Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02874872
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
University of Wisconsin, Madison

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
Antibiotics Behavioral: OASIS Collaborative Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 2016
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


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 Name: OASIS

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



Primary Outcome Measures :
  1. Days of Antibiotic Therapy (DOT)/1000 resident days [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874872


Sponsors and Collaborators
University of Wisconsin, Madison
University of Pittsburgh
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02874872     History of Changes
Other Study ID Numbers: 2016-0274
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Wisconsin, Madison:
Nursing homes
Antibiotic Stewardship
Antibiotic Resistance
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents