AzTrials
AzTrials

Upper Respiratory Tract InfectionsNCT05090475

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

A study testing Academic detailing intervention in people with Upper Respiratory Tract Infections and Acute Respiratory Tract Infection, run by General Hospital Koprivnica at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 75 yearsHealthy volunteers can take part
What is being tested?
Academic detailing intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteCroatia
Study dates
1 Apr 2020to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Primary care physicians outside Koprivnica Križevci County

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • Koprivnica križevci county

    Koprivnica, Koprivnica-Križevci County, 48000

Other trials in Croatia

About this study

Official title: 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.

Being tested
Academic detailing intervention
Keywords
Antimicrobial resistance, Hospital A-team, Academic detailing intervention, Antimicrobial prescribing, Primary care
Medical subject headings
Respiratory Tract Infections, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Academic detailing interventionBehavioural

    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

Study groups in NCT05090475
Study groupRoleWhat they receive
Experimental group in Koprivnica Križevci CountyExperimentalHospital A-team provided academic detailing intervention to primary care physicians in Koprivnica Križevci county who agree to participate
Receives: Behavioral: Academic detailing intervention
Control group in Koprivnica Križevci countyNo interventionPrimary care physicians in Koprivnica Križevci county who did not agree to participate in academic detailing intervention
Control group in Bjelovar Bilogora countyNo interventionPrimary care physicians in Bjelovar Bilogora county without the academic detailing intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 year

Secondary outcomes (1)

  1. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2021
  2. Study start1 Apr 2020
  3. Primary completion30 Apr 2020
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090475
Sponsor's protocol ID
hospital A-team_primary care
Status last verified
Dec 2023
First submitted
6 Jul 2021
Last updated
2 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Just IPD that underlie results in a publication

Publications

  • 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.

    PubMed 26980184

  • 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.

    PubMed 20483949

  • 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.

    PubMed 25888181

  • 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.

    PubMed 26482597

  • 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.

    PubMed 25667169

  • 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.

    PubMed 29732380

  • 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.

    PubMed 29779917

  • 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.

    PubMed 23780507

  • 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.

    PubMed 6406886

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

    PubMed 2104640

  • 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.

    PubMed 17943742

  • 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.

    PubMed 26864410

Questions about this trial

What is this clinical trial studying?

A study testing Academic detailing intervention in people with Upper Respiratory Tract Infections and Acute Respiratory Tract Infection, run by General Hospital Koprivnica at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of antimicrobials expressed as DDD per day for ATC group J01 associated with acute respiratory tract infections (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05090475, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.

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