- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03761043
Nurse Promotion of IV to PO Antimicrobial Conversion (FERN-IPO)
September 5, 2019 updated by: Sean Gorman, Kelowna General Hospital
Fostering Engagement From Nurses in Promoting IV to PO Antimicrobial Conversion: The FERN-IPO Study
This is a prospective, quasi-experimental, historically controlled study to evaluate if a behavioural change intervention informed by the COM-B model of behaviour change can improve nurses' self-perceived capability, opportunity, and motivation to engage in the assessment of patients who may be appropriate for IV to PO antimicrobial conversion.
This study also seeks to determine if this translates into an increase in IV to PO antimicrobial conversion rates in the acute care setting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Current antimicrobial stewardship guidelines recommend appropriate and timely IV to PO antimicrobial conversion in hospitalized patients.
Published rates of IV to PO antimicrobial conversion are consistently below 50% in eligible inpatients.
Studies have suggested that nurses may be well positioned to provide a positive influence on prescriber behavior related to antimicrobial IV to PO conversion, however, no published research has evaluated the impact of nurses on antimicrobial IV to PO conversion rates.
Published research has described the barriers and enablers to nurse participation in promoting antimicrobial IV to PO conversion using the COM-B model of behaviour change.
This quasi-experimental study will evaluate whether determinants of nurse behaviour and their actual behaviour can be changed to increase antimicrobial IV to PO conversion rates in hospitalized patients.
Study Type
Interventional
Enrollment (Actual)
853
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1Y1T2
- Kelowna General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Nineteen years of age or older
- Employed as a RN or LPN at KGH in any capacity (full-time, part-time or casual employee)
- Practicing on a medicine/thoracic surgery ward (4A) or medicine/oncology/respiratory ward (4B)
Exclusion Criteria:
- RNs or LPNs on orientation shifts/training
- RNs or LPNs not engaged in patient care
- Student nurses/nurses in training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre-Intervention Arm
The nurses will have not been exposed to the behavior change intervention.
|
|
|
Experimental: Post-Intervention Arm
The nurses will have been exposed to the behavior change intervention.
|
IV to PO antimicrobial conversion guidelines for nurses, nurse in-services and internet education sessions, IV to PO antimicrobial conversion health record reminder, endorsement from antimicrobial stewardship program, prescribers, and nurse educators.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IV to PO antimicrobial conversion rate
Time Frame: Six months (three months pre-intervention, three months post-intervention)
|
Incidence of IV to PO antimicrobial conversion (defined as the initiation of a PO antimicrobial within 24 hours of discontinuation of an IV antimicrobial during a single treatment course in a specific patient) before and after behavior change intervention
|
Six months (three months pre-intervention, three months post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days of IV therapy prior to conversion to PO antimicrobial
Time Frame: Six months (three months pre-intervention, three months post-intervention)
|
For treatment courses that undergo IV to PO antimicrobial conversion, the days of IV antimicrobial therapy prior to PO conversion before and after intervention
|
Six months (three months pre-intervention, three months post-intervention)
|
|
Nurse perceptions of capability, opportunity and motivation to promote IV to PO antimicrobial conversion
Time Frame: Six months (three months pre-intervention, three months post-intervention)
|
Constructs are derived using the Theoretical Domains Framework and assess nurse perceived capability, motivation, and opportunity to promote IV to PO antimicrobial conversion using a 7-point Likert scale (1 - Strongly Disagree, 2 - Disagree, 3- Slightly Disagree, 4 - Neither Agree or Disagree, 5 - Slightly Agree, 6 - Agree, 7- Strongly Agree).
The average Likert scale score for each of nine constructs (based on the Theoretical Domains Framework) will be calculated for the pre-intervention period and the post-intervention period.
Change in the average Likert score for each construct (question) in the pre-intervention period versus the post-intervention period will be compared for each construct.
A higher average Likert score on a construct in the post-intervention period compared to the pre-intervention period indicates improved perceptions about capability, opportunity, or motivation to promote IV to PO antimicrobial conversion.
|
Six months (three months pre-intervention, three months post-intervention)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balancing measure - Failed IV to PO antimicrobial conversion
Time Frame: Six months (three months pre-intervention, three months post-intervention
|
Incidence of failed IV to PO antimicrobial conversion (defined as the re-initiation of an IV antimicrobial within seven days following IV to PO conversion of an antimicrobial during a single treatment course for a specific patient) pre and post-intervention
|
Six months (three months pre-intervention, three months post-intervention
|
|
Subgroup Analysis 1: Nursing Unit Conversion Comparison
Time Frame: Six months (three months pre-intervention, three months post-intervention)
|
Incidence of IV to PO antimicrobial conversion on nursing unit 1 (contains a clinical pharmacist) versus nursing unit 2 (does not contain a clinical pharmacist) pre and post-intervention
|
Six months (three months pre-intervention, three months post-intervention)
|
|
Subgroup Analysis 2: High Bioavailability Antimicrobial Conversion
Time Frame: Six months (three months pre-intervention, three months post-intervention)
|
Incidence of IV to PO antimicrobial conversion for highly bioavailable (F ≥ 80%) antimicrobials pre and post-intervention
|
Six months (three months pre-intervention, three months post-intervention)
|
|
Subgroup Analysis 2: Non-High Bioavailability Antimicrobial Conversion
Time Frame: Six months (three months pre-intervention, three months post-intervention)
|
Incidence of IV to PO antimicrobial conversion for non-highly bioavailable (F < 80%) antimicrobials pre and post-intervention
|
Six months (three months pre-intervention, three months post-intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Victoria Cox, PharmD, Interior Health Authority
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2019
Primary Completion (Actual)
April 7, 2019
Study Completion (Actual)
April 7, 2019
Study Registration Dates
First Submitted
November 29, 2018
First Submitted That Met QC Criteria
November 29, 2018
First Posted (Actual)
December 3, 2018
Study Record Updates
Last Update Posted (Actual)
September 6, 2019
Last Update Submitted That Met QC Criteria
September 5, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IH1803202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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