Dynamic CDSA to Manage Sick Children in Tanzania

NCT05144763 | Completed

• 3 other identifiers: 2020-02800NIMR/HQ/R.8a/Vol.IX/3486Project_6278
• Study Type: interventional
• Target: 92,331
• Locations: 1 country
• Sites: 40

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 Tanzania. Furthermore, the tool provides opportunities to improve supervision and mentorship of health workers and enhance disease surveillance and outbreak detection.

Conditions

Child Health

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 health care worker.

  by the end of the initial consultation (day 0)

Secondary Outcomes (7)

• 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)

• Percentage of malaria positive children prescribed an antimalarial at day 0

  by the end of the initial consultation (day 0)

Other Outcomes (3)

• Change in percent of cases managed using ePOCT+ (uptake) over time

  through study 1 completion, thus 6 to 9 months

• Change in the percent of children with basic anthropometrics and clinical signs assessed over time

  through study 1 completion, thus 6 to 9 months

• Change in the percent of children with antibiotic prescribed over time

  through study 1 completion, thus 6 to 9 months

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
• Ifakara Health Institute: collaborator
• National Institute for Medical Research, Tanzania: collaborator
• University of Geneva, Switzerland: collaborator

Study Sites (40)

Isyesye Dispensary

Mbeya, Mbeya CC, Tanzania

Location

Idiga Dispensary

Mbeya, Tanzania

Location

Iganzo Dispensary

Mbeya, Tanzania

Location

Igoma Dispensary

Mbeya, Tanzania

Location

Ikukwa Health Center

Mbeya, Tanzania

Location

Inyala Health Center

Mbeya, Tanzania

Location

Isonso Dispensary

Mbeya, Tanzania

Location

Itagano Dispensary

Mbeya, Tanzania

Location

Itensa Dispensary

Mbeya, Tanzania

Location

Ituha Dispensary

Mbeya, Tanzania

Location

Iwowo Dispensary

Mbeya, Tanzania

Location

Iziwa Dispensary

Mbeya, Tanzania

Location

Izumbwe II Dispensary

Mbeya, Tanzania

Location

Ruanda Health Center

Mbeya, Tanzania

Location

Santilya Health Center

Mbeya, Tanzania

Location

Shuwa Dispensary

Mbeya, Tanzania

Location

Chita Rural Dispensary

Morogoro, Tanzania

Location

Ebuyu Dispensary

Morogoro, Tanzania

Location

Idete Dispensary

Morogoro, Tanzania

Location

Ikule Dispensary

Morogoro, Tanzania

Location

Isongo Dispensary

Morogoro, Tanzania

Location

Ketaketa Dispensary

Morogoro, Tanzania

Location

Kibaoni Health Center

Morogoro, Tanzania

Location

Kichangani Dispensary

Morogoro, Tanzania

Location

Kidatu Dispensary

Morogoro, Tanzania

Location

Kivukoni Dispensary

Morogoro, Tanzania

Location

Lukande Dispensary

Morogoro, Tanzania

Location

Mbingu Dispensary

Morogoro, Tanzania

Location

Mbuga Dispensary

Morogoro, Tanzania

Location

Michenga Dispensary

Morogoro, Tanzania

Location

Mkangawalo Dispensary

Morogoro, Tanzania

Location

Mlimba Health Center

Morogoro, Tanzania

Location

Mngeta Health Center

Morogoro, Tanzania

Location

Msolwa A Dispensary

Morogoro, Tanzania

Location

Msolwa Station Dispensary

Morogoro, Tanzania

Location

Mwaya Health Center

Morogoro, Tanzania

Location

Sagamaganga Dispensary

Morogoro, Tanzania

Location

Sonjo Dispensary

Morogoro, Tanzania

Location

Udagaji Dispensary

Morogoro, Tanzania

Location

Utengule Dispensary

Morogoro, Tanzania

Location

Related Publications (10)

• 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

• Tan R, Kavishe G, Kulinkina AV, Renggli S, Luwanda LB, Mangu C, Ashery G, Jorram M, Mtebene IE, Agrea P, Mhagama H, Keitel K, Le Pogam MA, Ntinginya N, Masanja H, D'Acremont V. A cluster randomized trial assessing the effect of a digital health algorithm on quality of care in Tanzania (DYNAMIC study). PLOS Digit Health. 2024 Dec 23;3(12):e0000694. doi: 10.1371/journal.pdig.0000694. eCollection 2024 Dec.

  PMID: 39715234 DERIVED

• Tan R, Kavishe G, Luwanda LB, Kulinkina AV, Renggli S, Mangu C, Ashery G, Jorram M, Mtebene IE, Agrea P, Mhagama H, Vonlanthen A, Faivre V, Thabard J, Levine G, Le Pogam MA, Keitel K, Taffe P, Ntinginya N, Masanja H, D'Acremont V. A digital health algorithm to guide antibiotic prescription in pediatric outpatient care: a cluster randomized controlled trial. Nat Med. 2024 Jan;30(1):76-84. doi: 10.1038/s41591-023-02633-9. Epub 2023 Dec 18.

  PMID: 38110580 DERIVED

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 (20) receiving the intervention and the other half serving as controls (20). Health facilities will be randomized to their respective study arm. A parallel design (all health facilities start at the same time) will be used. At the end of the cluster randomized controlled study, the control facilities will also receive the intervention, along with additional facilities for up to 100.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: December 3, 2021
• Study Start: December 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: September 30, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TA (40)