Clinical trial NCT02874872: Building a Novel Antibiotic Stewardship Intervention for Nursing Homes
Official title: Building a Novel Antibiotic Stewardship Intervention for Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotics
Keywords: Nursing homes
Antibiotic Stewardship
Antibiotic Resistance
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2016-08-22
Enrollment: 2942
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Days of Antibiotic Therapy (DOT)/1000 resident days
timeFrame: up to 12 months
measure: Proportion of Antibiotic Starts meeting Loeb Criteria
timeFrame: up to 12 months
Secondary outcomes:
measure: Incidence of antibiotic starts/1000 resident days
timeFrame: up to 12 months pre-implementation and up to 12 months post-implementation
measure: Fluoroquinolone Days of Therapy (FQD)/1000 resident days
timeFrame: up to 12 months pre-implementation and up to 12 months post-implementation
measure: Incidence of C.diff infection/1000 resident days
timeFrame: up to 12 months pre-implementation and up to 12 months post-implementation
measure: Fluoroquinolone resistance
timeFrame: up to 12 months pre-implementation and up to 12 months post-implementation
measure: Positive Enterococcus species
timeFrame: up to 12 months pre-implementation and up to 12 months post-implementation
measure: Positive Candida species
timeFrame: up to 12 months pre-implementation and up to 12 months post-implementation
Other outcomes:
measure: Incidence of nursing home deaths/1000 resident days
timeFrame: up to 12 months pre-implementation and up to 12 months post-implementation
measure: Incidence of unplanned transfers/1000 resident days
timeFrame: up to 12 months pre-implementation and up to 12 months post-implementation
measure: Combined deaths and unplanned transfers/1000 resident days
timeFrame: up to 12 months pre-implementation and up to 12 months post-implementation
Locations:
Study officials:
affiliation: University of Wisconsin-Madison, School of Medicine and Public Health
name: Christopher J Crnich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin-Madison, College of Engineering
name: James H Ford II, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: David A Nace, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: