- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05090475
Implementation of Academic Detailing Interventions on Prescribing of Antimicrobial Drugs in Primary Health Care
December 28, 2023 updated by: Darija Kuruc Poje, General Hospital Koprivnica
Evaluating Hospital Educator-led Academic Detailing on Improving Antibiotic Prescribing in Primary Healthcare: a Feasibility Study
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 A-team 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 was initiated using academic detailing method aimed at rationalization of the consumption of AMD.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Koprivnicko-krizevacka
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Koprivnica, Koprivnicko-krizevacka, Croatia, 48000
- Koprivnica križevci county
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group in Koprivnica Križevci County
Hospital A-team provided academic detailing intervention to primary care physicians in Koprivnica Križevci county who agree to participate
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Academic detailing or educational outreach 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
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No Intervention: Control group in Koprivnica Križevci county
Primary care physicians in Koprivnica Križevci county who did not agree to participate in academic detailing intervention
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No Intervention: Control group in Bjelovar Bilogora county
Primary care physicians in Bjelovar Bilogora county without the academic detailing intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of antimicrobials expressed as DDD per day for ATC group J01 associated with acute respiratory tract infections
Time Frame: 1 year
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Rationalization of consumption of antimicrobials for acute respiratory tract infections (for associated ICD diagnoses J01, J02, J03, J06, J20)
|
1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Clostridiodes dificile infection for patients on antimicrobial therapy
Time Frame: 1 year
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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.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Darija Kuruc Poje, General Hospital Koprivnica
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Marquet K, Liesenborgs A, Bergs J, Vleugels A, Claes N. Incidence and outcome of inappropriate in-hospital empiric antibiotics for severe infection: a systematic review and meta-analysis. Crit Care. 2015 Feb 16;19(1):63. doi: 10.1186/s13054-015-0795-y.
- Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010 May 18;340:c2096. doi: 10.1136/bmj.c2096.
- Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56.
- Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
- O'Brien MA, Rogers S, Jamtvedt G, Oxman AD, Odgaard-Jensen J, Kristoffersen DT, Forsetlund L, Bainbridge D, Freemantle N, Davis DA, Haynes RB, Harvey EL. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD000409. doi: 10.1002/14651858.CD000409.pub2.
- Bryce A, Hay AD, Lane IF, Thornton HV, Wootton M, Costelloe C. Global prevalence of antibiotic resistance in paediatric urinary tract infections caused by Escherichia coli and association with routine use of antibiotics in primary care: systematic review and meta-analysis. BMJ. 2016 Mar 15;352:i939. doi: 10.1136/bmj.i939.
- Teillant A, Gandra S, Barter D, Morgan DJ, Laxminarayan R. Potential burden of antibiotic resistance on surgery and cancer chemotherapy antibiotic prophylaxis in the USA: a literature review and modelling study. Lancet Infect Dis. 2015 Dec;15(12):1429-37. doi: 10.1016/S1473-3099(15)00270-4. Epub 2015 Oct 22.
- Bassetti M, Righi E. Development of novel antibacterial drugs to combat multiple resistant organisms. Langenbecks Arch Surg. 2015 Feb;400(2):153-65. doi: 10.1007/s00423-015-1280-4. Epub 2015 Feb 11.
- Gundlapalli AV, Beekmann SE, Graham DR, Polgreen PM; Members of the Emerging Infections Network. Antimicrobial Agent Shortages: The New Norm for Infectious Diseases Physicians. Open Forum Infect Dis. 2018 Apr 23;5(4):ofy068. doi: 10.1093/ofid/ofy068. eCollection 2018 Apr.
- Nellums LB, Thompson H, Holmes A, Castro-Sanchez E, Otter JA, Norredam M, Friedland JS, Hargreaves S. Antimicrobial resistance among migrants in Europe: a systematic review and meta-analysis. Lancet Infect Dis. 2018 Jul;18(7):796-811. doi: 10.1016/S1473-3099(18)30219-6. Epub 2018 May 17.
- Chitnis AS, Holzbauer SM, Belflower RM, Winston LG, Bamberg WM, Lyons C, Farley MM, Dumyati GK, Wilson LE, Beldavs ZG, Dunn JR, Gould LH, MacCannell DR, Gerding DN, McDonald LC, Lessa FC. Epidemiology of community-associated Clostridium difficile infection, 2009 through 2011. JAMA Intern Med. 2013 Jul 22;173(14):1359-67. doi: 10.1001/jamainternmed.2013.7056.
- Avorn J, Soumerai SB. Improving drug-therapy decisions through educational outreach. A randomized controlled trial of academically based "detailing". N Engl J Med. 1983 Jun 16;308(24):1457-63. doi: 10.1056/NEJM198306163082406.
Helpful Links
- WHO Antimicrobial resistance
- Antimicrobial Resistance: Tackling a crisis for the health and wealth of nations. The Review on Antimicrobial Resistance
- Prioritization of pathogens to guide discovery, research and development of new antibiotics for drug-resistant bacterial infections, including tuberculosis
- Antimicrobial consumption - Annual Epidemiological Report for 2017
- Global Action Plan on Antimicrobial Resistance.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
April 30, 2020
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
July 6, 2021
First Submitted That Met QC Criteria
October 11, 2021
First Posted (Actual)
October 22, 2021
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 28, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hospital A-team_primary care
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Just IPD that underlie results in a publication
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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