Improving Medication Management in World Trade Center Responders

Not Applicable

Recruiting

• Conditions: Polypharmacy

• Registration Number: NCT07022990
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

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 Timeline

• Study Start: 2025-04-08
• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-08
• Last Update Submitted: 2025-06-08
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Brief Medication Questionnaire 2 (BMQ2)	6 months after study enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Patient-reported Attitudes Towards Deprescribing (rPATD)	6 months after study enrollment	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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States