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

2 augusti 2018 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Förväntat)

302

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Albigny sur Saône, Frankrike
        • Har inte rekryterat ännu
        • Hôpital gériatrique du Mont d'Or
        • Kontakt:
          • Aurélia MARFISI - DUBOST, PH
        • Underutredare:
          • Ahmed SALMI, PH
      • Lyon, Frankrike
        • Rekrytering
        • Hopital des Charpennes
        • Kontakt:
          • Pierre Krolak Salmon, PU PH

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

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Sponsor

Hospices Civils de Lyon

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2016

Primärt slutförande (Förväntat)

1 november 2020

Avslutad studie (Förväntat)

1 november 2020

Studieregistreringsdatum

Först inskickad

6 april 2016

Först inskickad som uppfyllde QC-kriterierna

14 april 2016

Första postat (Uppskatta)

15 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 69HCL15-0104

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