Improving Medication Management in World Trade Center Responders

Promoting Healthy Aging Among WTC Responders: Frailty Trajectories And Intervention Strategies

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.

Study Overview

• Status: Recruiting
• Conditions: Polypharmacy
• Intervention / Treatment: Other: Educational brochure for deprescribing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Kim; Phone Number: 212-241-9370; Email: patricia.kim@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Fred Ko, MD; Phone Number: 212-241-9370; Email: fred.ko@mssm.edu
      • Contact: Patricia Kim, MBS; Phone Number: 201-232-8578; Email: patricia.kim@mssm.edu
      • Principal Investigator: Fred Ko

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: World Trade Center (WTC) Responders; World Trade Center (WTC) rescue and recovery workers (responders).

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Attitudes Towards Deprescribing (rPATD)	The Revised Patients' Attitudes Towards Deprescribing (rPATD) questionnaire consists of 22 items divided into five subscales: perceived burden of medication taking, concerns about stopping the medication, belief in appropriateness of medication use (harms/benefits), level of involvement/knowledge of medications, and global questions. Each item is rated on a 5-point Likert scale: 5 = strongly agree, 4 = agree, 3 = unsure, 2 = disagree, and 1 = strongly disagree. The total score ranges from 22 to 110, with higher scores indicating greater perceived burden, concern, involvement, or agreement with global questions. Subscale scores are: perceived burden (5 items, 5-25), concerns about stopping (5 items, 5-25), belief in appropriateness (5 items, 5-25, reversed), involvement/knowledge (5 items, 5-25), and global questions (2 items, 2-10). Higher scores indicate greater concern or involvement, with reversed scoring for the belief in appropriateness subscale.	6 months after study enrollment

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Fred Ko, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 8, 2025
• First Submitted That Met QC Criteria: June 8, 2025
• First Posted (Actual): June 15, 2025

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 8, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Medication management; Deprescribe
• Other Study ID Numbers: STUDY-22-00737; 21-2114-00001 (Other Grant/Funding Number: National Institute for Occupational Safety and Health); U01OH012473 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No