Dynamic CDSA to Manage Sick Children in Rwanda

NCT05108831 | Completed

• 3 other identifiers: 2020-02799No.752/RNEC/2020Project_7F-10361.01.01
• Study Type: interventional
• Target: 85,212
• Locations: 1 country
• Sites: 39

Brief Summary

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.

Conditions

Child Health

Keywords

Digital Health; Mobile Application; Clinical Decision Support Algorithm; Antibiotic Stewardship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percentage of children cured at day 7 in the intervention group (ePOCT+) as compared to the control group (routine care)

  at day 7 (range 6-14) after enrollment

• Percentage of children with one or more unscheduled re-attendance visits at any health facility by day 7

  by day 7 (range 6-14) after enrollment

• Percentage of children with severe clinical outcome (death or non-referred secondary hospitalization) by day 7

  by day 7 (range 6-14) after enrollment

• Percentage of children referred to hospital or inpatient ward at a health centre at initial consultation

  by the end of the initial consultation (day 0)

• Percentage of febrile children tested for malaria by RDT and/or microscopy at day 0

  by the end of the initial consultation (day 0)

Other Outcomes (2)

• Change in the percent of children with basic anthropometrics and clinical signs assessed over time / across three cluster studies

  through study completion, thus around 1 year

• Change in the percent of children with antibiotic prescribed over time / across three cluster studies

  through study completion, thus around 1 year

Study Arms (2)

ePOCT+

EXPERIMENTAL

Health facilities allocated to the ePOCT+ intervention arm will receive an electronic clinical decision support algorithm (ePOCT+) on a tablet that will guide them through pediatric consultations. Point-of-care tests proposed by ePOCT+ that are not part of routine care will be provided as part of the study (pulse oximeter, CRP rapid test, additional hemoglobin cuvettes, and salbutamol inhalers and spacers). Training on the use of ePOCT+ and associated clinical skills will be provided before the implementation of the study, along with mentorship visits to assist with issues related to the implementation of ePOCT+.

Device: ePOCT+

Routine care

NO INTERVENTION

In health facilities allocated to the control arm, pediatric consultations will be conducted in a routine manner; however, tests/test results, diagnoses, management and treatments will be recorded in an electronic case report form on a tablet. Equivalent clinical training will be provided before the start of the study.

Interventions

ePOCT+ DEVICE

ePOCT+ is an electronic clinical decision support algorithm

ePOCT+

Eligibility Criteria

• Age: 1 Day - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Presenting for an acute medical or surgical condition

You may not qualify if:

• 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)

Sponsors & Collaborators

• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: lead
• Swiss Tropical & Public Health Institute: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• Rwanda Biomedical Centre: collaborator

Study Sites (39)

Gisakura CS

Bushekeri, Nyamasheke, Rwanda

Location

Bushenge CS

Bushenge, Nyamasheke, Rwanda

Location

Yove CS

Cyato, Nyamasheke, Rwanda

Location

Kibingo CS

Gihombo, Nyamasheke, Rwanda

Location

Nyamasheke CS

Kagano, Nyamasheke, Rwanda

Location

Kibogora CS

Kanjongo, Nyamasheke, Rwanda

Location

Ruheru CS

Kanjongo, Nyamasheke, Rwanda

Location

Cyivugiza CS

Karambi, Nyamasheke, Rwanda

Location

Karambi CS

Karambi, Nyamasheke, Rwanda

Location

Ngange CS

Karambi, Nyamasheke, Rwanda

Location

Mwezi CS

Karengera, Nyamasheke, Rwanda

Location

Mahembe CS

Kibogora, Nyamasheke, Rwanda

Location

Gatare CS

Macuba, Nyamasheke, Rwanda

Location

Hanika CS

Macuba, Nyamasheke, Rwanda

Location

Rangiro CS

Rangiro, Nyamasheke, Rwanda

Location

Mugera CS

Shangi, Nyamasheke, Rwanda

Location

Islamic CS

Bugarama, Rusizi, Rwanda

Location

Mibilizi CS

Gashonga, Rusizi, Rwanda

Location

Giheke CS

Giheke, Rusizi, Rwanda

Location

Bweyeye CS

Gihundwe, Rusizi, Rwanda

Location

Nkombo CS

Gihundwe, Rusizi, Rwanda

Location

Shagasha CS

Gihundwe, Rusizi, Rwanda

Location

Mashesha CS

Gitambi, Rusizi, Rwanda

Location

Gihundwe CS

Kamembe, Rusizi, Rwanda

Location

Mont Cyangugu CS

Kamembe, Rusizi, Rwanda

Location

Bugarama CS

Mibilizi, Rusizi, Rwanda

Location

Gikundamvura CS

Mibilizi, Rusizi, Rwanda

Location

Nyabitimbo CS

Mibilizi, Rusizi, Rwanda

Location

Rusizi CS

Mururu, Rusizi, Rwanda

Location

Nkungu CS

Nkungu, Rusizi, Rwanda

Location

Nyakabuye CS

Nyakabuye, Rusizi, Rwanda

Location

Nyakarenzo CS

Nyakarenzo, Rusizi, Rwanda

Location

Rwinzuki CS

Nzahaha, Rusizi, Rwanda

Location

Mushaka CS

Rwimbogo, Rusizi, Rwanda

Location

Kamonyi CS

Nyamasheke, Rwanda

Location

Karengera CS

Nyamasheke, Rwanda

Location

Mukoma CS

Nyamasheke, Rwanda

Location

Muyange CS

Nyamasheke, Rwanda

Location

Nkanka CS

Rusizi, Rwanda

Location

Related Publications (8)

• 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.

  PMID: 28356302 BACKGROUND

• 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.

  PMID: 26603922 BACKGROUND

• 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.

  PMID: 31843383 BACKGROUND

• 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.

  PMID: 24571753 BACKGROUND

• 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.

  PMID: 27999159 BACKGROUND

• 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.

  PMID: 26161535 BACKGROUND

• 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.

  PMID: 25890078 BACKGROUND

• 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.

  PMID: 29059253 BACKGROUND

Related Links

• Dynamic study website

Study Officials

• Valerie D'Acremont, PhD

  Centre for Primary Care and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study involves two arms: intervention and control. Health facilities will serve as clusters, with half of the facilities (16) receiving the intervention and the other half serving as controls (16). Health facilities will be allocated to their respective study arm pragmatically with respect to geography. A parallel design (groups of matched intervention and control health facilities) will start the study in step-wedge manner. Every 2-4 months, a new group of 10-12 new facilities will be added to the study. At the end of the Phase 1 of the study, the control facilities will also receive the intervention, along with additional facilities for a total of up to 40 health facilities.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 5, 2021
• Study Start: December 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: December 31, 2024
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RW (39)