- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03761043
Nurse Promotion of IV to PO Antimicrobial Conversion (FERN-IPO)
5. september 2019 opdateret af: Sean Gorman, Kelowna General Hospital
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
853
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
British Columbia
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Kelowna, British Columbia, Canada, V1Y1T2
- Kelowna General Hospital
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Pre-Intervention Arm
The nurses will have not been exposed to the behavior change intervention.
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Eksperimentel: Post-Intervention Arm
The nurses will have been exposed to the behavior change intervention.
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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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
IV to PO antimicrobial conversion rate
Tidsramme: 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
|
Six months (three months pre-intervention, three months post-intervention)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Days of IV therapy prior to conversion to PO antimicrobial
Tidsramme: 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
|
Six months (three months pre-intervention, three months post-intervention)
|
Nurse perceptions of capability, opportunity and motivation to promote IV to PO antimicrobial conversion
Tidsramme: 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.
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Six months (three months pre-intervention, three months post-intervention)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Balancing measure - Failed IV to PO antimicrobial conversion
Tidsramme: Six months (three months pre-intervention, three months post-intervention
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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
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Six months (three months pre-intervention, three months post-intervention
|
Subgroup Analysis 1: Nursing Unit Conversion Comparison
Tidsramme: Six months (three months pre-intervention, three months post-intervention)
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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
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Six months (three months pre-intervention, three months post-intervention)
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Subgroup Analysis 2: High Bioavailability Antimicrobial Conversion
Tidsramme: Six months (three months pre-intervention, three months post-intervention)
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Incidence of IV to PO antimicrobial conversion for highly bioavailable (F ≥ 80%) antimicrobials pre and post-intervention
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Six months (three months pre-intervention, three months post-intervention)
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Subgroup Analysis 2: Non-High Bioavailability Antimicrobial Conversion
Tidsramme: Six months (three months pre-intervention, three months post-intervention)
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Incidence of IV to PO antimicrobial conversion for non-highly bioavailable (F < 80%) antimicrobials pre and post-intervention
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Six months (three months pre-intervention, three months post-intervention)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Victoria Cox, PharmD, Interior Health Authority
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. januar 2019
Primær færdiggørelse (Faktiske)
7. april 2019
Studieafslutning (Faktiske)
7. april 2019
Datoer for studieregistrering
Først indsendt
29. november 2018
Først indsendt, der opfyldte QC-kriterier
29. november 2018
Først opslået (Faktiske)
3. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IH1803202
Plan for individuelle deltagerdata (IPD)
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INGEN
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