- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07599735
The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among Hospitalised Older Patients (DART)
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Southampton, Det Forenede Kongerige
- University Hospital Southampton
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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number of medications
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and 3 months
|
Activities of Daily Living
|
Baseline and 3 months
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frailty status
Tidsramme: Baseline and 3 months
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frailty status
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Baseline and 3 months
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cognition
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline and 3 months
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delirium
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Baseline and 3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Healthcare resouce use
Tidsramme: Baseline and 3 months
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Healthcare resource use
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Baseline and 3 months
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adverse events
Tidsramme: Baseline and 3 months
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adverse events
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Baseline and 3 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kinda Ibrahim, PhD, University of Southampton
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DART351020
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Patients will receive a collaborative deprescribing intervention
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Vanderbilt University Medical CenterNational Institute on Aging (NIA)AfsluttetPolyfarmaci | Geriatriske syndromer | PlejeovergangeForenede Stater