Optimal Implementation of Antimicrobial Stewardship in General Practice

NCT06953804 | Not Yet Recruiting

• 3 other identifiers: 2024/337MRFF project 2029531U1111-1319-2201
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial aims to increase the use of antimicrobial stewardship resources when treating patients with respiratory tract infections. This trial is set in Australian general practices (family medicine or primary care). The main question it aims to answer is which type of implementation activities increase the use of antimicrobial stewardship resources. Researchers will compare doctors who receive face-to-face implementation activities (the Integrated Network group) to those who received virtual or online activities (the Virtual Network group). The primary hypothesis is that there will be a difference in how often interventions are used Participating doctors will be asked to record how often they use antimicrobial stewardship resources and which interventions they prefer. Participating practices will also provide researchers data on how many patients the doctors see. Patients with respiratory tract infections who saw a participating doctor will be asked to give feedback on their experience using surveys. A subgroup of doctors, practice staff, and patients will interviewed about their experience in the study.

Conditions

The Use of Antimicrobial Stewardship in in General Practice (Family Medicine); Respiratory Tract Infections (RTI)

Keywords

hybrid type 3 implementation trial; cluster randomised control trial; antimicrobial stewardship; antibiotic stewardship; respiratory tract infections; general practice; family medicine; primary care; Australia

Outcome Measures

Primary Outcomes (1)

• Change in use of antimicrobial interventions per 100 consults

  This score is derived from the number of times an intervention is used (measured using the AMS Toolbox online form) divided by the number of participants a doctor sees (measured using an audit). Measuring periods are fortnightly. The eligible range is 0-100, with higher values indicating a better outcome.

  From baseline for 5 months, from post intervention for 5 months

Secondary Outcomes (17)

• Reach: Number enrolled - Doctors

  Enrolment

• Reach: Representativeness of practices

  Baseline

• Reach: Completions - Doctors

  5 months post intervention

• Reach: Representativeness of participating doctors and staff

  Baseline.

• Reach: Representativeness of patients

  From baseline up to 5 months, from post intervention up 5 months

Study Arms (2)

Virtual network activities

EXPERIMENTAL

Participants randomised to the Virtual arm will receive online self-paced education modules regarding antimicrobial interventions, guided self-audit and reflection regarding intervention use, and reinforcement podcasts (\~7 hours).

Other: Antimicrobial stewardship activities delivered through Virtual Network

Integrated network activities

EXPERIMENTAL

Participants randomised to the Integrated Network arm will receive antimicrobial intervention education delivered by live interactive online webinar-based sessions, peer-group audit and reflection, and reinforcement online forum participation.

Other: Antimicrobial stewardship activities delivered through Integrated Network activities

Interventions

Antimicrobial stewardship activities delivered through Virtual Network OTHER

Participants will receive online self-paced education modules regarding antimicrobial interventions, guided self-audit and reflection regarding intervention use, and reinforcement podcasts (\~7 hours). Participants in the Virtual Newtwork arm will primarily receive these interventions online.

Virtual network activities

Antimicrobial stewardship activities delivered through Integrated Network activities OTHER

Participants will receive online self-paced education modules regarding antimicrobial interventions, guided self-audit and reflection regarding intervention use, and reinforcement podcasts (\~7 hours). Participants in the Integrated Network arm will primarily receive these interventions face-to-face and active online activities.

Integrated network activities

Eligibility Criteria

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

You may qualify if:

• New South Wales, Queensland, Tasmania, or Victoria
• at least two GPs per practice consent to be in the study,
• that at least one member of practice staff consents to be in the study

You may not qualify if:

• Participating doctors and healthcare workers
• Patients completing patient reported outcome measure survey
• patients consulted with a participating GP for a RTI,
• Patient reported experience measures survey
• Patients participating in interviews as part of the nested case studies
• consulted with a participating GP for a RTI,
• completed a patient survey,

Sponsors & Collaborators

• University of Wollongong: lead

Related Links

• Study website
• FDA approval of FebriDx for use in the USA

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Andrew Bonney, PhD,

  Graduate School of Medicine, University of Wollongong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin H Cortie, PhD

CONTACT

+67 02 4221 5610; optimas-gp@uow.edu.au

Andrew Bonney, PhD

CONTACT

andrew_bonney@uow.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General Practice

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 1, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: For IPD, data will be available from December 2029. For supporting information, the protocol paper and statistical analysis plan will be submitted for publication by November 2025. Informed consent form is attached. Analytical code will be provided with the primary outcomes publication. IPD and supporting data will be available at least until December 2039.
• Access Criteria: IPD: Supporting evidence: the protocol will be published in a peer-reviewed journal. Informed consent forms are available on request from the primary investigator or from the study website (). Analytical code will be provided with the primary outcomes publication