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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03941509




Registration number
NCT03941509
Ethics application status
Date submitted
6/05/2019
Date registered
8/05/2019
Date last updated
13/01/2022

Titles & IDs
Public title
Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential Aged Care Facilities
Scientific title
Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.
Secondary ID [1] 0 0
591/18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antimicrobial Stewardship 0 0
Urinary Tract Infections 0 0
Respiratory Tract Infections 0 0
Skin and Soft Tissue Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Antimicrobial stewardship

No intervention: Control - All facilities will receive usual care during the control phase of the trial.

Experimental: Antimicrobial stewardship - Implementation of the nurse-led bundled antimicrobial stewardship intervention


BEHAVIORAL: Antimicrobial stewardship
Education, guidelines, communication tools and audit and feedback
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative proportion of residents prescribed a systemic antimicrobial
Timepoint [1] 0 0
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Primary outcome [2] 0 0
Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
Timepoint [2] 0 0
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary outcome [1] 0 0
Number of courses of systemic antimicrobial therapy per 1,000 OBD.
Timepoint [1] 0 0
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary outcome [2] 0 0
Proportion of appropriate antimicrobial use.
Timepoint [2] 0 0
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary outcome [3] 0 0
Frequency of carriage of antimicrobial-resistant organisms
Timepoint [3] 0 0
Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
Secondary outcome [4] 0 0
Rate of Clostridium Difficile infection
Timepoint [4] 0 0
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary outcome [5] 0 0
Change in facility-level antimicrobial susceptibility profile
Timepoint [5] 0 0
Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
Secondary outcome [6] 0 0
Incidence of resident transfer to hospital for infectious indications
Timepoint [6] 0 0
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary outcome [7] 0 0
All-cause mortality
Timepoint [7] 0 0
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary outcome [8] 0 0
Perceptions from stakeholders on quality and uptake of the intervention
Timepoint [8] 0 0
Assessed at the conclusion of the trial at 16 months

Eligibility
Key inclusion criteria
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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2022
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Bupa residential aged care facilities - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Bupa Aged Care Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03941509
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Anton Peleg, MBBS, PhD, FRACP, PhD
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Natali Jokanovic, BPharm, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 0087
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03941509