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

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Enhanced feedback
Standard feedback
Sponsored by
KEMRI-Wellcome Trust Collaborative Research Program
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pneumonia focused on measuring feedback, pneumonia, quality of care

Eligibility Criteria

2 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Busia County Hospital
  • Embu County Hospital
  • Kakamega County Referral Hospital
  • Vihiga County Hospital
  • Karatina County Hospital
  • Kerugoya County Hospital
  • Kiambu County Hospital
  • Kisumu County Hospital
  • Kitale County Hospital
  • Machakos County Hospital
  • Mama Lucy Kibaki Hospital
  • Nyeri County Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced feedback

Standard feedback

Arm Description

Monthly written feedback incorporating goal setting, and action planning delivered by a senior clinical coordinator for selected pneumonia indicators Two-monthly written feedback on multiple quality of paediatric care indicators Clinical network promoting clinical leadership linked to mentorship and peer to peer support Improved use of health information on service delivery

Two-monthly written feedback on multiple quality of paediatric care indicators Clinical network promoting clinical leadership linked to mentorship and peer to peer support Improved use of health information on service delivery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Antibiotic change
The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure)

Full Information

First Posted
June 27, 2016
Last Updated
July 20, 2017
Sponsor
KEMRI-Wellcome Trust Collaborative Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT02817971
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KEMRI-Wellcome Trust Collaborative Research Program

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
feedback, pneumonia, quality of care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced feedback
Arm Type
Experimental
Arm Description
Monthly written feedback incorporating goal setting, and action planning delivered by a senior clinical coordinator for selected pneumonia indicators Two-monthly written feedback on multiple quality of paediatric care indicators Clinical network promoting clinical leadership linked to mentorship and peer to peer support Improved use of health information on service delivery
Arm Title
Standard feedback
Arm Type
Active Comparator
Arm Description
Two-monthly written feedback on multiple quality of paediatric care indicators Clinical network promoting clinical leadership linked to mentorship and peer to peer support Improved use of health information on service delivery
Intervention Type
Behavioral
Intervention Name(s)
Enhanced feedback
Intervention Description
Hospital level feedback delivered every month through paediatrician on the level of adherence to revised pneumonia treatment recommendations.
Intervention Type
Behavioral
Intervention Name(s)
Standard feedback
Intervention Description
Hospital level feedback delivered every two months through paediatrician on the performance of multiple paediatric care indicators for managing severely ill children.
Primary Outcome Measure Information:
Title
Pneumonia classification and treatment
Description
The proportion of all pneumonia admissions (fulfilling criteria for treatment with oral amoxicillin) who are correctly classified and treated using new guideline recommendations
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Antibiotic change
Description
The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike English, MD
Organizational Affiliation
KEMRI-Wellcome Trust Research Priogramme
Official's Role
Principal Investigator
Facility Information:
Facility Name
Busia County Hospital
City
Busia
Country
Kenya
Facility Name
Embu County Hospital
City
Embu
Country
Kenya
Facility Name
Kakamega County Referral Hospital
City
Kakamega
Country
Kenya
Facility Name
Vihiga County Hospital
City
Kakamega
Country
Kenya
Facility Name
Karatina County Hospital
City
Karatina
Country
Kenya
Facility Name
Kerugoya County Hospital
City
Kerugoya
Country
Kenya
Facility Name
Kiambu County Hospital
City
Kiambu
Country
Kenya
Facility Name
Kisumu County Hospital
City
Kisumu
Country
Kenya
Facility Name
Kitale County Hospital
City
Kitale
Country
Kenya
Facility Name
Machakos County Hospital
City
Machakos
Country
Kenya
Facility Name
Mama Lucy Kibaki Hospital
City
Nairobi
Country
Kenya
Facility Name
Nyeri County Hospital
City
Nyeri
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30832678
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.
Results Reference
derived
PubMed Identifier
28877729
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.
Results Reference
derived

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

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