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

Sponsor

Mario Negri Institute for Pharmacological Research (Other)

Overall Status

Completed

CT.gov ID

NCT02339792

Collaborator

Agenzia Italiana del Farmaco (Other)

697

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Drug Use	Other: E-learning	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

697 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Intervention

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

Other: E-learning

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

Other: Control

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

Other: E-learning

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

Outcome Measures

Primary Outcome Measures

Improvement of drug prescribing [Participants will be followed for the duration of hospital stay, an expected average of 12 days]
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.

Secondary Outcome Measures

clinical outcomes (lenght of hospitalization, mortality, rehospitalization) [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mario Negri Institute for Pharmacological Research
Agenzia Italiana del Farmaco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paola Boccardo, MD, Mario Negri Institute for Pharmacological Research

ClinicalTrials.gov Identifier:

NCT02339792

Other Study ID Numbers:

FARM87SA2B

First Posted:

Jan 15, 2015

Last Update Posted:

Jan 15, 2015

Last Verified:

Jan 1, 2015

Keywords provided by Paola Boccardo, MD, Mario Negri Institute for Pharmacological Research

COMPREHENSIVE GERIATRIC ASSESSMENT (CGA)

MEDICATION APPROPRIATENESS PRESCRIBING

DRUG INTERACTIONS

E-LEARNING

Study Results

No Results Posted as of Jan 15, 2015