NCT02817971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

June 27, 2016

Last Update Submit

July 20, 2017

Conditions

Keywords

feedbackpneumoniaquality of care

Outcome Measures

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

    9 months

Secondary Outcomes (1)

  • Antibiotic change

    9 months

Study Arms (2)

Enhanced feedback

EXPERIMENTAL

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

Standard feedback

ACTIVE COMPARATOR

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

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

Enhanced feedback

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

Standard feedback

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 2 to 59 months admitted to participating network hospitals with WHO pneumonia diagnosis eligible for treatment with oral amoxicillin

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Kerugoya County Hospital

Kerugoya, Kerugoya, Kenya

Location

Busia County Hospital

Busia, Kenya

Location

Embu County Hospital

Embu, Kenya

Location

Kakamega County Referral Hospital

Kakamega, Kenya

Location

Vihiga County Hospital

Kakamega, Kenya

Location

Karatina County Hospital

Karatina, Kenya

Location

Kiambu County Hospital

Kiambu, Kenya

Location

Kisumu County Hospital

Kisumu, Kenya

Location

Kitale County Hospital

Kitale, Kenya

Location

Machakos County Hospital

Machakos, Kenya

Location

Mama Lucy Kibaki Hospital

Nairobi, Kenya

Location

Nyeri County Hospital

Nyeri, Kenya

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mike English, MD

    KEMRI-Wellcome Trust Research Priogramme

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2016

First Posted

June 29, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 24, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations