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Elderly Appropriate Treatment in Primary Care (EAT)

Elderly Appropriate Treatment in Primary Care (EAT)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03298386
Acronym
TAPAGE
Enrollment
3032
Registered
2017-10-02
Start date
2017-08-01
Completion date
2019-10-01
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Polypharmacy

Keywords

Elderly, Multimorbidity, Polypharmacy

Brief 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.

Detailed description

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).

Interventions

OTHERSystematic 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

CIA : CNGE IRMG Association
CollaboratorUNKNOWN
CNGE : Collège National des Généralistes Enseignants
CollaboratorUNKNOWN
RMG : Institut de Recherche en Médecine Générale
CollaboratorUNKNOWN
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
A composite criterion: - percentage of unplanned hospitalization - percentage of death regardless of cause, - percentage of emergency department visit - percentage of institutionalizationat 12 monthsThe primary outcome measure will be a composite criterion comprising unplanned hospitalization, death regardless of cause, emergency department visits and institutionalization after 12 months of follow-up. Unplanned hospitalization is defined as either hospitalization decided after a visit to the emergency department (whether the patient was sent by a doctor or not) or hospitalization decided on the same day by the general practitioner.

Secondary

MeasureTime frameDescription
Percentage of death regardless of causeat 12 months
Percentage of emergency department visitsat 12 months
Percentage of institutionalizationat 12 months
Percentage of unplanned hospitalizationat 12 months
Decrease in the number of drugs on the prescription (%)at 12 monthsThe decrease in the number of drugs on the prescription (Polypharmacy decrease) between baseline and 12 months of follow-up
Percentage of fallsat 12 months
Percentage of recommendations followedat 12 months
Percentage of loss of autonomyat 12 monthsThe loss of autonomy at 12 months defined by the loss of at least one activity of the daily living (ADL) between the intervention and 12 months of follow-up.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026