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

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ClinicalTrials.gov Identifier: NCT02817971
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
KEMRI-Wellcome Trust Collaborative Research Program

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.

Condition or disease Intervention/treatment Phase
Pneumonia Behavioral: Enhanced feedback Behavioral: Standard feedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : March 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817971


Locations
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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, Kenya
Sponsors and Collaborators
KEMRI-Wellcome Trust Collaborative Research Program
Investigators
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Principal Investigator: Mike English, MD KEMRI-Wellcome Trust Research Priogramme
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KEMRI-Wellcome Trust Collaborative Research Program
ClinicalTrials.gov Identifier: NCT02817971    
Other Study ID Numbers: KEMRI_CT_2016\0021
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by KEMRI-Wellcome Trust Collaborative Research Program:
feedback
pneumonia
quality of care
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections