An interventional study of Educational nudge intervention in Polypharmacy and Dementia, sponsored by University of Michigan. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 129 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
- primary care clinicians review of participants and determines intervention is not appropriate
This arm will collect data on total standardized daily dosage of the medication classes contributing to CNS polyRx from the Electronic Medical Record (EMR).
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.
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
Time frame: 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)
Clinicians from intervention clinics were interviewed to assess their perceptions about the acceptability of the experimental intervention.
| Milestone | No Educational Tool | Educational Nudge Intervention | Clinicians |
|---|---|---|---|
| Started | 68 | 61 | 10 |
| Completed | 66 | 57 | 10 |
| Not completed | 2 | 4 | 0 |
| Withdrew: Death | 2 | 4 | 0 |
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
| doses per day | No Educational Tool | Educational Nudge Intervention |
|---|---|---|
| TSDD At Baseline | 9.0 ± 7.2 | 9.0 ± 7.2 |
| TSDD at 4 months | -1.3 ± 5.8 | -1.6 ± 6.0 |
Collected over 4 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Educational Tool | 2/68 (2.9%) | 2/68 (2.9%) | 0/68 (0%) |
| Educational Nudge Intervention | 4/61 (6.6%) | 4/61 (6.6%) | 0/61 (0%) |
| Clinicians | — | — | — |
| Event | No Educational Tool | Educational Nudge Intervention | Clinicians |
|---|---|---|---|
| DeathGeneral disorders | 2/68 | 4/61 | — |
| Age, Continuous(years) | No Educational Tool | Educational Nudge Intervention | Clinicians | Total |
|---|---|---|---|---|
| Mean | 71 ± 8.4 | 73.7 ± 10.7 | 45.2 ± 10.7 | 63.3 ± 9.75 |
| Sex: Female, Male(Participants) | No Educational Tool | Educational Nudge Intervention | Clinicians | Total |
|---|---|---|---|---|
| Female | 40 | 41 | 8 | 89 |
| Male | 21 | 27 | 2 | 50 |
| Race (NIH/OMB)(Participants) | No Educational Tool | Educational Nudge Intervention | Clinicians | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 3 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 1 |
| Black or African American | 4 | 11 | 0 | 15 |
| White | 56 | 53 | 6 | 115 |
| More than one race | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 0 | 3 | 4 |
| Region of Enrollment(Participants) | No Educational Tool | Educational Nudge Intervention | Clinicians | Total |
|---|---|---|---|---|
| United States | 61 | 68 | 10 | 139 |
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