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Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations (OPTIM)

2. august 2018 opdateret af: Hospices Civils de Lyon

Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations and Living at Home

Aging is often associated with multiple chronic conditions conducting increased consumption of drugs. Drug therapy is necessary for the treatment of many diseases. However, misuse of drugs, particularly linked to the potentially inappropriate prescribing and polypharmacy, increases the iatrogenic risks and can lead to adverse events such as falls, cognitive decline, increased use to the health system: hospital admissions, emergency room visits, and institutionalization. These problems are common since about 20% of emergency room use in elderly patients due to an adverse event related to drugs. Nearly 28% of adverse events related to drug prescriptions could be avoided.

Interventions to optimize drug therapy showed a reduction in the number of potentially inappropriate medications, but their impact on health, has rarely been evaluated. If an association with death has been established, the link with the loss of functional autonomy, which leads to reduced quality of life and significant cost of care, has not been investigated. The evolution towards functional disabilities, frequent with aging has many causes, among which some could be prevented. The optimization of drug prescriptions could thereby delay or prevent the loss of functional autonomy by reducing the risk of adverse events, such as falls or cognitive decline and improving the management of chronic diseases. Our hypothesis is that an optimization program of the drug prescribing may slow progression to functional dependence. To assess the effect of the optimization program of drug prescribing on the level of functional autonomy, a multicenter Randomized Controlled Trial will be conducted in geriatric and memory consultations.

Expected results The implementation of the "OPTIM" program should enable optimization of drug prescribing in elderly patients and therefore slow or prevent progression to addiction. It should also help to develop and strengthen collaboration and communication between the team of geriatric consultation, the clinician pharmacist and referring physicians in town (private practice). In addition, pharmaceutical notice sent to referring physicians should help raise awareness of the prescription of drugs in these patients.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

302

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Albigny sur Saône, Frankrig
        • Ikke rekrutterer endnu
        • Hôpital gériatrique du Mont d'Or
        • Kontakt:
          • Aurélia MARFISI - DUBOST, PH
        • Underforsker:
          • Ahmed SALMI, PH
      • Lyon, Frankrig
        • Rekruttering
        • Hopital des Charpennes
        • Kontakt:
          • Pierre Krolak Salmon, PU PH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients aged 65 and over;
  • Patients received for the first time in a geriatric or memory consultation of a study recruiting centers;
  • Patients living at home;
  • Patients with the ability to express themselves orally or in writing in French sufficiently to carry out clinical assessments;
  • Patients who led the last drugs prescription from his referring physician, at the geriatric/memory consultation (in current practice, patients should take the last prescription established by the referring physician);
  • Patients accompanied by a caregiver.

Exclusion Criteria:

  • Patients with no discernment;
  • Patient put under legal protection;

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Optimization of drug prescribing
The group with optimization program will have: (i) a medical history of the drug prescribing; (ii) analysis and pharmaceutical recommendations and (iii) preparation of a management plan. Notices will be sent only to referring physicians in this experimental group.
Andet: Optimization of drug prescribing
The patients included in this group will have the intervention. The optimization of drug prescribing consists to a history of the drugs prescribing leading to pharmaceutical recommendations by the pharmacist-clinician, accepted by the specialist physicians in charge of the patient at the hospital and sent to the referring physicians of patients, who can accept or not the recommendations.
Ingen indgriben: No intervention
This group will receive the current management of patients in geriatric or memory consultation, during which the intervention of a clinician pharmacist is not provided. There will be a history of the drugs prescribing leading to pharmaceutical recommendations by the pharmacist-clinician, accepted by the specialist physicians in charge of the patient at the hospital, but the recommendations will not be transmitted to the referring physicians of patients.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Tidsramme: At inclusion

The primary outcome will be calculated using the 4 successive evaluations of IADL scale.

The IADL scale assesses the level of functional autonomy of a patient through the assessment of instrumental activities of daily living: ability to use the telephone, transportation, shopping, managing medications, manage a budget, prepare meals, maintain the house and do the laundry. The rating scale provides a score from 0 to 8. A higher score indicates a higher level of dependency, while a lower score reflects a lower level of dependence. The IADL scale consists of 8 questions.
At inclusion
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Tidsramme: At 1 month
The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
At 1 month
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Tidsramme: At 6 months
The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
At 6 months
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Tidsramme: At 18 months
The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
At 18 months
The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
Tidsramme: At inclusion

The primary outcome will be calculated using the 4 successive evaluations of DAD-6 scale.

The scale DAD-6 assesses the patient's activities in his daily life. It includes six questions assessing the degree of autonomy for the following activities: Food, use the telephone or the computer, moving outside, finance and correspondence, medications, leisure and home maintenance. The score ranges from 0 to 18 points, the higher the score, the more the patient is autonomous.
At inclusion
The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
Tidsramme: At 1 month

The primary outcome will be calculated using the 4 successive evaluations of DAD-6 scale.

The scale DAD-6 assesses the patient's activities in his daily life. It includes six questions assessing the degree of autonomy for the following activities: Food, use the telephone or the computer, moving outside, finance and correspondence, medications, leisure and home maintenance. The score ranges from 0 to 18 points, the higher the score, the more the patient is autonomous.
At 1 month
The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
Tidsramme: At 6 months

The primary outcome will be calculated using the 4 successive evaluations of DAD-6 scale.

The scale DAD-6 assesses the patient's activities in his daily life. It includes six questions assessing the degree of autonomy for the following activities: Food, use the telephone or the computer, moving outside, finance and correspondence, medications, leisure and home maintenance. The score ranges from 0 to 18 points, the higher the score, the more the patient is autonomous.
At 6 months
The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
Tidsramme: At 18 months

The primary outcome will be calculated using the 4 successive evaluations of DAD-6 scale.

The scale DAD-6 assesses the patient's activities in his daily life. It includes six questions assessing the degree of autonomy for the following activities: Food, use the telephone or the computer, moving outside, finance and correspondence, medications, leisure and home maintenance. The score ranges from 0 to 18 points, the higher the score, the more the patient is autonomous.
At 18 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Hospitalizations
Tidsramme: Baseline, 1 month, 6 months and 18 months
the occurrence of hospitalizations within 18 months after baseline
Baseline, 1 month, 6 months and 18 months
Number of days before hospitalizations
Tidsramme: Baseline, 1 month, 6 months and 18 months
delay between baseline and the hospitalization
Baseline, 1 month, 6 months and 18 months
Occurrence of recourse to emergency service
Tidsramme: Baseline, 1 month, 6 months and 18 months
occurrence of recourse to emergency service within 18 months after baseline
Baseline, 1 month, 6 months and 18 months
Number of days before the recourse to emergency service
Tidsramme: Baseline, 1 month, 6 months and 18 months
delay between baseline and the recourse to emergency service
Baseline, 1 month, 6 months and 18 months
The occurrence of admission in institution
Tidsramme: Baseline, 1 month, 6 months and 18 months
the occurrence of admission in institution within 18 months after baseline
Baseline, 1 month, 6 months and 18 months
Number of days before admission in institution
Tidsramme: Baseline, 1 month, 6 months and 18 months
delay between baseline and the admission in institution
Baseline, 1 month, 6 months and 18 months
Death
Tidsramme: Baseline, 1 month, 6 months and 18 months
the occurrence of death within 18 months after baseline
Baseline, 1 month, 6 months and 18 months
Number of days before death
Tidsramme: Baseline, 1 month, 6 months and 18 months
delay between baseline and death
Baseline, 1 month, 6 months and 18 months
Falls
Tidsramme: Baseline, 1 month, 6 months and 18 months
the occurrence of falls within 18 months after baseline
Baseline, 1 month, 6 months and 18 months
Number of days before falls
Tidsramme: Baseline, 1 month, 6 months and 18 months
the delay between baseline and falls
Baseline, 1 month, 6 months and 18 months
Cognitive functions
Tidsramme: Baseline, 6 months and 18 months
The cognitive function is measured by the Mini Mental State Examination (MMSE) at every visit, as part of the routine care pathway of the patient. Successive scores will be used to measure the evolution of MMSE.
Baseline, 6 months and 18 months
Quality of life 1
Tidsramme: Baseline, 6 months and 18 months
Quality of life measured by questionnaire QoL-AD
Baseline, 6 months and 18 months
Quality of life 2
Tidsramme: Baseline, 6 months and 18 months
Quality of life measured by questionnaire EUROQOL 5D
Baseline, 6 months and 18 months
depression disorders
Tidsramme: Baseline, 6 months and 18 months
depression measured with the mini-GDS scale
Baseline, 6 months and 18 months
Anxiety disorders
Tidsramme: Baseline, 6 months and 18 months
Anxiety disorders will be measured with the Hamilton scale
Baseline, 6 months and 18 months
Compliance of patients with treatment
Tidsramme: Baseline, 6 months and 18 months
compliance is measured with the questionnaire Girerd
Baseline, 6 months and 18 months
Pain
Tidsramme: Baseline, 6 months and 18 months
Pain is measured with an ordinal scale from 0 to 10
Baseline, 6 months and 18 months
Proportion of potential inappropriate medication
Tidsramme: Baseline, 1 month, 6 months and 18 months
The proportion of potential inappropriate medication will be measured on the drug prescribing of the patients issued from the referring physician
Baseline, 1 month, 6 months and 18 months
Problems associated with drug therapy
Tidsramme: Baseline, 1 month, 6 months and 18 months
The proportion of problems associated with drug therapy will be measured on the drugs prescribing of the patients issued from the referring physician
Baseline, 1 month, 6 months and 18 months
acceptance rate by the referring physicians of pharmaceutical recommendation
Tidsramme: Baseline, 1 month, 6 months and 18 months

The acceptance rate of the pharmaceutical review will be evaluated in 2 complementary ways:

  • By comparing patients' prescriptions issued by the referring physician before and after the pharmaceutical review.
  • By interviewing the referring physician
Baseline, 1 month, 6 months and 18 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospices Civils de Lyon

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2016

Primær færdiggørelse (Forventet)

1. november 2020

Studieafslutning (Forventet)

1. november 2020

Datoer for studieregistrering

Først indsendt

6. april 2016

Først indsendt, der opfyldte QC-kriterier

14. april 2016

Først opslået (Skøn)

15. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 69HCL15-0104

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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