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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03218930
First Posted: July 17, 2017
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Malta
Information provided by (Responsible Party):
Erika Saliba Gustafsson, Karolinska Institutet
  Purpose

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.


Condition Intervention
Acute Respiratory Infection Behavioral: Delayed antibiotic prescription Behavioral: Antibiotic prescribing guidelines Behavioral: Education Behavioral: Educational materials

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Maltese Antibiotic Stewardship Programme in the Community (MASPIC): a Prospective Quasi-experimental Social Marketing Intervention

Resource links provided by NLM:


Further study details as provided by Erika Saliba Gustafsson, Karolinska Institutet:

Primary Outcome Measures:
  • 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.


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 [ 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.

  • 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.

  • 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.

  • 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.


Enrollment: 33
Actual Study Start Date: August 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Social marketing intervention
Participants will receive a total combination of four interventions.
Behavioral: Delayed antibiotic prescription
Delayed antibiotic prescription pads will be disseminated to all participating general practitioners in both hard and soft copies.
Behavioral: Antibiotic prescribing guidelines
Antibiotic prescribing guidelines will be disseminated to all participating general practitioners in both hard and soft copies.
Behavioral: Education
General practitioners will receive a package of educational sessions tailored towards their specific needs.
Behavioral: Educational materials
Educational materials for patients, namely posters and leaflets, will be disseminated to all participating general practitioners.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218930


Sponsors and Collaborators
Karolinska Institutet
University of Malta
Investigators
Principal Investigator: Cecilia Stålsby Lundborg, Prof Karolinska Institutet
  More Information

Responsible Party: Erika Saliba Gustafsson, Doctoral student, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03218930     History of Changes
Other Study ID Numbers: MASPIC
First Submitted: July 10, 2017
First Posted: July 17, 2017
Last Update Posted: July 17, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erika Saliba Gustafsson, Karolinska Institutet:
General Practice
Social Marketing
Behavior Change
Antibiotic Prescribing

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents