Elderly Appropriate Treatment in Primary Care (EAT)

Study Overview
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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).

Official Title
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Elderly Appropriate Treatment in Primary Care (EAT)

Conditions
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Elderly, Polypharmacy

Intervention / Treatment
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* Other: Systematic medication review with the STOPP/START tool


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group STOPP/START<br>Training of General Practitioners with the tool STOPP/START Systematic medication review by GP with STOPP/START | Other: Systematic medication review with the STOPP/START tool<br>* 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).<br>|
| No Intervention: Control group<br>Patient's usual care by the general practitioner (who will not be trained in the STOPP/START tool) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite criterion: - percentage of unplanned hospitalization - percentage of death regardless of cause, - percentage of emergency department visit - percentage of institutionalization | The 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. | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of unplanned hospitalization |  | at 12 months | 
| Percentage of death regardless of cause |  | at 12 months | 
| Percentage of emergency department visits |  | at 12 months | 
| Percentage of institutionalization |  | at 12 months | 
| Percentage of loss of autonomy | The 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. | at 12 months | 
| Decrease in the number of drugs on the prescription (%) | The decrease in the number of drugs on the prescription (Polypharmacy decrease) between baseline and 12 months of follow-up | at 12 months | 
| Percentage of falls |  | at 12 months | 
| Percentage of recommendations followed |  | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Multimorbidity, Polypharmacy