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

Aged Clinical Trial

— FARMA-CANP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04391218
• Other study ID #: FARMA-CANP
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: May 2021

Study information

• Verified date: March 2021
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Renata Marinello, MD, PhD
• Phone: 0116334771
• Email: rmarinello[@]cittadellasalute.to.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 89
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aged
• Multimorbidity
• Polypharmacy

Intervention

Other:
• Multidisciplinary 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino	ASL Città di Torino, Italy, Consoft Sistemi S.p.A. Turin, Italy, Infologic S.r.l., Padova, Italy, University of Turin, Italy

References & Publications (2)

By the 2019 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria® 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. — View 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. Review. Erratum in: Age Ageing. 2018 May 1;47(3):489. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

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