OASIS: Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT02874872
Collaborator
University of Pittsburgh (Other)
2,942
2
22.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: OASIS Collaborative
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2942 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Building a Novel Antibiotic Stewardship Intervention for Nursing Homes
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Jul 31, 2018
Actual Study Completion Date :
Jul 31, 2018

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Days of Antibiotic Therapy (DOT)/1000 resident days [up to 12 months]

      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.

    2. Proportion of Antibiotic Starts meeting Loeb Criteria [up to 12 months]

      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.

    Secondary Outcome Measures

    1. Incidence of antibiotic starts/1000 resident days [up to 12 months pre-implementation and up to 12 months post-implementation]

      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.

    2. Fluoroquinolone Days of Therapy (FQD)/1000 resident days [up to 12 months pre-implementation and up to 12 months post-implementation]

      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.

    3. Incidence of C.diff infection/1000 resident days [up to 12 months pre-implementation and up to 12 months post-implementation]

      Defined as the number of positive C. difficile tests per 1000 resident days

    4. Fluoroquinolone resistance [up to 12 months pre-implementation and up to 12 months post-implementation]

      Defined as the proportion of urine cultures that grow bacteria that are resistant to fluoroquinolone antibiotics.

    5. Positive Enterococcus species [up to 12 months pre-implementation and up to 12 months post-implementation]

      Defined as the proportion of urine cultures that grow Enterococcus species

    6. Positive Candida species [up to 12 months pre-implementation and up to 12 months post-implementation]

      Defined as the proportion of urine cultures that grow Candida species

    Other Outcome Measures

    1. Incidence of nursing home deaths/1000 resident days [up to 12 months pre-implementation and up to 12 months post-implementation]

      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.

    2. Incidence of unplanned transfers/1000 resident days [up to 12 months pre-implementation and up to 12 months post-implementation]

      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).

    3. Combined deaths and unplanned transfers/1000 resident days [up to 12 months pre-implementation and up to 12 months post-implementation]

      Defined as the sum of deaths and unplanned transfers, as defined above.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Wisconsin, Madison
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT02874872
    Other Study ID Numbers:
    • 2016-0274
    First Posted:
    Aug 22, 2016
    Last Update Posted:
    Oct 22, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University of Wisconsin, Madison

    Study Results

    No Results Posted as of Oct 22, 2018