Building a Novel Antibiotic Stewardship Intervention for Nursing Homes

NCT ID: NCT02874872

Last Updated: 2018-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2942 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antibiotics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

OASIS Collaborative

Intervention Type BEHAVIORAL

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OASIS Collaborative

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OASIS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pittsburgh

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher J Crnich, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin-Madison, School of Medicine and Public Health

James H Ford II, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin-Madison, College of Engineering

David A Nace, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-0274

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Reducing Overuse of Antibiotics at Discharge Home
NCT06106204 ENROLLING_BY_INVITATION NA