Clinical trial NCT04710615: Impact of an Artificial Intelligence Platform on Inappropriate Medication Use in Older Adults
Official title: Impact of an Artificial Intelligence Platform on Inappropriate Medication Use in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug-drug Interactions
Geriatric Disease
Keywords: Drugs
artificial
intelligence
medications
Elderly
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: * 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

Primary outcomes:
measure: Number of patients with decrease in STOPP criteria number between initial prescription and exist prescription.
timeFrame: Month 6
Secondary outcomes:
measure: Number of patients with increase in START criteria number between initial prescription and exist prescription.
timeFrame: Day 1
measure: Number of patients with increase in START criteria number between initial prescription and exist prescription.
timeFrame: Month 6
measure: Number of STOPP criteria
timeFrame: Day 1
measure: Number of STOPP criteria
timeFrame: Month 6
measure: Number of START criteria
timeFrame: Day 1
measure: Number of START criteria
timeFrame: Month 6
measure: number of patients with decrease in contraindicated drug-drug interaction
timeFrame: Day 1
measure: number of patients with decrease in contraindicated drug-drug interaction
timeFrame: Month 6
measure: Number of patients with decrease if active pharmaceutical ingredients
timeFrame: Day 1
measure: Number of patients with decrease if active pharmaceutical ingredients
timeFrame: Month 6
measure: Number of connections per week on Synapse platform by geriatricians
timeFrame: Month 6
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hôpital Pellegrin
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Libourne
country: France
facility: Centre Hospitalier de Libourne - Pôle Gériatrie
city: Pessac
country: France
facility: CHU de Bordeaux, Hôpital Xavier Arnozan
city: Pessac
country: France
facility: CHU de Bordeaux, Hôpital Xavier Arnozan
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre-Olivier GIRODET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: