NCT03761043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
853

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

3 months

First QC Date

November 29, 2018

Last Update Submit

September 5, 2019

Conditions

Behavior ChangeBacterial Infections

Keywords

NurseAntibiotic step-down

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Days of IV therapy prior to conversion to PO antimicrobial

    Six months (three months pre-intervention, three months post-intervention)

  • Nurse perceptions of capability, opportunity and motivation to promote IV to PO antimicrobial conversion

    Six months (three months pre-intervention, three months post-intervention)

Other Outcomes (4)

  • Balancing measure - Failed IV to PO antimicrobial conversion

    Six months (three months pre-intervention, three months post-intervention

  • Subgroup Analysis 1: Nursing Unit Conversion Comparison

    Six months (three months pre-intervention, three months post-intervention)

  • Subgroup Analysis 2: High Bioavailability Antimicrobial Conversion

    Six months (three months pre-intervention, three months post-intervention)

  • +1 more other outcomes

Study Arms (2)

Pre-Intervention Arm

NO INTERVENTION

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

Post-Intervention Arm

EXPERIMENTAL

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

Behavioral: Professional Behavior Change Intervention

Interventions

Professional Behavior Change InterventionBEHAVIORAL

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.

Also known as: Printed educational materials, Educational meetings, Educational outreach visits, Local opinion leaders, Reminders
Post-Intervention Arm

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • RNs or LPNs on orientation shifts/training
  • RNs or LPNs not engaged in patient care
  • Student nurses/nurses in training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kelowna General Hospital

Kelowna, British Columbia, V1Y1T2, Canada

Location

Related 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.

    PMID: 30077436BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Victoria Cox, PharmD

    Interior Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacy Coordinator, Clinical Quality & Research

Study Record Dates

First Submitted

November 29, 2018

First Posted

December 3, 2018

Study Start

January 8, 2019

Primary Completion

April 7, 2019

Study Completion

April 7, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)