Elderly Appropriate Treatment in Primary Care (EAT) (TAPAGE)

October 18, 2017 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

3032

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94010
        • Recruiting
        • Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group "STOPP/START"
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
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).
No Intervention: Control group
Patient's usual care by the general practitioner (who will not be trained in the STOPP/START tool)

What is the study measuring?

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
Time Frame: 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.
at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of unplanned hospitalization
Time Frame: at 12 months
at 12 months
Percentage of death regardless of cause
Time Frame: at 12 months
at 12 months
Percentage of emergency department visits
Time Frame: at 12 months
at 12 months
Percentage of institutionalization
Time Frame: at 12 months
at 12 months
Percentage of loss of autonomy
Time Frame: 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.
at 12 months
Decrease in the number of drugs on the prescription (%)
Time Frame: at 12 months
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
Time Frame: at 12 months
at 12 months
Percentage of recommendations followed
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

CIA : CNGE IRMG Association
CNGE : Collège National des Généralistes Enseignants
RMG : Institut de Recherche en Médecine Générale

Investigators

  • Principal Investigator: Julien Le Breton, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K170305
  • 2017- A01290 - 53 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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