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 | https://doi.org/10.1186/ISRCTN42996612 |
| Secondary identifying numbers | SSC911 |
- Submission date
- 20/11/2008
- Registration date
- 21/11/2008
- Last edited
- 15/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mike English
Scientific
Scientific
KEMRI/Wellcome Trust Programme
P.O. Box 43640
Nairobi
00100
Kenya
Study information
| Study design | Randomised, parallel, controlled intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised, parallel group trial of a multifaceted intervention to improve care of children in Kenyan district hospitals |
| Study objectives | 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(s) | Approved by the KEMRI National Ethical Review Committee on 21st September 2005 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2006 |
| Completion date | 31/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | Hospitals: intervention (n = 4) and control (n = 4). Childhood admissions: 12,800 |
| Key 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) |
| Key exclusion criteria | Children aged 0 - 59 months in participating hospitals with non-IMCI diagnoses |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 31/05/2009 |
Locations
Countries of recruitment
- Kenya
Study participating centre
KEMRI/Wellcome Trust Programme
Nairobi
00100
Kenya
00100
Kenya
Sponsor information
The Wellcome Trust (UK)
Charity
Charity
215 Euston Road
London
NW1 2BE
United Kingdom
| Phone | +44 (0)20 7611 8777 |
|---|---|
| s.dobson@wellcome.ac.uk | |
| Website | http://www.wellcome.ac.uk/ |
"ROR" |
https://ror.org/029chgv08 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 076827) - Senior Research Fellowship awarded to Dr. Mike English
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | discussion paper on study design | 01/06/2008 | Yes | No | |
| Results article | results | 25/11/2011 | Yes | No | |
| Results article | results | 18/07/2014 | Yes | No |
