HomeMed for Overmedication

Overseen By Jinjiao Wang, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: End-of-life prognosis, Hospice care, Severe cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a program called HomeMed, designed to improve health care for individuals transitioning from hospital to home. It focuses on those taking more than 10 medications daily, as this group often faces challenges when moving between care settings. The trial aims to determine if optimizing medication use can enhance health outcomes and prevent future hospital visits. Suitable candidates are English-speaking patients aged 65 and older who have been recently hospitalized and have arranged home health care services. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance post-hospitalization care for many.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, since the study focuses on medication optimization, your current medications might be reviewed and adjusted.

What prior data suggests that this medication optimization program is safe?

Research has shown that taking many medications at once, known as polypharmacy, can cause confusion, medication errors, and harmful side effects. Studies have found that excessive drug use can lead to more hospital visits due to these issues. Therefore, careful medication management is crucial.

HomeMed aims to improve the combination of medicines a person takes after leaving the hospital. Although specific data on HomeMed's safety is not yet available, its goal is to reduce the risks associated with polypharmacy. It seeks to provide a safe way to help people manage their medications better and avoid problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HomeMed because it offers a novel approach to tackling overmedication, which is a common issue with many current treatments relying heavily on pharmaceuticals. Unlike these traditional medication-based approaches, HomeMed is designed to empower individuals to manage their medication use more effectively at home, potentially reducing the need for excessive prescriptions. This method emphasizes patient autonomy and real-world application, making it a promising alternative that could lead to safer, more personalized care.

What evidence suggests that the HomeMed program is effective for medication optimization?

Research has shown that reviewing medications at home can reduce hospital visits for elderly patients at high risk. One study found that these reviews lowered unplanned hospital visits within six months. Another study demonstrated that reducing the number of medications can lead to better health outcomes, such as fewer hospital visits and lower death rates. Taking many medications often causes mistakes and side effects, so managing them can improve overall health. Trials focusing on safely reducing unnecessary medications support these findings by showing positive health results. This trial will evaluate the HomeMed program, which could effectively improve medication use and aid recovery after hospital discharge. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older who have been hospitalized recently and are transitioning to home care with a referral from URMHC. Participants must be on more than 10 daily medications, have a primary care provider in the URMC system, can consent themselves, and speak English. Those in hospice or end-of-life care, with severe cognitive issues or communication disabilities that prevent effective participation are excluded.

Inclusion Criteria

I am 65 years old or older.

English-speaking

Having a discharge disposition of home with a referral to receive HHC services from URMHC, or currently receiving HHC services from URMHC

Exclusion Criteria

End-of-life prognosis in the following 6 months

I am currently in hospice, end-of-life, or palliative care.

I do not have severe cognitive issues affecting my communication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a medication optimization program to improve health outcomes during the transition from hospital to home

3 months

Phone or survey follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HomeMed

Trial Overview

The study is testing 'HomeMed,' a medication optimization program designed to improve health outcomes for seniors after they leave the hospital and return home. The goal is to see if this program helps reduce complications and prevents future hospital stays during this vulnerable transition period.

How Is the Trial Designed?

Group I: All Participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The In-Home pilot program, which involved 22 home care offices, enabled caregivers to report changes in care recipients' conditions after 2% of shifts, potentially helping to manage health issues at home and avoid hospitalizations.

Caregivers and care managers generally had positive attitudes towards the intervention, although challenges included staff resistance to change and the need for a flexible approach to meet diverse patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Data on a Care Coordination Program for Home Care Recipients. Dean, KM., Hatfield, LA., Jena, AB., et al.[2018]

The FDA's MedWatch program allows consumers and healthcare professionals to voluntarily report adverse events related to medical devices, which is crucial for identifying issues in home and nonclinical settings.

As the use of medical devices increases outside of clinical environments, active participation in reporting by users and caregivers is essential for the FDA to effectively address and manage device-related problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical devices, the FDA, and the home healthcare clinician. Simone, LK., Brumbaugh, J., Ricketts, C.[2014]

In a study of 256 elderly patients receiving home health services after hospital discharge, 20% reported experiencing adverse drug events (ADEs), with the most common effects on the gastrointestinal and central nervous systems.

Women and patients with lower cognitive function who were prescribed multiple new medications were at a higher risk for ADEs, highlighting the need for careful medication management in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in elderly patients receiving home health services following hospital discharge. Gray, SL., Mahoney, JE., Blough, DK.[2017]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/17387123/

Home-based medication review in a high risk elderly ...

Main outcome measure: Total non-elective hospital admissions within 6 months. Secondary outcomes included number of deaths, care home admissions ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9468911/

Polypharmacy in the Homebound Population - PubMed Central

Polypharmacy can lead to confusion, errors, medication nonadherence, medication interactions, adverse medical events, higher costs, increased caregiver stress.

3.

bmcgeriatr.biomedcentral.com

bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-022-03279-x

Prevalence and factors associated with polypharmacy

The pooled estimated prevalence of polypharmacy in the 54 studies reporting on polypharmacy in all medication classes was 37% (95% CI: 31-43%).

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4972170/

Impact of strategies to reduce polypharmacy on clinically ...

The aim of the present study was to explore the impact of strategies to reduce polypharmacy on mortality, hospitalization and change in number of drugs.

5.

geriatric.theclinics.com

geriatric.theclinics.com/article/S0749-0690(12)00007-9/abstract

Deprescribing Trials: Methods to Reduce Polypharmacy ...

Deprescribing Trials: Methods to Reduce Polypharmacy and the Impact on Prescribing and Clinical Outcomes. Danijela Gnjidic, PhD, MPH.

6.

nia.nih.gov

nia.nih.gov/news/dangers-polypharmacy-and-case-deprescribing-older-adults

The dangers of polypharmacy and the case for deprescribing ...

Inappropriate polypharmacy — the use of excessive or unnecessary medications — increases the risk of adverse drug effects, including falls and ...

7.

bmcgeriatr.biomedcentral.com

bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05296-4

Polypharmacy and potentially inappropriate medications in ...

Polypharmacy exerts economic pressure on healthcare and leads to an increased risk of hospitalization due to adverse drug events [6,7,8,9].

8.

mdpi.com

mdpi.com/2077-0383/12/12/3960

Risk of Polypharmacy and Its Outcome in Terms of Drug ...

Five patients were taking less than two drugs, and thus, the prevalence of polypharmacy among this cohort was 98%, with 16 (5.1%) having minor ...

9.

link.springer.com

link.springer.com/article/10.1007/s11606-023-08364-4

Changes in Polypharmacy and Potentially Inappropriate ...

This study suggests that continued attention to medication optimization is required to achieve safe and effective HMC.