<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03298386</url>
  </required_header>
  <id_info>
    <org_study_id>K170305</org_study_id>
    <secondary_id>2017- A01290 - 53</secondary_id>
    <nct_id>NCT03298386</nct_id>
  </id_info>
  <brief_title>Elderly Appropriate Treatment in Primary Care (EAT)</brief_title>
  <acronym>TAPAGE</acronym>
  <official_title>Elderly Appropriate Treatment in Primary Care (EAT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CIA : CNGE IRMG Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CNGE : Collège National des Généralistes Enseignants</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RMG : Institut de Recherche en Médecine Générale</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The general practitioner (GP) is confronted, for a part of his clientele, with the management&#xD;
      of patients suffering from multimorbidity, leading most often to a polypharmacy. It has five&#xD;
      major consequences: increasing the number of inappropriate treatments, increasing the risk of&#xD;
      potentially dangerous drug interactions, increasing the risk of contraindications associated&#xD;
      with several concomitant pathologies, decreasing adherence to treatments by patients and the&#xD;
      increased cost of care. Drug misuse in the elderly is particularly common, due to the&#xD;
      age-related physiological changes and physiological alterations, with the consequent increase&#xD;
      in the risk of adverse events, particularly hospitalizations. Several tools have been&#xD;
      proposed to decrease morbimortality in elderly patients with polypharmacy. The studies&#xD;
      concluded that the STOPP/START tool was the most structured, sensitive and had the most&#xD;
      appropriate use format for clinical practice. However, there are currently no ambulatory&#xD;
      studies demonstrating the impact of prescription revision with STOPP/START on the&#xD;
      morbimortality of persons aged 75 years and over. This study aims to assess the effectiveness&#xD;
      of an intervention targeting GPs to decrease morbimortality in elderly patients with&#xD;
      polypharmacy. Volunteer GPs will be randomly assigned to either the intervention group or to&#xD;
      usual care (control group) and they will be followed one year. The intervention consists in&#xD;
      systematic medication review by GP with STOPP/START. In both groups, patient morbimortality&#xD;
      will be measured at the end of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      STOPP/START criteria for potential inappropriate prescribing in older people recognise the&#xD;
      dual nature of inappropriate prescribing by including a list of potentially inappropriate&#xD;
      medications (STOPP criteria) and potential prescribing omissions (START criteria).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A composite criterion: - percentage of unplanned hospitalization - percentage of death regardless of cause, - percentage of emergency department visit - percentage of institutionalization</measure>
    <time_frame>at 12 months</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of unplanned hospitalization</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of death regardless of cause</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of emergency department visits</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of institutionalization</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of loss of autonomy</measure>
    <time_frame>at 12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in the number of drugs on the prescription (%)</measure>
    <time_frame>at 12 months</time_frame>
    <description>The decrease in the number of drugs on the prescription (Polypharmacy decrease) between baseline and 12 months of follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of falls</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of recommendations followed</measure>
    <time_frame>at 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3032</enrollment>
  <condition>Elderly</condition>
  <condition>Polypharmacy</condition>
  <arm_group>
    <arm_group_label>Intervention Group &quot;STOPP/START&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training of General Practitioners with the tool STOPP/START Systematic medication review by GP with STOPP/START</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient's usual care by the general practitioner (who will not be trained in the STOPP/START tool)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Systematic medication review with the STOPP/START tool</intervention_name>
    <description>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).</description>
    <arm_group_label>Intervention Group &quot;STOPP/START&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient 75 years of age or older&#xD;
&#xD;
          -  With polypharmacy (≥ 5 medications)&#xD;
&#xD;
          -  Not institutionalized&#xD;
&#xD;
          -  Patient affiliated with the French health care system&#xD;
&#xD;
          -  Oral consent given to participate in the study&#xD;
&#xD;
          -  Patient who can be followed up 12 months&#xD;
&#xD;
          -  Patient visiting the GP for any reason&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient protected by law (under guardianship or curatorship)&#xD;
&#xD;
          -  Having an estimated life expectancy of less than 12 months&#xD;
&#xD;
          -  Participating in a therapeutic trial during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julien Le Breton</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC)</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Akim SOUAG</last_name>
      <phone>(0)1 44 84 17 15</phone>
      <phone_ext>+33</phone_ext>
      <email>akim.souag@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <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. Erratum In: Age Ageing. 2018 May 1;47(3):489.</citation>
    <PMID>25324330</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23044639</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21508941</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24566877</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25809727</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>Multimorbidity</keyword>
  <keyword>Polypharmacy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03298386
org study id: K170305
secondary id: 2017- A01290 - 53
nct id: NCT03298386
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
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
description: 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.
measure: Percentage of unplanned hospitalization
time frame: at 12 months
measure: Percentage of death regardless of cause
time frame: at 12 months
measure: Percentage of emergency department visits
time frame: at 12 months
measure: Percentage of institutionalization
time frame: at 12 months
measure: Percentage of loss of autonomy
time frame: at 12 months
description: 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.
measure: Decrease in the number of drugs on the prescription (%)
time frame: at 12 months
description: The decrease in the number of drugs on the prescription (Polypharmacy decrease) between baseline and 12 months of follow-up
measure: Percentage of falls
time frame: at 12 months
measure: Percentage of recommendations followed
time frame: at 12 months
arm group label: Intervention Group "STOPP/START"
arm group type: Experimental
description: Training of General Practitioners with the tool STOPP/START Systematic medication review by GP with STOPP/START
arm group label: Control group
arm group type: No Intervention
description: Patient's usual care by the general practitioner (who will not be trained in the STOPP/START tool)
intervention type: Other
intervention name: Systematic medication review with the STOPP/START tool
description: 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).
arm group label: Intervention Group "STOPP/START"
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Julien Le Breton
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
status: Recruiting
contact: 
country: France
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. Erratum In: Age Ageing. 2018 May 1;47(3):489.
PMID: 25324330
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.
PMID: 23044639
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.
PMID: 21508941
citation: 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: 24566877
citation: 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: 25809727
responsible party type: Sponsor
sharing ipd: Undecided