E-learning to Improve the Quality of Drug Prescribing in Hospitalized Elderly Patients

NCT02339792 | Completed DMC

• 1 other identifier: FARM87SA2B
• Study Type: interventional
• Target: 697
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled pragmatic study is aimed to set-up, assess and implement an integrated e-learning program of medical education in an hospital setting, focused on teaching and implementing CGA added to geriatric pharmacological notions (GPNs) to improve the quality of drug prescribing in elderly patients

Conditions

Drug Use

Keywords

COMPREHENSIVE GERIATRIC ASSESSMENT (CGA); MEDICATION APPROPRIATENESS PRESCRIBING; DRUG INTERACTIONS; E-LEARNING

Outcome Measures

Primary Outcomes (1)

• Improvement of drug prescribing

  The primary study objective is to evaluate whether an integrated e-learning program of medical education, focused on teaching and implementing CGA added to GPNs (intervention) is superior to delivering GPNs only (control) in reducing the prescription of potentially inappropriate medications (PID) or of potential drug-drug interactions (PDDI) during hospitalization and at hospital discharge in hospitalized elderly. The primary outcome is the change in prescription of PID,as defined by Beers' criteria , or of PDDI related to the 20 drugs most frequently prescribed during hospital stay and at discharge.

  Participants will be followed for the duration of hospital stay, an expected average of 12 days

Secondary Outcomes (1)

• clinical outcomes (lenght of hospitalization, mortality, rehospitalization)

  12 months

Study Arms (2)

Intervention

OTHER

e-learning program of medical education, focused on teaching and implementing Comprehensive Geriatric Assessment (CGA) added to geriatric pharmacological notions (GPNs)

Other: E-learning

Control

OTHER

e-learning program of medical education, focused on teaching only geriatric pharmacological notions (GPNs)

Other: E-learning

Interventions

E-learning OTHER

e-learning program of medical education, focused on teaching and implementing Comprehensive Geriatric Assessment (CGA) added to geriatric pharmacological notions (GPNs)

Control; Intervention

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• people aged 75 years or older

You may not qualify if:

• people aged 75 years or older
• refusal of consent to participate
• a life expectancy of less than 6 months

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• Agenzia Italiana del Farmaco: collaborator

Related Publications (1)

• Franchi C, Tettamanti M, Djade CD, Pasina L, Mannucci PM, Onder G, Gussoni G, Manfellotto D, Bonassi S, Salerno F, Nobili A; ELICADHE Investigators. E-learning in order to improve drug prescription for hospitalized older patients: a cluster-randomized controlled study. Br J Clin Pharmacol. 2016 Jul;82(1):53-63. doi: 10.1111/bcp.12922. Epub 2016 Apr 5.

  PMID: 26922904 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 15, 2015
• Study Start: November 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2015-01