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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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 10, 2017
    Last Updated
    August 7, 2018
    Sponsor
    Karolinska Institutet
    Collaborators
    University of Malta
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    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

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

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