Educational and Informative Interventions to Tackle Inappropriate Use of Drugs in Italy

Inappropriate Drug Prescription and Use Clinical Trial

— EDUREDRUG  

Official title:

Effectiveness of Informative and/or Educational Interventions Aimed at Improving the Appropriate Use of Drugs Designed for General Practitioners and Their Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04030468
• Other study ID #: FARM12KSBT
• Secondary ID: 2017-002622-21
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: April 2020

Study information

• Verified date: July 2019
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pharmacological intervention is an essential step in health promotion. However, lots of drugs are often used in inappropriate ways, especially in elderly patients. This study is aiming at evaluating the effectiveness of educational and/or informative interventions addressed to general practitioners and their adult patients in Italy, in order to improve appropriateness of prescribing in primary care.

Description:

EDU.RE.DRUG project is a prospective, multicentre, open‐label, parallel‐arm, controlled, pragmatic trial directed to general practitioners (GPs) and their patients from two Italian regions (Campania and Lombardy), with the objective of investigating the practice of prescribing among GPs to highlight the most frequent events of inappropriateness and to implement ad hoc interventions for GPs and patients.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4840
• Est. completion date: April 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• general practitioners of the Italian National Health System (NHS) operating at December 31, 2016 belonging to the 8 Local Health Units involved in the project

Exclusion Criteria:

• primary care pediatricians

Related Conditions & MeSH terms

• Inappropriate Drug Prescription and Use

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	SEFAP, University of Milan	Milan	MI

Sponsors (3)

Lead Sponsor	Collaborator
University of Milan	Federico II University, University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (13)

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. Review. — View Citation

Buetow SA, Sibbald B, Cantrill JA, Halliwell S. Appropriateness in health care: application to prescribing. Soc Sci Med. 1997 Jul;45(2):261-71. Review. — View Citation

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. — View Citation

Fialová D, Topinková E, Gambassi G, Finne-Soveri H, Jónsson PV, Carpenter I, Schroll M, Onder G, Sørbye LW, Wagner C, Reissigová 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. — View Citation

Goulding MR. Inappropriate medication prescribing for elderly ambulatory care patients. Arch Intern Med. 2004 Feb 9;164(3):305-12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: PLoS One.2013;8(11). doi:10.1371/annotation/01652378-8216-4387-9b89-a43429707cae. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inappropriate drug prescription and use indicators	Changes in prevalences of selected potentially inappropriate prescribing (including drug-drug interactions, duplicate therapies, inappropriate drugs in older people and drugs with high anticholinergic and sedative burden), consumption and adherence indicators between baseline and after the intervention	30 months
Secondary	Predictive factors of inappropriate prescribing	Identification of predictors of poor prescription appropriateness	30-36 months
Secondary	Health Technology Assessment of intervention implemented	HTA analysis	30-36 months
Secondary	GP's satisfaction	Level of general practitioners (GPs) satisfaction by using ad hoc web-based questionnaire	30-36 months