Clinical trial NCT04391218: A Multidisciplinary Intervention Including a Clinical Decision Support System and an App for Drug Therapy Management in Older Patients
Official title: Applicabilità ed Efficacia di un Approccio Multi-Disciplinare Comprendente un Sistema Informatico di Supporto Per la Decisione Della Terapia di Pazienti Anziani Polipatologici
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polypharmacy
Multimorbidity
Aged
Keywords: Clinical Decision Support System
App
Medication Adherence
Medication Reconciliation
Pharmacist
Inappropriate prescribing
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
name: Infologic S.r.l., Padova, Italy
name: Consoft Sistemi S.p.A. Turin, Italy
name: ASL Città di Torino, Italy
First posted: 2020-05-18
Enrollment: 89
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with a therapeutic adherence index ≥0.8
timeFrame: 6 months after Hospital at Home discharge
Secondary outcomes:
measure: Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Beers' PIP
timeFrame: At Hospital at Home discharge, an average of 14 days after group allocation
measure: Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Screening Tool of Older People's Prescriptions (STOPP) PIP
timeFrame: At Hospital at Home discharge, an average of 14 days after group allocation
measure: 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.
timeFrame: At Hospital at Home discharge, an average of 14 days after group allocation
Other outcomes:
Locations:
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy
name: Renata Marinello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.