Older Adults (60 - 85 Years Old)DARTNCT07489677
The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among Hospitalised Older Patients
A study testing DART in people with Older Adults (60 - 85 Years Old), run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults (60 - 85 Years Old)
- What is being tested?
- DART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Eligible patients aged 65 years or more admitted to one of the five MOP wards, who have ACB score of 3 or more, and able to provide an informed consent.
Who cannot join
- Those who are expected to have a limited life expectancy, receiving palliative care will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among Hospitalised Older Patients (DART)
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.
Read more
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.
Read the detailed description
Background It is estimated that between 33-47% of hospitalised older people are prescribed one or more medication with anticholinergic effects. Anticholinergic burden (ACB) - the accumulation of higher levels of exposure to one or more anticholinergic medications- is associated with physical impairment, increased risk of falls, cognitive impairment, delirium, dementia, and all-cause mortality in older people. Deprescribing anticholinergic medications is key to improve health outcomes of older people, and hospital admission could be ideal for deprescribing because it offers an opportunity to identify and prioritise patients at high-risk of anticholinergic burden. However, lack of collaborative working, low confidence, system resources and organisation of care are reported barriers for deprescribing anticholinergic burden in routine practice. In addition, most deprescribing studies focused on community or nursing home settings, and little has been done in a hospital setting.
Aims and objectives The aim is to test the feasibility and acceptability of using a digital tool to identify and reduce medications with a high anticholinergic burden among hospitalised older patients. The research team has recently worked with a software company (TRISCRIBE) to develop and validate a digital tool with an embedded evidence-based database, that quantifies the overall anticholinergic burden score for each patient, listing the individual medicines contributing to that score and their individualised drug score.
The objectives are to
- Assess the feasibility of using and integrating the TRISCRIBE tool in the workflow of the clinical team to reduce anticholinergic burden scores.
- Examine the acceptability of the intervention to patients and carers as well as healthcare professionals involved in delivering the intervention.
- Determine the potential effects of the intervention on medication- and patient-related outcomes using pre-post quasi study design.
- Determine the feasibility of collecting resource use and identify key resource items that will be important to capture in the future trial.
Methods A feasibility study using a pre-post study design will be conducted with 50 older patients admitted to Medicine for Older People (MOP) wards at the University Hospital Southampton. Patients will receive a collaborative deprescribing intervention including: 1) pharmacist-led identification of patients using TRISCRIBE digital tool and highlighting anticholinergics medications on their clinical notes for targeted deprescribing, 2) doctor-led medication review to stop, reduce dose or switch to safer alternatives based on individual patient needs, and 3) highlighting and communicating medication changes to GP on discharge summaries.
Feasibility of the intervention will be determined by collecting data on recruitment rates, follow-up rates, time and resources needed. Baseline and 3months follow-up data will be collected on medication-related outcomes (number of medications, anticholinergic burden scores), health-related outcomes (function, frailty status, cognition, quality of life, delirium), costs, and adverse events (e.g., hospitalisation) to determine the effects and safety of the intervention. Acceptability of the intervention will be determined through qualitative interviews with a purposive sample of patients and their carers as well as healthcare professionals involved in delivering the intervention.
Impact and dissemination An inclusive dissemination plan will be co-developed in collaboration with our stakeholders and PPIE group to identify who to engage with and how best to engage them to ensure accessible and inclusive outputs. The findings will be shared with public, health professionals, researchers and policymakers through plain English summaries, social media, policy briefing documents, scientific papers, conferences and other meetings.
- Conditions
- Older Adults (60 - 85 Years Old)
- Being tested
- DART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DARTOther
Patients will receive a collaborative deprescribing intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients will receive a collaborative deprescribing intervention | Other | Patients will receive a collaborative deprescribing intervention including: 1) pharmacist-led identification of patients using TRISCRIBE digital tool and highlighting anticholinergics medications on their clinical notes for targeted deprescribing, 2) doctor-led medication review to stop, reduce dose or switch to safer alternatives based on individual patient needs, and 3) highlighting and communicating medication changes to GP on discharge summaries. Receives: Other: DART |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of eligible patients and the feasibility of recruiting
The proportion of eligible patients and the feasibility of recruiting
Measured: 3 months
Follow up rates and response rates to questionnaires.
- Follow up rates and response rates to questionnaires.
Measured: 3 months
• Time needed for implementing the intervention (e.g. screening time using the TRISCRIBE tool) and resources
- Time needed for implementing the intervention (e.g. screening time using the TRISCRIBE tool) and resources
Measured: 3 months
Proportion of patients identified to have high ACB score who received the intervention
- Proportion of patients identified to have high ACB score who received the intervention
Measured: 3 months
Secondary outcomes (9)
Activities of Daily living
Activities of Daily living (Barthel)
Measured: 3 months
Clinical Frailty Score
Clinical Frailty Score
Measured: 3 months
Geriatric Depression Scale
depression using the Geriatric Depression Scale
Measured: 3 months
Mini-Mental State Examination
Mini-Mental State Examination
Measured: 3 months
Sarcopenia
SARC-F
Measured: 3 months
delirium using the 4AT
delirium using the 4AT
Measured: 3 months
EQ-5D-5L
Quality of life EQ-5D-5L
Measured: 3 months
Health care resource use
Health care resource use
Measured: 3 months
Adverse Drug Events
Adverse Drug Events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start22 May 2025
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (60 - 85 Years Old)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489677
- Sponsor's protocol ID
- DARTMED2091
- Acronym
- DART
- Status last verified
- Jan 2025
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) that support the findings of this study are not publicly available due to privacy and confidentiality restrictions. The dataset contains small sample size and potentially identifiable information, and sharing the raw data could compromise participant confidentiality. Aggregated data supporting the findings will be included within the article.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among Hospitalised Older Patients (DART)
- ClinicalTrials.gov ID
- NCT07489677
- Acronym / sponsor ID
- DART / DARTMED2091
- Conditions
- Older Adults (60 - 85 Years Old)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background It is estimated that between 33-47% of hospitalised older people are prescribed one or more medication with anticholinergic effects. Anticholinergic burden (ACB) - the accumulation of higher levels of exposure to one or more anticholinergic medications- is associated with physical impairment, increased risk of falls, cognitive impairment, delirium, dementia, and all-cause mortality in older people. Deprescribing anticholinergic medications is key to improve health outcomes of older people, and hospital admission could be ideal for deprescribing because it offers an opportunity to identify and prioritise patients at high-risk of anticholinergic burden. However, lack of collaborative working, low confidence, system resources and organisation of care are reported barriers for deprescribing anticholinergic burden in routine practice. In addition, most deprescribing studies focused on community or nursing home settings, and little has been done in a hospital setting.
Aims and objectives The aim is to test the feasibility and acceptability of using a digital tool to identify and reduce medications with a high anticholinergic burden among hospitalised older patients. The research team has recently worked with a software company (TRISCRIBE) to develop and validate a digital tool with an embedded evidence-based database, that quantifies the overall anticholinergic burden score for each patient, listing the individual medicines contributing to that score and their individualised drug score.
The objectives are to
- Assess the feasibility of using and integrating the TRISCRIBE tool in the workflow of the clinical team to reduce anticholinergic burden scores.
- Examine the acceptability of the intervention to patients and carers as well as healthcare professionals involved in delivering the intervention.
- Determine the potential effects of the intervention on medication- and patient-related outcomes using pre-post quasi study design.
- Determine the feasibility of collecting resource use and identify key resource items that will be important to capture in the future trial.
Methods A feasibility study using a pre-post study design will be conducted with 50 older patients admitted to Medicine for Older People (MOP) wards at the University Hospital Southampton. Patients will receive a collaborative deprescribing intervention including: 1) pharmacist-led identification of patients using TRISCRIBE digital tool and highlighting anticholinergics medications on their clinical notes for targeted deprescribing, 2) doctor-led medication review to stop, reduce dose or switch to safer alternatives based on individual patient needs, and 3) highlighting and communicating medication changes to GP on discharge summaries.
Feasibility of the intervention will be determined by collecting data on recruitment rates, follow-up rates, time and resources needed. Baseline and 3months follow-up data will be collected on medication-related outcomes (number of medications, anticholinergic burden scores), health-related outcomes (function, frailty status, cognition, quality of life, delirium), costs, and adverse events (e.g., hospitalisation) to determine the effects and safety of the intervention. Acceptability of the intervention will be determined through qualitative interviews with a purposive sample of patients and their carers as well as healthcare professionals involved in delivering the intervention.
Impact and dissemination An inclusive dissemination plan will be co-developed in collaboration with our stakeholders and PPIE group to identify who to engage with and how best to engage them to ensure accessible and inclusive outputs. The findings will be shared with public, health professionals, researchers and policymakers through plain English summaries, social media, policy briefing documents, scientific papers, conferences and other meetings.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients will receive a collaborative deprescribing intervention | Other | Other: DARTPatients will receive a collaborative deprescribing intervention including: 1) pharmacist-led identification of patients using TRISCRIBE digital tool and highlighting anticholinergics medications on their clinical notes for targeted deprescribing, 2) doctor-led medication review to stop, reduce dose or switch to safer alternatives based on individual patient needs, and 3) highlighting and communicating medication changes to GP on discharge summaries. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Eligible patients aged 65 years or more admitted to one of the five MOP wards, who have ACB score of 3 or more, and able to provide an informed consent.
Key exclusion criteria (1 listed)
- Those who are expected to have a limited life expectancy, receiving palliative care will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DARTPatients will receive a collaborative deprescribing intervention | Other | Patients will receive a collaborative deprescribing intervention |
Primary outcome
The proportion of eligible patients and the feasibility of recruiting
Time frame: 3 months
The proportion of eligible patients and the feasibility of recruiting
Follow up rates and response rates to questionnaires.
Time frame: 3 months
• Follow up rates and response rates to questionnaires.
• Time needed for implementing the intervention (e.g. screening time using the TRISCRIBE tool) and resources
Time frame: 3 months
• Time needed for implementing the intervention (e.g. screening time using the TRISCRIBE tool) and resources
Proportion of patients identified to have high ACB score who received the intervention
Time frame: 3 months
• Proportion of patients identified to have high ACB score who received the intervention
9 secondary outcomes
Activities of Daily living
Time frame: 3 months
Clinical Frailty Score
Time frame: 3 months
Geriatric Depression Scale
Time frame: 3 months
Mini-Mental State Examination
Time frame: 3 months
Sarcopenia
Time frame: 3 months
delirium using the 4AT
Time frame: 3 months
EQ-5D-5L
Time frame: 3 months
Health care resource use
Time frame: 3 months
Adverse Drug Events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- NIHR ARC Wessex DART websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. The individual participant data (IPD) that support the findings of this study are not publicly available due to privacy and confidentiality restrictions. The dataset contains small sample size and potentially identifiable information, and sharing the raw data could compromise participant confidentiality. Aggregated data supporting the findings will be included within the article.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DART in people with Older Adults (60 - 85 Years Old), run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of eligible patients and the feasibility of recruiting (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.