Maltese Antibiotic Stewardship Programme in the Community (MASPIC): Antibiotic Prescribing for Acute Respiratory Tract Complaints

Not Applicable

Completed

• Conditions: Acute Respiratory Infection
• Interventions: Behavioral: Delayed antibiotic prescription; Behavioral: Antibiotic prescribing guidelines; Behavioral: Education; Behavioral: Educational materials

• Registration Number: NCT03218930
• Lead Sponsor: Karolinska Institutet

Brief Summary

Antibiotic resistance has become a major threat to global public health. It is driven by a multitude of factors, however one of the leading factors is antibiotic prescribing. Inappropriate antibiotic use and overuse of broad-spectrum antibiotics can lead to the development of resistant strains. Since in Malta the vast majority of antibiotics are acquired through prescription, targeting providers' prescribing behavior is an important strategy needed to try to curb antibiotic overuse and resistance.

The aim of this study is to evaluate the effect of a multifaceted social marketing intervention in changing general practitioners' (GPs) antibiotic prescribing behavior for patients with acute respiratory tract complaints in Malta. This quasi-experimental intervention study using an interrupted time series design includes three phases; a formative pre-intervention phase, an intervention phase and post-intervention evaluation phase, and will last a total of four years.

During the pre-intervention phase, various stakeholders, including GPs, pharmacists and parents will be interviewed in order to get a better contextual understanding of antibiotic use in Malta. A 1-year baseline surveillance system will also be set up to collect actual diagnosis-specific antibiotic prescribing by GP. This data will, at a later stage, be used to measure the change in antibiotic prescribing behavior post-intervention stage. GPs stage of behavior change and intention to prescribe antibiotics will also be measure pre-intervention using questionnaires based on the theory of planned behavior and the transtheoretical model.

The intervention stage will last 6 months and will include multiple components, including, delayed prescription pads, educational sessions, educational materials for patients and distribution of antibiotic guidelines. The intervention will be monitored closely through numerous process indicators.

Following the intervention, GPs' stage of change and intention to prescribe antibiotics will be re-measured using the same questionnaire used pre-intervention. Surveillance data collection will be also be resumed and will provide data to measure the primary outcome as well as additional secondary outcomes.

The primary outcome of interest is the change in the rate of antibiotic prescribing for patients presenting with an acute respiratory tract complaint.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-17
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• All actively practicing general practitioners and trainees specializing within family medicine are eligible to participate regardless of whether they work on a part-time or full-time basis, or in the public and/or private sectors

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Exclusion Criteria

• General practitioners who are no longer actively working

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Social marketing intervention	Educational materials	Participants will receive a total combination of four interventions.
Social marketing intervention	Delayed antibiotic prescription	Participants will receive a total combination of four interventions.
Social marketing intervention	Antibiotic prescribing guidelines	Participants will receive a total combination of four interventions.
Social marketing intervention	Education	Participants will receive a total combination of four interventions.

Primary Outcome Measures

Name	Time	Method
The antibiotic prescribing rate for patients with acute respiratory tract complaints.	Three years	An interrupted time series design will allow us to measure the change in the antibiotic prescribing rate post-intervention compared with the pre-intervention phase through segmented regression analysis. Surveillance data will be collected pre- and post-intervention using a tool adapted from previous research. The tool will be piloted locally and checked for face validity.

Secondary Outcome Measures

Name	Time	Method
The proportion of diagnosis-specific antibiotic prescription, specifically for the common cold, acute pharyngitis, acute sinusitis, acute bronchitis, acute tonsillitis, acute otitis media, pneumonia, allergy and influenza	Three years	The change in diagnosis-specific antibiotic prescribing rates post-intervention compared with the pre-intervention phase will be analysed using segmented regression.
The change in general practitioners' (GPs) stage-of-change	Three years	In order to be able to measure the change in GPs' stage of behavior change post-intervention, a questionnaire will be developed based on the transtheoretical model (or stage-of-change theory) and distributed to GPs pre- and post-intervention. The questionnaire will be informed by previous studies and adapted to the local context.
The change in general practitioners' (GPs) behavioral intention to prescribe antibiotics	Three years	In order to be able to measure the change in GPs' intention to prescribe antibiotics post-intervention, a questionnaire will be developed based on the theory of planned behavior and distributed to GPs pre- and post-intervention. The questionnaire will be informed by previous studies and adapted to the local context.
The proportion of symptomatic relief medication prescribed	Three years	The change in the proportion of symptomatic relief medication prescribed post-intervention compared with the pre-intervention phase will be analysed.