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

5 Participants Needed

Trial Summary

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 data supports the effectiveness of the HomeMed treatment for overmedication?

A study on improving medication use in home healthcare patients showed that a program involving collaboration between pharmacists and nurses helped address medication problems, which could support the effectiveness of HomeMed in managing overmedication. ^{1 2 3 4 5}

Is HomeMed safe for humans?

The research articles do not provide specific safety data for HomeMed, but they highlight the importance of monitoring adverse drug events (unwanted effects from medications) in home healthcare, especially for older adults who are more vulnerable to these events. ^{6 7 8 9 10}

How is the HomeMed treatment different from other treatments for medication-overuse headache?

HomeMed is unique because it focuses on detoxifying the overused medication, which is a simple and effective strategy for treating medication-overuse headache. Unlike other treatments that may require complex interventions, HomeMed can be managed with brief advice from general practitioners, making it accessible and straightforward for patients. ^{11 12 13 14 15}

What is the purpose of this trial?

The purpose of this study is to examine the feasibility of providing a medication optimization program to improve patient health outcomes during the transition from hospital to home. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations.

Eligibility Criteria

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.

I can make my own medical decisions.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Neuroscience: reporting bias. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Preliminary Data on a Care Coordination Program for Home Care Recipients. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Avoiding Overmedication of Elderly Patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Improving medication use in newly admitted home healthcare patients: a randomized controlled trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The interaction of patient perception of overmedication with drug compliance and side effects. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Medical devices, the FDA, and the home healthcare clinician. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Exploring diabetic care deficiencies and adverse events in home healthcare. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Identification and prevalence of adverse drug events caused by potentially inappropriate medication in homebound elderly patients: a retrospective study using a nationwide survey in Japan. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events in elderly patients receiving home health services following hospital discharge. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Improving over-the-counter medication safety for older adults: A study protocol for a demonstration and dissemination study. [2018]

11. Italy pubmed.ncbi.nlm.nih.gov

Epidemiology and management of medication-overuse headache in the general population. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Short-term effectiveness of simple advice as a withdrawal strategy in simple and complicated medication overuse headache. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Medication-overuse headache: epidemiology, diagnosis and treatment. [2022]

14. Germany pubmed.ncbi.nlm.nih.gov

Brief intervention by general practitioners for medication-overuse headache, follow-up after 6 months: a pragmatic cluster-randomised controlled trial. [2018]

15. Denmark pubmed.ncbi.nlm.nih.gov

[Clinical presentation and treatment of medication-overuse headache]. [2018]