Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations (OPTIM)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Albigny sur Saône, Francia
- Aún no reclutando
- Hôpital gériatrique du Mont d'Or
-
Contacto:
- Aurélia MARFISI - DUBOST, PH
-
Sub-Investigador:
- Ahmed SALMI, PH
-
Lyon, Francia
- Reclutamiento
- Hopital des Charpennes
-
Contacto:
- Pierre Krolak Salmon, PU PH
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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;
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
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.
|
|
Sin intervención: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Hospitalizations
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, 1 month, 6 months and 18 months
|
delay between baseline and death
|
Baseline, 1 month, 6 months and 18 months
|
|
Falls
Periodo de tiempo: 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
Periodo de tiempo: Baseline, 1 month, 6 months and 18 months
|
the delay between baseline and falls
|
Baseline, 1 month, 6 months and 18 months
|
|
Cognitive functions
Periodo de tiempo: 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
Periodo de tiempo: Baseline, 6 months and 18 months
|
Quality of life measured by questionnaire QoL-AD
|
Baseline, 6 months and 18 months
|
|
Quality of life 2
Periodo de tiempo: Baseline, 6 months and 18 months
|
Quality of life measured by questionnaire EUROQOL 5D
|
Baseline, 6 months and 18 months
|
|
depression disorders
Periodo de tiempo: Baseline, 6 months and 18 months
|
depression measured with the mini-GDS scale
|
Baseline, 6 months and 18 months
|
|
Anxiety disorders
Periodo de tiempo: 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
Periodo de tiempo: Baseline, 6 months and 18 months
|
compliance is measured with the questionnaire Girerd
|
Baseline, 6 months and 18 months
|
|
Pain
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, 1 month, 6 months and 18 months
|
The acceptance rate of the pharmaceutical review will be evaluated in 2 complementary ways:
|
Baseline, 1 month, 6 months and 18 months
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 69HCL15-0104
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .