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

2 augustus 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

302

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Frankrijk
      • Albigny sur Saône, Frankrijk
        • Nog niet aan het werven
        • Hôpital gériatrique du Mont d'Or
        • Contact:
          • Aurélia MARFISI - DUBOST, PH
        • Onderonderzoeker:
          • Ahmed SALMI, PH
      • Lyon, Frankrijk
        • Werving
        • Hopital des Charpennes
        • Contact:
          • Pierre Krolak Salmon, PU PH

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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;

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospices Civils de Lyon

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 mei 2016

Primaire voltooiing (Verwacht)

1 november 2020

Studie voltooiing (Verwacht)

1 november 2020

Studieregistratiedata

Eerst ingediend

6 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

14 april 2016

Eerst geplaatst (Schatting)

15 april 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 augustus 2018

Laatste update ingediend die voldeed aan QC-criteria

2 augustus 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 69HCL15-0104

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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