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

NCT05628181 | Completed Results DMC

• 2 other identifiers: HUM002180483U54AG063546-03
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this project is to address central nervous system-active polypharmacy (CNS polyRx) in people living with dementia (PLWD) through focus groups and an educational intervention. The project included three interconnected aims and engaged PLWD, care partners (CP), and clinicians. Aim 1 consisted of focus group discussions with PLWD and CPs, conducted to inform the development of the educational intervention. This aim was not considered a clinical trial. Therefore, this registration covers Aims 2 and 3, which constitute the clinical trial components. These included mailing the educational "nudge" intervention to PLWD and conducting qualitative interviews with clinicians. No care partners were involved in Aims 2 and 3. The study hypothesizes that the total standardized daily dosage (TSDD) of medication classes contributing to CNS polyRx will decrease from baseline to 4 months among participants receiving the intervention.

Conditions

Polypharmacy; Dementia

Keywords

Central Nervous System medication; Education

Outcome Measures

Primary Outcomes (1)

• Change in Total Standardized Daily Dosage (TSDD) of CNS-Active Medications From Baseline to 4 Months, as Measured in the EHR

  CNS-polyRx included multiple meds from different classes. To track prescribing changes total standardized daily dosage (TSDD) unit is used. TSDD was calculated by dividing each med's prescribed daily dose by its Minimal Effective Geriatric Daily Dose (MEGDD) a framework for identifying the lowest effective daily dose for older adults to balance benefit and reduce harm. E.g., citalopram 20mg daily with MEGDD of 10mg=2 TSDD units. TSDD was assessed during 2 periods: 45day baseline and 45days before the 4month follow-up. For each period, the total supply of each CNS-active med was summed and divided by 45 days to get a daily dose, then divided by MEGDD to yield standardized daily dose for each med. Values were summed to get total TSDD/ participant. Primary outcome is change in TSDD, calculated as TSDD at 4months minus baseline TSDD. E.g.,45day supply of citalopram 20mg daily (MEGDD=10mg)=2, gabapentin 300mg TID (MEGDD=900mg)=1, and zolpidem 5mg daily (MEGDD=5mg)=1, results in TSDD of 4.0

  Baseline (i.e., the 45 days prior to intervention) and 4 months post-intervention (i.e., the final 45 days of the 4-month period)

Study Arms (2)

No educational tool

NO INTERVENTION

This arm will collect data on total standardized daily dosage of the medication classes contributing to CNS polyRx from the Electronic Medical Record (EMR).

Educational nudge intervention

EXPERIMENTAL

Participants will be mailed the educational tool in the form of a brochure.

Behavioral: Educational nudge intervention

Interventions

Educational nudge intervention BEHAVIORAL

This project will adapt the EMPOWER educational brochure for PLWD receiving CNS polyRx. The educational brochure will be mailed to intervention participants identified through EHR at Michigan Medicine and Henry Ford Health System. The brochure will describe what CNS polyRx is, present information about the associated risks, and suggest that participants speak with the prescribing clinician or pharmacist about ways to potentially simplify the medication regimen. The tool will be adapted through three successive rounds of focus groups (AIM one of this project) of PLWD.

Educational nudge intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are receiving care at the one of the selected primary care clinics at Michigan Medicine and Henry Ford Health System
• Individuals who have a diagnosis of dementia or mild cognitive impairment (MCI) of any type based on International Classification of Diseases (ICD-10) codes
• Individuals 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 review

You may not qualify if:

• \- primary care clinicians review of participants and determines intervention is not appropriate

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• Barnett NM, Vordenberg SE, Kim HM, Turnwald M, Strominger J, Leggett AN, Akinyemi E, Blow FC, Vanderziel A, Pappas C, Maust DT. An Educational Intervention to Promote Central Nervous System-Active Deprescribing in Dementia: A Pilot Study. Drugs Aging. 2025 Mar;42(3):257-265. doi: 10.1007/s40266-024-01178-x. Epub 2025 Jan 20.

  PMID: 39832105 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The primary limitation of this pilot study was that it was conducted with a small number of PLWD at two health systems.

Results Point of Contact

• Title: Donovan Maust
• Organization: University of Michigan

maustd@med.umich.edu

734-845-3649

Study Officials

• Donovan Maust, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: There will be a total of four primary care clinics at University of Michigan Health and Henry Ford Health; potentially more clinics will be engaged if necessary.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: May 8, 2023
• Primary Completion: January 19, 2024
• Study Completion: August 19, 2024
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)