Medication Review for Deprescribing

Overseen By Kayla Marvin, PharmD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Hospice, Palliative care, Cancer treatment, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pharmacist-led medication reviews can reduce the number of medications, falls, and hospitalizations in older adults while improving their quality of life. The focus is on deprescribing, which involves safely reducing or stopping medications that might not be needed. Participants will collaborate with healthcare professionals to review their current medications and possibly adjust their treatment plans. The trial seeks individuals aged 75 and older who are currently taking six or more medications and are not receiving cancer treatment or in hospice care. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance medication management for older adults.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it focuses on reviewing and possibly reducing the number of medications you take.

What prior data suggests that pharmacist-led medication reviews are safe for geriatric patients?

Research has shown that reviewing and reducing unnecessary medications can be safe and helpful. Studies have found that these reviews lead to fewer hospital visits for older adults, indicating that the process is generally well-tolerated. However, stopping medications can sometimes cause problems if not done carefully.

Healthcare professionals, such as pharmacists and doctors, can manage these changes to reduce the risk of harm. This careful approach ensures that any changes in medication are safe and improve the patient's health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to refine the way we manage multiple medications in patients, potentially leading to safer and more effective healthcare. Unlike standard care where medication lists are often maintained without regular review, this approach involves a detailed medication review by internal medicine providers and pharmacists. This process could lead to deprescribing, or the reduction of unnecessary medications, minimizing the risk of side effects like falls and hospitalizations. By tailoring drug regimens to individual patient needs, this method could enhance patient outcomes and reduce healthcare costs.

What evidence suggests that medication review is effective for reducing medications and improving quality of life in geriatric patients?

This trial will compare a medication review intervention with historical controls. Research has shown that reviewing medications, which may involve reducing or stopping unnecessary ones, can improve health for older adults. One study found that these reviews led to an 8% drop in hospital readmissions, resulting in fewer hospital visits and better health management. Other studies have also found benefits such as improved mental health and reduced frailty. Overall, medication reviews can simplify treatment plans and may enhance the quality of life for elderly patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Julia Clements, PharmD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for older adults who are likely taking multiple medications. It aims to see if reducing or adjusting their meds can help lower the risk of falls and hospital visits, and improve their quality of life.

Inclusion Criteria

I am 75 years old or older.

I am taking 6 or more medications.

Exclusion Criteria

In Skilled Nursing Facility

I am currently in hospice or receiving palliative care.

I am currently undergoing treatment for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Medication Review and Deprescribing

Pharmacists perform comprehensive medication reviews and collaborate with providers and patients to deprescribe or de-escalate medication therapy.

3 months

Regular visits as needed for medication review

Follow-up

Participants are monitored for changes in medication number, quality of life, and other health outcomes.

3 months

Monthly follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Medication Review

Trial Overview The study tests a process where pharmacists review each patient's medications and decide which ones can be reduced or stopped. The goal is to find out if this 'deprescribing' approach has positive effects on health outcomes in geriatric patients.

How Is the Trial Designed?

Group I: medication review - deprescribing / de-escalation may occur Experimental Treatment 1 Intervention

Internal medicine providers and PharmDs will identify patients for whom a medication review and potential deprescribing / de-escalation intervention may be beneficial, and make recommendations to adjust therapy as appropriate.

Group II: historical controls Active Control 1 Intervention

No contact or intervention will be made with these patients, only retrospective chart review to gather data such as number of medications, hospitalizations, and falls. Patients included in the historical control arm will be matched to the intervention group based on sex, age, and number of medications as much as possible. The goal will be to include 50 patients in both the intervention and control arms.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38822740/

Clinical impact of medication review and deprescribing in ... The meta-analysis revealed a slight but statistically significant 8% reduction in hospital readmissions (HR: 0.92; 95% CI: 0.85-0.99) following medication ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1568163724000552

Review article Efficacy of deprescribing on health outcomes Review article. Efficacy of deprescribing on health outcomes: An umbrella review of systematic reviews with meta-analysis of randomized controlled trials.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833713

Deprescribing in Community-Dwelling Older Adults Efficacy of deprescribing on health outcomes: an umbrella review of systematic reviews with meta-analysis of randomized controlled trials.

4. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.19035

Clinical impact of medication review and deprescribing in ... Medication review and deprescribing are associated with potential benefits in reducing hospital readmission rates among hospitalized older ...

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

A systematic review of the evidence for deprescribing ... Three studies reported positive impact on clinical outcomes including depression, mental health status, function and frailty; with mixed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10923734/

Medication review and deprescribing in different healthcare ... This scenario increases the risk of drug interactions and adverse drug reactions, highlighting the need for medication review and deprescribing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11101016/

Evaluating the Safety of an Educational Deprescribing ... - PMC While deprescribing is conducted with the intent of improving (or not changing) patient outcomes, it may potentially lead to harms including ...

8. journals.lww.com journals.lww.com/journalpatientsafety/fulltext/2020/09001/using_deprescribing_practices_and_the_screening.6.aspx

Using Deprescribing Practices and the Screening Tool of... Deprescribing involves reducing doses or stopping medications that are not useful or no longer needed to reduce polypharmacy, reduce harm, and improve health.

9. hsrd.research.va.gov hsrd.research.va.gov/publications/management_briefs/default.cfm?ManagementBriefsMenu=eBrief-no170

Management Briefs eBrief-no170 -- Secondary outcomes included total number of medications discontinued, number of medications with dosage decreased, number of potentially inappropriate ...