Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

NCT02874872 | Completed DMC

• 1 other identifier: 2016-0274
• Study Type: interventional
• Target: 2,942
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Antibiotics

Keywords

Nursing homes; Antibiotic Stewardship; Antibiotic Resistance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Incidence of antibiotic starts/1000 resident days

  up to 12 months pre-implementation and up to 12 months post-implementation

• Fluoroquinolone Days of Therapy (FQD)/1000 resident days

  up to 12 months pre-implementation and up to 12 months post-implementation

• Incidence of C.diff infection/1000 resident days

  up to 12 months pre-implementation and up to 12 months post-implementation

• Fluoroquinolone resistance

  up to 12 months pre-implementation and up to 12 months post-implementation

• Positive Enterococcus species

  up to 12 months pre-implementation and up to 12 months post-implementation

Other Outcomes (3)

• Incidence of nursing home deaths/1000 resident days

  up to 12 months pre-implementation and up to 12 months post-implementation

• Incidence of unplanned transfers/1000 resident days

  up to 12 months pre-implementation and up to 12 months post-implementation

• Combined deaths and unplanned transfers/1000 resident days

  up to 12 months pre-implementation and up to 12 months post-implementation

Study Arms (2)

OASIS Collaborative

EXPERIMENTAL

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

Control

NO INTERVENTION

The nursing homes in this arm will continue care as usual, with no tools or facilitated implementation.

Interventions

OASIS Collaborative BEHAVIORAL

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

Also known as: OASIS

OASIS Collaborative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any nursing home resident who has received antibiotic therapy in any of the 12 participating nursing home facilities.

You may not qualify if:

• Nursing home residents who have not received antibiotic therapy in any of the 12 participating nursing home facilities.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• University of Pittsburgh: collaborator

MeSH Terms

Interventions

poly(divinyl-co-N-vinylpyrrolidinone)

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 22, 2016
• Study Start: September 1, 2016
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share