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

NCT03218930 | Completed

• 1 other identifier: MASPIC
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Infection

Keywords

General Practice; Social Marketing; Behavior Change; Antibiotic Prescribing

Outcome Measures

Primary Outcomes (1)

• 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.

  Three years

Secondary Outcomes (4)

• 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

  Three years

• The proportion of symptomatic relief medication prescribed

  Three years

• The change in general practitioners' (GPs) stage-of-change

  Three years

• The change in general practitioners' (GPs) behavioral intention to prescribe antibiotics

  Three years

Study Arms (1)

Social marketing intervention

OTHER

Participants will receive a total combination of four interventions.

Behavioral: Delayed antibiotic prescription; Behavioral: Antibiotic prescribing guidelines; Behavioral: Education; Behavioral: Educational materials

Interventions

Delayed antibiotic prescription BEHAVIORAL

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

Social marketing intervention

Antibiotic prescribing guidelines BEHAVIORAL

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

Social marketing intervention

Education BEHAVIORAL

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

Social marketing intervention

Educational materials BEHAVIORAL

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

Social marketing intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• General practitioners who are no longer actively working

Sponsors & Collaborators

• Karolinska Institutet: lead
• University of Malta: collaborator

Related Publications (4)

• 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.

  PMID: 33571265 DERIVED

• 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.

  PMID: 31857311 DERIVED

• 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.

  PMID: 31756197 DERIVED

• 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.

  PMID: 28947463 DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Cecilia Stålsby Lundborg, Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 17, 2017
• Study Start: August 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08