Clinical trial NCT03298386: Elderly Appropriate Treatment in Primary Care (EAT)
Official title: Elderly Appropriate Treatment in Primary Care (EAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Polypharmacy
Keywords: Elderly
Multimorbidity
Polypharmacy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: CIA : CNGE IRMG Association
name: CNGE : Collège National des Généralistes Enseignants
name: RMG : Institut de Recherche en Médecine Générale
First posted: 2017-10-02
Enrollment: 3032
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: A composite criterion: - percentage of unplanned hospitalization - percentage of death regardless of cause, - percentage of emergency department visit - percentage of institutionalization
timeFrame: at 12 months
Secondary outcomes:
measure: Percentage of unplanned hospitalization
timeFrame: at 12 months
measure: Percentage of death regardless of cause
timeFrame: at 12 months
measure: Percentage of emergency department visits
timeFrame: at 12 months
measure: Percentage of institutionalization
timeFrame: at 12 months
measure: Percentage of loss of autonomy
timeFrame: at 12 months
measure: Decrease in the number of drugs on the prescription (%)
timeFrame: at 12 months
measure: Percentage of falls
timeFrame: at 12 months
measure: Percentage of recommendations followed
timeFrame: at 12 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC)
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Julien Le Breton
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.