A Multidisciplinary Intervention Including a Clinical Decision Support System and an App for Drug Therapy Management in Older Patients

Study Overview
=================
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.

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

Conditions
-----------------
Polypharmacy, Multimorbidity, Aged

Intervention / Treatment
-----------------
* Other: Multidisciplinary Approach Group


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidisciplinary Approach Group<br>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. | Other: Multidisciplinary Approach Group<br>* 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.<br>|
| No Intervention: Control Group<br>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 | 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 | 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 | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clinical Decision Support System, App, Medication Adherence, Medication Reconciliation, Pharmacist, Inappropriate prescribing