Educational and Informative Interventions to Tackle Inappropriate Use of Drugs in Italy
NCT ID: NCT04030468
Last Updated: 2019-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4840 participants
INTERVENTIONAL
2017-04-20
2020-04-30
Brief Summary
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Detailed Description
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Appropriateness of prescribing in general practice will be assessed by evaluating selected prescribing, consumption and adherence indicators, using Regional administrative pharmaceutical prescription databases.
Primary care physicians and their patients will be assigned to four trial arms: informative intervention (leaflets and posters for patients), educational intervention (feedback reports and online CME courses for GPs), combined interventions, or no intervention. Intervention effectiveness will be assessed measuring the variation in rates of inappropriate prescription indicators after 1-year of follow-up.
EDU.RE.DRUG project will provide with improvements in the prescribing performance of GPs and in patients' adherence to treatment, with relevant clinical implications in terms of rational and safe use of drugs and optimized patient care, and with economic benefits (optimization of available resources use and savings in direct and indirect health costs).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. intervention on GPs (LHUs of Napoli 1 Nord and Bergamo)
2. intervention on patients (LHUs of Avellino and Val Padana-Mantova District)
3. intervention on GPs and patients (LHUs of Napoli 2 Centro and Brianza-Lecco District)
4. no intervention (LHUs of Caserta and Brianza-Monza Brianza District)
OTHER
NONE
Study Groups
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General practitioners
Educational intervention
Educational intervention addressed to general practitioners
* feedback reports regarding the status of their patients according to the appropriateness indicators determined at baseline and the pooled prevalences for their patients, Local Health Units, and region
* Continuous Medical Education (CME) course
Patients
Informative intervention
Informative intervention addressed to patients
• leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use
General practitioners and patients
Combined strategy
Educational intervention addressed to general practitioners
* feedback reports regarding the status of their patients according to the appropriateness indicators determined at baseline and the pooled prevalences for their patients, Local Health Units, and region
* Continuous Medical Education (CME) course
Informative intervention addressed to patients
• leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use
Control
No intervention
No interventions assigned to this group
Interventions
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Educational intervention addressed to general practitioners
* feedback reports regarding the status of their patients according to the appropriateness indicators determined at baseline and the pooled prevalences for their patients, Local Health Units, and region
* Continuous Medical Education (CME) course
Informative intervention addressed to patients
• leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Federico II University
OTHER
University of Milano Bicocca
OTHER
University of Milan
OTHER
Responsible Party
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Elena Tragni
Researcher at Epidemiology and Preventive Pharmacology Centre
Principal Investigators
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Alberico L Catapano
Role: PRINCIPAL_INVESTIGATOR
University of Milan
Locations
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SEFAP, University of Milan
Milan, MI, Italy
Countries
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References
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Leendertse AJ, Egberts AC, Stoker LJ, van den Bemt PM; HARM Study Group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008 Sep 22;168(17):1890-6. doi: 10.1001/archinternmed.2008.3.
Buetow SA, Sibbald B, Cantrill JA, Halliwell S. Appropriateness in health care: application to prescribing. Soc Sci Med. 1997 Jul;45(2):261-71. doi: 10.1016/s0277-9536(96)00342-5.
Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, Hanlon JT. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007 Jul 14;370(9582):173-184. doi: 10.1016/S0140-6736(07)61091-5.
Goulding MR. Inappropriate medication prescribing for elderly ambulatory care patients. Arch Intern Med. 2004 Feb 9;164(3):305-12. doi: 10.1001/archinte.164.3.305.
Fialova D, Topinkova E, Gambassi G, Finne-Soveri H, Jonsson PV, Carpenter I, Schroll M, Onder G, Sorbye LW, Wagner C, Reissigova J, Bernabei R; AdHOC Project Research Group. Potentially inappropriate medication use among elderly home care patients in Europe. JAMA. 2005 Mar 16;293(11):1348-58. doi: 10.1001/jama.293.11.1348.
Maio V, Yuen EJ, Novielli K, Smith KD, Louis DZ. Potentially inappropriate medication prescribing for elderly outpatients in Emilia Romagna, Italy: a population-based cohort study. Drugs Aging. 2006;23(11):915-24. doi: 10.2165/00002512-200623110-00006.
Tragni E, Casula M, Pieri V, Favato G, Marcobelli A, Trotta MG, Catapano AL. Prevalence of the prescription of potentially interacting drugs. PLoS One. 2013 Oct 11;8(10):e78827. doi: 10.1371/journal.pone.0078827. eCollection 2013.
Beers MH, Ouslander JG, Rollingher I, Reuben DB, Brooks J, Beck JC. Explicit criteria for determining inappropriate medication use in nursing home residents. UCLA Division of Geriatric Medicine. Arch Intern Med. 1991 Sep;151(9):1825-32.
Casula M, Tragni E, Catapano AL. Adherence to lipid-lowering treatment: the patient perspective. Patient Prefer Adherence. 2012;6:805-14. doi: 10.2147/PPA.S29092. Epub 2012 Nov 8.
Thomas AN, Boxall EM, Laha SK, Day AJ, Grundy D. An educational and audit tool to reduce prescribing error in intensive care. Qual Saf Health Care. 2008 Oct;17(5):360-3. doi: 10.1136/qshc.2007.023242.
Ostini R, Hegney D, Jackson C, Williamson M, Mackson JM, Gurman K, Hall W, Tett SE. Systematic review of interventions to improve prescribing. Ann Pharmacother. 2009 Mar;43(3):502-13. doi: 10.1345/aph.1L488. Epub 2009 Mar 3.
Maio V, Del Canale S, Abouzaid S; GAP Investigators. Using explicit criteria to evaluate the quality of prescribing in elderly Italian outpatients: a cohort study. J Clin Pharm Ther. 2010 Apr;35(2):219-29. doi: 10.1111/j.1365-2710.2009.01094.x.
Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, Augustovski F, Briggs AH, Mauskopf J, Loder E; ISPOR Health Economic Evaluation Publication Guidelines-CHEERS Good Reporting Practices Task Force. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health. 2013 Mar-Apr;16(2):231-50. doi: 10.1016/j.jval.2013.02.002.
Other Identifiers
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2017-002622-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FARM12KSBT
Identifier Type: -
Identifier Source: org_study_id
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