Medication Use and Quality of Life Among Older People (Pilot)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In a pragmatic randomized controlled trial, this project will test whether a comprehensive and patient-centered deprescribing intervention can improve quality of life among older people with limited life expectancy. This registration concerns the initial pilot study. All patients included in the pilot study will receive the intervention (that is, the pilot study will not include randomization).
The intervention will comprise a series of consultations between the patient and general practitioner (GP) (at least three) to continuously adjust the patient's medication according to the patient's goals, needs, and preferences, thereby ensuring alignment with the patient's priorities. Thus, the purpose of this intervention is to initiate and facilitate a continued deprescribing process. The process can be summarized in seven steps: During an initial consultation (1: Consultation 0), the GP assesses patient eligibility. If the patient would like to participate, a project nurse subsequently visits the patient at home (2: Home visit) for retrieval of informed consent as well as baseline measurements. During the next consultation (3: Consultation 1), the patient and GP discuss how the patient feels about his/her medical treatment, and the GP provides the patient with written material for the patient to prepare prior to the next consultation. The patients prepares (4: Preparation) by considering and verbalizing his/her goals of care and treatment preferences. Simultaneously, a clinical pharmacist examines the patient's medication list and provides suggestions to the GP on which drugs can be continued and deprescribed, respectively. During the next consultation (5: Consultation 2), the patient and GP discuss the patient's preferences and initiate deprescribing initiatives aligned with the patient's priorities. During a new consultation (6: Consultation 3), the patient and GP follow up on the changes initiated and initiate new deprescribing initiatives if such can be identified. If needed, subsequent consultations (7: Consultation X) are planned until the patient and GP consider the patient's medical treatment optimal.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Region Of Southern Denmark
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Odense, Region Of Southern Denmark, Dinamarca, 5000
- Odense University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- Aged ≥80 years
- Take ≥8 different medications
- Have a life expectancy of <2 years, estimated via the Surprise Question ("Would you be surprised if this patient died within 1-2 years?") by the general practitioner
- Have a Mini-Mental State Exam (MMSE) score of ≥15
- Are able to provide informed consent
Exclusion Criteria:
- Not able to communicate
- Does not speak and understand Danish
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Consultations
The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.
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The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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HEALTH-RELATED QUALITY OF LIFE
Periodo de tiempo: Baseline
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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Baseline
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 3 MONTHS
Periodo de tiempo: 3 months
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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3 months
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE AT 6 MONTHS
Periodo de tiempo: 6 months
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Health-related quality of life will be measured using the Danish version of the SF-12v2 Health Survey.
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6 months
|
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HEALTH-RELATED QUALITY OF LIFE (DEPRESSION)
Periodo de tiempo: Baseline
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Health-related quality of life will be measured using the Danish version of the Depression List.
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Baseline
|
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 3 MONTHS
Periodo de tiempo: 3 months
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Health-related quality of life will be measured using the Danish version of the Depression List.
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3 months
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CHANGE FROM BASELINE HEALTH-RELATED QUALITY OF LIFE (DEPRESSION) AT 6 MONTHS
Periodo de tiempo: 6 months
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Health-related quality of life will be measured using the Danish version of the Depression List.
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6 months
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MORTALITY
Periodo de tiempo: 3 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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3 months
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MORTALITY
Periodo de tiempo: 6 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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6 months
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MORTALITY
Periodo de tiempo: 12 months
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Mortality will be assessed through the nationwide Danish Central Person Registry.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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NIVEL FUNCIONAL
Periodo de tiempo: Línea de base, 3 meses y 6 meses
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El nivel funcional se medirá utilizando la versión danesa de Vulnerable Elders Survey 13 (VES-13).
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Línea de base, 3 meses y 6 meses
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FUERZA DE AGARRE
Periodo de tiempo: Línea de base, 3 meses y 6 meses
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La fuerza de prensión manual se medirá utilizando un dinamómetro de prensión manual.
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Línea de base, 3 meses y 6 meses
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NÚMERO DE CAMBIOS DE MEDICAMENTOS
Periodo de tiempo: 3 meses, 6 meses y 12 meses
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El número de cambios de medicamentos se evaluará a través de las listas de medicamentos.
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3 meses, 6 meses y 12 meses
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COGNITIVE FUNCTION
Periodo de tiempo: Baseline, 3 months and 6 months
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Cognitive function will be measured using the Danish version of the Mini-Mental State Examination-2 (MMSE-2) Standard Form.
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Baseline, 3 months and 6 months
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ABILITY TO SIT AND STAND
Periodo de tiempo: Baseline, 3 months and 6 months
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Ability to sit and stand will be measured via the 30-second stand-sit-test.
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Baseline, 3 months and 6 months
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NUMBER OF MEDICATIONS DISCONTINUED
Periodo de tiempo: 3 months, 6 months and 12 months
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Number of medications dicontinued will be assessed through the medication lists.
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3 months, 6 months and 12 months
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HOSPITAL ADMISSIONS
Periodo de tiempo: 3 months, 6 months and 12 months
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Admissions will be assessed through the nationwide Danish National Patient Register.
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3 months, 6 months and 12 months
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HEALTH CARE COSTS
Periodo de tiempo: 3 months, 6 months and 12 months
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Health care costs.
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3 months, 6 months and 12 months
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SUCCESS RATE OF THE INTERVENTION
Periodo de tiempo: 3 months, 6 months and 12 months
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Succes rate of the intervention.
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3 months, 6 months and 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anton Pottegård, Prof, apottegaard@health.sdu.dk
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- ODIN-1 Pilot
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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