Childhood Illnesses Clinical Trial
— IeDAOfficial title:
Integrated eDiagnosis Assessment (IeDA) for Children Under Five Years Old: a Stepped-wedge Randomized Cluster Trial of a Quality Improvement of the Management of Children Illnesses in Burkina Faso at the Primary Health Care Level
| Verified date | October 2017 |
| Source | London School of Hygiene and Tropical Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 7200 |
| Est. completion date | October 15, 2017 |
| Est. primary completion date | October 15, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 5 Years |
| Eligibility |
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: 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. |
| Country | Name | City | State |
|---|---|---|---|
| Burkina Faso | Centre Muraz | Bobo-Dioulasso |
| Lead Sponsor | Collaborator |
|---|---|
| London School of Hygiene and Tropical Medicine | Centre Muraz, Terre des hommes, Burkina Faso & Switzerland - SPONSOR |
Burkina Faso,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Three years | |
| Primary | 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). | Three years | |
| Secondary | Correct identification of danger signs | Three years | ||
| Secondary | Correct classification of children | Three years | ||
| Secondary | Prescription of the correct medicine | Three years | ||
| Secondary | Correct referral or hospitalisation | Three years | ||
| Secondary | Correct counselling delivered to child carer | Three years |