Deprescribing Intervention for Polypharmacy

(POP-MED Trial)

Overseen By An Nguyen, OTD, OTR/L, BCG

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Substance use disorder, Organ transplant, others

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

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 safely reduce the number of medications people take, particularly when excessive medications may harm their health. It tests a personalized approach where a pharmacist reviews medications and collaborates with the patient and their doctor to make changes. This method is known as a patient-tailored deprescribing assessment and intervention. The study includes four groups: two receive usual care, and two undergo this special medication review, divided by the presence of memory issues like Mild Cognitive Impairment or Dementia. This trial suits individuals 65 and older who already see a primary care doctor at Cedars-Sinai and are at high risk for medication-related problems. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance medication safety for older adults.

Will I have to stop taking my current medications?

The trial is focused on reducing the number of medications participants take, so you may need to stop or change some of your current medications. However, the specific details about which medications to stop are not provided in the information.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that deprescribing, which involves reducing or stopping medications, can enhance healthcare safety and quality. This is particularly crucial for older adults who take multiple medications simultaneously. Studies have found that deprescribing can decrease the total number of drugs a person takes and reduce the risk of harmful drug interactions.

Some trials have employed a team-based approach, where healthcare professionals collaborate to review and adjust medication plans. This method has shown promise in managing and reducing unnecessary medications. The goal is to minimize adverse drug events, which are harmful effects from medications.

Regarding safety, this intervention is generally well-tolerated. It involves a careful review and discussion with healthcare providers to ensure that any changes are safe and beneficial for the patient. While no treatment is without risk, the aim is to minimize those risks by tailoring medication plans to each person's needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the deprescribing intervention for polypharmacy because it offers a personalized approach to medication management, especially for patients with complex medication regimens. Unlike standard care, which often involves routine medication reviews by primary care clinicians, this intervention uses a pharmacist-led clinic to conduct thorough medication assessments tailored to each patient’s needs. The treatment plan involves identifying potentially inappropriate medications and omissions, engaging in shared decision-making with patients or caregivers, and providing ongoing follow-up and support. This comprehensive and patient-centered approach aims to optimize medication use, reduce the risks of adverse effects, and improve overall patient health outcomes.

What evidence suggests that this trial's treatments could be effective for polypharmacy?

Research shows that reducing or stopping certain medications can help older adults, including those with dementia, manage their medication better. In this trial, pharmacists will lead a patient-tailored deprescribing assessment and intervention for some participants. Studies have shown this approach improves medication use and enhances health for people with memory problems. This process identifies and removes unnecessary medications, reducing harmful effects and improving quality of life. For patients without dementia, similar methods have effectively managed multiple medications, reducing the risk of side effects. Overall, personalized plans for reducing medications can lead to safer and more effective treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Michelle Keller, PhD, MPH

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for older adults (65+) who are at high risk of medication-related issues due to polypharmacy, as determined by a predictive model. They must be under the care of a primary clinician within the Cedars-Sinai Health System and enrolled in certain health programs. One group specifically includes those with Mild Cognitive Impairment or Dementia.

Inclusion Criteria

I am 65 years old or older.

Patients will be invited to enroll in the study if they are identified as having a high risk of experiencing polypharmacy-related adverse events, based on an evaluation of factors such as age, sex, recent healthcare encounters, current and past medications, laboratory tests results and diagnoses.

You have a designated primary care provider who utilizes the MyCSLink electronic health record system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a patient-tailored deprescribing assessment and intervention, including medication reconciliation and shared decision-making.

12 months

Monthly follow-ups

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with outcome measures assessed at 12 months.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient-tailored deprescribing assessment and intervention

Trial Overview The study tests a personalized approach to reducing unnecessary medications in elderly patients. It's set up as a randomized controlled pilot with four groups: two will receive the deprescribing intervention and two will serve as controls for comparison.

How Is the Trial Designed?

Group I: Patient-tailored deprescribing assessment and intervention (no MCI and Dementia diagnosis) Experimental Treatment 1 Intervention

Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the prescriber. Once the prescriber has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with NO diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.

Group II: Patient-tailored deprescribing assessment and intervention (MCI and Dementia diagnosis) Experimental Treatment 1 Intervention

Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the prescriber. Once the prescriber has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with a diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.

Group III: Usual care (MCI and Dementia diagnosis) Active Control 1 Intervention

Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with a diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.

Group IV: Usual care (no MCI and Dementia diagnosis) Active Control 1 Intervention

Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with NO diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12003602/

Medicine Optimisation and Deprescribing Intervention ... This systematic review aimed to summarise the evidence on the outcomes of medicine optimisation and deprescribing interventions for older people with dementia ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04938648

Study Details | NCT04938648 | Aligning Medications With ... The Aligning Medications with What Matters Most (ALIGN) study will assess the feasibility and preliminary efficacy of a deprescribing intervention to reduce ...

3. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-025-05783-2

Multicomponent intervention to tailor prescriptions to patients ... The objectives of this study conducted at an intermediate care were to: i) identify inappropriate prescribing per the main care goal; ii) compare the ...

4. deprescribingresearch.org deprescribingresearch.org/network-activities/grant-opportunities/research-in-dementia/

Research in Dementia The network supports a variety of scholarship on deprescribing that is focused on the unique needs of people with cognitive impairment or dementia.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2950307825000669

Tackling polypharmacy in geriatric patients: Is increasing ... This narrative review highlights the importance of comprehensive, evidence-based interventions to optimize medication management.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK600387/

Deprescribing To Reduce Medication Harms in Older Adults Deprescribing has the potential to improve multiple aspects of patient safety and quality of care, including by reducing drug burden, ADEs, and morbidity.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10193598/

Team approach to polypharmacy evaluation and reduction Team approach to polypharmacy evaluation and reduction: feasibility randomized trial of a structured clinical pathway to reduce polypharmacy.

8. who.int who.int/docs/default-source/patient-safety/who-uhc-sds-2019-11-eng.pdf

Medication Safety in Polypharmacy Medication review is a structured evaluation of patient's medicines with the aim of optimizing medicines use and improving health outcomes. This entails.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2667032125000411

Polypharmacy and deprescribing among geriatric patients While appropriate polypharmacy can improve clinical outcomes when tailored to individual needs, inappropriate use heightens risks such as adverse drug reactions ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2813802

Cumulative Update of a Systematic Overview Evaluating ... This systematic overview examines meta-analyses and systematic reviews on the use of polypharmacy-related interventions in adults.