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

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Polypharmacy
• Intervention / Treatment: Behavioral: Educational nudge intervention

Detailed 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 than 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 used the electronic health records (EHR) of two healthcare systems (UM and Henry Ford) to identify PLWD with CNS polypharmacy and sent the educational tool to these individuals. EHR review was then conducted 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 queried the EHR to assess change in CNS-active prescribing in the months following receipt of 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.

Note: While this project included three aims, only Aims 2 and 3 involved intervention activities and are included in this record. Aim 1, which involved qualitative focus groups with PLWD and their CP to inform the intervention's development, was exploratory in nature, did not constitute an intervention, and is therefore not included in this record. No care partners were involved in Aims 2 and 3 and are not included in this record.

This pragmatic trial of a clinic-level intervention received a waiver of informed consent. There is no informed consent document for the intervention. Clinicians from intervention clinics were interviewed to explore their perceptions about the acceptability of the experimental intervention only. No clinicians received an intervention, and no primary or secondary outcomes were planned based on these interviews.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No educational tool; This arm will collect data on total standardized daily dosage of the medication classes contributing to CNS polyRx from the Electronic Medical Record (EMR).
Experimental: Educational nudge intervention; Participants will be mailed the educational tool in the form of a brochure.	Behavioral: Educational nudge intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Donovan Maust, MD, MS, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): January 19, 2024
• Study Completion (Actual): August 19, 2024

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Education; Central Nervous System medication
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: HUM00218048; 3U54AG063546-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No