- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07599735
The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among Hospitalised Older Patients (DART)
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Southampton, Vereinigtes Königreich
- University Hospital Southampton
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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number of medications
Zeitfenster: Baseline and 3 months
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number of medications
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Baseline and 3 months
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anticholinergic burden scores
Zeitfenster: baseline and 3 months
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anticholinergic burden scores
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baseline and 3 months
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Activities of Daily Living
Zeitfenster: Baseline and 3 months
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Activities of Daily Living
|
Baseline and 3 months
|
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frailty status
Zeitfenster: Baseline and 3 months
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frailty status
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Baseline and 3 months
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cognition
Zeitfenster: Baseline and 3 months
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cognition
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Baseline and 3 months
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Health related quality of life (SF36)
Zeitfenster: 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
Zeitfenster: Baseline and 3 months
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delirium
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Baseline and 3 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Healthcare resouce use
Zeitfenster: Baseline and 3 months
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Healthcare resource use
|
Baseline and 3 months
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adverse events
Zeitfenster: Baseline and 3 months
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adverse events
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Baseline and 3 months
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Kinda Ibrahim, PhD, University of Southampton
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DART351020
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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