Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

Antibiotics Clinical Trial

— OASIS  

Official title:

Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874872
• Other study ID #: 2016-0274
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: October 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2942
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotics

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	University of Pittsburgh

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of nursing home deaths/1000 resident days	Includes 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.	up to 12 months pre-implementation and up to 12 months post-implementation
Other	Incidence of unplanned transfers/1000 resident days	Includes 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).	up to 12 months pre-implementation and up to 12 months post-implementation
Other	Combined deaths and unplanned transfers/1000 resident days	Defined as the sum of deaths and unplanned transfers, as defined above.	up to 12 months pre-implementation and up to 12 months post-implementation
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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