Condition category
Not Applicable
Date applied
20/11/2008
Date assigned
21/11/2008
Last edited
13/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mike English

ORCID ID

Contact details

KEMRI/Wellcome Trust Programme
P.O. Box 43640
Nairobi
00100
Kenya

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 measures

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

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

http://www.wellcome.ac.uk/

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes