Inappropriate Drug Prescription and UseEDUREDRUGNCT04030468
Educational and Informative Interventions to Tackle Inappropriate Use of Drugs in Italy
A study testing Educational intervention addressed to general practitioners and Informative intervention addressed to patients in people with Inappropriate Drug Prescription and Use, run by University of Milan at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inappropriate Drug Prescription and Use
- What is being tested?
- Educational intervention addressed to general practitioners and Informative intervention addressed to patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,840 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2017to Apr 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- primary care pediatricians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Informative and/or Educational Interventions Aimed at Improving the Appropriate Use of Drugs Designed for General Practitioners and Their Patients
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.
Read the detailed 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).
- Conditions
- Inappropriate Drug Prescription and Use
- Being tested
- Educational intervention addressed to general practitioners, Informative intervention addressed to patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention addressed to general practitionersOther
- 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 patientsOther
- leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use
| Study group | Role | What they receive |
|---|---|---|
| General practitioners | Experimental | Educational intervention Receives: Other: Educational intervention addressed to general practitioners |
| Patients | Experimental | Informative intervention Receives: Other: Informative intervention addressed to patients |
| General practitioners and patients | Experimental | Combined strategy Receives: Other: Educational intervention addressed to general practitioners; Other: Informative intervention addressed to patients |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 months
Secondary outcomes (3)
Predictive factors of inappropriate prescribing
Identification of predictors of poor prescription appropriateness
Measured: 30-36 months
Health Technology Assessment of intervention implemented
HTA analysis
Measured: 30-36 months
GP's satisfaction
Level of general practitioners (GPs) satisfaction by using ad hoc web-based questionnaire
Measured: 30-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start20 Apr 2017
- Primary completionOct 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Inappropriate Drug Prescription and UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- According to the Local Health Unit (LHU), general practitioners (GPs) with their patients will be assigned to one of the following intervention arms: 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)
- Masking
- None (open label)
- Enrolment
- 4,840 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, University of Milano Bicocca
- Responsible party
- Principal investigator, Elena Tragni, University of Milan
- Investigators
- Alberico L Catapano, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030468
- Sponsor's protocol ID
- FARM12KSBT
- Other IDs
- 2017-002622-21, 2017
- Acronym
- EDUREDRUG
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18809816Buetow 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.
PubMed 9225413Spinewine 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.
PubMed 17630041Goulding 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.
PubMed 14769626Fialova 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.
PubMed 15769968Maio 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.
PubMed 17109569Tragni 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.
PubMed 24147143Beers 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.
PubMed 1888249Casula 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.
PubMed 23152673Thomas 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.
PubMed 18842975Ostini 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.
PubMed 19261953Maio 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.
PubMed 20456742Husereau 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.
PubMed 23538175
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Informative and/or Educational Interventions Aimed at Improving the Appropriate Use of Drugs Designed for General Practitioners and Their Patients
- ClinicalTrials.gov ID
- NCT04030468
- Acronym / sponsor ID
- EDUREDRUG / FARM12KSBT
- Conditions
- Inappropriate Drug Prescription and Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,840 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Federico II University, University of Milano Bicocca
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- According to the Local Health Unit (LHU), general practitioners (GPs) with their patients will be assigned to one of the following intervention arms: 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)
| Arm | Type | Receives |
|---|---|---|
| General practitioners | Experimental | Other: Educational intervention addressed to general practitionersEducational intervention |
| Patients | Experimental | Other: Informative intervention addressed to patientsInformative intervention |
| General practitioners and patients | Experimental | Other: Educational intervention addressed to general practitioners, Other: Informative intervention addressed to patientsCombined strategy |
| Control | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- primary care pediatricians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | General practitioners, General practitioners and patients |
| Informative intervention addressed to patients• leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use | Other | General practitioners and patients, Patients |
Primary outcome
Inappropriate drug prescription and use indicators
Time frame: 30 months
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
3 secondary outcomes
Predictive factors of inappropriate prescribing
Time frame: 30-36 months
Health Technology Assessment of intervention implemented
Time frame: 30-36 months
GP's satisfaction
Time frame: 30-36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Background: PubMed 18809816Leendertse 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.
- Background: PubMed 9225413Buetow 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.
- Background: PubMed 17630041Spinewine 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.
- Background: PubMed 14769626Goulding 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.
- Background: PubMed 15769968Fialova 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.
- Background: PubMed 17109569Maio 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.
- Background: PubMed 24147143Tragni 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.
- Background: PubMed 1888249Beers 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.
- Background: PubMed 23152673Casula 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.
- Background: PubMed 18842975Thomas 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.
- Background: PubMed 19261953Ostini 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.
- Background: PubMed 20456742Maio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberico L Catapano principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention addressed to general practitioners and Informative intervention addressed to patients in people with Inappropriate Drug Prescription and Use, run by University of Milan at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 24 Jul 2019. 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 Italy. 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?
Results are not available in the source record.
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?
Inappropriate drug prescription and use indicators (time frame: 30 months). 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 NCT04030468, which also lists 13 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 24 Jul 2019.