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Clinical Trials/NCT02817971
NCT02817971
Completed
Not Applicable

Effect of Enhanced Feedback to Hospitals That Are Part of an Emerging Clinical Information Network on Uptake of Revised Childhood Pneumonia Treatment Policy: A Pragmatic Cluster Randomized Trial Protocol

KEMRI-Wellcome Trust Collaborative Research Program12 sites in 1 country900 target enrollmentMarch 2016
ConditionsPneumonia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumonia
Sponsor
KEMRI-Wellcome Trust Collaborative Research Program
Enrollment
900
Locations
12
Primary Endpoint
Pneumonia classification and treatment
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

A cluster randomised pragmatic trial will be conducted within an emerging clinical information network composed of 12 Kenyan county hospitals. Hospitals will be randomised to an enhanced feedback intervention delivered over a nine-month period and compared to standard feedback. The trial to be implemented during a phase of implementing change in guideline recommendations for pneumonia will assess the impact of enhanced feedback on hospital uptake of the revised pneumonia treatment recommendations.

Detailed Description

The international guidelines for the classification and treatment of childhood pneumonia were revised recently and in Kenya the national guidelines changed in February 2016. We designed an enhanced feedback intervention aimed at improving uptake of the revised pneumonia treatment policy within a clinical network of 12 Kenyan county referral hospitals. Hospitals were randomized to receive either enhanced feedback (n = 6 hospitals) or standard feedback (n = 6 hospitals) delivered over a six-month period following nationwide pneumonia treatment policy change. The primary outcome is the proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations. The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure) will be reported as a secondary outcome.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
KEMRI-Wellcome Trust Collaborative Research Program
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children aged 2 to 59 months admitted to participating network hospitals with WHO pneumonia diagnosis eligible for treatment with oral amoxicillin

Exclusion Criteria

  • Children aged 2 to 59 months with WHO pneumonia diagnosis and co-morbid illnesses requiring intravenous antibiotic treatment including severe acute malnutrition, bacteraemia, meningitis, or
  • children presenting with pneumonia and tuberculosis or cough lasting more than 2 weeks, or severe malaria

Outcomes

Primary Outcomes

Pneumonia classification and treatment

Time Frame: 9 months

The proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations

Secondary Outcomes

  • Antibiotic change(9 months)

Study Sites (12)

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