Child Health Clinical Trial
— DYNAMIC-RWOfficial title:
Dynamic Clinical Decision Support Algorithms to Manage Sick Children in Primary Health Care Settings in Rwanda
This study aims to reduce morbidity and mortality among children and mitigate antimicrobial resistance using a novel clinical decision support algorithm, enhanced with point-of-care technologies to help health workers in primary health care settings in Rwanda. Furthermore, the tool provides opportunities to improve supervision and mentorship of health workers and enhance syndromic disease surveillance and outbreak detection.
Status | Recruiting |
Enrollment | 50000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 14 Years |
Eligibility | Inclusion Criteria: - Presenting for an acute medical or surgical condition Exclusion Criteria: - Presenting for scheduled consultation for a chronic disease (e.g. HIV, TB, NCD, malnutrition) - Presenting for routine preventive care (e.g. growth monitoring, vitamin supplementation, deworming, vaccination) - Caregiver unavailable, unable or unwilling to provide written informed consent (except for older children who can provide verbal assent with an adult witness during the consenting process) |
Country | Name | City | State |
---|---|---|---|
Rwanda | Islamic CS | Bugarama | Rusizi |
Rwanda | Gisakura CS | Bushekeri | Nyamasheke |
Rwanda | Bushenge CS | Bushenge | Nyamasheke |
Rwanda | Yove CS | Cyato | Nyamasheke |
Rwanda | Mibilizi CS | Gashonga | Rusizi |
Rwanda | Giheke CS | Giheke | Rusizi |
Rwanda | Kibingo CS | Gihombo | Nyamasheke |
Rwanda | Mashesha CS | Gitambi | Rusizi |
Rwanda | Nyamasheke CS | Kagano | Nyamasheke |
Rwanda | Gihundwe CS | Kamembe | Rusizi |
Rwanda | Mont Cyangugu CS | Kamembe | Rusizi |
Rwanda | Kibogora CS | Kanjongo | Nyamasheke |
Rwanda | Ruheru CS | Kanjongo | Nyamasheke |
Rwanda | Cyivugiza CS | Karambi | Nyamasheke |
Rwanda | Karambi CS | Karambi | Nyamasheke |
Rwanda | Ngange CS | Karambi | Nyamasheke |
Rwanda | Mwezi CS | Karengera | Nyamasheke |
Rwanda | Gatare CS | Macuba | Nyamasheke |
Rwanda | Hanika CS | Macuba | Nyamasheke |
Rwanda | Rusizi CS | Mururu | Rusizi |
Rwanda | Nkungu CS | Nkungu | Rusizi |
Rwanda | Nyakabuye CS | Nyakabuye | Rusizi |
Rwanda | Nyakarenzo CS | Nyakarenzo | Rusizi |
Rwanda | Kamonyi CS | Nyamasheke | |
Rwanda | Karengera CS | Nyamasheke | |
Rwanda | Mukoma CS | Nyamasheke | |
Rwanda | Muyange CS | Nyamasheke | |
Rwanda | Rwinzuki CS | Nzahaha | Rusizi |
Rwanda | Rangiro CS | Rangiro | Nyamasheke |
Rwanda | Nkanka CS | Rusizi | |
Rwanda | Mushaka CS | Rwimbogo | Rusizi |
Rwanda | Mugera CS | Shangi | Nyamasheke |
Lead Sponsor | Collaborator |
---|---|
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | Ecole Polytechnique Fédérale de Lausanne, Rwanda Biomedical Centre, Swiss Tropical & Public Health Institute |
Rwanda,
Benoun JM, Labuda JC, McSorley SJ. Collateral Damage: Detrimental Effect of Antibiotics on the Development of Protective Immune Memory. mBio. 2016 Dec 20;7(6):e01520-16. doi: 10.1128/mBio.01520-16. — View Citation
D'Acremont V, Kilowoko M, Kyungu E, Philipina S, Sangu W, Kahama-Maro J, Lengeler C, Cherpillod P, Kaiser L, Genton B. Beyond malaria--causes of fever in outpatient Tanzanian children. N Engl J Med. 2014 Feb 27;370(9):809-17. doi: 10.1056/NEJMoa1214482. — View Citation
Fink G, D'Acremont V, Leslie HH, Cohen J. Antibiotic exposure among children younger than 5 years in low-income and middle-income countries: a cross-sectional study of nationally representative facility-based and household-based surveys. Lancet Infect Dis. 2020 Feb;20(2):179-187. doi: 10.1016/S1473-3099(19)30572-9. Epub 2019 Dec 13. — View Citation
Holmes AH, Moore LS, Sundsfjord A, Steinbakk M, Regmi S, Karkey A, Guerin PJ, Piddock LJ. Understanding the mechanisms and drivers of antimicrobial resistance. Lancet. 2016 Jan 9;387(10014):176-87. doi: 10.1016/S0140-6736(15)00473-0. Epub 2015 Nov 18. — View Citation
Hopkins H, Bruxvoort KJ, Cairns ME, Chandler CI, Leurent B, Ansah EK, Baiden F, Baltzell KA, Bjorkman A, Burchett HE, Clarke SE, DiLiberto DD, Elfving K, Goodman C, Hansen KS, Kachur SP, Lal S, Lalloo DG, Leslie T, Magnussen P, Jefferies LM, Martensson A, Mayan I, Mbonye AK, Msellem MI, Onwujekwe OE, Owusu-Agyei S, Reyburn H, Rowland MW, Shakely D, Vestergaard LS, Webster J, Wiseman VL, Yeung S, Schellenberg D, Staedke SG, Whitty CJ. Impact of introduction of rapid diagnostic tests for malaria on antibiotic prescribing: analysis of observational and randomised studies in public and private healthcare settings. BMJ. 2017 Mar 29;356:j1054. doi: 10.1136/bmj.j1054. Erratum In: BMJ. 2017 Jun 29;357:j3168. — View Citation
Keitel K, Kagoro F, Samaka J, Masimba J, Said Z, Temba H, Mlaganile T, Sangu W, Rambaud-Althaus C, Gervaix A, Genton B, D'Acremont V. A novel electronic algorithm using host biomarker point-of-care tests for the management of febrile illnesses in Tanzanian children (e-POCT): A randomized, controlled non-inferiority trial. PLoS Med. 2017 Oct 23;14(10):e1002411. doi: 10.1371/journal.pmed.1002411. eCollection 2017 Oct. — View Citation
Shao AF, Rambaud-Althaus C, Samaka J, Faustine AF, Perri-Moore S, Swai N, Kahama-Maro J, Mitchell M, Genton B, D'Acremont V. New Algorithm for Managing Childhood Illness Using Mobile Technology (ALMANACH): A Controlled Non-Inferiority Study on Clinical Outcome and Antibiotic Use in Tanzania. PLoS One. 2015 Jul 10;10(7):e0132316. doi: 10.1371/journal.pone.0132316. eCollection 2015. — View Citation
Shao AF, Rambaud-Althaus C, Swai N, Kahama-Maro J, Genton B, D'Acremont V, Pfeiffer C. Can smartphones and tablets improve the management of childhood illness in Tanzania? A qualitative study from a primary health care worker's perspective. BMC Health Serv Res. 2015 Apr 2;15:135. doi: 10.1186/s12913-015-0805-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in the percent of children with basic anthropometrics and clinical signs assessed over time / across three cluster studies | Change in the percent of children with anthropometric measurements (weight, height, MUAC) and clinical signs (respiratory rate) assessed and documented by the health worker. This outcome will be assessed month to month and compared across the three cluster studies in the intervention arm only. Dated changes in implementation will be presented for context of temporal changes in outcome. | through study completion, thus around 1 year | |
Other | Change in the percent of children with antibiotic prescribed over time / across three cluster studies | Change in the percent of children with an antibiotic prescribed during initial consultation. This outcome will be compared between intervention and control arms month to month and across the three cluster studies. Dated changes in implementation will be presented for context of temporal changes in outcome. | through study completion, thus around 1 year | |
Primary | Percentage of children prescribed an antibiotic at initial consultation in the intervention group (ePOCT+) as compared to the control group (routine care) | Prescription of oral or parenteral antibiotic at initial consultation, as reported by the HW. | by the end of the initial consultation (day 0) | |
Secondary | Percentage of children cured at day 7 in the intervention group (ePOCT+) as compared to the control group (routine care) | The child is defined as being cured at day 7 if the caregiver says that the child is cured or has improved since the initial consultation. Non-referred secondary hospitalizations (if caregiver says that child was hospitalized between day 0 and day 7 but the electronic clinical data does not indicate a referral for hospitalization) will however be considered as clinical failures even if the child is already cured at day 7. | at day 7 (range 6-14) after enrollment | |
Secondary | Percentage of children with one or more unscheduled re-attendance visits at any health facility by day 7 | Telephone or home visit follow-up 7 days (range 6-14 days) after enrollment of the subject. The day of enrollment of the subject is considered as day 0. | by day 7 (range 6-14) after enrollment | |
Secondary | Percentage of children with severe clinical outcome (death or non-referred secondary hospitalization) by day 7 | Death and non-referred secondary hospitalization will be assessed by telephone or home visit follow-up 7 days (range 6-14 days) after enrollment of the subject. The day of enrollment of the subject is considered as day 0. | by day 7 (range 6-14) after enrollment | |
Secondary | Percentage of children referred to hospital or inpatient ward at a health centre at initial consultation | Documented by the HW at the end of the initial consultation in the eCRF (control arm) or in ePOCT+ (intervention arm) when the subject was enrolled (day 0). | by the end of the initial consultation (day 0) | |
Secondary | Percentage of febrile children tested for malaria by RDT and/or microscopy at day 0 | A febrile child is a child with a history of fever (measured or suspected fever in the past 48 hours) or a high temperature. | by the end of the initial consultation (day 0) | |
Secondary | Percentage of malaria positive children prescribed an antimalarial at day 0 | Antimalarial prescription is any oral, rectal, intramuscular or intravenous antimalarial prescribed by a HCW during the initial consultation or a re-attendance visit. | by the end of the initial consultation (day 0) | |
Secondary | Percentage of malaria negative children prescribed an antimalarial at day 0 | Antimalarial prescription is any oral, rectal, intramuscular or intravenous antimalarial prescribed by a HCW during the initial consultation or a re-attendance visit. | by the end of the initial consultation (day 0) | |
Secondary | Percentage of children untested for malaria prescribed an antimalarial at day 0 | Antimalarial prescription is any oral, rectal, intramuscular or intravenous antimalarial prescribed by a HCW during the initial consultation or a re-attendance visit. | by the end of the initial consultation (day 0) |
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