Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

Study Overview
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Brief Summary
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The OASIS Collaborative is an organizational intervention aimed at reducing unnecessary antibiotic use in skilled nursing facilities. The first target of intervention is the tasks carried out by nursing staff after a change in condition and after an antibiotic prescription is initiated. The second target are the management staff who provide feedback to staff. The third target are the administrators who identify and overcome organizational barriers to implementation. In this study, we will implement two tools that are intended to minimize unnecessary antibiotic use in skilled nursing facilities. The first tool helps skilled nursing facility staff assess risk and communicate with prescribers when residents experience a change in health status that may result in the use of antibiotics. The second tool is used after an antibiotic is prescribed; the tool streamlines reassessment of the patient, and provides prescribers the opportunity to consider stopping unnecessary antibiotic prescriptions, narrowing the spectrum of antibiotic therapy, or shortening the duration of antibiotic therapy.

Official Title
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Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

Conditions
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Antibiotics

Intervention / Treatment
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* Behavioral: OASIS Collaborative


Participation Criteria
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Eligibility Criteria
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This is an organizational intervention. Outcomes will be evaluated at the population-level by facility. Nursing home residents: Inclusion Criteria: Any nursing home resident who has received antibiotic therapy in any of the 12 participating nursing home facilities. Exclusion Criteria: Nursing home residents who have not received antibiotic therapy in any of the 12 participating nursing home facilities.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OASIS Collaborative<br>The nursing homes in this arm will receive facilitated implementation of two tools aimed at minimizing unnecessary antibiotic use. Facilitated implementation includes coaching of the nursing home staff on use of the tools. In addition, nursing home management will be coached on how to monitor implementation fidelity, antibiotic utilization, and consequences to over- and under-utilization of antibiotics as feedback on the effectiveness of the intervention. Finally, nursing home management will receive coaching on how to develop and implement a sustain plan for the OASIS intervention. | Behavioral: OASIS Collaborative<br>* OASIS (Optimizing Antibiotic Stewardship in Skilled Nursing Facilities) is a system redesign of skilled nursing facility work systems<br>* Other names: OASIS;|
| No Intervention: Control<br>The nursing homes in this arm will continue care as usual, with no tools or facilitated implementation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of Antibiotic Therapy (DOT)/1000 resident days | Utilization of antibiotics initiated in the nursing home, defined as the number of days a nursing home resident receives antibiotic therapy. This measure includes antibiotic courses initiated 1) in the nursing home or 2) Emergency Department, if the resident returned to the nursing home without intercurrent hospitalization. This measure excludes antibiotic courses started during a hospital stay and continued in the nursing home after discharge. | up to 12 months | 
| Proportion of Antibiotic Starts meeting Loeb Criteria | Defined as the proportion of antibiotic courses started in the nursing home or Emergency department that satisfy the Loeb minimum criteria for initiation of antibiotics. This measure includes antibiotic courses initiated 1) in the nursing home or 2) Emergency Department, if the resident returned to the nursing home without intercurrent hospitalization. This measure excludes antibiotic courses started during a hospital stay and continued in the nursing home after discharge. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of antibiotic starts/1000 resident days | Defined as the number of antibiotic courses started per 1000 resident days. This measure includes antibiotic courses initiated 1) in the nursing home or 2) Emergency Department, if the resident returned to the nursing home without intercurrent hospitalization. This measure excludes antibiotic courses started during a hospital stay and continued in the nursing home after discharge. | up to 12 months pre-implementation and up to 12 months post-implementation | 
| Fluoroquinolone Days of Therapy (FQD)/1000 resident days | Defined as the number of days a nursing home resident receives fluoroquinolone therapy. This measure includes antibiotic courses initiated 1) in the nursing home or 2) Emergency Department, if the resident returned to the nursing home without intercurrent hospitalization. This measure excludes antibiotic courses started during a hospital stay and continued in the nursing home after discharge. | up to 12 months pre-implementation and up to 12 months post-implementation | 
| Incidence of C.diff infection/1000 resident days | Defined as the number of positive C. difficile tests per 1000 resident days | up to 12 months pre-implementation and up to 12 months post-implementation | 
| Fluoroquinolone resistance | Defined as the proportion of urine cultures that grow bacteria that are resistant to fluoroquinolone antibiotics. | up to 12 months pre-implementation and up to 12 months post-implementation | 
| Positive Enterococcus species | Defined as the proportion of urine cultures that grow Enterococcus species | up to 12 months pre-implementation and up to 12 months post-implementation | 
| Positive Candida species | Defined as the proportion of urine cultures that grow Candida species | up to 12 months pre-implementation and up to 12 months post-implementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic Stewardship, Nursing homes, Antibiotic Resistance