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

NCT ID: NCT02817971

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-12-31

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.

Conditions

Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Enhanced feedback

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

Standard feedback

Intervention Type: BEHAVIORAL

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

Interventions

Enhanced feedback

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KEMRI-Wellcome Trust Collaborative Research Program

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike English, MD

Role: PRINCIPAL_INVESTIGATOR

KEMRI-Wellcome Trust Research Priogramme

Locations

Kerugoya County Hospital

Kerugoya, Kerugoya, 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

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

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 30832678 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28877729 (View on PubMed)

Other Identifiers

KEMRI_CT_2016\0021

Identifier Type: -

Identifier Source: org_study_id