NCT03298386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,032

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 28, 2025

Status Verified

January 1, 2025

Enrollment Period

2.2 years

First QC Date

July 31, 2017

Last Update Submit

February 26, 2025

Conditions

ElderlyPolypharmacy

Keywords

ElderlyMultimorbidityPolypharmacy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

    at 12 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention Group "STOPP/START"

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Systematic medication review with the STOPP/START toolOTHER

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).

Intervention Group "STOPP/START"

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC)

Créteil, 94010, France

Location

Related Publications (6)

  • 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.

    PMID: 25324330BACKGROUND

  • 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.

    PMID: 23044639BACKGROUND

  • 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.

    PMID: 21508941BACKGROUND

  • 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.

    PMID: 24566877BACKGROUND

  • 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.

    PMID: 25809727BACKGROUND

  • Guellich A, Oubaya N, Cogneau J, Lacoin F, Clerc P, Audureau E, Le Breton J. Identifying patterns of multimorbidity, polypharmacy and frailty in the elderly: a clustering analysis of baseline data from a French, randomised, controlled trial in primary care. BMJ Open. 2025 Jun 27;15(6):e083584. doi: 10.1136/bmjopen-2023-083584.

    PMID: 40578876DERIVED

Study Officials

  • Julien Le Breton

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

October 2, 2017

Study Start

August 1, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

February 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Data are available upon reasonable request. Proposals should be directed to ASSISTANCE PUBLIQUE HOPITAUX DE PARIS \[AP-HP\], Department for Clinical Research, Innovation (DRCI) represented by Mr Milan LAZAREVIC,Director . To gain access, data requestors will will need to sign a data transfer agreement with the sponsor.

Locations

FR(1)