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

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ClinicalTrials.gov Identifier: NCT04710615
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Drug-drug Interactions Geriatric Disease Device: Synapse platform Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of an Artificial Intelligence Platform on Inappropriate Medication Use in Older Adults
Actual Study Start Date : October 5, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


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®, …



Primary Outcome Measures :
  1. Number of patients with decrease in STOPP criteria number between initial prescription and exist prescription. [ Time Frame: Month 6 ]
    Proportion of patients with decrease in STOPP criteria number between initial prescription and exist prescription.


Secondary Outcome Measures :
  1. Number of patients with increase in START criteria number between initial prescription and exist prescription. [ Time Frame: Day 1 ]
    Proportion of patients with increase in START criteria number between initial prescription and exist prescription.

  2. Number of patients with increase in START criteria number between initial prescription and exist prescription. [ Time Frame: Month 6 ]
    Proportion of patients with increase in START criteria number between initial prescription and exist prescription.

  3. Number of STOPP criteria [ Time Frame: Day 1 ]
    Difference in the number of STOPP criteria between initial and discharge prescription

  4. Number of STOPP criteria [ Time Frame: Month 6 ]
    Difference in the number of STOPP criteria between initial and discharge prescription

  5. Number of START criteria [ Time Frame: Day 1 ]
    Difference in the number of START criteria between initial and discharge prescription.

  6. Number of START criteria [ Time Frame: Month 6 ]
    Difference in the number of START criteria between initial and discharge prescription.

  7. number of patients with decrease in contraindicated drug-drug interaction [ Time Frame: Day 1 ]
    Proportion of patients with decrease in contraindicated drug-drug interaction number between initial and discharge prescription

  8. number of patients with decrease in contraindicated drug-drug interaction [ Time Frame: Month 6 ]
    Proportion of patients with decrease in contraindicated drug-drug interaction number between initial and discharge prescription

  9. Number of patients with decrease if active pharmaceutical ingredients [ Time Frame: Day 1 ]
    Proportion of patients with decrease in number of active pharmaceutical ingredients between initial and discharge prescription

  10. Number of patients with decrease if active pharmaceutical ingredients [ Time Frame: Month 6 ]
    Proportion of patients with decrease in number of active pharmaceutical ingredients between initial and discharge prescription

  11. Number of connections per week on Synapse platform by geriatricians [ Time Frame: Month 6 ]
    Number of connections per week on Synapse platform by geriatricians



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04710615


Contacts
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Contact: Pierre-Olivier GIRODET, MD, PhD +335 57 57 15 60 pierre-olivier.girodet@chu-bordeaux.fr
Contact: Karelle FOREST +335 57 57 46 66 karelle.forest@u-bordeaux.fr

Locations
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France
CHU de Bordeaux, Hôpital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Claire ROUBAUD-BAUDRON, MD, PhD    +335 56 82 18 44    claire.roubaud@chu-bordeaux.fr   
Principal Investigator: Claire ROUBAUD-BAUDRON, MD, PhD         
CHU de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Fabrice BONNET, MD, PhD    +335 56 79 58 26    fabrice.bonnet@chu-bordeaux.fr   
Principal Investigator: Fabrice BONNET, MD,PhD         
Centre Hospitalier de Libourne - Pôle Gériatrie Recruiting
Libourne, France, 33500
Contact: Elsa ESTAQUE, MD    +335 57 55 16 03    elsa.estaque@ch-libourne.fr   
Principal Investigator: Elsa ESTAQUE, MD         
CHU de Bordeaux, Hôpital Xavier Arnozan Recruiting
Pessac, France, 33400
Contact: Claire ROUBAUD-BAUDRON, MD, PhD    +335 56 82 18 44    claire.roubaud@chu-bordeaux.fr   
Principal Investigator: Claire ROUBAUD-BAUDRON, MD, PhD         
CHU de Bordeaux, Hôpital Xavier Arnozan Recruiting
Pessac, France, 33600
Contact: Nathalie SALLES, MD, PhD    +335 57 65 65 53    nathalie.salles@chu-bordeaux.fr   
Principal Investigator: Nathalie SALLES, MD, PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Pierre-Olivier GIRODET, MD, PhD University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04710615    
Other Study ID Numbers: CHUBX 2019/33
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Drugs
artificial
intelligence
medications
Elderly