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

NCT ID: NCT05628181

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2024-08-19

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.

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.

Conditions

Polypharmacy; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Educational nudge intervention

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

Group Type: EXPERIMENTAL

Educational nudge intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Donovan Maust

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donovan Maust, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 39832105 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3U54AG063546-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00218048

Identifier Type: -

Identifier Source: org_study_id