Behavior ChangeFERN-IPONCT03761043
Nurse Promotion of IV to PO Antimicrobial Conversion
A study testing Professional Behavior Change Intervention in people with Behavior Change and Bacterial Infections, run by Kelowna General Hospital at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Behavior Change, Bacterial Infections
- What is being tested?
- Professional Behavior Change Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 853 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jan 2019to 7 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- RNs or LPNs on orientation shifts/training
- RNs or LPNs not engaged in patient care
- Student nurses/nurses in training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fostering Engagement From Nurses in Promoting IV to PO Antimicrobial Conversion: The FERN-IPO Study
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.
Read the 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.
- Conditions
- Behavior Change, Bacterial Infections
- Being tested
- Professional Behavior Change Intervention
- Keywords
- Nurse, Antibiotic step-down
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional Behavior Change InterventionBehavioural
Also called Printed educational materials, Educational meetings, Educational outreach visits, Local opinion leaders
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Professional Behavior Change Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months (three months pre-intervention, three months post-intervention)
Secondary outcomes (2)
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
Measured: Six months (three months pre-intervention, three months post-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.
Measured: Six months (three months pre-intervention, three months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start8 Jan 2019
- Primary completion7 Apr 2019
- Study completion7 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 853 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelowna General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sean Gorman, Kelowna General Hospital
- Investigators
- Victoria Cox, PharmD, Principal investigator, Interior Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761043
- Sponsor's protocol ID
- IH1803202
- Acronym
- FERN-IPO
- Status last verified
- Sep 2019
- First submitted
- 29 Nov 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30077436
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fostering Engagement From Nurses in Promoting IV to PO Antimicrobial Conversion: The FERN-IPO Study
- ClinicalTrials.gov ID
- NCT03761043
- Acronym / sponsor ID
- FERN-IPO / IH1803202
- Conditions
- Behavior Change, Bacterial Infections
- Keywords
- Nurse, Antibiotic step-down
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 853 participants (actual)
- Lead sponsor
- Kelowna General HospitalOther government
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 7 Apr 2019 (actual)
- Study completion
- 7 Apr 2019 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention Arm | No intervention | –The nurses will have not been exposed to the behavior change intervention. |
| Post-Intervention Arm | Experimental | Behavioral: Professional Behavior Change InterventionThe nurses will have been exposed to the behavior change intervention. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- RNs or LPNs on orientation shifts/training
- RNs or LPNs not engaged in patient care
- Student nurses/nurses in training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Professional Behavior Change InterventionAlso: Printed educational materials, Educational meetings, Educational outreach visits, Local opinion leadersIV 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. | Behavioural | Post-Intervention Arm |
Primary outcome
IV to PO antimicrobial conversion rate
Time frame: 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
2 secondary outcomes
Days of IV therapy prior to conversion to PO antimicrobial
Time frame: Six months (three months pre-intervention, three months post-intervention)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 30077436Fisher 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.
- Individual participant dataSharing planned: No
Related trials for Behavior Change
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Cox, PharmD principal investigator
Interior Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professional Behavior Change Intervention in people with Behavior Change and Bacterial Infections, run by Kelowna General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IV to PO antimicrobial conversion rate (time frame: Six months (three months pre-intervention, three months post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03761043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.