Clinical trial NCT02817971: Effect of Enhanced Feedback to Hospitals in an Emerging Clinical Information Network
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Keywords: feedback
pneumonia
quality of care
Lead sponsor: KEMRI-Wellcome Trust Collaborative Research Program
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 900
Sex: ALL
Minimum age (years): 2
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Pneumonia classification and treatment
timeFrame: 9 months
Secondary outcomes:
measure: Antibiotic change
timeFrame: 9 months
Other outcomes:
Locations:
city: Busia
country: Kenya
facility: Busia County Hospital
city: Embu
country: Kenya
facility: Embu County Hospital
city: Kakamega
country: Kenya
facility: Kakamega County Referral Hospital
city: Kakamega
country: Kenya
facility: Vihiga County Hospital
city: Karatina
country: Kenya
facility: Karatina County Hospital
city: Kerugoya
country: Kenya
facility: Kerugoya County Hospital
city: Kiambu
country: Kenya
facility: Kiambu County Hospital
city: Kisumu
country: Kenya
facility: Kisumu County Hospital
city: Kitale
country: Kenya
facility: Kitale County Hospital
city: Machakos
country: Kenya
facility: Machakos County Hospital
city: Nairobi
country: Kenya
facility: Mama Lucy Kibaki Hospital
city: Nyeri
country: Kenya
facility: Nyeri County Hospital
Study officials:
affiliation: KEMRI-Wellcome Trust Research Priogramme
name: Mike English, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ayieko P, Irimu G, Ogero M, Mwaniki P, Malla L, Julius T, Chepkirui M, Mbevi G, Oliwa J, Agweyu A, Akech S, Were F, English M; Clinical Information Network Authors. Effect of enhancing audit and feedback on uptake of childhood pneumonia treatment policy in hospitals that are part of a clinical network: a cluster randomized trial. Implement Sci. 2019 Mar 4;14(1):20. doi: 10.1186/s13012-019-0868-4.
citation: Ayieko P, Irimu G, English M. Effect of enhanced feedback to hospitals that are part of an emerging clinical information network on uptake of revised childhood pneumonia treatment policy: study protocol for a cluster randomized trial. Trials. 2017 Sep 7;18(1):416. doi: 10.1186/s13063-017-2152-8.