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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03761043
Other study ID # IH1803202
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 8, 2019
Est. completion date April 7, 2019

Study information

Verified date September 2019
Source Kelowna General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 853
Est. completion date April 7, 2019
Est. primary completion date April 7, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
Canada Kelowna General Hospital Kelowna British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Kelowna General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Balancing measure - Failed IV to PO antimicrobial conversion 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
Other Subgroup Analysis 1: Nursing Unit Conversion Comparison 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)
Other Subgroup Analysis 2: High Bioavailability Antimicrobial Conversion 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)
Other Subgroup Analysis 2: Non-High Bioavailability Antimicrobial Conversion 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)
Primary 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 Six months (three months pre-intervention, three months post-intervention)
Secondary 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 Six months (three months pre-intervention, three months post-intervention)
Secondary 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. Six months (three months pre-intervention, three months post-intervention)
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