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CompletedNCT02817971Updated Jul 24, 2017

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

An interventional study of Enhanced feedback and Standard feedback in Pneumonia, sponsored by KEMRI-Wellcome Trust Collaborative Research Program. Completed at 12 sites in Kenya. Open to participants aged 2 Months to 59 Months. Per ClinicalTrials.gov, last updated 2017-07-24.

Sponsored by KEMRI-Wellcome Trust Collaborative Research Program · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
2 Months to 59 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pneumonia

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Keywords

  • feedback
  • pneumonia
  • quality of care
03

Who can participate

Ages eligible
2 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
900 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralEnhanced feedback

    Hospital level feedback delivered every month through paediatrician on the level of adherence to revised pneumonia treatment recommendations.

  • BehavioralStandard feedback

    Hospital level feedback delivered every two months through paediatrician on the performance of multiple paediatric care indicators for managing severely ill children.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 9 months

Secondary outcomes

  1. Antibiotic change

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

    Time frame: 9 months

06

Study locations

12 sites
  • 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
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References and documents

Publications

  • 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. PubMed 30832678 ↗
  • 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. PubMed 28877729 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT02817971
Lead sponsor
KEMRI-Wellcome Trust Collaborative Research Program
Responsible party
Sponsor
First posted
Jun 29, 2016
Start date
Mar 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jul 24, 2017

Study contacts

Mike English, MD
principal investigator · KEMRI-Wellcome Trust Research Priogramme

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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