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The Implementation of Educational Interventions on the Prescribing of Antimicrobial Drugs in Primary Health Care

Primary Purpose

Upper Respiratory Tract Infections, Acute Respiratory Tract Infection, Clostridium Difficile Infection

Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Educational outreach intervention
Sponsored by
General Hospital Koprivnica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Upper Respiratory Tract Infections focused on measuring Antimicrobial resistance, Hospital A-team, Educational outreach intervention, Antimicrobial prescribing, Primary care

Eligibility Criteria

25 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All primary care physicians in Koprivnica Križevci County that agree to participate in the study

Exclusion Criteria:

  • Primary care physicians outside Koprivnica Križevci County

Sites / Locations

  • Koprivnica križevci county

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hospital A-team led intervention in Koprivnica Križevci County

Control group

Arm Description

Hospital A-team will give educational outreach intervention to primary care physicians

Primary care physicians in Bjelovar Bilogora county will not receive intervention

Outcomes

Primary Outcome Measures

Proportion of antimicrobials expressed as DDD per 1000 inhabitants per day for ATC group J01
Rationalization of general consumption of antimicrobials
Proportion of antimicrobials expressed as DDD per 1000 inhabitants per day for ATC group J01 associated with acute respiratory tract infections
Rationalization of consumption of antimicrobials for acute respiratory tract infections (for associated ICD diagnoses J01, J02, J03, J06, J20)

Secondary Outcome Measures

Change in Clostridiodes dificile infection for patients on antimicrobial therapy
Number of Clostridiodes dificile infection for patients on antimicrobial therapy. A case of Clostridioides difficile infection (CDI) is defined as diarrhoeal stools or toxic megacolon and a positive laboratory assay for C. difficile toxin A and/or B in stools or a toxin-producing C. difficile organism detected in stool via culture or other means e.g. a positive PCR result.

Full Information

First Posted
July 6, 2021
Last Updated
January 21, 2023
Sponsor
General Hospital Koprivnica
Collaborators
Koprivnica Križevci County, Interdisciplinary section for the control of antibiotic resistance (ISKRA)
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1. Study Identification

Unique Protocol Identification Number
NCT05090475
Brief Title
The Implementation of Educational Interventions on the Prescribing of Antimicrobial Drugs in Primary Health Care
Official Title
The Impact of the Implementation of Educational Interventions Based on Scientific Evidence on the Prescribing of Antimicrobial Drugs in Primary Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital Koprivnica
Collaborators
Koprivnica Križevci County, Interdisciplinary section for the control of antibiotic resistance (ISKRA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
World increase in mortality from consequences of antimicrobial resistance (AMR) represents a significant public health problem. Irrational prescribing of antimicrobial drugs (AMD) in general population is one of the main causes of development AMR. This is also contributed by fact that up to 90% of total antimicrobial consumption in Europe is related to the general population. Problem of AMR has been recognized by World Health Organization and Council of European Union, which support the establishment of the antimicrobial stewardship team (A-team). A-team provides co-ordinated interventions that promote rational use of AMD. To date, no study has been carried out in which Ateam from hospital environment goes to primary health care for the purpose of rationalization prescribing of AMD by primary health care practitioners. Project for implementation of hospital A-team in primary health care in Koprivnica-Križevci County will be initiated using educational outreach method aimed at rationalization of the consumption of AMD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections, Acute Respiratory Tract Infection, Clostridium Difficile Infection, Viral Infection, Bacterial Infections
Keywords
Antimicrobial resistance, Hospital A-team, Educational outreach intervention, Antimicrobial prescribing, Primary care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospital A-team led intervention in Koprivnica Križevci County
Arm Type
Experimental
Arm Description
Hospital A-team will give educational outreach intervention to primary care physicians
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Primary care physicians in Bjelovar Bilogora county will not receive intervention
Intervention Type
Behavioral
Intervention Name(s)
Educational outreach intervention
Intervention Description
Educational outreach or academic detailing is a method based on scientific data with the help of educated A-team members in the form of direct (face-to-face) interactions, prescribing practices change and adherence improves according to the application of currently valid therapeutic guidelines
Primary Outcome Measure Information:
Title
Proportion of antimicrobials expressed as DDD per 1000 inhabitants per day for ATC group J01
Description
Rationalization of general consumption of antimicrobials
Time Frame
1 year
Title
Proportion of antimicrobials expressed as DDD per 1000 inhabitants per day for ATC group J01 associated with acute respiratory tract infections
Description
Rationalization of consumption of antimicrobials for acute respiratory tract infections (for associated ICD diagnoses J01, J02, J03, J06, J20)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Clostridiodes dificile infection for patients on antimicrobial therapy
Description
Number of Clostridiodes dificile infection for patients on antimicrobial therapy. A case of Clostridioides difficile infection (CDI) is defined as diarrhoeal stools or toxic megacolon and a positive laboratory assay for C. difficile toxin A and/or B in stools or a toxin-producing C. difficile organism detected in stool via culture or other means e.g. a positive PCR result.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All primary care physicians in Koprivnica Križevci County that agree to participate in the study Exclusion Criteria: Primary care physicians outside Koprivnica Križevci County
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darija Kuruc Poje
Organizational Affiliation
General Hospital Koprivnica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koprivnica križevci county
City
Koprivnica
State/Province
Koprivnicko-krizevacka
ZIP/Postal Code
48000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Just IPD that underlie results in a publication
Citations:
PubMed Identifier
26980184
Citation
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Citation
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Citation
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Results Reference
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Links:
URL
https://www.who.int/en/news-room/fact-sheets/detail/antimicrobial-resistance
Description
WHO Antimicrobial resistance
URL
https://amr-review.org/
Description
Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations. The Review on Antimicrobial Resistance
URL
https://apps.who.int/iris/handle/10665/311820?locale-attribute=pt&
Description
Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections, including tuberculosis
URL
https://www.ecdc.europa.eu/en/publications-data/antimicrobial-consumption-annual-epidemiological-report-2017
Description
Antimicrobial consumption - Annual Epidemiological Report for 2017
URL
http://www.wpro.who.int/entity/drug_resistance/resources/global_action_plan_eng.pdf,
Description
Global Action Plan on Antimicrobial Resistance.

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The Implementation of Educational Interventions on the Prescribing of Antimicrobial Drugs in Primary Health Care

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