Building a Novel Antibiotic Stewardship Intervention for Nursing Homes (OASIS)

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.

Study Overview

• Status: Completed
• Conditions: Antibiotics
• Intervention / Treatment: Behavioral: OASIS Collaborative

• Study Type: Interventional
• Enrollment (Actual): 2942
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OASIS Collaborative; 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; OASIS (Optimizing Antibiotic Stewardship in Skilled Nursing Facilities) is a system redesign of skilled nursing facility work systems; Other Names: OASIS
NO_INTERVENTION: Control; The nursing homes in this arm will continue care as usual, with no tools or facilitated implementation.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: University of Pittsburgh
• Investigators: Principal Investigator: Christopher J Crnich, MD, PhD, University of Wisconsin-Madison, School of Medicine and Public Health; Principal Investigator: James H Ford II, PhD, University of Wisconsin-Madison, College of Engineering; Principal Investigator: David A Nace, MD, MPH, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ACTUAL): July 31, 2018
• Study Completion (ACTUAL): July 31, 2018

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (ESTIMATE): August 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Nursing homes; Antibiotic Stewardship; Antibiotic Resistance
• Other Study ID Numbers: 2016-0274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO