Elderly Appropriate Treatment in Primary Care (EAT)
- Conditions
- PolypharmacyElderly
- Interventions
- Other: Systematic medication review with the STOPP/START tool
- Registration Number
- NCT03298386
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3032
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group "STOPP/START" Systematic medication review with the STOPP/START tool Training of General Practitioners with the tool STOPP/START Systematic medication review by GP with STOPP/START
- Primary Outcome Measures
Name Time Method A composite criterion: - percentage of unplanned hospitalization - percentage of death regardless of cause, - percentage of emergency department visit - percentage of institutionalization at 12 months 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.
- Secondary Outcome Measures
Name Time Method Percentage of death regardless of cause at 12 months Decrease in the number of drugs on the prescription (%) at 12 months The decrease in the number of drugs on the prescription (Polypharmacy decrease) between baseline and 12 months of follow-up
Percentage of unplanned hospitalization at 12 months Percentage of recommendations followed at 12 months Percentage of loss of autonomy at 12 months 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.
Percentage of emergency department visits at 12 months Percentage of institutionalization at 12 months Percentage of falls at 12 months
Trial Locations
- Locations (1)
Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC)
🇫🇷Créteil, France