Maltese Antibiotic Stewardship Programme in the Community (MASPIC): Antibiotic Prescribing for Acute Respiratory Tract Complaints
Primary Purpose
Acute Respiratory Infection
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delayed antibiotic prescription
Antibiotic prescribing guidelines
Education
Educational materials
Sponsored by
About this trial
This is an interventional other trial for Acute Respiratory Infection focused on measuring General Practice, Social Marketing, Behavior Change, Antibiotic Prescribing
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Social marketing intervention
Arm Description
Participants will receive a total combination of four interventions.
Outcomes
Primary Outcome Measures
The antibiotic prescribing rate for patients with acute respiratory tract complaints.
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
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
The 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 prescribed
The 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-change
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
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.
Full Information
NCT ID
NCT03218930
First Posted
July 10, 2017
Last Updated
August 7, 2018
Sponsor
Karolinska Institutet
Collaborators
University of Malta
1. Study Identification
Unique Protocol Identification Number
NCT03218930
Brief Title
Maltese Antibiotic Stewardship Programme in the Community (MASPIC): Antibiotic Prescribing for Acute Respiratory Tract Complaints
Official Title
Maltese Antibiotic Stewardship Programme in the Community (MASPIC): a Prospective Quasi-experimental Social Marketing Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
University of Malta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection
Keywords
General Practice, Social Marketing, Behavior Change, Antibiotic Prescribing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social marketing intervention
Arm Type
Other
Arm Description
Participants will receive a total combination of four interventions.
Intervention Type
Behavioral
Intervention Name(s)
Delayed antibiotic prescription
Intervention Description
Delayed antibiotic prescription pads will be disseminated to all participating general practitioners in both hard and soft copies.
Intervention Type
Behavioral
Intervention Name(s)
Antibiotic prescribing guidelines
Intervention Description
Antibiotic prescribing guidelines will be disseminated to all participating general practitioners in both hard and soft copies.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
General practitioners will receive a package of educational sessions tailored towards their specific needs.
Intervention Type
Behavioral
Intervention Name(s)
Educational materials
Intervention Description
Educational materials for patients, namely posters and leaflets, will be disseminated to all participating general practitioners.
Primary Outcome Measure Information:
Title
The antibiotic prescribing rate for patients with acute respiratory tract complaints.
Description
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.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
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
Description
The change in diagnosis-specific antibiotic prescribing rates post-intervention compared with the pre-intervention phase will be analysed using segmented regression.
Time Frame
Three years
Title
The proportion of symptomatic relief medication prescribed
Description
The change in the proportion of symptomatic relief medication prescribed post-intervention compared with the pre-intervention phase will be analysed.
Time Frame
Three years
Title
The change in general practitioners' (GPs) stage-of-change
Description
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.
Time Frame
Three years
Title
The change in general practitioners' (GPs) behavioral intention to prescribe antibiotics
Description
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.
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Stålsby Lundborg, Prof
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33571265
Citation
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.
Results Reference
derived
PubMed Identifier
31857311
Citation
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.
Results Reference
derived
PubMed Identifier
31756197
Citation
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.
Results Reference
derived
PubMed Identifier
28947463
Citation
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.
Results Reference
derived
Learn more about this trial
Maltese Antibiotic Stewardship Programme in the Community (MASPIC): Antibiotic Prescribing for Acute Respiratory Tract Complaints
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