Drug UseNCT02339792
E-learning to Improve the Quality of Drug Prescribing in Hospitalized Elderly Patients
A study testing E-learning in people with Drug Use, run by Mario Negri Institute for Pharmacological Research.
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 Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Use
- What is being tested?
- E-learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 697 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Sep 2014
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- people aged 75 years or older
Who cannot join
- people aged 75 years or older
- refusal of consent to participate
- a life expectancy of less than 6 months
About this study
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
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
Read the 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.
- Conditions
- Drug Use
- Being tested
- E-learning
- Keywords
- COMPREHENSIVE GERIATRIC ASSESSMENT (CGA), MEDICATION APPROPRIATENESS PRESCRIBING, DRUG INTERACTIONS, E-LEARNING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learningOther
e-learning program of medical education, focused on teaching and implementing Comprehensive Geriatric Assessment (CGA) added to geriatric pharmacological notions (GPNs)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | e-learning program of medical education, focused on teaching and implementing Comprehensive Geriatric Assessment (CGA) added to geriatric pharmacological notions (GPNs) Receives: Other: E-learning |
| Control | Other | e-learning program of medical education, focused on teaching only geriatric pharmacological notions (GPNs) Receives: Other: E-learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Responsible party
- Principal investigator, Paola Boccardo, Mario Negri Institute for Pharmacological Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339792
- Sponsor's protocol ID
- FARM87SA2B
- Status last verified
- Jan 2015
- First submitted
- 16 Dec 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26922904
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02339792
- Acronym / sponsor ID
- FARM87SA2B
- Conditions
- Drug Use
- Keywords
- COMPREHENSIVE GERIATRIC ASSESSMENT (CGA), MEDICATION APPROPRIATENESS PRESCRIBING, DRUG INTERACTIONS, E-LEARNING
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Jan 2015 (estimated)
- 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.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: E-learninge-learning program of medical education, focused on teaching and implementing Comprehensive Geriatric Assessment (CGA) added to geriatric pharmacological notions (GPNs) |
| Control | Other | Other: E-learninge-learning program of medical education, focused on teaching only geriatric pharmacological notions (GPNs) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- people aged 75 years or older
Key exclusion criteria (3 listed)
- people aged 75 years or older
- refusal of consent to participate
- a life expectancy of less than 6 months
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 |
|---|---|---|
| E-learninge-learning program of medical education, focused on teaching and implementing Comprehensive Geriatric Assessment (CGA) added to geriatric pharmacological notions (GPNs) | Other | Control, Intervention |
Primary outcome
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.
1 secondary outcome
clinical outcomes (lenght of hospitalization, mortality, rehospitalization)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- Derived from this study: PubMed 26922904Franchi 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing E-learning in people with Drug Use, run by Mario Negri Institute for Pharmacological Research.
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 3 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: finished, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement of drug prescribing (time frame: Participants will be followed for the duration of hospital stay, an expected average of 12 days). 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 NCT02339792, which also lists 1 linked publication.
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 15 Jan 2015.