A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD)

Dementia Clinical Trial

Official title: A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia

Status Completed

Clinical Trial 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.

Clinical Trial Description

The United States (U.S.) health care system is poorly equipped to deal with the growing number of persons living with dementia (PLWD) in the U.S. and their complex medical and psychosocial needs. While memory impairment is the cardinal feature of Alzheimer's disease and related dementias (ADRD), behavioral and psychological symptoms (e.g., apathy, delusions, agitation) are common during all stages of illness and cause significant caregiver distress. CNS polyRx, defined by the American Geriatrics Society Beers Criteria as overlapping use of greater or equal to (≥) 3 medications from any of the following six classes: antidepressants, antipsychotics, anti-epileptics, benzodiazepines, non-benzodiazepine benzodiazepine receptor agonist hypnotics, or opioids. CNS polyRx is common among PLWD with limited evidence to support such prescribing despite significant evidence of harms, an example of routine care provided to PLWD that is potentially harmful in the vast majority of cases.

Minimizing CNS polypharmacy is a critical opportunity to improve safe medication use for PLWD. Direct-to-patient education has been demonstrated as one successful approach to initiate deprescribing in older adults. For this pilot study, after developing the tool (AIM 1), the study team will use the electronic health records (EHR) of the two healthcare systems (UM and Henry Ford) to identify PLWD with CNS polypharmacy and will send the educational tool, with subsequent EHR review to determine the implementation outcome of whether the recipients' clinicians were engaged in a discussion about these specific prescriptions. Finally, in preparation for a pragmatic trial, the study team will then query the EHR to assess change in CNS-active prescribing in the months following receiving the tool. The data generated during this pilot will allow the study team to seek future funding for a pragmatic trial to test this nudge intervention to reduce CNS polypharmacy among PLWD.

This pragmatic trial of a clinic-level intervention received a waiver of informed consent. There is no informed consent document for the intervention. ;

Related Conditions & MeSH terms

• Dementia
• Polypharmacy

• NCT number: NCT05628181
• Study type: Interventional
• Source: University of Michigan
• Status: Completed
• Phase: N/A
• Start date: May 8, 2023
• Completion date: January 19, 2024