Elderly Appropriate Treatment in Primary Care (EAT)

NCT ID: NCT03298386

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3032 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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STOPP/START criteria for potential inappropriate prescribing in older people recognise the dual nature of inappropriate prescribing by including a list of potentially inappropriate medications (STOPP criteria) and potential prescribing omissions (START criteria).

Conditions

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Elderly Polypharmacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Group "STOPP/START"

Training of General Practitioners with the tool STOPP/START Systematic medication review by GP with STOPP/START

Group Type EXPERIMENTAL

Systematic medication review with the STOPP/START tool

Intervention Type OTHER

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).

Control group

Patient's usual care by the general practitioner (who will not be trained in the STOPP/START tool)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient 75 years of age or older
* With polypharmacy (≥ 5 medications)
* Not institutionalized
* Patient affiliated with the French health care system
* Oral consent given to participate in the study
* Patient who can be followed up 12 months
* Patient visiting the GP for any reason

Exclusion Criteria

* Patient protected by law (under guardianship or curatorship)
* Having an estimated life expectancy of less than 12 months
* Participating in a therapeutic trial during the study period
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CIA : CNGE IRMG Association

UNKNOWN

Sponsor Role collaborator

CNGE : Collège National des Généralistes Enseignants

UNKNOWN

Sponsor Role collaborator

RMG : Institut de Recherche en Médecine Générale

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien Le Breton

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC)

Créteil, , France

Site Status

Countries

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France

References

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O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16.

Reference Type BACKGROUND
PMID: 25324330 (View on PubMed)

Dalleur O, Spinewine A, Henrard S, Losseau C, Speybroeck N, Boland B. Inappropriate prescribing and related hospital admissions in frail older persons according to the STOPP and START criteria. Drugs Aging. 2012 Oct;29(10):829-37. doi: 10.1007/s40266-012-0016-1.

Reference Type BACKGROUND
PMID: 23044639 (View on PubMed)

Gallagher PF, O'Connor MN, O'Mahony D. Prevention of potentially inappropriate prescribing for elderly patients: a randomized controlled trial using STOPP/START criteria. Clin Pharmacol Ther. 2011 Jun;89(6):845-54. doi: 10.1038/clpt.2011.44. Epub 2011 Apr 20.

Reference Type BACKGROUND
PMID: 21508941 (View on PubMed)

Dalleur O, Boland B, Losseau C, Henrard S, Wouters D, Speybroeck N, Degryse JM, Spinewine A. Reduction of potentially inappropriate medications using the STOPP criteria in frail older inpatients: a randomised controlled study. Drugs Aging. 2014 Apr;31(4):291-8. doi: 10.1007/s40266-014-0157-5.

Reference Type BACKGROUND
PMID: 24566877 (View on PubMed)

Frely A, Chazard E, Pansu A, Beuscart JB, Puisieux F. Impact of acute geriatric care in elderly patients according to the Screening Tool of Older Persons' Prescriptions/Screening Tool to Alert doctors to Right Treatment criteria in northern France. Geriatr Gerontol Int. 2016 Feb;16(2):272-8. doi: 10.1111/ggi.12474. Epub 2015 Mar 21.

Reference Type BACKGROUND
PMID: 25809727 (View on PubMed)

Guellich A, Oubaya N, Cogneau J, Lacoin F, Clerc P, Audureau E, Le Breton J. Identifying patterns of multimorbidity, polypharmacy and frailty in the elderly: a clustering analysis of baseline data from a French, randomised, controlled trial in primary care. BMJ Open. 2025 Jun 27;15(6):e083584. doi: 10.1136/bmjopen-2023-083584.

Reference Type DERIVED
PMID: 40578876 (View on PubMed)

Other Identifiers

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2017- A01290 - 53

Identifier Type: OTHER

Identifier Source: secondary_id

K170305

Identifier Type: -

Identifier Source: org_study_id

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