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

Drug-drug Interactions Clinical Trial

— PING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04710615
• Other study ID #: CHUBX 2019/33
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: May 5, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Bordeaux
• Contact: Pierre-Olivier GIRODET, MD, PhD
• Phone: +335 57 57 15 60
• Email: pierre-olivier.girodet[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 5, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Drug-drug Interactions
• Geriatric Disease

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Bordeaux, Hôpital Pellegrin	Bordeaux
France	Centre Hospitalier de Libourne - Pôle Gériatrie	Libourne
France	CHU de Bordeaux, Hôpital Xavier Arnozan	Pessac
France	CHU de Bordeaux, Hôpital Xavier Arnozan	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of STOPP criteria	Difference in the number of STOPP criteria between initial and discharge prescription	Day 1
Secondary	Number of STOPP criteria	Difference in the number of STOPP criteria between initial and discharge prescription	Month 6
Secondary	Number of START criteria	Difference in the number of START criteria between initial and discharge prescription.	Day 1
Secondary	Number of START criteria	Difference in the number of START criteria between initial and discharge prescription.	Month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of connections per week on Synapse platform by geriatricians	Number of connections per week on Synapse platform by geriatricians	Month 6