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NCT05628181
A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD)
Conditions: Polypharmacy, Dementia
Sex: All
Ages: 50 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: University of Michigan
Location: United States
Summary
The goal of this project is to address Central nervous system-active polypharmacy (CNS polyRx) in people with living dementia (PLWD) through focus group and an educational intervention.This project involves three interconnected Aims and includes engaging clinicians, patients/PLWD, and care partners (CP).
AIM 1 will be completed for the development of the educational tool and is not considered a clinical trial.
Therefore, this registration includes the clinical trial (Aims 2 and 3) of the project.The study hypothesizes that the total standardized daily dosage (TSDD) of the medication classes contributing to CNS polyRx will decline from baseline to 4 months in participants receiving the nudge intervention.
Eligibility Criteria
Inclusion Criteria:Individuals who are receiving care at the one of the selected primary care clinics at Michigan Medicine and Henry Ford Health SystemIndividuals who have a diagnosis of dementia or mild cognitive impairment (MCI) of any type based on International Classification of Diseases (ICD-10) codesIndividuals who have been prescribed ≥3 of the medications that contribute to CNS polyRx (e.g., antidepressants, antipsychotics, anti-epileptics, benzodiazepines, non-benzodiazepine benzodiazepine receptor agonist hypnotics, or opioids) based on chart reviewExclusion Criteria:- primary care clinicians review of participants and determines intervention is not appropriate
Source: ClinicalTrials.gov (NCT05628181). StuddyBuddy aggregates publicly available trial information.