CClinicalTrials.gg
CompletedNCT02341469IeDAUpdated Jan 11, 2018

A Trial of an Integrated E-diagnosis Assessment to Improve the Management of Childhood Illnesses in Burkina Faso

An interventional study of integrated ediagnostic approach (IeDA) in IMCI Guidelines and Childhood Illnesses, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Burkina Faso. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2018-01-11.

Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
7,200
Allocation
Randomized
Ages
Up to 5 Years
Sex
All
01

Study summary

In 2010, one in six children in Burkina Faso died before the age of five, mainly due to lack of access to quality health care services. Most of these deaths could have been avoided through cost-effective interventions. Ensuring that sick children receive adequate care in a country where 80% of the population lives in rural areas requires improved accessibility and high quality primary health care services. The Integrated Management of Childhood Illnesses strategy (IMCI) was developed by the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) in the 1990s and is an excellent way to improve the quality of country's child health services. However, in Burkina Faso IMCI suffers from a low level of adherence by health workers. According to a recent evaluation by the Ministry of Health (MoH), only 8.2% of children had benefited in 2012 from an consultation using IMCI guideline. Moreover, an analysis of children's records showed that only 15% of IMCI consultations were being correctly delivered and, for instance, only 34% of children with pneumonia who needed an antibiotic were prescribed the correct treatment. The obstacles to IMCI adoption in Burkina Faso are diverse and include inadequate training methods, shortage of material (papers, forms), lack of quality supervision by district executive teams, lack of integration between IMCI monitoring tools and the national health information system etc.

The Integrated eDiagnosis Approach (IeDA) aims to address the poor quality of child health services in Burkina Faso by increasing the level of adherence to IMCI guidelines. IeDA is an innovative strategy combining information and communication technologies (using the Registre Electronique des Consultations [REC], an electronic IMCI patient record designed by Terre des hommes, Tdh) and a quality improvement approach. The approach has been piloted over three years in two different districts in the north of Burkina Faso, Tougan and Séguénéga. This medium scaling-up demonstration project will combine implementation and research components with a goal to enable national scaleup.

Terre des hommes is in charge of the implementation of the project and the London School of Hygiene and Tropical Medicine (LSHTM) will coordinate the research component of the study in partnership with Centre Muraz.

The primary hypothesis is that the Integrated eDiagnosis Approach will lead to improved adherence to IMCI guidelines and management of childhood illnesses in two regions (with a target of 75% of correct diagnoses and prescriptions).

02

Conditions studied

  • IMCI Guidelines
  • Childhood Illnesses

Keywords

  • Burkina Faso
  • cluster randomised
  • stepped-wedge
  • IMCI
03

In context

Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 296 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Regions and Districts - The two regions Boucle du Mouhoune and Region du Nord were purposively chosen based on discussions with the MoH. Eight districts in these two regions will be included in the trial.

Health centres - Ten health centres in each district will be randomly selected and stratified so that, in each district, five health centres with fewer children aged 0-59 months than the district median and five health centres with more than the district median will be selected. The stratification reflects the variation in size between large and small health centres.

Patients - Children aged under five years old who attend the health centre for consultation at the day of the visit of the researchers.

Exclusion criteria

Exclusion Criteria:

Health centres - All health centres not selected in the study will be excluded from the evaluation of the trial, but will still receive the intervention.

Patients - All children not present during the day of the visit of the researchers will be excluded. All patients above five years old will be excluded.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
7,200 participants (estimated)

Study arms

  • No intervention
    Standard-of-care
  • Experimental
    integrated ediagnostic approach

    Other: integrated ediagnostic approach (IeDA)

Interventions

  • Otherintegrated ediagnostic approach (IeDA)

    IeDA is a package of several interventions with the objective of improving the quality of child health care in health centres to ultimately decrease child morbidity and mortality. The components of IedA are described as follows: * REC: the IMCI protocol translated into a computer-based tool that aims to guide nurses during consultations. * The training of nurses on IMCI and REC. * A quality assurance mechanism through which each district and health centre is encouraged to find appropriate solutions in response to their local needs. * A supervision system conducted implemented by district managers to provide support and guidance to health centres. * A health information system based on data collected through the REC and fed back to the district managers and Heads of health centres.

06

What researchers measure

Primary outcomes

  1. Adherence to IMCI guidelines

    Clinical observations will be conducted for children presenting at primary healthcare centres to determine the level of adherence to IMCI guidelines. This will be done at each step of the stepped-wedge trial, including at a baseline step (i.e. before any clusters are in the intervention phase).

    Time frame: Three years

  2. Correct disease classification and prescription

    Following the clinical observation of each child, the child will be re-consulted by study staff to determine the correct disease classification(s) and prescription(s). A binary variable will be created for the consultation based on whether the classification(s) and prescription(s) decided by the healthcare worker are in agreement with those of our study staff.This will be done at each step of the stepped-wedge trial, including at a baseline step (i.e. before any clusters are in the intervention phase).

    Time frame: Three years

Secondary outcomes

  1. Correct identification of danger signs

    Time frame: Three years

  2. Correct classification of children

    Time frame: Three years

  3. Prescription of the correct medicine

    Time frame: Three years

  4. Correct referral or hospitalisation

    Time frame: Three years

  5. Correct counselling delivered to child carer

    Time frame: Three years

07

Study locations

1 site
  • Centre Muraz
    Bobo-Dioulasso, Burkina Faso
08

References and documents

Publications

  • Sarrassat S, Lewis JJ, Some AS, Somda S, Cousens S, Blanchet K. An Integrated eDiagnosis Approach (IeDA) versus standard IMCI for assessing and managing childhood illness in Burkina Faso: a stepped-wedge cluster randomised trial. BMC Health Serv Res. 2021 Apr 16;21(1):354. doi: 10.1186/s12913-021-06317-3. PubMed 33863326 ↗
  • Blanchet K, Lewis JJ, Pozo-Martin F, Satouro A, Somda S, Ilboudo P, Sarrassat S, Cousens S. A mixed methods protocol to evaluate the effect and cost-effectiveness of an Integrated electronic Diagnosis Approach (IeDA) for the management of childhood illnesses at primary health facilities in Burkina Faso. Implement Sci. 2016 Aug 4;11(1):111. doi: 10.1186/s13012-016-0476-5. PubMed 27488566 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02341469
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Terre des hommes, Burkina Faso & Switzerland - SPONSOR, Centre Muraz
Responsible party
Sponsor
First posted
Jan 19, 2015
Start date
Sep 2014
Primary completion
Oct 15, 2017
Completion
Oct 15, 2017
Last update
Jan 11, 2018

Study contacts

Karl Blanchet, PhD
principal investigator · London School of Hygiene and Tropical Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion