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

Sponsor
General Hospital Koprivnica (Other)
Overall Status
Recruiting
CT.gov ID
NCT05090475
Collaborator
Koprivnica Križevci County (Other), Interdisciplinary section for the control of antibiotic resistance (ISKRA) (Other)
60
1
2
35.9
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational outreach intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Impact of the Implementation of Educational Interventions Based on Scientific Evidence on the Prescribing of Antimicrobial Drugs in Primary Health Care
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hospital A-team led intervention in Koprivnica Križevci County

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

Behavioral: Educational outreach intervention
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

No Intervention: Control group

Primary care physicians in Bjelovar Bilogora county will not receive intervention

Outcome Measures

Primary Outcome Measures

  1. Proportion of antimicrobials expressed as DDD per 1000 inhabitants per day for ATC group J01 [1 year]

    Rationalization of general consumption of antimicrobials

  2. Proportion of antimicrobials expressed as DDD per 1000 inhabitants per day for ATC group J01 associated with acute respiratory tract infections [1 year]

    Rationalization of consumption of antimicrobials for acute respiratory tract infections (for associated ICD diagnoses J01, J02, J03, J06, J20)

Secondary Outcome Measures

  1. Change in Clostridiodes dificile infection for patients on antimicrobial therapy [1 year]

    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.

  2. Proportion of antimicrobials expressed as DDD per 1000 inhabitants per day for ATC group J01 associated with urinary tract infections [1 year]

    Rationalization of consumption of antimicrobials for urinary tract infections

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Koprivnica križevci county Koprivnica Koprivnicko-krizevacka Croatia 48000

Sponsors and Collaborators

  • General Hospital Koprivnica
  • Koprivnica Križevci County
  • Interdisciplinary section for the control of antibiotic resistance (ISKRA)

Investigators

  • Principal Investigator: Darija Kuruc Poje, General Hospital Koprivnica

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Darija Kuruc Poje, Head of hospital pharmacy, Clinical pharmacist, General Hospital Koprivnica
ClinicalTrials.gov Identifier:
NCT05090475
Other Study ID Numbers:
  • hospital A-team_primary care
First Posted:
Oct 22, 2021
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Darija Kuruc Poje, Head of hospital pharmacy, Clinical pharmacist, General Hospital Koprivnica
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2022