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OpenTrials
Completed

NCT Number: NCT02874872

Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

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.

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Key information

Conditions

Antibiotics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OASIS Collaborative

Behavioral

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

Other names: OASIS

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • University of Pittsburgh

Registry information

Acronym: OASIS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2016
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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