- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07599735
The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among Hospitalised Older Patients (DART)
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Southampton, United Kingdom
- University Hospital Southampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of medications
Time Frame: Baseline and 3 months
|
number of medications
|
Baseline and 3 months
|
|
anticholinergic burden scores
Time Frame: baseline and 3 months
|
anticholinergic burden scores
|
baseline and 3 months
|
|
Activities of Daily Living
Time Frame: Baseline and 3 months
|
Activities of Daily Living
|
Baseline and 3 months
|
|
frailty status
Time Frame: Baseline and 3 months
|
frailty status
|
Baseline and 3 months
|
|
cognition
Time Frame: Baseline and 3 months
|
cognition
|
Baseline and 3 months
|
|
Health related quality of life (SF36)
Time Frame: Baseline and 3 months
|
Heath related quality of life (SF36)
|
Baseline and 3 months
|
|
delirium
Time Frame: Baseline and 3 months
|
delirium
|
Baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare resouce use
Time Frame: Baseline and 3 months
|
Healthcare resource use
|
Baseline and 3 months
|
|
adverse events
Time Frame: Baseline and 3 months
|
adverse events
|
Baseline and 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kinda Ibrahim, PhD, University of Southampton
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DART351020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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