The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms
Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness,...
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Taylor & Francis Group
2024-12-01
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| Series: | Global Health Action |
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| Online Access: | http://dx.doi.org/10.1080/16549716.2024.2326253 |
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| author | Fenella Beynon Hélène Langet Leah F. Bohle Shally Awasthi Ousmane Ndiaye James Machoki M’Imunya Honorati Masanja Susan Horton Maymouna Ba Silvia Cicconi Mira Emmanuel-Fabula Papa Moctar Faye Tracy R. Glass Kristina Keitel Divas Kumar Gaurav Kumar Gillian A. Levine Lena Matata Grace Mhalu Andolo Miheso Deusdedit Mjungu Francis Njiri Elisabeth Reus Michael Ruffo Fabian Schär Kovid Sharma Helen L. Storey Irene Masanja Kaspar Wyss Valérie D’Acremont TIMCI Collaborator Group |
| author_facet | Fenella Beynon Hélène Langet Leah F. Bohle Shally Awasthi Ousmane Ndiaye James Machoki M’Imunya Honorati Masanja Susan Horton Maymouna Ba Silvia Cicconi Mira Emmanuel-Fabula Papa Moctar Faye Tracy R. Glass Kristina Keitel Divas Kumar Gaurav Kumar Gillian A. Levine Lena Matata Grace Mhalu Andolo Miheso Deusdedit Mjungu Francis Njiri Elisabeth Reus Michael Ruffo Fabian Schär Kovid Sharma Helen L. Storey Irene Masanja Kaspar Wyss Valérie D’Acremont TIMCI Collaborator Group |
| author_sort | Fenella Beynon |
| collection | DOAJ |
| description | Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly 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; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0–59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. 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 registration: NCT04910750 and NCT05065320 |
| format | Article |
| id | doaj-art-66d1400ed24d4fdda7c2ac16ab5b0a27 |
| institution | Kabale University |
| issn | 1654-9880 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
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| series | Global Health Action |
| spelling | doaj-art-66d1400ed24d4fdda7c2ac16ab5b0a272025-02-05T12:46:13ZengTaylor & Francis GroupGlobal Health Action1654-98802024-12-0117110.1080/16549716.2024.23262532326253The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithmsFenella Beynon0Hélène Langet1Leah F. Bohle2Shally Awasthi3Ousmane Ndiaye4James Machoki M’Imunya5Honorati Masanja6Susan Horton7Maymouna Ba8Silvia Cicconi9Mira Emmanuel-Fabula10Papa Moctar Faye11Tracy R. Glass12Kristina Keitel13Divas Kumar14Gaurav Kumar15Gillian A. Levine16Lena Matata17Grace Mhalu18Andolo Miheso19Deusdedit Mjungu20Francis Njiri21Elisabeth Reus22Michael Ruffo23Fabian Schär24Kovid Sharma25Helen L. Storey26Irene Masanja27Kaspar Wyss28Valérie D’Acremont29TIMCI Collaborator GroupSwiss Tropical and Public Health InstituteSwiss Tropical and Public Health InstituteSwiss Tropical and Public Health InstituteKing George’s Medical UniversityUniversité Cheikh Anta DiopUniversity of NairobiIfakara Health InstituteUniversity of WaterlooPATHUniversity of BaselPATHUniversité Cheikh Anta DiopUniversity of BaselSwiss Tropical and Public Health InstituteKing George’s Medical UniversitySwiss Tropical and Public Health InstituteUniversity of BaselSwiss Tropical and Public Health InstituteIfakara Health InstitutePATHPATHUniversity of NairobiUniversity of BaselPATHSwiss Tropical and Public Health InstitutePATHPATHIfakara Health InstituteSwiss Tropical and Public Health InstituteSwiss Tropical and Public Health InstituteEffective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly 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; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0–59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. 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 registration: NCT04910750 and NCT05065320http://dx.doi.org/10.1080/16549716.2024.2326253hypoxaemiaimciprimary carequality of carecluster randomized controlled trial |
| spellingShingle | Fenella Beynon Hélène Langet Leah F. Bohle Shally Awasthi Ousmane Ndiaye James Machoki M’Imunya Honorati Masanja Susan Horton Maymouna Ba Silvia Cicconi Mira Emmanuel-Fabula Papa Moctar Faye Tracy R. Glass Kristina Keitel Divas Kumar Gaurav Kumar Gillian A. Levine Lena Matata Grace Mhalu Andolo Miheso Deusdedit Mjungu Francis Njiri Elisabeth Reus Michael Ruffo Fabian Schär Kovid Sharma Helen L. Storey Irene Masanja Kaspar Wyss Valérie D’Acremont TIMCI Collaborator Group The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms Global Health Action hypoxaemia imci primary care quality of care cluster randomized controlled trial |
| title | The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms |
| title_full | The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms |
| title_fullStr | The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms |
| title_full_unstemmed | The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms |
| title_short | The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms |
| title_sort | tools for integrated management of childhood illness timci study protocol a multi country mixed method evaluation of pulse oximetry and clinical decision support algorithms |
| topic | hypoxaemia imci primary care quality of care cluster randomized controlled trial |
| url | http://dx.doi.org/10.1080/16549716.2024.2326253 |
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