- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03218930
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Social marketing intervention
Participants will receive a total combination of four interventions.
|
Delayed antibiotic prescription pads will be disseminated to all participating general practitioners in both hard and soft copies.
Antibiotic prescribing guidelines will be disseminated to all participating general practitioners in both hard and soft copies.
General practitioners will receive a package of educational sessions tailored towards their specific needs.
Educational materials for patients, namely posters and leaflets, will be disseminated to all participating general practitioners.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The antibiotic prescribing rate for patients with acute respiratory tract complaints.
Time Frame: 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.
|
Three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Three years
|
The change in diagnosis-specific antibiotic prescribing rates post-intervention compared with the pre-intervention phase will be analysed using segmented regression.
|
Three years
|
The proportion of symptomatic relief medication prescribed
Time Frame: Three years
|
The change in the proportion of symptomatic relief medication prescribed post-intervention compared with the pre-intervention phase will be analysed.
|
Three years
|
The change in general practitioners' (GPs) stage-of-change
Time Frame: 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.
|
Three years
|
The change in general practitioners' (GPs) behavioral intention to prescribe antibiotics
Time Frame: 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.
|
Three years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cecilia Stålsby Lundborg, Prof, Karolinska Institutet
Publications and helpful links
General Publications
- Saliba-Gustafsson EA, Nyberg A, Borg MA, Rosales-Klintz S, Stalsby Lundborg C. Barriers and facilitators to prudent antibiotic prescribing for acute respiratory tract infections: A qualitative study with general practitioners in Malta. PLoS One. 2021 Feb 11;16(2):e0246782. doi: 10.1371/journal.pone.0246782. eCollection 2021.
- Saliba-Gustafsson EA, Dunberger Hampton A, Zarb P, Orsini N, Borg MA, Stalsby Lundborg C. Factors associated with antibiotic prescribing in patients with acute respiratory tract complaints in Malta: a 1-year repeated cross-sectional surveillance study. BMJ Open. 2019 Dec 18;9(12):e032704. doi: 10.1136/bmjopen-2019-032704.
- Saliba-Gustafsson EA, Roing M, Borg MA, Rosales-Klintz S, Lundborg CS. General practitioners' perceptions of delayed antibiotic prescription for respiratory tract infections: A phenomenographic study. PLoS One. 2019 Nov 22;14(11):e0225506. doi: 10.1371/journal.pone.0225506. eCollection 2019.
- Saliba-Gustafsson EA, Borg MA, Rosales-Klintz S, Nyberg A, StalsbyLundborg C. Maltese Antibiotic Stewardship Programme in the Community (MASPIC): protocol of a prospective quasiexperimental social marketing intervention. BMJ Open. 2017 Sep 24;7(9):e017992. doi: 10.1136/bmjopen-2017-017992.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MASPIC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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