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

NCT04391218 | Unknown

• 1 other identifier: FARMA-CANP
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polypharmacy; Multimorbidity; Aged

Keywords

Clinical Decision Support System; App; Medication Adherence; Medication Reconciliation; Pharmacist; Inappropriate prescribing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Multidisciplinary Approach Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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).

Interventions

Multidisciplinary Approach Group OTHER

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.

Multidisciplinary Approach Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient age ≥ 65 years
• Hospital at Home admission
• Presence of a caregiver
• Written informed consent signed by both the patient and the caregiver

You may not qualify if:

• 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.

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• University of Turin, Italy: collaborator
• Infologic S.r.l., Padova, Italy: collaborator
• Consoft Sistemi S.p.A. Turin, Italy: collaborator
• ASL Città di Torino, Italy: collaborator

Related Publications (2)

• 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.

  PMID: 25324330 BACKGROUND

• 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.

  PMID: 30693946 BACKGROUND

Related Links

• Micromedex® online database. International Business Machines Corporation (IBM) Watson Health, Greenwood Village, Colorado, USA.

MeSH Terms

Conditions

Alzheimer Disease; Medication Adherence

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Renata Marinello, MD, PhD

  A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renata Marinello, MD, PhD

CONTACT

0116334771; rmarinello@cittadellasalute.to.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dirigente Medico, S.C. Geriatria e Malattie Metaboliche dell'Osso U, Ospedalizzazione a Domicilio

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 18, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share