Icahn School of Medicine at Mount Sinai
New York, 10029, United States
Location status: Recruiting
Location contact
Fred Ko
PRINCIPAL_INVESTIGATOR
Fred Ko, MD
CONTACT
Patricia Kim, MBS
CONTACT
NCT Number: NCT07022990
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
New York, 10029, United States
Location status: Recruiting
Fred Ko
PRINCIPAL_INVESTIGATOR
Fred Ko, MD
CONTACT
Patricia Kim, MBS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Icahn School of Medicine at Mount Sinai
Other
Promoting Healthy Aging Among WTC Responders: Frailty Trajectories And Intervention Strategies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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