Elderly Appropriate Treatment in Primary Care (EAT)

NCT03298386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3032

Last updated 2025-02-28

No results posted yet for this study

Summary

The general practitioner (GP) is confronted, for a part of his clientele, with the management of patients suffering from multimorbidity, leading most often to a polypharmacy. It has five major consequences: increasing the number of inappropriate treatments, increasing the risk of potentially dangerous drug interactions, increasing the risk of contraindications associated with several concomitant pathologies, decreasing adherence to treatments by patients and the increased cost of care. Drug misuse in the elderly is particularly common, due to the age-related physiological changes and physiological alterations, with the consequent increase in the risk of adverse events, particularly hospitalizations. Several tools have been proposed to decrease morbimortality in elderly patients with polypharmacy. The studies concluded that the STOPP/START tool was the most structured, sensitive and had the most appropriate use format for clinical practice. However, there are currently no ambulatory studies demonstrating the impact of prescription revision with STOPP/START on the morbimortality of persons aged 75 years and over. This study aims to assess the effectiveness of an intervention targeting GPs to decrease morbimortality in elderly patients with polypharmacy. Volunteer GPs will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. The intervention consists in systematic medication review by GP with STOPP/START. In both groups, patient morbimortality will be measured at the end of the study.

Conditions

  • Elderly
  • Polypharmacy

Interventions

OTHER

Systematic medication review with the STOPP/START tool

The STOPP / START tool includes a list of 42 substances / drug classes whose prescription could be discontinued based on specific criteria (81 STOPP criteria: Screening Tool of Older Person's Prescriptions) and a list of 34 clinical situations involving consideration of the usefulness of a new prescription (START criteria: Screening Tool to Action the Right Treatment).

Sponsors & Collaborators

  • CIA : CNGE IRMG Association

    collaborator UNKNOWN
  • CNGE : Collège National des Généralistes Enseignants

    collaborator UNKNOWN
  • RMG : Institut de Recherche en Médecine Générale

    collaborator UNKNOWN
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Julien Le Breton · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-10-01
Completion
2019-10-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03298386 on ClinicalTrials.gov