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Randomized Controlled Trial
. 2017 Sep 7;18(1):416.
doi: 10.1186/s13063-017-2152-8.

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

Affiliations
Randomized Controlled Trial

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

Philip Ayieko et al. Trials. .

Abstract

Background: The national pneumonia treatment guidelines in Kenya changed in February 2016 but such guideline changes are often characterized by prolonged delays in affecting practice. We designed an enhanced feedback intervention, delivered within an ongoing clinical network that provides a general form of feedback, aimed at improving and sustaining uptake of the revised pneumonia treatment policy. The objective was to determine whether an enhanced feedback intervention will improve correctness of classification and treatment of childhood pneumonia, compared to an existing approach to feedback, after nationwide treatment policy change and within an existing hospital network.

Methods/design: A pragmatic, cluster randomized trial conducted within a clinical network of 12 Kenyan county referral hospitals providing inpatient pediatric care to children (aged 2-59 months) with acute medical conditions between March and November 2016. The intervention comprised enhanced feedback (monthly written feedback incorporating goal setting, and action planning delivered by a senior clinical coordinator for selected pneumonia indicators) and this was compared to standard feedback (2-monthly written feedback on multiple quality of pediatric care indicators) both delivered within a clinical network promoting clinical leadership linked to mentorship and peer-to-peer support, and improved use of health information on service delivery. The 12 hospitals were randomized to receive either enhanced feedback (n = 6) or standard feedback (n = 6) delivered over a 9-month period following nationwide pneumonia treatment policy change. The primary outcome is the proportion of all admitted patients with pneumonia (fulfilling criteria for treatment with orally administered amoxicillin) who are correctly classified and treated in the first 24 h. The secondary outcome will be measured over the course of the admission as any change in treatment for pneumonia after the first 24 h.

Discussion: This trial protocol employs a pragmatic trial design during a period of nationwide change in treatment guidelines to address two high-priority areas within implementation research: promoting adoption of health policies and optimizing effectiveness of feedback.

Trial registration: ClinicalTrials.gov, ID: NCT02817971 . Registered retrospectively on 27 June 2016.

Keywords: Audit; Cluster trial; Feedback; Guidelines; Pneumonia; Pragmatic trial; Quality of care.

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Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Kenya Medical Research Institute Scientific and Ethical Review Committee (KEMRI SERC – SSC protocol no. 2465). KEMRI SERC is a National Review Board mandated by the Kenyan Ministry of Health to provide ethical clearance to conduct studies within Kenyan health facilities. This National Committee approved the use of hospital assent to participate in the trial rather than written consent of the hospital administration and all hospitals retained their right to withdraw from the study at any point. The Ethics Committee also confirmed that informed consent was not needed from individual patients (or their carers) whose data were obtained retrospectively from medical records for the purposes of service evaluation and implementation research.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Clinical information network (CIN)-enhanced feedback intervention schedule of enrollment, interventions, and assessments
Fig. 2
Fig. 2
Graphical depiction of interventions in clinical information network (CIN)-enhanced feedback trial (adapted from Perera et al. [25])

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