Effect of Enhanced Feedback to Hospitals in an Emerging Clinical Information Network

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817971
• Other study ID #: KEMRI_CT_2016\0021
• Status: Completed
• Phase: N/A
• First received: June 27, 2016
• Last updated: July 20, 2017
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: KEMRI-Wellcome Trust Collaborative Research Program
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

Behavioral:
• Enhanced feedback
Hospital level feedback delivered every month through paediatrician on the level of adherence to revised pneumonia treatment recommendations.
• Standard feedback
Hospital level feedback delivered every two months through paediatrician on the performance of multiple paediatric care indicators for managing severely ill children.

Locations

Country	Name	City	State
Kenya	Busia County Hospital	Busia
Kenya	Embu County Hospital	Embu
Kenya	Kakamega County Referral Hospital	Kakamega
Kenya	Vihiga County Hospital	Kakamega
Kenya	Karatina County Hospital	Karatina
Kenya	Kerugoya County Hospital	Kerugoya
Kenya	Kiambu County Hospital	Kiambu
Kenya	Kisumu County Hospital	Kisumu
Kenya	Kitale County Hospital	Kitale
Kenya	Machakos County Hospital	Machakos
Kenya	Mama Lucy Kibaki Hospital	Nairobi
Kenya	Nyeri County Hospital	Nyeri

Sponsors (1)

Lead Sponsor	Collaborator
KEMRI-Wellcome Trust Collaborative Research Program

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumonia classification and treatment	The proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations	9 months
Secondary	Antibiotic change	The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure)	9 months