<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03761043</url>
  </required_header>
  <id_info>
    <org_study_id>IH1803202</org_study_id>
    <nct_id>NCT03761043</nct_id>
  </id_info>
  <brief_title>Nurse Promotion of IV to PO Antimicrobial Conversion</brief_title>
  <acronym>FERN-IPO</acronym>
  <official_title>Fostering Engagement From Nurses in Promoting IV to PO Antimicrobial Conversion: The FERN-IPO Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kelowna General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kelowna General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, quasi-experimental, historically controlled study to evaluate if a&#xD;
      behavioural change intervention informed by the COM-B model of behaviour change can improve&#xD;
      nurses' self-perceived capability, opportunity, and motivation to engage in the assessment of&#xD;
      patients who may be appropriate for IV to PO antimicrobial conversion. This study also seeks&#xD;
      to determine if this translates into an increase in IV to PO antimicrobial conversion rates&#xD;
      in the acute care setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current antimicrobial stewardship guidelines recommend appropriate and timely IV to PO&#xD;
      antimicrobial conversion in hospitalized patients. Published rates of IV to PO antimicrobial&#xD;
      conversion are consistently below 50% in eligible inpatients. Studies have suggested that&#xD;
      nurses may be well positioned to provide a positive influence on prescriber behavior related&#xD;
      to antimicrobial IV to PO conversion, however, no published research has evaluated the impact&#xD;
      of nurses on antimicrobial IV to PO conversion rates. Published research has described the&#xD;
      barriers and enablers to nurse participation in promoting antimicrobial IV to PO conversion&#xD;
      using the COM-B model of behaviour change. This quasi-experimental study will evaluate&#xD;
      whether determinants of nurse behaviour and their actual behaviour can be changed to increase&#xD;
      antimicrobial IV to PO conversion rates in hospitalized patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Actual">April 7, 2019</completion_date>
  <primary_completion_date type="Actual">April 7, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IV to PO antimicrobial conversion rate</measure>
    <time_frame>Six months (three months pre-intervention, three months post-intervention)</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Days of IV therapy prior to conversion to PO antimicrobial</measure>
    <time_frame>Six months (three months pre-intervention, three months post-intervention)</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nurse perceptions of capability, opportunity and motivation to promote IV to PO antimicrobial conversion</measure>
    <time_frame>Six months (three months pre-intervention, three months post-intervention)</time_frame>
    <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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Balancing measure - Failed IV to PO antimicrobial conversion</measure>
    <time_frame>Six months (three months pre-intervention, three months post-intervention</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Subgroup Analysis 1: Nursing Unit Conversion Comparison</measure>
    <time_frame>Six months (three months pre-intervention, three months post-intervention)</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>Subgroup Analysis 2: High Bioavailability Antimicrobial Conversion</measure>
    <time_frame>Six months (three months pre-intervention, three months post-intervention)</time_frame>
    <description>Incidence of IV to PO antimicrobial conversion for highly bioavailable (F ≥ 80%) antimicrobials pre and post-intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>Subgroup Analysis 2: Non-High Bioavailability Antimicrobial Conversion</measure>
    <time_frame>Six months (three months pre-intervention, three months post-intervention)</time_frame>
    <description>Incidence of IV to PO antimicrobial conversion for non-highly bioavailable (F &lt; 80%) antimicrobials pre and post-intervention</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">853</enrollment>
  <condition>Behavior Change</condition>
  <condition>Bacterial Infections</condition>
  <arm_group>
    <arm_group_label>Pre-Intervention Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The nurses will have not been exposed to the behavior change intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The nurses will have been exposed to the behavior change intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Professional Behavior Change Intervention</intervention_name>
    <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.</description>
    <arm_group_label>Post-Intervention Arm</arm_group_label>
    <other_name>Printed educational materials</other_name>
    <other_name>Educational meetings</other_name>
    <other_name>Educational outreach visits</other_name>
    <other_name>Local opinion leaders</other_name>
    <other_name>Reminders</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nineteen years of age or older&#xD;
&#xD;
          -  Employed as a RN or LPN at KGH in any capacity (full-time, part-time or casual&#xD;
             employee)&#xD;
&#xD;
          -  Practicing on a medicine/thoracic surgery ward (4A) or medicine/oncology/respiratory&#xD;
             ward (4B)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  RNs or LPNs on orientation shifts/training&#xD;
&#xD;
          -  RNs or LPNs not engaged in patient care&#xD;
&#xD;
          -  Student nurses/nurses in training&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria Cox, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Interior Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kelowna General Hospital</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y1T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>30077436</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kelowna General Hospital</investigator_affiliation>
    <investigator_full_name>Sean Gorman</investigator_full_name>
    <investigator_title>Pharmacy Coordinator, Clinical Quality &amp; Research</investigator_title>
  </responsible_party>
  <keyword>Nurse</keyword>
  <keyword>Antibiotic step-down</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03761043
org study id: IH1803202
nct id: NCT03761043
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: IV to PO antimicrobial conversion rate
time frame: Six months (three months pre-intervention, three months post-intervention)
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
measure: Days of IV therapy prior to conversion to PO antimicrobial
time frame: Six months (three months pre-intervention, three months post-intervention)
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
measure: 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)
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.
measure: Balancing measure - Failed IV to PO antimicrobial conversion
time frame: Six months (three months pre-intervention, three months post-intervention
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
measure: Subgroup Analysis 1: Nursing Unit Conversion Comparison
time frame: Six months (three months pre-intervention, three months post-intervention)
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
measure: Subgroup Analysis 2: High Bioavailability Antimicrobial Conversion
time frame: Six months (three months pre-intervention, three months post-intervention)
description: Incidence of IV to PO antimicrobial conversion for highly bioavailable (F ≥ 80%) antimicrobials pre and post-intervention
measure: Subgroup Analysis 2: Non-High Bioavailability Antimicrobial Conversion
time frame: Six months (three months pre-intervention, three months post-intervention)
description: Incidence of IV to PO antimicrobial conversion for non-highly bioavailable (F < 80%) antimicrobials pre and post-intervention
arm group label: Pre-Intervention Arm
arm group type: No Intervention
description: The nurses will have not been exposed to the behavior change intervention.
arm group label: Post-Intervention Arm
arm group type: Experimental
description: The nurses will have been exposed to the behavior change intervention.
intervention type: Behavioral
intervention name: Professional Behavior Change 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.
arm group label: Post-Intervention Arm
other name: Printed educational materials
other name: Educational meetings
other name: Educational outreach visits
other name: Local opinion leaders
other name: Reminders
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Victoria Cox, PharmD
role: Principal Investigator
affiliation: Interior Health Authority
facility: 
country: Canada
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.
PMID: 30077436
responsible party type: Principal Investigator
investigator affiliation: Kelowna General Hospital
investigator full name: Sean Gorman
investigator title: Pharmacy Coordinator, Clinical Quality & Research
mesh term: Bacterial Infections
sharing ipd: No