Trial Outcomes & Findings for A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD) (NCT NCT05628181)

Last Updated: 2025-07-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

129 participants

Primary outcome timeframe

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)

Results posted on

2025-07-24

Participant Flow

Clinicians from intervention clinics were interviewed to assess their perceptions about the acceptability of the experimental intervention.

Individuals in the Clinicians arm did not receive an intervention.

Participant milestones

Participant milestones
Measure	No Educational Tool Participants (PLWD) who did not receive the mailed the educational tool in the form of a brochure. 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 Participants (PLWD) will be mailed the educational tool in the form of a brochure. 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).	Clinicians Clinicians from intervention clinics were interviewed to assess their perceptions about the acceptability of the experimental intervention.
Overall Study STARTED	68	61	10
Overall Study COMPLETED	66	57	10
Overall Study NOT COMPLETED	2	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	No Educational Tool Participants (PLWD) who did not receive the mailed the educational tool in the form of a brochure. 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 Participants (PLWD) will be mailed the educational tool in the form of a brochure. 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).	Clinicians Clinicians from intervention clinics were interviewed to assess their perceptions about the acceptability of the experimental intervention.
Overall Study Death	2	4	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Educational Tool n=61 Participants 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 n=68 Participants Participants will be mailed the educational tool in the form of a brochure. 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.	Clinicians n=10 Participants Clinicians who were interviewed but were not randomized to an intervention.	Total n=139 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 8.4 • n=5 Participants	73.7 years STANDARD_DEVIATION 10.7 • n=7 Participants	45.2 years STANDARD_DEVIATION 10.7 • n=5 Participants	63.3 years STANDARD_DEVIATION 9.75 • n=4 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	41 Participants n=7 Participants	8 Participants n=5 Participants	89 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	27 Participants n=7 Participants	2 Participants n=5 Participants	50 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	11 Participants n=7 Participants	0 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants	53 Participants n=7 Participants	6 Participants n=5 Participants	115 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment United States	61 Participants n=5 Participants	68 Participants n=7 Participants	10 Participants n=5 Participants	139 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	No Educational Tool n=68 Participants 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 n=61 Participants Participants will be mailed the educational tool in the form of a brochure. 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.
Change in Total Standardized Daily Dosage (TSDD) of CNS-Active Medications From Baseline to 4 Months, as Measured in the EHR TSDD At Baseline	9.0 doses per day Standard Deviation 7.2	9.0 doses per day Standard Deviation 7.2
Change in Total Standardized Daily Dosage (TSDD) of CNS-Active Medications From Baseline to 4 Months, as Measured in the EHR TSDD at 4 months	-1.3 doses per day Standard Deviation 5.8	-1.6 doses per day Standard Deviation 6.0

Adverse Events

No Educational Tool

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Educational Nudge Intervention

Serious events: 4 serious events

Other events: 0 other events

Deaths: 4 deaths

Clinicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	No Educational Tool n=68 participants at risk 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 n=61 participants at risk Participants will be mailed the educational tool in the form of a brochure. 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.	Clinicians Clinicians from intervention clinics were interviewed to assess their perceptions about the acceptability of the experimental intervention.
General disorders Death	2.9% 2/68 • Number of events 2 • 4 Months The intervention period was 4 months (i.e., potential prescription medication changes were examined 4 months after sending the educational intervention), during which time adverse events, including deaths, were also assessed. A final retrospective analysis at study completion (Aug 2024) captured any deaths during the intervention period that were not available in the EHR at the time of initial review. No adverse event data were collected from clinicians, as they did not receive an intervention.	6.6% 4/61 • Number of events 4 • 4 Months The intervention period was 4 months (i.e., potential prescription medication changes were examined 4 months after sending the educational intervention), during which time adverse events, including deaths, were also assessed. A final retrospective analysis at study completion (Aug 2024) captured any deaths during the intervention period that were not available in the EHR at the time of initial review. No adverse event data were collected from clinicians, as they did not receive an intervention.	— 0/0 • 4 Months The intervention period was 4 months (i.e., potential prescription medication changes were examined 4 months after sending the educational intervention), during which time adverse events, including deaths, were also assessed. A final retrospective analysis at study completion (Aug 2024) captured any deaths during the intervention period that were not available in the EHR at the time of initial review. No adverse event data were collected from clinicians, as they did not receive an intervention.

Other adverse events

Adverse event data not reported

Additional Information

Donovan Maust

University of Michigan

Phone: 734-845-3649

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place