Improving Medication Management in World Trade Center Responders

NCT07022990 | Recruiting

• 3 other identifiers: STUDY-22-0073721-2114-00001U01OH012473
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polypharmacy

Keywords

Deprescribe; Medication management

Outcome Measures

Primary Outcomes (1)

• Brief Medication Questionnaire 2 (BMQ2)

  Brief Medication Questionnaire 2 (BMQ2) to measure participants feel/views about Z Drugs, Skeletal Muscle Relaxants, Proton Pump Inhibitors and Benzodiazepines. Min scale: Strongly Agree - Max scale: Strongly Disagree. Higher score means patient strongly disagrees with the extent medications makes them feel/views about their medication.

  6 months after study enrollment

Secondary Outcomes (1)

• Patient-reported Attitudes Towards Deprescribing (rPATD)

  6 months after study enrollment

Study Arms (1)

World Trade Center (WTC) Responders

EXPERIMENTAL

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

Other: Educational brochure for deprescribing

Interventions

Educational brochure for deprescribing 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.

World Trade Center (WTC) Responders

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

Deprescriptions

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Fred Ko, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Kim

CONTACT

212-241-9370; patricia.kim@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism Data will be provided directly to researchers who have approval under the direction of WTC General Responder Data Center and study PIs.

Locations

US (1)