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| Name | Class |
|---|---|
| Bupa Aged Care Australia | UNKNOWN |
| Monash University | OTHER |
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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.
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:
Education
Guidelines
Communication
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:
Following the 16-month trial, the refined intervention bundle will be implemented nationally across a network of RACFs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antimicrobial stewardship | Behavioral | Education, guidelines, communication tools and audit and feedback |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Antimicrobials will be considered to be appropriate if minimum criteria for their initiation are met according to guidelines by the Society of Healthcare Epidemiology of America. |
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Inclusion Criteria:
Residents:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Anton Peleg, MBBS, PhD, FRACP, PhD | Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bupa residential aged care facilities | Recruiting | Melbourne | Victoria | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33653766 | Derived | 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. |
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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.
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| 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 | Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens. | 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 | Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens. | Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention). |
| Incidence of resident transfer to hospital for infectious indications | Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months |
| All-cause mortality | Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months |
| Perceptions from stakeholders on quality and uptake of the intervention | Semi-structured interviews conducted one-on-one or in moderated focus groups with stakeholders including aged care staff, GPs, residents and families. | Assessed at the conclusion of the trial at 16 months |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D012141 | Respiratory Tract Infections |
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000073602 | Antimicrobial Stewardship |
| ID | Term |
|---|---|
| D017723 | Drug Utilization Review |
| D004363 | Drug Utilization |
| D010605 | Pharmacy Administration |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D014600 | Utilization Review |
| D011787 | Quality of Health Care |
| D011785 | Quality Assurance, Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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