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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03218930
Collaborator
University of Malta (Other)
33
1
45

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Delayed antibiotic prescription
  • Behavioral: Antibiotic prescribing guidelines
  • Behavioral: Education
  • Behavioral: Educational materials
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
N/A
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
Actual Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. The antibiotic prescribing rate for patients with acute respiratory tract complaints. [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

  1. 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 change in diagnosis-specific antibiotic prescribing rates post-intervention compared with the pre-intervention phase will be analysed using segmented regression.

  2. The proportion of symptomatic relief medication prescribed [Three years]

    The change in the proportion of symptomatic relief medication prescribed post-intervention compared with the pre-intervention phase will be analysed.

  3. The change in general practitioners' (GPs) stage-of-change [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.

  4. The change in general practitioners' (GPs) behavioral intention to prescribe antibiotics [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • Karolinska Institutet
  • University of Malta

Investigators

  • Principal Investigator: Cecilia StĂ„lsby Lundborg, Prof, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erika Saliba Gustafsson, Doctoral student, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT03218930
Other Study ID Numbers:
  • MASPIC
First Posted:
Jul 17, 2017
Last Update Posted:
Aug 8, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erika Saliba Gustafsson, Doctoral student, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2018