AntibioticsOASISNCT02874872
Building a Novel Antibiotic Stewardship Intervention for Nursing Homes
A study testing OASIS Collaborative in people with Antibiotics, run by University of Wisconsin, Madison.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotics
- What is being tested?
- OASIS Collaborative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,942 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any nursing home resident who has received antibiotic therapy in any of the 12 participating nursing home facilities.
Who cannot join
- Nursing home residents who have not received antibiotic therapy in any of the 12 participating nursing home facilities.
About this study
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
- Being tested
- OASIS Collaborative
- Keywords
- Nursing homes, Antibiotic Stewardship, Antibiotic Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OASIS CollaborativeBehavioural
Also called OASIS
OASIS (Optimizing Antibiotic Stewardship in Skilled Nursing Facilities) is a system redesign of skilled nursing facility work systems
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: OASIS Collaborative |
| Control | No intervention | The nursing homes in this arm will continue care as usual, with no tools or facilitated implementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 12 months
Secondary outcomes (6)
Incidence of antibiotic starts/1000 resident days
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.
Measured: up to 12 months pre-implementation and up to 12 months post-implementation
Fluoroquinolone Days of Therapy (FQD)/1000 resident days
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.
Measured: up to 12 months pre-implementation and up to 12 months post-implementation
Incidence of C.diff infection/1000 resident days
Defined as the number of positive C. difficile tests per 1000 resident days
Measured: up to 12 months pre-implementation and up to 12 months post-implementation
Fluoroquinolone resistance
Defined as the proportion of urine cultures that grow bacteria that are resistant to fluoroquinolone antibiotics.
Measured: up to 12 months pre-implementation and up to 12 months post-implementation
Positive Enterococcus species
Defined as the proportion of urine cultures that grow Enterococcus species
Measured: up to 12 months pre-implementation and up to 12 months post-implementation
Positive Candida species
Defined as the proportion of urine cultures that grow Candida species
Measured: up to 12 months pre-implementation and up to 12 months post-implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntibioticsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,942 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Christopher J Crnich, MD, PhD, Principal investigator, University of Wisconsin-Madison, School of Medicine and Public HealthJames H Ford II, PhD, Principal investigator, University of Wisconsin-Madison, College of EngineeringDavid A Nace, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874872
- Sponsor's protocol ID
- 2016-0274
- Acronym
- OASIS
- Status last verified
- Oct 2018
- First submitted
- 9 Aug 2016
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building a Novel Antibiotic Stewardship Intervention for Nursing Homes
- ClinicalTrials.gov ID
- NCT02874872
- Acronym / sponsor ID
- OASIS / 2016-0274
- Conditions
- Antibiotics
- Keywords
- Nursing homes, Antibiotic Stewardship, Antibiotic Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,942 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- Sep 2016
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OASIS Collaborative | Experimental | Behavioral: OASIS CollaborativeThe 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. |
| Control | No intervention | –The nursing homes in this arm will continue care as usual, with no tools or facilitated implementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any nursing home resident who has received antibiotic therapy in any of the 12 participating nursing home facilities.
Key exclusion criteria (1 listed)
- Nursing home residents who have not received antibiotic therapy in any of the 12 participating nursing home facilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OASIS CollaborativeAlso: OASISOASIS (Optimizing Antibiotic Stewardship in Skilled Nursing Facilities) is a system redesign of skilled nursing facility work systems | Behavioural | OASIS Collaborative |
Primary outcome
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.
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.
6 secondary outcomes
Incidence of antibiotic starts/1000 resident days
Time frame: up to 12 months pre-implementation and up to 12 months post-implementation
Fluoroquinolone Days of Therapy (FQD)/1000 resident days
Time frame: up to 12 months pre-implementation and up to 12 months post-implementation
Incidence of C.diff infection/1000 resident days
Time frame: up to 12 months pre-implementation and up to 12 months post-implementation
Fluoroquinolone resistance
Time frame: up to 12 months pre-implementation and up to 12 months post-implementation
Positive Enterococcus species
Time frame: up to 12 months pre-implementation and up to 12 months post-implementation
Positive Candida species
Time frame: up to 12 months pre-implementation and up to 12 months post-implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Crnich, MD, PhD principal investigator
University of Wisconsin-Madison, School of Medicine and Public Health
James H Ford II, PhD principal investigator
University of Wisconsin-Madison, College of Engineering
David A Nace, MD, MPH principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing OASIS Collaborative in people with Antibiotics, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of Antibiotic Therapy (DOT)/1000 resident days (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.