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Dynamic CDSA to Manage Sick Children in Tanzania (DYNAMIC-TZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05144763
Recruitment Status : Recruiting
First Posted : December 3, 2021
Last Update Posted : December 20, 2023
Sponsor:
Collaborators:
Swiss Tropical & Public Health Institute
Ecole Polytechnique Fédérale de Lausanne
Ifakara Health Institute
National Institute for Medical Research, Tanzania
University of Geneva, Switzerland
Information provided by (Responsible Party):
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Child Health Device: ePOCT+ Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: None (Open Label)
Masking Description: Masking is not possible
Primary Purpose: Diagnostic
Official Title: Dynamic Clinical Decision Support Algorithms to Manage Sick Children in Primary Health Care Settings in Tanzania
Actual Study Start Date : December 1, 2021
Actual Primary Completion Date : October 31, 2022
Estimated Study Completion Date : March 31, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: ePOCT+
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+
ePOCT+ is an electronic clinical decision support algorithm
No Intervention: Routine care
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of children cured at day 7 in the intervention group (ePOCT+) as compared to the control group (routine care) [ Time Frame: at day 7 (range 6-14) after enrollment ]
    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.

  2. Percentage of children prescribed an antibiotic at initial consultation in the intervention group (ePOCT+) as compared to the control group (routine care) [ Time Frame: by the end of the initial consultation (day 0) ]
    Prescription of oral or parenteral antibiotic at initial consultation, as reported by the health care worker.


Secondary Outcome Measures :
  1. Percentage of children with one or more unscheduled re-attendance visits at any health facility by day 7 [ Time Frame: by day 7 (range 6-14) after enrollment ]
    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.

  2. Percentage of children with severe clinical outcome (death or non-referred secondary hospitalization) by day 7 [ Time Frame: by day 7 (range 6-14) after enrollment ]
    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.

  3. Percentage of children referred to hospital or inpatient ward at a health centre at initial consultation [ Time Frame: by the end of the initial consultation (day 0) ]
    Documented by the health care worker at the end of the initial consultation in the eCRF (control arm) or in ePOCT+ (intervention arm) when the subject was enrolled (day 0)

  4. Percentage of febrile children tested for malaria by RDT and/or microscopy at day 0 [ Time Frame: by the end of the initial consultation (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.

  5. Percentage of malaria positive children prescribed an antimalarial at day 0 [ Time Frame: by the end of the initial consultation (day 0) ]
    An antimalarial prescription is any oral, rectal, intramuscular or intravenous antimalarial prescribed by a HCW during the initial consultation or a re-attendance visit.

  6. Percentage of malaria negative children prescribed an antimalarial at day 0 [ Time Frame: by the end of the initial consultation (day 0) ]
    An antimalarial prescription is any oral, rectal, intramuscular or intravenous antimalarial prescribed by a HCW during the initial consultation or a re-attendance visit.

  7. Percentage of children untested for malaria prescribed an antimalarial at day 0 [ Time Frame: by the end of the initial consultation (day 0) ]
    An antimalarial prescription is any oral, rectal, intramuscular or intravenous antimalarial prescribed by a HCW during the initial consultation or a re-attendance visit.


Other Outcome Measures:
  1. Change in percent of cases managed using ePOCT+ (uptake) over time [ Time Frame: through study 1 completion, thus 6 to 9 months ]
    Change in the percent of cases fully managed using ePOCT+ meaning that the medications and referral steps completed and case closed by healthcare worker. This outcome will be assessed month to month in the intervention arm only. Dated changes in implementation will be presented for context of temporal changes in outcome.

  2. Change in the percent of children with basic anthropometrics and clinical signs assessed over time [ Time Frame: through study 1 completion, thus 6 to 9 months ]
    Change in the percent of children with anthropometric measurements (weight, height, MUAC) and clinical signs (respiratory rate) assessed and documented by the healthcare worker. This outcome will be assessed month to month in the intervention arm only. Dated changes in implementation will be presented for context of temporal changes in outcome.

  3. Change in the percent of children with antibiotic prescribed over time [ Time Frame: through study 1 completion, thus 6 to 9 months ]
    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. Dated changes in implementation will be presented for context of temporal changes in outcome.


Eligibility Criteria
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Ages Eligible for Study:   1 Day to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05144763


Contacts
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Contact: Valerie D'Acremont, PhD +41 61 284 8679 Valerie.DAcremont@unisante.ch
Contact: Alexandra V Kulinkina, PhD +41 79 555 9046 alexandra.kulinkina@swisstph.ch

Locations
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Sponsors and Collaborators
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Swiss Tropical & Public Health Institute
Ecole Polytechnique Fédérale de Lausanne
Ifakara Health Institute
National Institute for Medical Research, Tanzania
University of Geneva, Switzerland
Investigators
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Principal Investigator: Valerie D'Acremont, PhD Centre for Primary Care and Public Health
  Study Documents (Full-Text)

Documents provided by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland:
Study Protocol  [PDF] September 10, 2021
Statistical Analysis Plan  [PDF] September 7, 2022

More Information
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Additional Information:

Publications:

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Responsible Party: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
ClinicalTrials.gov Identifier: NCT05144763    
Other Study ID Numbers: 2020-02800
NIMR/HQ/R.8a/Vol.IX/3486 ( Other Identifier: National Institute for Medical Research, Tanzania )
Project_6278 ( Other Grant/Funding Number: Botnar Foundation )
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: December 20, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland:
Digital Health
Mobile Application
Clinical Decision Support Algorithm
Antibiotic Stewardship