A Multidisciplinary Intervention Including a Clinical Decision Support System and an App for Drug Therapy Management in Older Patients
NCT ID: NCT04391218
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
89 participants
INTERVENTIONAL
2021-05-31
2021-05-31
Brief Summary
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The main objectives of the study are to evaluate the impact of the intervention on 1) medication adherence after discharge 2) medication appropriateness.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Multidisciplinary Approach Group
Multidisciplinary medication review and reconciliation during hospitalization involving geriatricians, nurses, pharmacists and supported by a Clinical Decision Support System, followed by an end-user App to support patients/caregivers in the correct drug intake after discharge.
Multidisciplinary Approach Group
Geriatricians will introduce medication review data on a Clinical Decision Support System, that will help both pharmacists and physicians in medication reconciliation, highligting potentially inappropriate prescriptions according to Beers' criteria and STOPP/START criteria, and potential controindicated and major Drug-Drug Interactions according to Micromedex. Before Hospital at Home discharge, nurses will instruct patients and/or caregivers to the use of an App, where daily drug therapy at discharge will be inserted and scheduled. This App will automatically create an alert everytime a drug dose needs to be taken, alongside an image of the specific drug packaging. The App will register if and when the patient actually takes the drug, or the reason for the delayed/missed dose.
Control Group
Medication review and reconciliation will be performed by geriatricians according to Good Clinical Practice and usual habits, that might also include digital and printed supports for medication appropriateness and drug interaction. Drug therapy will be listed and explained to the patient/caregiver at discharge. Patients/caregivers will be allowed to use any tools to support medication adherence, according to their habits and preferences (i.e. calendars, alarms, pill boxes).
No interventions assigned to this group
Interventions
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Multidisciplinary Approach Group
Geriatricians will introduce medication review data on a Clinical Decision Support System, that will help both pharmacists and physicians in medication reconciliation, highligting potentially inappropriate prescriptions according to Beers' criteria and STOPP/START criteria, and potential controindicated and major Drug-Drug Interactions according to Micromedex. Before Hospital at Home discharge, nurses will instruct patients and/or caregivers to the use of an App, where daily drug therapy at discharge will be inserted and scheduled. This App will automatically create an alert everytime a drug dose needs to be taken, alongside an image of the specific drug packaging. The App will register if and when the patient actually takes the drug, or the reason for the delayed/missed dose.
Eligibility Criteria
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Inclusion Criteria
* Hospital at Home admission
* Presence of a caregiver
* Written informed consent signed by both the patient and the caregiver
Exclusion Criteria
* Severe cognitive impairment with behavioural symptoms
* Estimated life expectancy less than 3 months
* Death during Hospital at Home stay
* Hospital at Home discharge to an other healthcare facility (i.e. Emergency Department, Nursing Home)
* No regular medications precribed at Hospital at Home discharge.
65 Years
ALL
No
Sponsors
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University of Turin, Italy
OTHER
Infologic S.r.l., Padova, Italy
UNKNOWN
Consoft Sistemi S.p.A. Turin, Italy
UNKNOWN
ASL Città di Torino, Italy
UNKNOWN
A.O.U. Città della Salute e della Scienza
OTHER
Responsible Party
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Dott.ssa RENATA MARINELLO
Dirigente Medico, S.C. Geriatria e Malattie Metaboliche dell'Osso U, Ospedalizzazione a Domicilio
Principal Investigators
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Renata Marinello, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy
Central Contacts
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References
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O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16.
By the 2019 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria(R) for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019 Apr;67(4):674-694. doi: 10.1111/jgs.15767. Epub 2019 Jan 29.
Related Links
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Micromedex® online database. International Business Machines Corporation (IBM) Watson Health, Greenwood Village, Colorado, USA.
Other Identifiers
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FARMA-CANP
Identifier Type: -
Identifier Source: org_study_id
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