Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential Aged Care Facilities

NCT03941509 | Unknown

• 1 other identifier: 591/18
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities. The intervention will be assessed in a stepped-wedge cluster randomised controlled trial across 14 residential aged care facilities over an 18-month period.

Conditions

Antimicrobial Stewardship; Urinary Tract Infections; Respiratory Tract Infections; Skin and Soft Tissue Infections

Outcome Measures

Primary Outcomes (2)

• Cumulative proportion of residents prescribed a systemic antimicrobial

  Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months

• Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)

  Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months

Secondary Outcomes (8)

• Number of courses of systemic antimicrobial therapy per 1,000 OBD.

  Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months

• Proportion of appropriate antimicrobial use.

  Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months

• Frequency of carriage of antimicrobial-resistant organisms

  Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).

• Rate of Clostridium Difficile infection

  Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months

• Change in facility-level antimicrobial susceptibility profile

  Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).

Study Arms (2)

Control

NO INTERVENTION

All facilities will receive usual care during the control phase of the trial.

Antimicrobial stewardship

EXPERIMENTAL

Implementation of the nurse-led bundled antimicrobial stewardship intervention

Behavioral: Antimicrobial stewardship

Interventions

Antimicrobial stewardship BEHAVIORAL

Education, guidelines, communication tools and audit and feedback

Antimicrobial stewardship

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents:
• All residents from 12 RACFs will have de-identified data collected including antimicrobial use, infection, hospitalisation and mortality.
• Residents or their guardians who provide informed consent to monthly biospecimen sampling and participation in one-on-one interviews or focus groups.
• Health professionals:
• \- Health professionals (including aged care staff and GPs) who provide informed consent to participate in one-on-one interviews or focus groups.

You may not qualify if:

• Residents or their guardians who do not consent to biospecimen sampling and/or participation in interviews/focus groups.
• Health professionals who do not consent to participate in interviews/focus groups.

Sponsors & Collaborators

• Bayside Health: lead
• Bupa Aged Care Australia: collaborator
• Monash University: collaborator

Study Sites (1)

Bupa residential aged care facilities

Melbourne, Victoria, Australia

RECRUITING

Related Publications (1)

• Jokanovic N, Haines T, Cheng AC, Holt KE, Hilmer SN, Jeon YH, Stewardson AJ, Stuart RL, Spelman T, Peel TN, Peleg AY; START Trial Group. Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial. BMJ Open. 2021 Mar 2;11(3):e046142. doi: 10.1136/bmjopen-2020-046142.

  PMID: 33653766 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Respiratory Tract Infections; Soft Tissue Infections

Interventions

Antimicrobial Stewardship

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Utilization Review; Drug Utilization; Pharmacy Administration; Organization and Administration; Health Services Administration; Utilization Review; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Anton Peleg, MBBS, PhD, FRACP, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natali Jokanovic, BPharm, PhD

CONTACT

+61 3 9903 0087; natali.jokanovic@monash.edu

Trisha Peel, MBBS, FRACP, PhD

CONTACT

+61 3 9076 2000; trisha.peel@monash.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Stepped-wedge design will see a staggered roll out of the intervention over 16 months. Each cluster of two facilities will commence in the control phase (2 months) and transition to the intervention phase until all facilities receive the intervention. A transition phase of 2 months between the control and intervention phase will occur to allow for education and integration of the intervention.

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: January 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 13, 2022

Record last verified: 2022-01

Locations

AU (1)