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

January 12, 2015 updated by: Paola Boccardo, Mario Negri Institute for Pharmacological Research

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

697

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of drug prescribing
Time Frame: 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.
Participants will be followed for the duration of hospital stay, an expected average of 12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical outcomes (lenght of hospitalization, mortality, rehospitalization)
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mario Negri Institute for Pharmacological Research

Collaborators

Agenzia Italiana del Farmaco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 15, 2015

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FARM87SA2B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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