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Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02874872
Acronym
OASIS
Enrollment
2942
Registered
2016-08-22
Start date
2016-09-30
Completion date
2018-07-31
Last updated
2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotics

Keywords

Nursing homes, Antibiotic Stewardship, Antibiotic Resistance

Brief summary

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.

Interventions

BEHAVIORALOASIS Collaborative

OASIS (Optimizing Antibiotic Stewardship in Skilled Nursing Facilities) is a system redesign of skilled nursing facility work systems

Sponsors

University of Pittsburgh
CollaboratorOTHER
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Days of Antibiotic Therapy (DOT)/1000 resident daysup to 12 monthsUtilization 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.
Proportion of Antibiotic Starts meeting Loeb Criteriaup to 12 monthsDefined 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.

Secondary

MeasureTime frameDescription
Positive Candida speciesup to 12 months pre-implementation and up to 12 months post-implementationDefined as the proportion of urine cultures that grow Candida species
Incidence of C.diff infection/1000 resident daysup to 12 months pre-implementation and up to 12 months post-implementationDefined as the number of positive C. difficile tests per 1000 resident days
Fluoroquinolone resistanceup to 12 months pre-implementation and up to 12 months post-implementationDefined as the proportion of urine cultures that grow bacteria that are resistant to fluoroquinolone antibiotics.
Positive Enterococcus speciesup to 12 months pre-implementation and up to 12 months post-implementationDefined as the proportion of urine cultures that grow Enterococcus species
Incidence of antibiotic starts/1000 resident daysup to 12 months pre-implementation and up to 12 months post-implementationDefined 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.
Fluoroquinolone Days of Therapy (FQD)/1000 resident daysup to 12 months pre-implementation and up to 12 months post-implementationDefined 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.

Other

MeasureTime frameDescription
Incidence of unplanned transfers/1000 resident daysup to 12 months pre-implementation and up to 12 months post-implementationIncludes unplanned transfers to 1) the hospital or 2) the emergency room that do not result in hospitalization. This measure excludes planned transfers (e.g., physician clinic visits) or hospitalizations (e.g., for a planned surgical procedure or other therapy).
Combined deaths and unplanned transfers/1000 resident daysup to 12 months pre-implementation and up to 12 months post-implementationDefined as the sum of deaths and unplanned transfers, as defined above.
Incidence of nursing home deaths/1000 resident daysup to 12 months pre-implementation and up to 12 months post-implementationIncludes deaths that occur in 1) the nursing home or 2) the hospital if a resident's bed is kept on hold at the nursing home.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026