FERN-IPO: Nurse Promotion of IV to PO Antimicrobial Conversion

Sponsor
Kelowna General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03761043
Collaborator
(none)
853
1
2
2.9
291.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Professional Behavior Change Intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
853 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Fostering Engagement From Nurses in Promoting IV to PO Antimicrobial Conversion: The FERN-IPO Study
Actual Study Start Date :
Jan 8, 2019
Actual Primary Completion Date :
Apr 7, 2019
Actual Study Completion Date :
Apr 7, 2019

Arms and Interventions

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.

Behavioral: Professional 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:
  • Printed educational materials
  • Educational meetings
  • Educational outreach visits
  • Local opinion leaders
  • Reminders
  • Outcome Measures

    Primary Outcome Measures

    1. IV to PO antimicrobial conversion rate [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

    Secondary Outcome Measures

    1. Days of IV therapy prior to conversion to PO antimicrobial [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

    2. Nurse perceptions of capability, opportunity and motivation to promote IV to PO antimicrobial conversion [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.

    Other Outcome Measures

    1. Balancing measure - Failed IV to PO antimicrobial conversion [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

    2. Subgroup Analysis 1: Nursing Unit Conversion Comparison [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

    3. Subgroup Analysis 2: High Bioavailability Antimicrobial Conversion [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

    4. Subgroup Analysis 2: Non-High Bioavailability Antimicrobial Conversion [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kelowna General Hospital Kelowna British Columbia Canada V1Y1T2

    Sponsors and Collaborators

    • Kelowna General Hospital

    Investigators

    • Principal Investigator: Victoria Cox, PharmD, Interior Health Authority

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sean Gorman, Pharmacy Coordinator, Clinical Quality & Research, Kelowna General Hospital
    ClinicalTrials.gov Identifier:
    NCT03761043
    Other Study ID Numbers:
    • IH1803202
    First Posted:
    Dec 3, 2018
    Last Update Posted:
    Sep 6, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sean Gorman, Pharmacy Coordinator, Clinical Quality & Research, Kelowna General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 6, 2019