Elderly Appropriate Treatment in Primary Care (EAT) (TAPAGE)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Polypharmacy; Elderly

Treatments: Other: Systematic medication review with the STOPP/START tool

Study type: Interventional

Funder types: Other

Identifiers

NCT03298386

K170305

2017- A01290 - 53 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3,032 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,032 participants in 2 patient groups

Intervention Group "STOPP/START"

Experimental group

Description:

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

Treatment:

Other: Systematic medication review with the STOPP/START tool

Control group

No Intervention group

Description:

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