Impact of an Artificial Intelligence Platform on Inappropriate Medication Use in Older Adults (PING)

Polypharmacy in the older adults is common and promotes the risk of drug interactions. The hypothesis evoked is that a virtual platform with artificial intelligence applied to the health, and in particular to the good use of the drug, could bring aids to the doctors them of the prescription of drugs. The main objective of this study is to evaluate the impact of geriatric use of the Synapse platform on the frequency of inappropriate medication prescriptions (STOPP criteria) in discharge orders for patients 65 years of age or older hospitalized in geriatric department.

Study Overview

• Status: Recruiting
• Conditions: Drug-drug Interactions; Geriatric Disease
• Intervention / Treatment: Device: Synapse platform

Detailed Description

The French 2018-2022 National Health Strategy plan aims to reduce the proportion of potentially harmful medication use. One particular challenge is the phenomenon of polypharmacy and inappropriate medication use in elderly, which is associated to an increased risk of drug-drug interactions. Several scales and tools have been proposed to identify inappropriate drugs prescription in older adults. Among them, the STOPP / START criteria (Screening Tool of Older Persons' Prescriptions / Screening Tool to Alert to Right Treatment) are internationally recognized.

The Synapse platform offers a panel of functions that may help physicians to prescribe medications. For instance, the prescriber can interact with the Synapse platform by asking any type of question about a drug (dosage, contraindication, interaction ...) before prescription. It also allows them to take a picture of prescription. The software detects in less than 10 seconds criteria for inappropriate medication prescriptions and potential drug-drug interactions.

More precisely, the Synapse platform provides information on a particular drug or prescription analysis regarding:

• Indications, contraindications, dosage and adverse effects of drugs.
• STOPP criteria.
• START criteria.
• Associations at risk for drug-drug interactions.

Multiple new health technologies are emerging, but few of them have demonstrated their scientific and medical added value using an evidence-based medicine approach.

This clinical trial aims to validate the clinical interest of the Synapse application in a geriatric environment.

Prescriptions made by geriatricians participating in this study will be analyzed by two independent experts, including one pharmacist and one geriatrician.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre-Olivier GIRODET, MD, PhD; Phone Number: +335 57 57 15 60; Email: pierre-olivier.girodet@chu-bordeaux.fr
• Study Contact Backup: Name: Karelle FOREST; Phone Number: +335 57 57 46 66; Email: karelle.forest@u-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • CHU de Bordeaux
    • Contact: Fabrice BONNET, MD, PhD; Phone Number: +335 56 79 58 26; Email: fabrice.bonnet@chu-bordeaux.fr
    • Principal Investigator: Fabrice BONNET, MD,PhD
  • Bordeaux, France, 33000
    • Recruiting
    • CHU de Bordeaux, Hôpital Pellegrin
    • Contact: Claire ROUBAUD-BAUDRON, MD, PhD; Phone Number: +335 56 82 18 44; Email: claire.roubaud@chu-bordeaux.fr
    • Principal Investigator: Claire ROUBAUD-BAUDRON, MD, PhD
  • Libourne, France, 33500
    • Recruiting
    • Centre Hospitalier de Libourne - Pôle Gériatrie
    • Contact: Elsa ESTAQUE, MD; Phone Number: +335 57 55 16 03; Email: elsa.estaque@ch-libourne.fr
    • Principal Investigator: Elsa ESTAQUE, MD
  • Pessac, France, 33400
    • Recruiting
    • CHU de Bordeaux, Hôpital Xavier Arnozan
    • Contact: Claire ROUBAUD-BAUDRON, MD, PhD; Phone Number: +335 56 82 18 44; Email: claire.roubaud@chu-bordeaux.fr
    • Principal Investigator: Claire ROUBAUD-BAUDRON, MD, PhD
  • Pessac, France, 33600
    • Recruiting
    • CHU de Bordeaux, Hôpital Xavier Arnozan
    • Contact: Nathalie SALLES, MD, PhD; Phone Number: +335 57 65 65 53; Email: nathalie.salles@chu-bordeaux.fr
    • Principal Investigator: Nathalie SALLES, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

• Inclusion criteria:

  • Male or female age aged more than 65 years
  • Hospitalization in geriatric department at Bordeaux University Hospital or Libourne Hospital
  • Initial drug prescription with at least 2 active pharmaceutical ingredients
  • Affiliation to French social security
  • Written informed consent signed by participant and investigator

• Exclusion criteria:

  • Adults protected by law
  • Subject included in a clinical trial with an experimental treatment
  • Subject during exclusion period relative to another trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assistance device; With prescription assistance device: During the other 3 months, investigators will have the Synapse platform on different media (mobile phones, tablets, laptops and landline).	Device: Synapse platform; The Synapse platform made available to health professionals, is a virtual assistant capable of understanding the questions of natural language doctors and providing an answer by specifying the source of information used. This device also allows you to photograph a prescription and analyze it automatically to detect potential drug interactions. The Synapse platform offers a panel of functions to help the doctor to prescribe medication.
No Intervention: No device; During 3 months, investigators will not have the Synapse platform and will make their prescriptions with the usual tools which they have: Modules of help in the DxCare® software of the CHU, public database of the drugs, dictionary Vidal®, …

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with decrease in STOPP criteria number between initial prescription and exist prescription.	Proportion of patients with decrease in STOPP criteria number between initial prescription and exist prescription.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with increase in START criteria number between initial prescription and exist prescription.	Proportion of patients with increase in START criteria number between initial prescription and exist prescription.	Day 1
Number of patients with increase in START criteria number between initial prescription and exist prescription.	Proportion of patients with increase in START criteria number between initial prescription and exist prescription.	Month 6
Number of STOPP criteria	Difference in the number of STOPP criteria between initial and discharge prescription	Day 1
Number of STOPP criteria	Difference in the number of STOPP criteria between initial and discharge prescription	Month 6
Number of START criteria	Difference in the number of START criteria between initial and discharge prescription.	Day 1
Number of START criteria	Difference in the number of START criteria between initial and discharge prescription.	Month 6
number of patients with decrease in contraindicated drug-drug interaction	Proportion of patients with decrease in contraindicated drug-drug interaction number between initial and discharge prescription	Day 1
number of patients with decrease in contraindicated drug-drug interaction	Proportion of patients with decrease in contraindicated drug-drug interaction number between initial and discharge prescription	Month 6
Number of patients with decrease if active pharmaceutical ingredients	Proportion of patients with decrease in number of active pharmaceutical ingredients between initial and discharge prescription	Day 1
Number of patients with decrease if active pharmaceutical ingredients	Proportion of patients with decrease in number of active pharmaceutical ingredients between initial and discharge prescription	Month 6
Number of connections per week on Synapse platform by geriatricians	Number of connections per week on Synapse platform by geriatricians	Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Pierre-Olivier GIRODET, MD, PhD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Estimated): May 5, 2024
• Study Completion (Estimated): May 5, 2024

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; artificial; intelligence; Drugs; medications
• Other Study ID Numbers: CHUBX 2019/33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No