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

Drug Use Clinical Trial

Official title:

Effect of an Integrated E-learning Intervention, Focused on Comprehensive Geriatric Assessment to Improve the Quality of Drug Prescribing in Hospitalized Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339792
• Other study ID #: FARM87SA2B
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: January 12, 2015
• Start date: November 2012
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Description:

The integrated e-learning program (intervention group) is focused on teaching and implementing knowledge on CGA and GPNs to help clinicians to improve the quality of drug prescribing in the elderly.The GPNs is focused on pharmaco-epidemiological issues of drug prescribing, pharmacokinetic and pharmacodynamic changes during aging, topics in evaluating and managing polypharmacy, criteria to review the appropriateness of drug therapies and the clinical relevance of PDDI in the elderly. The control group receives only GPNs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 697
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• people aged 75 years or older

Exclusion Criteria:

• people aged 75 years or older

• refusal of consent to participate

• a life expectancy of less than 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Use

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	Agenzia Italiana del Farmaco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	clinical outcomes (lenght of hospitalization, mortality, rehospitalization)	Secondary objectives are the assessment of: - the impact of the integrated e-learning intervention in terms of length of hospitalization, in-hospital and overall mortality, re-hospitalization and institutionalization during a follow-up of 12 months; - the persistence and the clinical impact on the enrolled patients of the effect of the integrated e-learning intervention on the improvement of quality of drug prescribing during a follow-up of 12 months.; Secondary outcomes are the persistence and the clinical impact of the integrated e-learning intervention on duration of hospitalization, rate of in-hospital and overall mortality, re-hospitalization and institutionalization during 12 months of follow-up.	12 months	Yes