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 |
| Protocol serial number | SSC911 |
| Sponsor | The Wellcome Trust (UK) |
| Funder | The Wellcome Trust (UK) (grant ref: 076827) - Senior Research Fellowship awarded to Dr. Mike English |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
KEMRI/Wellcome Trust Programme
P.O. Box 43640
Nairobi
00100
Kenya
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, parallel, controlled intervention study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(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. |
| Key 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. |
| Completion date | 31/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Months |
| Upper age limit | 59 Months |
| Sex | All |
| Target sample size at registration | 12800 |
| 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
00100
Kenya
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/11/2011 | Yes | No | |
| Results article | results | 18/07/2014 | Yes | No | |
| Other publications | discussion paper on study design | 01/06/2008 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
