Aged, Multimorbidity, Polypharmacy
Conditions
Keywords
Clinical Decision Support System, App, Medication Adherence, Medication Reconciliation, Pharmacist, Inappropriate prescribing
Brief summary
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.
Interventions
OTHERMultidisciplinary 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.
Sponsors
University of Turin, Italy
Infologic S.r.l., Padova, Italy
Consoft Sistemi S.p.A. Turin, Italy
ASL Città di Torino, Italy
A.O.U. Città della Salute e della Scienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a therapeutic adherence index ≥0.8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Beers' PIP | At Hospital at Home discharge, an average of 14 days after group allocation | Beers' PIPs will be identified according to the Beers' 2019 Criteria |
| Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Screening Tool of Older People's Prescriptions (STOPP) PIP | 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 |
| 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. | 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 |
Contacts
Primary ContactRenata Marinello, MD, PhD
Outcome results
None listed