A Multidisciplinary Intervention Including a Clinical Decision Support System and an App for Drug Therapy Management in Older Patients (FARMA-CANP)
March 3, 2021 updated by: Dott.ssa RENATA MARINELLO, Azienda Ospedaliera Città della Salute e della Scienza di Torino
Applicabilità ed Efficacia di un Approccio Multi-Disciplinare Comprendente un Sistema Informatico di Supporto Per la Decisione Della Terapia di Pazienti Anziani Polipatologici
"La Casa nel Parco" (CANP) Project is a European Union and Regione Piemonte funded multidisciplinary project aimed to explore innovative technology application in older subject care. In this context, FARMA-CANP is a randomized open-label clinical trial evaluating a multidisciplinary intervention in older patients hospitalized at home. The intervention involves physicians, pharmacists, nurses and includes a Clinical Decision Support System to help the processes of therapeutic review and reconciliation, and an end-user App to support patients and/or caregivers in the daily management of drug therapy.
The main objectives of the study are to evaluate the impact of the intervention on 1) medication adherence after discharge 2) medication appropriateness.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
89
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
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient age ≥ 65 years
- Hospital at Home admission
- Presence of a caregiver
- Written informed consent signed by both the patient and the caregiver
Exclusion Criteria:
- Unavailable internet access and/or portable device to install the App on
- 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.
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
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.
|
|
NO_INTERVENTION: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with a therapeutic adherence index ≥0.8
Time Frame: 6 months after Hospital at Home discharge
|
The therapeutic adherence index is defined as the ratio of number of drug units dispensed on total number of drug units prescribed at discharge. Data on drug units dispensed will be derived from a central database of territorial pharmaceutical center of A.S.L.Città di Torino. |
6 months after Hospital at Home discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Beers' PIP
Time Frame: At Hospital at Home discharge, an average of 14 days after group allocation
|
Beers' PIPs will be identified according to the Beers' 2019 Criteria
|
At Hospital at Home discharge, an average of 14 days after group allocation
|
|
Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Screening Tool of Older People's Prescriptions (STOPP) PIP
Time Frame: At Hospital at Home discharge, an average of 14 days after group allocation
|
STOPP IPs will be identified according to the Screening Tool of Older People's Prescriptions version 2
|
At Hospital at Home discharge, an average of 14 days after group allocation
|
|
Number of potential contraindicated and/or major Drug-Drug Interactions (DDI) and number of participants with at least one potential contraindicated and/or major DDI.
Time Frame: At Hospital at Home discharge, an average of 14 days after group allocation
|
Potential contraindicated and major DDIs will be identified using the Micromedex database
|
At Hospital at Home discharge, an average of 14 days after group allocation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Renata Marinello, MD, PhD, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy
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
- 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. Erratum In: Age Ageing. 2018 May 1;47(3):489.
- 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.
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 (ANTICIPATED)
May 1, 2021
Primary Completion (ANTICIPATED)
May 1, 2021
Study Completion (ANTICIPATED)
May 1, 2021
Study Registration Dates
First Submitted
May 6, 2020
First Submitted That Met QC Criteria
May 12, 2020
First Posted (ACTUAL)
May 18, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 5, 2021
Last Update Submitted That Met QC Criteria
March 3, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FARMA-CANP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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