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

July 20, 2017 updated by: KEMRI-Wellcome Trust Collaborative Research Program

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced feedback
  1. Monthly written feedback incorporating goal setting, and action planning delivered by a senior clinical coordinator for selected pneumonia indicators
  2. Two-monthly written feedback on multiple quality of paediatric care indicators
  3. Clinical network promoting clinical leadership linked to mentorship and peer to peer support
  4. Improved use of health information on service delivery
Behavioral: Enhanced feedback
Hospital level feedback delivered every month through paediatrician on the level of adherence to revised pneumonia treatment recommendations.
Active Comparator: Standard feedback
  1. Two-monthly written feedback on multiple quality of paediatric care indicators
  2. Clinical network promoting clinical leadership linked to mentorship and peer to peer support
  3. Improved use of health information on service delivery
Behavioral: Standard feedback
Hospital level feedback delivered every two months through paediatrician on the performance of multiple paediatric care indicators for managing severely ill children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic change
Time Frame: 9 months
The proportion of treatment change from oral amoxicillin to alternative antibiotics for pneumonia (considered a proxy measure of treatment failure)
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KEMRI-Wellcome Trust Collaborative Research Program

Investigators

  • Principal Investigator: Mike English, MD, KEMRI-Wellcome Trust Research Priogramme

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEMRI_CT_2016\0021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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