Clinical trial NCT03941509: Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential Aged Care Facilities
Official title: Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antimicrobial Stewardship
Urinary Tract Infections
Respiratory Tract Infections
Skin and Soft Tissue Infections
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Bupa Aged Care Australia
name: Monash University
First posted: 2019-05-08
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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 (RACFs).

The antimicrobial stewardship intervention will include the following components:

1. Education

   * Focused on antimicrobial stewardship and appropriate antimicrobial use
   * Delivered face-to-face, via workbooks and fact sheets to aged care staff, general practitioners (GPs), pharmacists, and residents and families. Education will be delivered by the research coordinator.
2. Guidelines

   * Aged care-specific guidelines for the assessment and antimicrobial management of urinary tract infections, respiratory tract infections and skin and soft tissue infections.
   * Antimicrobial management recommendations including empirical oral therapy, doses and duration of therapy.
3. Communication

   * Documentation for the assessment and antimicrobial management of infections.
   * Nurse-led engagement with residents and families.
   * Newsletters and online updates to highlight evidence-based prescribing practice
4. Audit and feedback - Surveillance and feedback to prescribers on antimicrobial use and facility-level antimicrobial susceptibility data.

The intervention bundle will first be implemented and tested for feasibility and acceptability over a 3-month period in two RACFs in Victoria, Australia. This tailored intervention will then be assessed in a stepped-wedge cluster randomised controlled trial across 12 RACFs over an 16-month period.

A cluster of two facilities will each transition through three phases over the 16 month trial:

* Control phase: baseline data collection. Usual care at each facility.
* Transition phase: Delivery of education and integration of the intervention. No data collection.
* Intervention phase: implementation of the intervention and outcome data collection. Ongoing education to new and existing staff will be provided as required.

Following the 16-month trial, the refined intervention bundle will be implemented nationally across a network of RACFs.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Cumulative proportion of residents prescribed a systemic antimicrobial
timeFrame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
measure: Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
timeFrame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary outcomes:
measure: Number of courses of systemic antimicrobial therapy per 1,000 OBD.
timeFrame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
measure: Proportion of appropriate antimicrobial use.
timeFrame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
measure: Frequency of carriage of antimicrobial-resistant organisms
timeFrame: Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
measure: Rate of Clostridium Difficile infection
timeFrame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
measure: Change in facility-level antimicrobial susceptibility profile
timeFrame: Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
measure: Incidence of resident transfer to hospital for infectious indications
timeFrame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
measure: All-cause mortality
timeFrame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
measure: Perceptions from stakeholders on quality and uptake of the intervention
timeFrame: Assessed at the conclusion of the trial at 16 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Bupa residential aged care facilities
state: Victoria
Study officials:
affiliation: Monash University
name: Anton Peleg, MBBS, PhD, FRACP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.