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

Maltese Antibiotic Stewardship Programme in the Community (MASPIC): a Prospective Quasi-experimental Social Marketing Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03218930
Enrollment
33
Registered
2017-07-17
Start date
2014-08-31
Completion date
2018-05-31
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Infection

Keywords

General Practice, Social Marketing, Behavior Change, Antibiotic Prescribing

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.

Interventions

BEHAVIORALDelayed antibiotic prescription

Delayed antibiotic prescription pads will be disseminated to all participating general practitioners in both hard and soft copies.

BEHAVIORALAntibiotic prescribing guidelines

Antibiotic prescribing guidelines will be disseminated to all participating general practitioners in both hard and soft copies.

BEHAVIORALEducation

General practitioners will receive a package of educational sessions tailored towards their specific needs.

BEHAVIORALEducational materials

Educational materials for patients, namely posters and leaflets, will be disseminated to all participating general practitioners.

Sponsors

University of Malta
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Exclusion criteria

* General practitioners who are no longer actively working

Design outcomes

Primary

MeasureTime frameDescription
The antibiotic prescribing rate for patients with acute respiratory tract complaints.Three yearsAn 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

MeasureTime frameDescription
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 influenzaThree yearsThe change in diagnosis-specific antibiotic prescribing rates post-intervention compared with the pre-intervention phase will be analysed using segmented regression.
The proportion of symptomatic relief medication prescribedThree yearsThe change in the proportion of symptomatic relief medication prescribed post-intervention compared with the pre-intervention phase will be analysed.
The change in general practitioners' (GPs) stage-of-changeThree yearsIn 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 antibioticsThree yearsIn 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026