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NCT05090475 Clinical Trial

Implementation of Academic Detailing Interventions on Prescribing of Antimicrobial Drugs in Primary Health Care

Viral Infection Clinical Trial

Official title:
Evaluating Hospital Educator-led Academic Detailing on Improving Antibiotic Prescribing in Primary Healthcare: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05090475
Other study ID # hospital A-team_primary care
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date December 31, 2022

Study information
Verified date December 2023
Source General Hospital Koprivnica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date December 31, 2022
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Academic detailing intervention
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

Locations
Country Name City State
Croatia Koprivnica križevci county Koprivnica Koprivnicko-krizevacka

Sponsors (3)
Lead Sponsor Collaborator
General Hospital Koprivnica Interdisciplinary section for the control of antibiotic resistance (ISKRA), Koprivnica Križevci County

Country where clinical trial is conducted

Croatia, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of antimicrobials expressed as DDD 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) 1 year
Secondary 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. 1 year
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