NCT04705259

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2022

Completed
Last Updated

October 14, 2021

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

December 3, 2020

Last Update Submit

October 5, 2021

Conditions

Antimicrobial StewardshipAntibiotics Causing Adverse Effects in Therapeutic Use

Keywords

Antimicrobial stewardshipAntibiotic prescribingAged care

Outcome Measures

Primary Outcomes (1)

  • Defined Daily Doses (DDDs) of Antibiotics

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

    18 months

Secondary Outcomes (4)

  • Urine Samples

    18 months

  • Susceptibility of pathogens

    18 months

  • All cause on-year mortality

    18 months

  • Hospital admissions

    18 months

Study Arms (2)

ENGAGEMENT bundle

ACTIVE COMPARATOR

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

Usual care

PLACEBO COMPARATOR

Usual facility practices with regards to antibiotic prescribing and review

Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle

Interventions

Antimicrobial Stewardship ENGAGEMENT bundleBEHAVIORAL

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

ENGAGEMENT bundleUsual care

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All residents of RACFs with at least 50 residents
  • RACFs located in South East Queensland, Australia

You may not qualify if:

  • RACFs with less than 50 residents;
  • RACFs unable to provide reports for baseline data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bethany Christian Care

Eight Mile Plains, Queensland, 4113, Australia

RECRUITING

Carinity Aged Care

Mitchelton, Queensland, 4053, Australia

RECRUITING

Beaumont Care

Rothwell, Queensland, 4022, Australia

RECRUITING

Vacenti Aged Care

Upper Mount Gravatt, Queensland, 4122, Australia

RECRUITING

Related Publications (1)

  • Falconer N, Paterson DL, Peel N, Welch A, Freeman C, Burkett E, Hubbard R, Comans T, Hanjani LS, Pascoe E, Hawley C, Gray L. A multimodal intervention to optimise antimicrobial use in residential aged care facilities (ENGAGEMENT): protocol for a stepped-wedge cluster randomised trial. Trials. 2022 May 21;23(1):427. doi: 10.1186/s13063-022-06323-8.

    PMID: 35597993DERIVED

Central Study Contacts

Alyssa Welch

CONTACT

+61438629310ams.engagementstudy@uq.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Education intervention where the facilities will be made aware of best practice guidelines and protocols with respect to antibiotic prescribing
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Stepped wedge randomised control study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

January 12, 2021

Study Start

October 1, 2021

Primary Completion

May 30, 2022

Study Completion

December 24, 2022

Last Updated

October 14, 2021

Record last verified: 2020-11

Locations

AU(4)