Medication Use and Quality of Life Among Older People (Pilot)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Region Of Southern Denmark
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Odense, Region Of Southern Denmark, Danemark, 5000
- Odense University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: 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.
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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HEALTH-RELATED QUALITY OF LIFE
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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NIVEAU FONCTIONNEL
Délai: Baseline, 3 mois et 6 mois
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Le niveau fonctionnel sera mesuré à l'aide de la version danoise du Vulnerable Elders Survey 13 (VES-13).
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Baseline, 3 mois et 6 mois
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FORCE DE LA PRISE EN MAIN
Délai: Baseline, 3 mois et 6 mois
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La force de préhension sera mesurée à l'aide d'un dynamomètre à main.
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Baseline, 3 mois et 6 mois
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NOMBRE DE CHANGEMENTS DE MÉDICAMENTS
Délai: 3 mois, 6 mois et 12 mois
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Le nombre de changements de médicaments sera évalué à l'aide des listes de médicaments.
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3 mois, 6 mois et 12 mois
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COGNITIVE FUNCTION
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Anton Pottegård, Prof, apottegaard@health.sdu.dk
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ODIN-1 Pilot
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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