Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

2 agosto 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

302

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Albigny sur Saône, Francia
        • Non ancora reclutamento
        • Hôpital gériatrique du Mont d'Or
        • Contatto:
          • Aurélia MARFISI - DUBOST, PH
        • Sub-investigatore:
          • Ahmed SALMI, PH
      • Lyon, Francia
        • Reclutamento
        • Hopital des Charpennes
        • Contatto:
          • Pierre Krolak Salmon, PU PH

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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;

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Hospitalizations
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, 1 month, 6 months and 18 months
delay between baseline and death
Baseline, 1 month, 6 months and 18 months
Falls
Lasso di tempo: 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
Lasso di tempo: Baseline, 1 month, 6 months and 18 months
the delay between baseline and falls
Baseline, 1 month, 6 months and 18 months
Cognitive functions
Lasso di tempo: 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
Lasso di tempo: Baseline, 6 months and 18 months
Quality of life measured by questionnaire QoL-AD
Baseline, 6 months and 18 months
Quality of life 2
Lasso di tempo: Baseline, 6 months and 18 months
Quality of life measured by questionnaire EUROQOL 5D
Baseline, 6 months and 18 months
depression disorders
Lasso di tempo: Baseline, 6 months and 18 months
depression measured with the mini-GDS scale
Baseline, 6 months and 18 months
Anxiety disorders
Lasso di tempo: 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
Lasso di tempo: Baseline, 6 months and 18 months
compliance is measured with the questionnaire Girerd
Baseline, 6 months and 18 months
Pain
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospices Civils de Lyon

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2016

Completamento primario (Anticipato)

1 novembre 2020

Completamento dello studio (Anticipato)

1 novembre 2020

Date di iscrizione allo studio

Primo inviato

6 aprile 2016

Primo inviato che soddisfa i criteri di controllo qualità

14 aprile 2016

Primo Inserito (Stima)

15 aprile 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 agosto 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 agosto 2018

Ultimo verificato

1 agosto 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 69HCL15-0104

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Montenegro

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi