Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SSC911
Study information
Scientific title
A randomised, parallel group trial of a multifaceted intervention to improve care of children in Kenyan district hospitals
Acronym
Study hypothesis
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.
Ethics approval
Approved by the KEMRI National Ethical Review Committee on 21st September 2005
Study design
Randomised, parallel, controlled intervention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Quality of paediatric inpatient care
Intervention
Intervention arms:
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.
Control arm:
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.
Intervention type
Other
Phase
Not Specified
Drug names
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
01/07/2006
Overall trial end date
31/05/2009
Reason abandoned (if study stopped)
Eligibility
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)
Participant type
Patient
Age group
Child
Gender
Both
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
01/07/2006
Recruitment end date
31/05/2009
Locations
Countries of recruitment
Kenya
Trial participating centre
KEMRI/Wellcome Trust Programme
Nairobi
00100
Kenya
Sponsor information
Organisation
The Wellcome Trust (UK)
Sponsor details
215 Euston Road
London
NW1 2BE
United Kingdom
+44 (0)20 7611 8777
s.dobson@wellcome.ac.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 076827) - Senior Research Fellowship awarded to Dr. Mike English
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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)
Publication list
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
Publication citations
-
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.
-
Results
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.
-
Results
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.