Deprescribing Medications for Physical Function

Overseen By Marilyn 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

Must not be taking: Antidepressants, Benzodiazepines, Opioids

Disqualifiers: Dementia, Walker, Unstable condition

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how reducing or stopping certain medications can enhance physical and cognitive function in older adults. The focus is on medications such as antidepressants, opioids, and other anticholinergic and sedative drugs that may impair clear thinking or movement. Participants will follow a plan to lower their medication levels and have their physical abilities assessed using special sensors both in a lab and in their daily lives. This trial targets individuals aged 65 and older who live at home, take multiple medications that might affect their physical and mental abilities, and are willing to adjust their medication use. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, aiding researchers in understanding its benefits for more patients.

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 is the safety track record for deprescribing anticholinergic and sedative medications?

Previous studies have linked reducing anticholinergic and sedative medications in older adults to fewer falls and less frailty. Research shows that medications like antidepressants and benzodiazepines can cause memory problems and increase fall risk. Deprescribing, or reducing these medications, can improve overall physical and mental health. A review of studies found that following a specific plan to reduce these drugs lowered fall rates among older adults in care homes. Overall, deprescribing appears well-tolerated and may lead to better health outcomes for older adults. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the deprescribing of anticholinergic and sedative medications because this approach focuses on reducing the overall drug burden in patients, which is quite different from the standard practice of prescribing more medications to manage conditions. Most current treatments for improving physical function often involve adding or adjusting medications. However, deprescribing aims to enhance physical function by reducing the potential negative effects of anticholinergic and sedative drugs, which are known to impair cognitive and physical abilities. This method has the potential to improve patients' quality of life by minimizing medication side effects and simplifying their treatment regimens.

What evidence suggests that deprescribing anticholinergic and sedative medications could improve physical function in older adults?

Research shows that reducing certain medications in older adults can lead to fewer falls, less frailty, and fewer side effects. Taking more of these medications links to worse physical and mental function. Several studies found that cutting down on these drugs improved physical and mental health. Reducing these medications also decreased the number of drugs taken and improved overall health. This trial will focus on deprescribing anticholinergic and sedative medications, aiming to improve movement and thinking skills in older adults. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Deprescribing anticholinergic and sedative medications Experimental Treatment 1 Intervention

Deprescribing plan targeting a reduction in drug burden index score of ≥ 0.5

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead Sponsor

Trials

64

Recruited

33,600+

Published Research Related to This Trial

A pharmacist-led deprescribing intervention in three residential care facilities successfully reduced the Drug Burden Index (DBI) by 0.34 and led to significant improvements in mood, frailty, and a decrease in falls and adverse drug reactions among 46 participants over 6 months.

The intervention had a high implementation rate, with 72% of deprescribing recommendations accepted by general practitioners, and 96% of residents agreeing to the changes, highlighting the effectiveness of a patient-centered approach in managing polypharmacy in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DEFEAT-polypharmacy: deprescribing anticholinergic and sedative medicines feasibility trial in residential aged care facilities. Ailabouni, N., Mangin, D., Nishtala, PS.[2020]

In a study of 200 older adults with psychiatric illnesses, 81.5% were using medications with anticholinergic and/or sedative properties, leading to an average Drug Burden Index (DBI) score of 1.25, which indicates a significant medication burden.

Higher DBI scores were linked to increased dependency in daily activities, particularly in patients with schizophrenia, higher levels of dependency, and those on multiple medications (polypharmacy), highlighting the need for careful medication management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Burden Index in Older Adults with Psychiatric Illnesses: A Cross-Sectional Study. Chahine, B.[2023]

This study will evaluate a supportive tool designed to help general practitioners (GPs) in Switzerland deprescribe benzodiazepines and other sedative hypnotics (BSH) for patients aged 65 and older, aiming to improve medication safety and quality of care.

The effectiveness of this tool will be measured by the percentage of patients who change their BSH use within 6 months, providing insights into barriers and facilitators of deprescribing in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Weiss, K., Pichierri, G., Grischott, T., et al.[2023]

In a study of 122 patients recovering from cerebrovascular accidents, 66% were exposed to anticholinergic and sedative medications, which were found to negatively impact recovery of daily living activities and physical function.

Higher daily drug burdens of anticholinergics and sedatives were independently associated with slower recovery times in both activities of daily living and balance, highlighting the importance of monitoring medication effects in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticholinergic and Sedative Drug Burden and Functional Recovery after Cerebrovascular Accident: A Retrospective Descriptive Study. Ogawa, Y., Nibe, F., Ogawa, R., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deprescribing anticholinergic and sedative medicines: protocol for a Feasibility Trial (DEFEAT-polypharmacy) in residential aged care facilities. Ailabouni, N., Mangin, D., Nishtala, PS.[2022]

In a study of 13,627 older adults with mild cognitive impairment or dementia, 24% had a high anticholinergic burden, which can lead to negative health outcomes like delirium and falls.

The research identified specific clusters of medications contributing to this burden, particularly cardiovascular drugs and antidepressants, highlighting the need for targeted clinical strategies to manage medication use in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Profiles of Patients with Cognitive Impairment and High Anticholinergic Burden. Green, AR., Reifler, LM., Boyd, CM., et al.[2019]

Deprescribing involves reviewing and adjusting multiple medications for patients, particularly frail elderly or terminally ill individuals, to ensure that the benefits of the drugs outweigh the risks and align with patient care goals.

The process is supported by scientific and ethical reasons, as many medications may have unknown efficacy or cause significant side effects, making their removal potentially safe and justified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Polypharmacy in frail elderly patients: is deprescribing the answer?]. Gavilán-Moral, E., Villafaina-Barroso, A., Jiménez-de Gracia, L., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov/articles/PMC10460556/

Deprescribing Anticholinergic and Sedative Drugs to ...

Greater exposure to anticholinergic and sedative medications is associated with poorer physical and cognitive functioning and a higher risk of falls, fractures, ...

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Deprescribing anticholinergic and sedative medicines

Outcomes The primary outcome will be the change in the participants' DBI total and DBI PRN 3 and 6 months after implementing the deprescribing intervention.

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Deprescribing Anticholinergic Medications in Hospitalised ...

Six studies reported reductions in anticholinergic burden scores; three showed significant decreases in the proportion of patients prescribed ...

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withpower.com/trial/phase-4-deprescribing-anticholinergic-and-sedative-medications-1-2023-d71d1

Deprescribing Medications for 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 ...

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bmcgeriatr.biomedcentral.com

bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02208-8

A systematic review of the evidence for deprescribing ...

Deprescribing interventions led to a significant reduction in the number of medications and PIMs with potential cost saving. Included studies ...