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

2. august 2018 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

302

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Albigny sur Saône, Frankrike
        • Har ikke rekruttert ennå
        • Hôpital gériatrique du Mont d'Or
        • Ta kontakt med:
          • Aurélia MARFISI - DUBOST, PH
        • Underetterforsker:
          • Ahmed SALMI, PH
      • Lyon, Frankrike
        • Rekruttering
        • Hopital des Charpennes
        • Ta kontakt med:
          • Pierre Krolak Salmon, PU PH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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 inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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Sponsor

Hospices Civils de Lyon

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2016

Primær fullføring (Forventet)

1. november 2020

Studiet fullført (Forventet)

1. november 2020

Datoer for studieregistrering

Først innsendt

6. april 2016

Først innsendt som oppfylte QC-kriteriene

14. april 2016

Først lagt ut (Anslag)

15. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2018

Sist bekreftet

1. august 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 69HCL15-0104

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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