N/A N=139 Randomized Treatment

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

Polypharmacy · Dementia

Bottom Line

View on ClinicalTrials.gov: NCT05628181 ↗

Enrolled (actual)

139

Serious AEs

4.7%

Results posted

Jul 2025

Primary outcome: Primary: Change in Total Standardized Daily Dosage (TSDD) of CNS-Active Medications From Baseline to 4 Months, as Measured in the EHR — 9.0; 9.0; -1.3; -1.6 doses per day

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Educational nudge intervention (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Total Standardized Daily Dosage (TSDD) of CNS-Active Medications From Baseline to 4 Months, as Measured in the EHR	9.0; 9.0; -1.3; -1.6	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05628181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.