182 Participants Needed

Deprescribing Medications for Physical Function

MT
Overseen ByMarilyn Tousignant, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Must be taking: Anticholinergics, Sedatives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial involves a plan to gradually reduce or stop certain medications that have sedative or anticholinergic effects, like antidepressants, benzodiazepines, or opioids. Participants will follow a deprescribing plan to lower their medication burden, so you may need to change your current medications.

What data supports the effectiveness of deprescribing anticholinergic and sedative medications for improving physical function?

Research shows that reducing the use of anticholinergic and sedative medications in older adults can lead to fewer falls, less frailty, and fewer adverse drug reactions, although it may not improve cognition or quality of life.12345

Is deprescribing anticholinergic and sedative medications safe for older adults?

Deprescribing anticholinergic and sedative medications in older adults is generally considered safe and may improve health outcomes, but these medications have been linked to risks like falls, fractures, and cognitive issues. It's important to have healthcare providers guide the process to ensure safety.12678

How is deprescribing anticholinergic and sedative drugs unique?

Deprescribing anticholinergic and sedative drugs is unique because it focuses on reducing or stopping medications that may cause harm, especially in older adults, to improve their physical function and reduce side effects. This approach is patient-centered and often led by pharmacists, which is different from traditional treatments that typically involve adding medications rather than removing them.12359

What is the purpose of this trial?

Medications with sedative or anticholinergic effects such as antidepressants, benzodiazepines, or opioids have been associated with impaired cognitive and physical function. They are referred to as potentially inappropriate medications or medications that are best avoided by older adults. The accumulated evidence has now shifted the clinical and research focus to evaluating the who, what, and how of the best way to deprescribe (i.e., dose reduction or cessation of these medications). The Drug Burden Index (DBI) allows researchers and clinicians to quantify the cumulative burden of anticholinergic and sedative medications in each patient. Deprescribing these medications is a complex health intervention based on trade-offs between their clinical benefits (e.g., symptom management and prevention of diseases) and their adverse drug events to improve physical and cognitive function. Existing physical function performance metrics, such as gait speed captured in the clinic, are often non-specific and do not reflect real-life performance. Innovative mobility metrics are required to better understand specific deficits with age and disease and the effects of medications on these deficits.The goal of this project is to better characterize the impact of reducing the anticholinergic and sedative medication burden on physical function in older adults by novel mobility metrics in lab and real-life environments.A prospective, longitudinal cohort of 182 community-dwelling older adults (≥ 65 years) with a DBI of ≥ 1 will be completed. Using a quasi-experimental design, recruited patients will undergo a medication deprescribing plan, as part of usual clinical care, that includes three gradual changes to their medication regimen resulting in three DBI levels. At each DBI level, physical function mobility including dual-task tests) will be assessed in the lab with wearable sensors during validated clinical tests such as the Short Physical Performance Battery. Objective balance and mobility metrics (e.g., sway area and frequency, stride length) will be extracted. Physical function will also be assessed continuously in the patient's real-life environment from recruitment to the last lab visit, using wearable (Apple Watch® with ankle inertial measurement unit) and environmental sensors. Cognition will be measured using the Montreal Cognitive Assessment, Trail Making Test Part A \& B, and Digit Symbol Substitution Test.

Eligibility Criteria

This trial is for community-dwelling adults aged 65 or older who are currently taking medications with sedative or anticholinergic effects, and have a Drug Burden Index (DBI) score of at least 1. They must agree to a plan that reduces their DBI by at least 0.5. Those with dementia, reliance on walkers for mobility, or unstable medical conditions requiring recent hospital visits cannot participate.

Inclusion Criteria

I agree to follow a plan to reduce my medication load.
I am 65 years old or older.
My medication load is considered high.
See 1 more

Exclusion Criteria

Dementia
I use a walker to help me move around.
I have not been hospitalized unexpectedly or visited the emergency room multiple times in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Deprescribing Plan

Participants undergo a medication deprescribing plan with three gradual changes to their medication regimen resulting in three DBI levels.

12 weeks
Regular visits for monitoring and assessment

Assessment

Physical function mobility is assessed in the lab with wearable sensors during validated clinical tests such as the Short Physical Performance Battery.

4 months
Continuous assessment in real-life environment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Deprescribing anticholinergic and sedative medications
Trial Overview The study is testing the impact of reducing medication burden from drugs like antidepressants and opioids on physical function in older adults. Participants will undergo changes to their medication regimen and wear sensors to measure mobility in both lab tests and real-life settings over time.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Deprescribing anticholinergic and sedative medicationsExperimental Treatment1 Intervention
Deprescribing plan targeting a reduction in drug burden index score of ≥ 0.5

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead Sponsor

Trials
64
Recruited
33,600+

Findings from Research

This feasibility study aims to assess the effectiveness of a pharmacist-led intervention to reduce the use of anticholinergic and sedative medications in older adults living in residential care, with outcomes measured at 3 and 6 months after implementation.
The study will evaluate changes in the Drug Burden Index (DBI) and various health outcomes, including cognitive function and quality of life, to determine the impact of targeted deprescribing on the health of older individuals.
Deprescribing anticholinergic and sedative medicines: protocol for a Feasibility Trial (DEFEAT-polypharmacy) in residential aged care facilities.Ailabouni, N., Mangin, D., Nishtala, PS.[2022]
This trial aims to evaluate whether pharmacist-led medication reviews can effectively encourage general practitioners to deprescribe harmful anticholinergic and sedative medications in older adults, potentially improving health outcomes.
The study will involve community-dwelling frail adults aged 65 and older in New Zealand, with the primary outcome being the change in the Drug Burden Index (DBI) over six months, assessing the impact of deprescribing on medication use and related health issues.
Deprescribing to reduce polypharmacy: study protocol for a randomised controlled trial assessing deprescribing of anticholinergic and sedative drugs in a cohort of frail older people living in the community.Bergler, U., Ailabouni, NJ., Pickering, JW., et al.[2022]
In a pilot study involving 18 older patients in a clinic-based deprescribing intervention, 96% of eligible high-risk anticholinergic medications were successfully deprescribed, leading to a significant 93% reduction in total standardized dose and improved safety regarding cognitive risks.
In contrast, a telephone-based deprescribing intervention for 24 older patients resulted in only 50% of eligible medications being deprescribed, with no significant change in total standardized dose, highlighting the effectiveness of in-person pharmacist consultations over remote interventions.
Deprescribing anticholinergics in primary care older adults: Experience from two models and impact on a continuous measure of exposure.Campbell, NL., Pitts, C., Corvari, C., et al.[2023]

References

Deprescribing anticholinergic and sedative medicines: protocol for a Feasibility Trial (DEFEAT-polypharmacy) in residential aged care facilities. [2022]
Deprescribing to reduce polypharmacy: study protocol for a randomised controlled trial assessing deprescribing of anticholinergic and sedative drugs in a cohort of frail older people living in the community. [2022]
Deprescribing anticholinergics in primary care older adults: Experience from two models and impact on a continuous measure of exposure. [2023]
Anticholinergic and Sedative Drug Burden and Functional Recovery after Cerebrovascular Accident: A Retrospective Descriptive Study. [2022]
DEFEAT-polypharmacy: deprescribing anticholinergic and sedative medicines feasibility trial in residential aged care facilities. [2020]
Medication Profiles of Patients with Cognitive Impairment and High Anticholinergic Burden. [2019]
Drug Burden Index in Older Adults with Psychiatric Illnesses: A Cross-Sectional Study. [2023]
Impact of a deprescribing tool on the use of sedative hypnotics among older patients: study protocol for a cluster randomised controlled trial in Swiss primary care (the HYPE trial). [2023]
[Polypharmacy in frail elderly patients: is deprescribing the answer?]. [2022]
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