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Nurse Promotion of IV to PO Antimicrobial Conversion (FERN-IPO)

Primary Purpose

Behavior Change, Bacterial Infections

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Professional Behavior Change Intervention
Sponsored by
Kelowna General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Behavior Change focused on measuring Nurse, Antibiotic step-down

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kelowna General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-Intervention Arm

Post-Intervention Arm

Arm Description

The nurses will have not been exposed to the behavior change intervention.

The nurses will have been exposed to the behavior change intervention.

Outcomes

Primary Outcome Measures

IV to PO antimicrobial conversion rate
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

Secondary Outcome Measures

Days of IV therapy prior to conversion to PO antimicrobial
For treatment courses that undergo IV to PO antimicrobial conversion, the days of IV antimicrobial therapy prior to PO conversion before and after intervention
Nurse perceptions of capability, opportunity and motivation to promote IV to PO antimicrobial conversion
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.

Full Information

First Posted
November 29, 2018
Last Updated
September 5, 2019
Sponsor
Kelowna General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03761043
Brief Title
Nurse Promotion of IV to PO Antimicrobial Conversion
Acronym
FERN-IPO
Official Title
Fostering Engagement From Nurses in Promoting IV to PO Antimicrobial Conversion: The FERN-IPO Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
April 7, 2019 (Actual)
Study Completion Date
April 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kelowna General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Change, Bacterial Infections
Keywords
Nurse, Antibiotic step-down

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
853 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Intervention Arm
Arm Type
No Intervention
Arm Description
The nurses will have not been exposed to the behavior change intervention.
Arm Title
Post-Intervention Arm
Arm Type
Experimental
Arm Description
The nurses will have been exposed to the behavior change intervention.
Intervention Type
Behavioral
Intervention Name(s)
Professional Behavior Change Intervention
Other Intervention Name(s)
Printed educational materials, Educational meetings, Educational outreach visits, Local opinion leaders, Reminders
Intervention Description
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.
Primary Outcome Measure Information:
Title
IV to PO antimicrobial conversion rate
Description
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
Time Frame
Six months (three months pre-intervention, three months post-intervention)
Secondary Outcome Measure Information:
Title
Days of IV therapy prior to conversion to PO antimicrobial
Description
For treatment courses that undergo IV to PO antimicrobial conversion, the days of IV antimicrobial therapy prior to PO conversion before and after intervention
Time Frame
Six months (three months pre-intervention, three months post-intervention)
Title
Nurse perceptions of capability, opportunity and motivation to promote IV to PO antimicrobial conversion
Description
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.
Time Frame
Six months (three months pre-intervention, three months post-intervention)
Other Pre-specified Outcome Measures:
Title
Balancing measure - Failed IV to PO antimicrobial conversion
Description
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
Time Frame
Six months (three months pre-intervention, three months post-intervention
Title
Subgroup Analysis 1: Nursing Unit Conversion Comparison
Description
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
Time Frame
Six months (three months pre-intervention, three months post-intervention)
Title
Subgroup Analysis 2: High Bioavailability Antimicrobial Conversion
Description
Incidence of IV to PO antimicrobial conversion for highly bioavailable (F ≥ 80%) antimicrobials pre and post-intervention
Time Frame
Six months (three months pre-intervention, three months post-intervention)
Title
Subgroup Analysis 2: Non-High Bioavailability Antimicrobial Conversion
Description
Incidence of IV to PO antimicrobial conversion for non-highly bioavailable (F < 80%) antimicrobials pre and post-intervention
Time Frame
Six months (three months pre-intervention, three months post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Cox, PharmD
Organizational Affiliation
Interior Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kelowna General Hospital
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y1T2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30077436
Citation
Fisher CC, Cox VC, Gorman SK, Lesko N, Holdsworth K, Delaney N, McKenna C. A theory-informed assessment of the barriers and facilitators to nurse-driven antimicrobial stewardship. Am J Infect Control. 2018 Dec;46(12):1365-1369. doi: 10.1016/j.ajic.2018.05.020. Epub 2018 Aug 1.
Results Reference
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Nurse Promotion of IV to PO Antimicrobial Conversion

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