NCT04710615

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

2.6 years

First QC Date

January 8, 2021

Last Update Submit

February 1, 2024

Conditions

Drug-drug InteractionsGeriatric Disease

Keywords

DrugsartificialintelligencemedicationsElderly

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Number 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.

    Month 6

  • Number of STOPP criteria

    Day 1

  • Number of STOPP criteria

    Month 6

  • Number of START criteria

    Day 1

  • +6 more secondary outcomes

Study Arms (2)

Assistance device

EXPERIMENTAL

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

No device

NO INTERVENTION

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®, …

Interventions

Synapse platformDEVICE

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.

Assistance device

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Adults protected by law
  • Subject included in a clinical trial with an experimental treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Bordeaux, Hôpital Pellegrin

Bordeaux, 33000, France

RECRUITING

CHU de Bordeaux

Bordeaux, 33000, France

RECRUITING

Centre Hospitalier de Libourne - Pôle Gériatrie

Libourne, 33500, France

RECRUITING

CHU de Bordeaux, Hôpital Xavier Arnozan

Pessac, 33400, France

RECRUITING

CHU de Bordeaux, Hôpital Xavier Arnozan

Pessac, 33600, France

RECRUITING

Study Officials

  • Pierre-Olivier GIRODET, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Olivier GIRODET, MD, PhD

CONTACT

+335 57 57 15 60pierre-olivier.girodet@chu-bordeaux.fr

Karelle FOREST

CONTACT

+335 57 57 46 66karelle.forest@u-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 14, 2021

Study Start

October 5, 2021

Primary Completion

May 5, 2024

Study Completion

May 5, 2024

Last Updated

February 2, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)