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ISRCTN
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ISRCTN42996612
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DOI
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10.1186/ISRCTN42996612
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Assessing the impact of an intervention to implement the referral care component of Integrated Management of Childhood Illnesses (IMCI) in district hospitals
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Scientific title
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A randomised, parallel group trial of a multifaceted intervention to improve care of children in Kenyan district hospitals
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Acronym
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N/A
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Serial number at source
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SSC911
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approved by the KEMRI National Ethical Review Committee on 21st September 2005
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Study design
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Randomised, parallel, controlled intervention study
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Countries of recruitment
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Kenya
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Disease/condition/study domain
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Quality of paediatric inpatient care
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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Children aged 0 - 59 months in participating hospitals with non-IMCI diagnoses
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Anticipated start date
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01/07/2006
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Anticipated end date
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31/05/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Hospitals: intervention (n = 4) and control (n = 4). Childhood admissions: 12,800
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 076827) - Senior Research Fellowship awarded to Dr. Mike English
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Trial website
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Publications
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1. 2008 discussion paper on study design in http://www.ncbi.nlm.nih.gov/pubmed/18495913
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22117602
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Contact name
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Dr
Mike
English
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Address
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KEMRI/Wellcome Trust Programme
P.O. Box 43640
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City/town
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Nairobi
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Zip/Postcode
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00100
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Country
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Kenya
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Sponsor
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The Wellcome Trust (UK)
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Address
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215 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2BE
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Country
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United Kingdom
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Tel
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+44 (0)20 7611 8777
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Fax
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+44 (0)20 7611 8237
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Email
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s.dobson@wellcome.ac.uk
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Sponsor website:
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http://www.wellcome.ac.uk/
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Date applied
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20/11/2008
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Last edited
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13/03/2013
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Date ISRCTN assigned
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21/11/2008
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