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ElderlyTAPAGENCT03298386

Elderly Appropriate Treatment in Primary Care (EAT)

A study testing Systematic medication review with the STOPP/START tool in people with Elderly and Polypharmacy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Elderly, Polypharmacy
What is being tested?
Systematic medication review with the STOPP/START tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,032 participants
Where
1 siteFrance
Study dates
1 Aug 2017to 1 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Créteil, 94010

Other trials in France

About this study

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.

Read the 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).

Being tested
Systematic medication review with the STOPP/START tool
Keywords
Elderly, Multimorbidity, Polypharmacy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT03298386
Study groupRoleWhat they receive
Intervention Group "STOPP/START"ExperimentalTraining of General Practitioners with the tool STOPP/START Systematic medication review by GP with STOPP/START
Receives: Other: Systematic medication review with the STOPP/START tool
Control groupNo interventionPatient's usual care by the general practitioner (who will not be trained in the STOPP/START tool)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at 12 months

Secondary outcomes (8)

  1. Percentage of unplanned hospitalization

    Measured: at 12 months

  2. Percentage of death regardless of cause

    Measured: at 12 months

  3. Percentage of emergency department visits

    Measured: at 12 months

  4. Percentage of institutionalization

    Measured: at 12 months

  5. 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.

    Measured: at 12 months

  6. 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

    Measured: at 12 months

  7. Percentage of falls

    Measured: at 12 months

  8. Percentage of recommendations followed

    Measured: at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start1 Aug 2017
  3. Primary completion1 Oct 2019
  4. Study completion1 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,032 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298386
Sponsor's protocol ID
K170305
Other IDs
2017- A01290 - 53
Acronym
TAPAGE
Status last verified
Jan 2025
First submitted
31 Jul 2017
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 25324330

  • 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.

    PubMed 23044639

  • 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.

    PubMed 21508941

  • 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.

    PubMed 24566877

  • 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.

    PubMed 25809727

  • 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.

    PubMed 40578876

Questions about this trial

What is this clinical trial studying?

A study testing Systematic medication review with the STOPP/START tool in people with Elderly and Polypharmacy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298386, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.

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