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

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ClinicalTrials.gov Identifier: NCT03298386
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : October 19, 2017
Sponsor:
Collaborators:
CIA : CNGE IRMG Association
CNGE : Collège National des Généralistes Enseignants
RMG : Institut de Recherche en Médecine Générale
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Elderly Polypharmacy Other: Systematic medication review with the STOPP/START tool Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Elderly Appropriate Treatment in Primary Care (EAT)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

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)



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Percentage of unplanned hospitalization [ Time Frame: at 12 months ]
  2. Percentage of death regardless of cause [ Time Frame: at 12 months ]
  3. Percentage of emergency department visits [ Time Frame: at 12 months ]
  4. Percentage of institutionalization [ Time Frame: at 12 months ]
  5. 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.

  6. 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

  7. Percentage of falls [ Time Frame: at 12 months ]
  8. Percentage of recommendations followed [ Time Frame: at 12 months ]


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298386


Locations
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France
Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC) Recruiting
Créteil, France, 94010
Contact: Akim SOUAG    (0)1 44 84 17 15 ext +33    akim.souag@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
CIA : CNGE IRMG Association
CNGE : Collège National des Généralistes Enseignants
RMG : Institut de Recherche en Médecine Générale
Investigators
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Principal Investigator: Julien Le Breton Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03298386     History of Changes
Other Study ID Numbers: K170305
2017- A01290 - 53 ( Other Identifier: IDRCB )
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Elderly
Multimorbidity
Polypharmacy