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01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

BMC Family Practice 1/2016

General Practitioner Antimicrobial Stewardship Programme Study (GAPS): protocol for a cluster randomised controlled trial

Zeitschrift:
BMC Family Practice > Ausgabe 1/2016
Autoren:
Minyon L. Avent, Malene Plejdrup Hansen, Charles Gilks, Chris Del Mar, Kate Halton, Hanna Sidjabat, Lisa Hall, Annette Dobson, David L. Paterson, Mieke L. van Driel
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

MLA wrote the initial and final drafts of the manuscript. The concept for the study was proposed by CG. The original protocol was developed by all the authors. MPH, AD, KH, MLvD and HS contributed to the overall writing of the manuscript. Statistical support was provided by AD. All authors have reviewed the final manuscript and approve its contents.

Authors’ information

MLA: Project Manager and Consultant Clinical Pharmacist.
MPH: Postdoctoral Fellow at the Centre for Research in Evidence Based Practice, Bond University.
CG: Head of School of Public Health at the University of Queensland.
CDM: Academic general practitioner Centre for Research in Evidence Based Practice, Bond University at Bond University.
KH: Senior Research Fellow in the Centre for Research Excellence in Reducing Healthcare Associated Infection, Queensland University of Technology.
HS: Research Coordinator at the University of Queensland Centre for Clinical Research.
LH: epidemiologist at the Queensland University of Technology and sits on the Healthcare Associated Infection Advisory Committee and the HAI Technical Working Group for the Australian Commission on Safety and Quality in Health Care.
AD: Professor of Biostatistics, School of Public Health, the University of Queensland.
DLP: Director of University of Queensland Centre for Clinical Research (UQCCR). Consultant Infectious Diseases Physician and Consultant Microbiologist.
MLvD: Head of Discipline of General Practice, School of Medicine, The University of Queensland.

Abstract

Background

There is a strong link between antibiotic consumption and the rate of antibiotic resistance. In Australia, the vast majority of antibiotics are prescribed by general practitioners, and the most common indication is for acute respiratory infections. The aim of this study is to assess if implementing a package of integrated, multifaceted interventions reduces antibiotic prescribing for acute respiratory infections in general practice.

Methods/design

This is a cluster randomised trial comparing two parallel groups of general practitioners in 28 urban general practices in Queensland, Australia: 14 intervention and 14 control practices. The protocol was peer-reviewed by content experts who were nominated by the funding organization.
This study evaluates an integrated, multifaceted evidence-based package of interventions implemented over a six month period. The included interventions, which have previously been demonstrated to be effective at reducing antibiotic prescribing for acute respiratory infections, are: delayed prescribing; patient decision aids; communication training; commitment to a practice prescribing policy for antibiotics; patient information leaflet; and near patient testing with C-reactive protein.
In addition, two sub-studies are nested in the main study: (1) point prevalence estimation carriage of bacterial upper respiratory pathogens in practice staff and asymptomatic patients; (2) feasibility of direct measures of antibiotic resistance by nose/throat swabbing.
The main outcome data are from Australia’s national health insurance scheme, Medicare, which will be accessed after the completion of the intervention phase. They include the number of antibiotic prescriptions and the number of patient visits per general practitioner for periods before and during the intervention. The incidence of antibiotic prescriptions will be modelled using the numbers of patients as the denominator and seasonal and other factors as explanatory variables. Results will compare the change in prescription rates before and during the intervention in the two groups of practices.
Semi-structured interviews will be conducted with the general practitioners and practice staff (practice nurse and/or practice manager) from the intervention practices on conclusion of the intervention phase to assess the feasibility and uptake of the interventions.
An economic evaluation will be conducted to estimate the costs of implementing the package, and its cost-effectiveness in terms of cost per unit reduction in prescribing.

Discussion

The results on the effectiveness, cost-effectiveness, acceptability and feasibility of this package of interventions will inform the policy for any national implementation.

Trial registration

The GAPS trial is registered under the Australian New Zealand Clinical Trials Register, reference number: ACTRN12615001128​583 (registered 26/10/2015).
Literatur
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