Welcome
Support Centre
18 September 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Assessing the impact of an intervention to implement the referral care component of Integrated Management of Childhood Illnesses (IMCI) in district hospitals
ISRCTN ISRCTN42996612
DOI 10.1186/ISRCTN42996612
ClinicalTrials.gov identifier
EudraCT number
Public title Assessing the impact of an intervention to implement the referral care component of Integrated Management of Childhood Illnesses (IMCI) in district hospitals
Scientific title A randomised, parallel group trial of a multifaceted intervention to improve care of children in Kenyan district hospitals
Acronym N/A
Serial number at source SSC911
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.
Lay summary Not provided at time of registration
Ethics approval Approved by the KEMRI National Ethical Review Committee on 21st September 2005
Study design Randomised, parallel, controlled intervention study
Countries of recruitment Kenya
Disease/condition/study domain Quality of paediatric inpatient care
Participants - 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)
Participants - exclusion criteria Children aged 0 - 59 months in participating hospitals with non-IMCI diagnoses
Anticipated start date 01/07/2006
Anticipated end date 31/05/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Hospitals: intervention (n = 4) and control (n = 4). Childhood admissions: 12,800
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding The Wellcome Trust (UK) (grant ref: 076827) - Senior Research Fellowship awarded to Dr. Mike English
Trial website
Publications 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
Contact name Dr  Mike  English
  Address KEMRI/Wellcome Trust Programme
P.O. Box 43640
  City/town Nairobi
  Zip/Postcode 00100
  Country Kenya
Sponsor The Wellcome Trust (UK)
  Address 215 Euston Road
  City/town London
  Zip/Postcode NW1 2BE
  Country United Kingdom
  Tel +44 (0)20 7611 8777
  Fax +44 (0)20 7611 8237
  Email s.dobson@wellcome.ac.uk
  Sponsor website: http://www.wellcome.ac.uk/
Date applied 20/11/2008
Last edited 13/03/2013
Date ISRCTN assigned 21/11/2008
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.