A randomised, parallel group trial of a multifaceted intervention to improve care of children in Kenyan district hospitals
That the quality of paediatric inpatient care at district hospitals in Kenya can be improved by an intervention over 18 months comprising evidence based guidelines, training, supervision, feedback and facilitation of local problem solving.
Approved by the KEMRI National Ethical Review Committee on 21st September 2005
Randomised, parallel, controlled intervention study
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Quality of paediatric inpatient care
Baseline survey followed by training, provision of guidelines and job aides (guideline booklets, standard admission record forms), external supervision and feedback after surveys and local facilitation provided over 18 months. Cross-sectional surveys conducted at 6, 12 and 18 months post-baseline.
Baseline survey followed by limited training, provision of guidelines and job aides (guideline booklets, standard admission record forms), written feedback after surveys over 18 months. Cross-sectional surveys conducted at 6, 12 and 18 months post-baseline.
Primary outcome measure
Proportion of children with admission assessment, classification and treatment that is adherent to guidelines provided for pneumonia, diarrhoea/dehydration and malaria. Measurements will be available at 6, 12 and 18 months post-baseline with the primary endpoint being 18 months.
Secondary outcome measures
Proportion of key clinical signs documented for pneumonia, diarrhoea/dehydration and malaria admissions at 6, 12 and 18 months post-baseline with the primary endpoint being 18 months and will use a facility inventory to describe the proportion of items on a pre-specified checklist that are available at the time of the survey also at 6, 12 and 18 months post-baseline with the primary endpoint being 18 months.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Hospitals purposefully selected to represent diversity of Kenyan context and fulfilling minimum size requirements of 1,000 paediatric admissions per annum.
2. Random selection of all childhood admissions:
2.1. Aged 0 - 59 months, either sex
2.2. In participating hospitals with a diagnosis covered by inpatient IMCI guidelines (malaria, pneumonia, meningitis, malnutrition, diarrhoea/dehydration, neonatal sepsis, prematurity/low birthweight)
Target number of participants
Hospitals: intervention (n = 4) and control (n = 4). Childhood admissions: 12,800
Participant exclusion criteria
Children aged 0 - 59 months in participating hospitals with non-IMCI diagnoses
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
KEMRI/Wellcome Trust Programme
The Wellcome Trust (UK) (grant ref: 076827) - Senior Research Fellowship awarded to Dr. Mike English
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
2008 discussion paper on study design in http://www.ncbi.nlm.nih.gov/pubmed/18495913
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22117602
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/25035114
Discussion paper on study design
English M, Irimu G, Wamae A, Were F, Wasunna A, Fegan G, Peshu N, Health systems research in a low-income country: easier said than done., Arch. Dis. Child., 2008, 93, 6, 540-544, doi: 10.1136/adc.2007.126466.
Opondo C, Ayieko P, Ntoburi S, Wagai J, Opiyo N, Irimu G, Allen E, Carpenter J, English M, Effect of a multi-faceted quality improvement intervention on inappropriate antibiotic use in children with non-bloody diarrhoea admitted to district hospitals in Kenya., BMC Pediatr, 2011, 11, 109, doi: 10.1186/1471-2431-11-109.
Mwaniki P, Ayieko P, Todd J, English M, Assessment of paediatric inpatient care during a multifaceted quality improvement intervention in Kenyan district hospitals--use of prospectively collected case record data, BMC Health Serv Res, 2014, 14, 312, doi: 10.1186/1472-6963-14-312.