Improving Medication Management in World Trade Center Responders

NCT ID: NCT07022990

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-08

Study Completion Date

2026-06-30

Brief Summary

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By 2030, the majority of World Trade Center (WTC) rescue and recovery workers (responders) will be aged 65 and over and at risk for aging-related conditions and consequences including the concurrent use of five or more medications (i.e., polypharmacy). The purpose of this research study is to investigate an educational approach targeting polypharmacy through de-prescribing unnecessary and burdensome medications via the support of informed discussions between WTC responders and their prescribing physicians.

Detailed Description

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De-prescribing is the act of reducing or stopping medications that are no longer necessary or may cause harm, to reduce adverse drug reactions and ensure the safety of patients. Polypharmacy is the simultaneous use of five or more medications. Through education brochures and discussions about potential side effects of medications, the research team will see whether these approaches lead to discussions between a study participant (WTC responder) and the prescribing physician, to make informed decisions about management of medications. Specifically, the participant will be provided information about one of the five medication classes they may be taking that are known to have potential side effects for older adults: proton pump inhibitors (PPIs), benzodiazepine (BZs) and non-benzodiazepine sedative hypnotics ("Z-drugs"), first-generation antihistamines (FGA), and skeletal muscle relaxants (SMR) to determine their necessity. To be clear, changes to medications will only be done under the guidance of the prescriber.

Study participants will be asked to complete baseline surveys that ask about beliefs and attitudes regarding medications and de-prescribing; review patient education brochure about a medication the participant is taking; discuss deprescribing options with the participant's prescriber; and complete a survey regarding acceptance of the deprescribing intervention and how this process may have affected the physician-patient relationship.

Conditions

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Polypharmacy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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World Trade Center (WTC) Responders

World Trade Center (WTC) rescue and recovery workers (responders).

Group Type EXPERIMENTAL

Educational brochure for deprescribing

Intervention Type OTHER

Study participant will be provided information (i.e., educational brochure) about one of the five medication classes participants may be taking that are known to have potential side effects for older adults: proton pump inhibitors (PPIs), benzodiazepine (BZs) and non-benzodiazepine sedative hypnotics ("Z-drugs"), first-generation antihistamines (FGA), and skeletal muscle relaxants (SMR) to determine their necessity.

Interventions

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Educational brochure for deprescribing

Study participant will be provided information (i.e., educational brochure) about one of the five medication classes participants may be taking that are known to have potential side effects for older adults: proton pump inhibitors (PPIs), benzodiazepine (BZs) and non-benzodiazepine sedative hypnotics ("Z-drugs"), first-generation antihistamines (FGA), and skeletal muscle relaxants (SMR) to determine their necessity.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A WTC responder already enrolled in the "Promoting Healthy Aging Among WTC Responders: Frailty Trajectories and Intervention Strategies" study cohort
* aged 50 years or older, and
* taking one of the five medication classes:

* proton pump inhibitors (PPIs),
* benzodiazepine (BZs) and
* non-benzodiazepine sedative hypnotics ("Z-drugs"),
* first-generation antihistamines (FGA), and
* skeletal muscle relaxants (SMR).

Exclusion Criteria

* None
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Fred Ko

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fred Ko, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia Kim

Role: CONTACT

212-241-9370

Facility Contacts

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Fred Ko, MD

Role: primary

212-241-9370

Patricia Kim, MBS

Role: backup

201-232-8578

Other Identifiers

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21-2114-00001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

U01OH012473

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-22-00737

Identifier Type: -

Identifier Source: org_study_id

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