Clinical trial NCT02341469: A Trial of an Integrated E-diagnosis Assessment to Improve the Management of Childhood Illnesses in Burkina Faso
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IMCI Guidelines
Childhood Illnesses
Keywords: Burkina Faso
cluster randomised
stepped-wedge
IMCI
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Terre des hommes, Burkina Faso & Switzerland - SPONSOR
name: Centre Muraz
First posted: 2015-01-19
Enrollment: 7200
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to IMCI guidelines
timeFrame: Three years
measure: Correct disease classification and prescription
timeFrame: Three years
Secondary outcomes:
measure: Correct identification of danger signs
timeFrame: Three years
measure: Correct classification of children
timeFrame: Three years
measure: Prescription of the correct medicine
timeFrame: Three years
measure: Correct referral or hospitalisation
timeFrame: Three years
measure: Correct counselling delivered to child carer
timeFrame: Three years
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Centre Muraz
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Karl Blanchet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.