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


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


BACKGROUND
The GAPS trial is registered under the Australian New Zealand Clinical Trials Register, reference number: ACTRN12615001128583 (registered 26/10/2015).
The University of Queensland, School of Public Health, Herston, QLD, 4006, Australia. m.avent@uq.edu.au.|The University of Queensland, UQ Centre for Clinical Research, Herston, QLD, 4006, Australia. m.avent@uq.edu.au.
Minyon L
ML
Avent
Centre for Research in Evidence-Based Practice, Faculty of Health Sciences and Medicine, Bond University, Robina, QLD, 4226, Australia.
Malene Plejdrup
MP
Hansen
The University of Queensland, School of Public Health, Herston, QLD, 4006, Australia.
Charles
C
Gilks
Centre for Research in Evidence-Based Practice, Faculty of Health Sciences and Medicine, Bond University, Robina, QLD, 4226, Australia.
Chris
C
Del Mar
Institute of Health and Biomedical Innovation and School of Public Health & Social Work, Queensland University of Technology, Kelvin Grove, QLD, 4059, Australia.
Kate
K
Halton
The University of Queensland, UQ Centre for Clinical Research, Herston, QLD, 4006, Australia.
Hanna
H
Sidjabat
Institute of Health and Biomedical Innovation and School of Public Health & Social Work, Queensland University of Technology, Kelvin Grove, QLD, 4059, Australia.
Lisa
L
Hall
The University of Queensland, School of Public Health, Herston, QLD, 4006, Australia.
Annette
A
Dobson
The University of Queensland, UQ Centre for Clinical Research, Herston, QLD, 4006, Australia.
David L
DL
Paterson
The University of Queensland, Discipline of General Practice, School of Medicine, Herston, QLD, 4006, Australia.
Mieke L
ML
van Driel
D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001315:Australia; D002985:Clinical Protocols; D058006:General Practice / Q000706:statistics & numerical data*; D006801:Humans; D057970:Inappropriate Prescribing / Q000517:prevention & control* / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011793:Queensland; D012141:Respiratory Tract Infections / Q000188:drug therapy*
D000900:Anti-Bacterial Agents
Antibiotics; Antimicrobial resistance; Antimicrobial stewardship; General practice; Primary care; Protocol