is suspected).
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.
The comparison between arms will be assessed through two main primary outcomes: a.) the proportion of children with severe complication (death or secondary hospitalization i.e. delayed beyond 24 hours of primary care consultation, or without referral) by Day 7; and b.) the proportion of children appropriately hospitalised (admitted to hospital within 24 hours of primary care consultation and as a result of referral).
The sample size for the trial is calculated separately for each country, taking the following assumptions into account: a.) a power of 80%, b.) alpha level of 0.05 per arm, c.) intracluster correlation coefficient (ICC) of 0.001, d.) control arm severe complication of 1.1%, e.) control arm appropriate hospitalization of 1.5% and f.) a recruitment period of 12 months. Based on these assumptions, to be able to detect a 30% or greater decrease in severe complication and 30% or greater increase in appropriate hospitalization for each arm compared to the control, 120 and 66 facilities will be required in India and in Tanzania respectively. The estimated average recruitment over the 12-months period is 61,200 children in India (510 per cluster) and 110,880 children in Tanzania (1680 per cluster).
The main trial is is complemented by embedded mixed-method, cost & cost-effectiveness studies, including periodic service provision assessments, process mapping and time-flow studies, in-depth interviews with caregivers, and healthcare providers, key informant interviews and online surveys with stakeholders, and document routine data review. The main is preceded by a 3-month pilot phase, in which sub-studies are also conducted.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumonia Primary Health Care Child Health Hypoxia Referral and Consultation Decision Support Systems, Clinical Oxymetry | Device: Pulse oximetry Device: Clinical Decision Support Algorithm | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 172080 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Basic Science |
| 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 |
| Actual Study Start Date : | July 5, 2021 |
| Estimated Primary Completion Date : | June 2023 |
| Estimated Study Completion Date : | September 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Intervention Arm 1 - Pulse oximetry and Clinical Decision Support Algorithm
Facilities in intervention arm 1 will be provided with handheld pulse oximeters and tablet-based clinical decision support algorithms, with pulse oximetry, CDSA and IMCI refresher training
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Device: Pulse oximetry
Pulse oximeters are a non-invasive, accurate and easy to use method of evaluating blood oxygen saturation Device: Clinical Decision Support Algorithm 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 |
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Active Comparator: Intervention Arm 2 - Pulse oximetry alone
Facilities in intervention arm 2 will be provided with handheld pulse oximeters and paper-based guidance (pulse oximetry job aid and IMCI chart booklet integrating pulse oximetry), with pulse oximetry and IMCI refresher training
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Device: Pulse oximetry
Pulse oximeters are a non-invasive, accurate and easy to use method of evaluating blood oxygen saturation |
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No Intervention: Control Arm - Routine Primary Health Care
Facilities in the control arm will be provided with IMCI refresher training
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- Proportion of children with a severe complication (death or secondary hospitalisation) by Day 7 [ Time Frame: 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 [ Time Frame: 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 outcomes is 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 with severe complication (death or secondary hospitalisation) by Day 28 [ Time Frame: 28 days ]
- Proportion of children cured (defined as caregiver reported recovery from illness) by Day 7 [ Time Frame: 7 days ]
- 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 [ Time Frame: 24 hours ]
- Proportion of children completing referral to a higher level of care within 24 hours, of all children referred at Day 0 consultation [ Time Frame: 24 hours ]
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| Ages Eligible for Study: | 1 Day to 5 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Individual child inclusion:
- Children 0 - 59 months for whom caregivers provide consent
- Consulting for an illness, or reported to be unwell when attending for a routine visit (e.g. vaccination, growth or chronic disease monitoring)
Individual child exclusion:
- Children in the immediate post-natal period or first day of life
- Attending for a consultation related to trauma only (including new and follow-up presentations for burns, injuries, wounds)
- Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother)
- Enrolled in the study within the preceding 28 days at any study facility
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04910750
| Contact: Fabian Schaer, PhD | +41612848813 | fabian.schaer@swisstph.ch | |
| Contact: Fenella Beynon, MD | +41612848772 | fenella.beynon@swisstph.ch |
Show 27 study locations
| Principal Investigator: | Kaspar Wyss, Prof, PhD | Swiss Tropical & Public Health Institute | |
| Principal Investigator: | Valérie D'Acremont, MD, PhD | Swiss Tropical & Public Health Institute |
| Responsible Party: | Swiss Tropical & Public Health Institute |
| ClinicalTrials.gov Identifier: | NCT04910750 |
| Other Study ID Numbers: |
ERC.0003405 |
| First Posted: | June 2, 2021 Key Record Dates |
| Last Update Posted: | December 6, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Hypoxia Signs and Symptoms, Respiratory |