Elderly Appropriate Treatment in Primary Care (EAT)

Elderly Clinical Trial

— TAPAGE  

Official title:

Elderly Appropriate Treatment in Primary Care (EAT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03298386
• Other study ID #: K170305
• Secondary ID: 2017- A01290 - 5
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2017
• Last updated: October 18, 2017
• Start date: August 1, 2017
• Est. completion date: October 2019

Study information

• Verified date: October 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3032
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Polypharmacy

Intervention

Other:
• Systematic 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).

Locations

Country	Name	City	State
France	Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC)	Créteil

Sponsors (4)

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

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View Citation

Frély 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of unplanned hospitalization		at 12 months
Secondary	Percentage of death regardless of cause		at 12 months
Secondary	Percentage of emergency department visits		at 12 months
Secondary	Percentage of institutionalization		at 12 months
Secondary	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
Secondary	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
Secondary	Percentage of falls		at 12 months
Secondary	Percentage of recommendations followed		at 12 months