- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07599735
The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among Hospitalised Older Patients (DART)
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Why this research is important? It is estimated that over one third of all older adults are prescribed medication which are known to have "anticholinergic" side effects. These anticholinergic side effects can include an increased risk of falls, delirium, and memory problems. People who have a high number of anticholinergic medications have an increased risk of these side effects. This can be measured as their anticholinergic burden (ACB). Several tools have been developed to assess the ACB score, by checking a person's medication list, with the aim of reducing these medications where possible (deprescribing).
The study aim The project team worked with a company to design an online tool which can calculate the total ACB score for patients using their electronic medication list. It can also list the individual anticholinergic medications contributing to that score. Patients with high ACB score will be highlighted to healthcare staff including pharmacists, nurses, and doctors. In this project, we plan to understand how this tool can be used by clinicians in older persons wards to reduce the number of anticholinergic medications prescribed where appropriate.
Our approach Working with doctors and pharmacists in one large hospital, we agreed how the tool should be used. First, pharmacists with check weekly using the digital tool how many patients have high ACB scores. Then they would highlight in patients' medical notes the list of medications with high anticholinergic effects using a sticker note. The doctor looking after the patient then sees the note which would prompt him/her to either stop the drug, reduce the dose or switch to a safer drug.
We will test this intervention among 50 patients admitted to older people wards. We will collect information before and after receiving the intervention including number and type of medications prescribed, quality of life, and cognition. We will also talk to staff and patients to understand their views about the intervention, any challenges, and how to improve the process.
Involving patients and public Two patient and public contributors have been actively involved in developing this research proposal. They represent an older person with comorbidity and polypharmacy and a carer, and both have lived experience of managing polypharmacy following hospital admission. They will continue to provide input on study procedures and materials and contribute to plans for sharing the findings.
Sharing the study findings We will share the findings with public, health professionals, researchers and policymakers through plain English summaries, social media, policy briefing documents, scientific papers, conferences and other meetings.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Southampton, Royaume-Uni
- University Hospital Southampton
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Eligible patients aged 65 years or more admitted to one of the five Medicine for Older People wards, who have ACB score of 3 or more
Exclusion Criteria:
- Those who are expected to have a limited life expectancy, receiving palliative care will be excluded.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
number of medications
Délai: Baseline and 3 months
|
number of medications
|
Baseline and 3 months
|
|
anticholinergic burden scores
Délai: baseline and 3 months
|
anticholinergic burden scores
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baseline and 3 months
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|
Activities of Daily Living
Délai: Baseline and 3 months
|
Activities of Daily Living
|
Baseline and 3 months
|
|
frailty status
Délai: Baseline and 3 months
|
frailty status
|
Baseline and 3 months
|
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cognition
Délai: Baseline and 3 months
|
cognition
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Baseline and 3 months
|
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Health related quality of life (SF36)
Délai: Baseline and 3 months
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Heath related quality of life (SF36)
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Baseline and 3 months
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delirium
Délai: Baseline and 3 months
|
delirium
|
Baseline and 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Healthcare resouce use
Délai: Baseline and 3 months
|
Healthcare resource use
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Baseline and 3 months
|
|
adverse events
Délai: Baseline and 3 months
|
adverse events
|
Baseline and 3 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kinda Ibrahim, PhD, University of Southampton
Publications et liens utiles
Liens utiles
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DART351020
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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