IMCI GuidelinesIeDANCT02341469
A Trial of an Integrated E-diagnosis Assessment to Improve the Management of Childhood Illnesses in Burkina Faso
A study testing integrated ediagnostic approach (IeDA) in people with IMCI Guidelines and Childhood Illnesses, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- IMCI Guidelines, Childhood Illnesses
- What is being tested?
- integrated ediagnostic approach (IeDA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,200 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Sep 2014to 15 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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).
- Conditions
- IMCI Guidelines, Childhood Illnesses
- Being tested
- integrated ediagnostic approach (IeDA)
- Keywords
- Burkina Faso, cluster randomised, stepped-wedge, IMCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated ediagnostic approach (IeDA)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care | No intervention | Not described |
| integrated ediagnostic approach | Experimental | Not described Receives: Other: integrated ediagnostic approach (IeDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Three years
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).
Measured: Three years
Secondary outcomes (5)
Correct identification of danger signs
Measured: Three years
Correct classification of children
Measured: Three years
Prescription of the correct medicine
Measured: Three years
Correct referral or hospitalisation
Measured: Three years
Correct counselling delivered to child carer
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startSep 2014
- Primary completion15 Oct 2017
- Study completion15 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IMCI GuidelinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Terre des hommes, Burkina Faso & Switzerland - SPONSOR, Centre Muraz
- Responsible party
- Sponsor
- Investigators
- Karl Blanchet, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341469
- Sponsor's protocol ID
- ITCRZC78
- Acronym
- IeDA
- Status last verified
- Oct 2017
- First submitted
- 27 Aug 2014
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
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 33863326Blanchet 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02341469
- Acronym / sponsor ID
- IeDA / ITCRZC78
- Conditions
- IMCI Guidelines, Childhood Illnesses
- Keywords
- Burkina Faso, cluster randomised, stepped-wedge, IMCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Terre des hommes, Burkina Faso & Switzerland - SPONSOR, Centre Muraz
- Study start
- Sep 2014 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care | No intervention | – |
| integrated ediagnostic approach | Experimental | Other: integrated ediagnostic approach (IeDA) |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated 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. | Other | integrated ediagnostic approach |
Primary outcome
Adherence to IMCI guidelines
Time frame: Three years
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).
Correct disease classification and prescription
Time frame: Three years
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).
5 secondary outcomes
Correct identification of danger signs
Time frame: Three years
Correct classification of children
Time frame: Three years
Prescription of the correct medicine
Time frame: Three years
Correct referral or hospitalisation
Time frame: Three years
Correct counselling delivered to child carer
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Derived from this study: PubMed 33863326Sarrassat 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.
- Derived from this study: PubMed 27488566Blanchet 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.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Blanchet, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated ediagnostic approach (IeDA) in people with IMCI Guidelines and Childhood Illnesses, run by London School of Hygiene and Tropical Medicine at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to IMCI guidelines (time frame: Three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341469, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.