PolypharmacyNCT07022990
Improving Medication Management in World Trade Center Responders
A study testing Educational brochure for deprescribing in people with Polypharmacy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polypharmacy
- What is being tested?
- Educational brochure for deprescribing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
Read the 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.
- Conditions
- Polypharmacy
- Being tested
- Educational brochure for deprescribing
- Keywords
- Deprescribe, Medication management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational brochure for deprescribingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| World Trade Center (WTC) Responders | Experimental | World Trade Center (WTC) rescue and recovery workers (responders). Receives: Other: Educational brochure for deprescribing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after study enrollment
Secondary outcomes (1)
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.
Measured: 6 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start8 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Hung, Icahn School of Medicine at Mount Sinai
- Investigators
- William Hung, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022990
- Sponsor's protocol ID
- STUDY-22-00737
- Other IDs
- 21-2114-00001, U01OH012473
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).