NCT05630144

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 29, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

2.2 years

First QC Date

November 17, 2022

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • mean time spent on intervention

    3 months

  • number of participants who complete a post intervention survey about feasibility

    3 months

  • Percentage of participants undergoing deprescribing

    3 months

  • Percentage of intervention adherence indicators checked

    3 months

  • Percentage of patients who improve in ability to do things that are important before and after intervention

    3 months

  • Total number of medications used per participant

    3 months

  • Percentage of patients who report a reduction in medication burden

    Medication burden will be reported by phone or survey.

    3 months

  • Percentage of participants who report a reduction in medication side effect

    Side effects will be collected by phone.

    3 months

Study Arms (1)

All Participants

EXPERIMENTAL
Behavioral: HomeMed

Interventions

HomeMedBEHAVIORAL

The HomeMed intervention is a multidisciplinary deprescribing intervention including home visits and team-based telehealth communication (optional). The components included in the HomeMed intervention include home medication review, medication education and provision of tools to assist the patients with medication administration, assessment of deprescribing targets by a trained geriatric clinical pharmacist, communication with the patient's treating primary care provider about deprescribing recommendation, deprescribing implementation (optional), and deprescribing monitoring (optional). Depending on the patient's treating primary care provider's decision on deprescribing and monitoring, the number of home visits ranges from a minimum of three to more with the entire duration of the intervention ranging from approximately 1 to 3 months.

All Participants

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age and older
  • currently hospitalized or having been hospitalized in the previous 2 weeks
  • having a discharge disposition of home with a referral to receive HHC services from URMHC, or currently receiving HHC services from URMHC
  • taking more than 10 regular medications daily
  • having a primary care provider who is in the URMC system
  • Ability to self-consent
  • English-speaking

You may not qualify if:

  • end-of-life prognosis in the following 6 months
  • currently receiving hospice care, end-of-life care, or palliative care
  • conditions that impact the receipt of the intervention, such as severe cognitive impairment that interferes with the subject's ability to communicate with interventionists;
  • substantial difficulties in hearing, vision, and verbal expression that disable the participant from communicating effectively while receiving the HomeMed intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Department of Medicine, Geriatrics/Aging (SMD)

Study Record Dates

First Submitted

November 17, 2022

First Posted

November 29, 2022

Study Start

March 29, 2023

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations