A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study)

Sponsor
The University of Queensland (Other)
Overall Status
Recruiting
CT.gov ID
NCT04705259
Collaborator
National Health and Medical Research Council, Australia (Other)
18
4
2
14.8
4.5
0.3

Study Details

Study Description

Brief Summary

The antimicrobial stewardship ENGAGEMENT study aims to deliver a bundle of interventions, including education of GPs and nursing staff, guideline implementation and telehealth support for 18 residential aged care facilities (RACFs) in Queensland Australia to help optimise antibiotic prescribing and reduce inappropriate use. The trial will involve 18 licenced RACFs with 50 or more residents and is set to commence in June 2021.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle
N/A

Detailed Description

INTRODUCTION Inappropriate antibiotic use can cause harm and promote antimicrobial resistance, which has been declared a major health challenge by the World Health Organisation. In Australian Residential Aged Care Facilities (RACFs), the most common indications for antibiotic prescribing are for suspected infections of the urinary tract, respiratory tract, and skin and soft tissue. Studies indicate that a high proportion of these prescriptions are noncompliant with best prescribing guidelines. To date a variety of interventions have been reported to address inappropriate prescribing and overuse of antibiotics but with mixed outcomes. The present study aims to identify the impact of a set of sustainable, multi-modal interventions in residential aged care targeting three common infection types, using a robust methodology.

METHODS AND ANALYSIS This study will be conducted using a stepped-wedge cluster randomised trial that will recruit 18 RACFs (each RACF will be considered as one cluster), over a 20 month observation period. Initially an antimicrobial stewardship needs assessment toolkit will be piloted in seven RACFs from different service providers. This will enable the refinement and targeted implementation of the intervention bundle, based on existing requirement of facilities. A multimodal multi-disciplinary set of interventions, the 'ENGAGEMENT bundle', will be tailored to the needs of facilities. This bundle will be implemented as part of the stepped wedge randomised control trial. The key elements of the intervention bundle include education for nurses and general practitioners, telehealth support and formation of an antimicrobial stewardship team. Prior to the sequential introduction of the intervention, each site will act as its own control, in relation to usual care processes for antibiotic use and stewardship.

The primary outcome for this study will be antibiotic consumption measured using defined daily doses (DDDs). Cluster-level rates will be calculated using total occupied bed numbers within each RACF during the post-randomisation observation period as the denominator. Results will be expressed as rates per 1000 occupied bed days. An economic analysis will be conducted to compare the costs associated with the intervention to that of usual care.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Stepped wedge randomised control studyStepped wedge randomised control study
Masking:
None (Open Label)
Masking Description:
Education intervention where the facilities will be made aware of best practice guidelines and protocols with respect to antibiotic prescribing
Primary Purpose:
Health Services Research
Official Title:
A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study): Protocol for a Stepped Wedge Cluster Randomised Trial
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Dec 24, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: ENGAGEMENT bundle

A multimodal bundle of interventions to optimise antibiotic prescribing in residential aged care facilities. The bundle includes education for nurses and general practitioners caring for residents, telehealth support and implementation of state-wide guidelines.

Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle
Given that a single intervention is unlikely to be effective in stewardship programs, nor in care improvement processes at RACFs [7], this trial will deliver a set of multimodal, multidisciplinary interventions to optimise antibiotic use in RACFs. This RACF AMS ENGAGEMENT bundle will comprise the following key interventions: Education and engagement of prescribers, nurses, pharmacists and residents and family members Nursing initiatives to improve UTI diagnosis and reduce inappropriate urine testing Guideline development specific to antibiotic use in RACF residents Antimicrobial stewardship team creation in RACF with GP involvement EMergency department liaison and use of clinical pathways to ensure consistency of practice across the care continuum ElectroNic decision support to guide RACF urine testing and GP antibiotic prescribing Telehealth support for key intervention components

Placebo Comparator: Usual care

Usual facility practices with regards to antibiotic prescribing and review

Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle
Given that a single intervention is unlikely to be effective in stewardship programs, nor in care improvement processes at RACFs [7], this trial will deliver a set of multimodal, multidisciplinary interventions to optimise antibiotic use in RACFs. This RACF AMS ENGAGEMENT bundle will comprise the following key interventions: Education and engagement of prescribers, nurses, pharmacists and residents and family members Nursing initiatives to improve UTI diagnosis and reduce inappropriate urine testing Guideline development specific to antibiotic use in RACF residents Antimicrobial stewardship team creation in RACF with GP involvement EMergency department liaison and use of clinical pathways to ensure consistency of practice across the care continuum ElectroNic decision support to guide RACF urine testing and GP antibiotic prescribing Telehealth support for key intervention components

Outcome Measures

Primary Outcome Measures

  1. Defined Daily Doses (DDDs) of Antibiotics [18 months]

    The primary outcome measure for this trial is antibiotic use as measured by DDDs of antibiotics per 1000 resident bed days.

Secondary Outcome Measures

  1. Urine Samples [18 months]

    Number of urine samples collected per 1000 resident bed days between the control vs intervention periods

  2. Susceptibility of pathogens [18 months]

    Percent susceptibility of Enterobacteriaceae to ceftriaxone, ciprofloxacin, cephalexin and amoxicillin-clavulanate measured using antibiograms

  3. All cause on-year mortality [18 months]

    All-cause on-year mortality rates of residential aged care facility (RACF) residents between the control vs intervention periods (per 1000 resident bed days and median rate across facilities)

  4. Hospital admissions [18 months]

    Number of RACF residents admitted to hospital during the control vs intervention periods (per 1000 resident bed days and median rate across facilities)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Eligibility is at the Residential Aged Care Facility (RACF) level. If the facility is eligible to participate de-identified data from all facility residents will be included for the duration of the the study.

Inclusion Criteria:
  • All residents of RACFs with at least 50 residents

  • RACFs located in South East Queensland, Australia

Exclusion Criteria:
  • RACFs with less than 50 residents;

  • RACFs unable to provide reports for baseline data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bethany Christian Care Eight Mile Plains Queensland Australia 4113
2 Carinity Aged Care Mitchelton Queensland Australia 4053
3 Beaumont Care Rothwell Queensland Australia 4022
4 Vacenti Aged Care Upper Mount Gravatt Queensland Australia 4122

Sponsors and Collaborators

  • The University of Queensland
  • National Health and Medical Research Council, Australia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Queensland
ClinicalTrials.gov Identifier:
NCT04705259
Other Study ID Numbers:
  • 2020002193
First Posted:
Jan 12, 2021
Last Update Posted:
Oct 14, 2021
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The University of Queensland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021