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

1. Trial at a Glance

This page covers the registry results for A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD) (NCT05628181), a randomized na study. The primary outcome is Change in Total Standardized Daily Dosage (TSDD) of CNS-Active Medications From Baseline to 4 Months, as Measured in the EHR.

2. Clinical Question

3. Trial Design

The registry record describes a completed, randomized, parallel-group study sponsored by the University of Michigan. The recorded enrollment was 129. The study began on 2023-05-08, and primary completion was recorded as 2024-01-19. The trial status is completed, and the phase is listed as NA. Masking is listed as none. These design details describe how the study was registered; they do not establish how closely every aspect of the intended conduct matched the registration.

The broader project had three connected aims. Focus groups with PLWD and care partners informed development of the educational intervention, but that aim was not considered a clinical trial. The registered trial components were mailing the educational nudge to PLWD and conducting qualitative interviews with clinicians. The registry specifically states that care partners were not involved in those trial aims. The registered intervention was a brochure mailed to participants; the comparator arm had no educational tool and was described as collecting TSDD data from the EMR.

The primary outcome was a continuous measure: change in TSDD from baseline to four months. The registry identifies the outcome as a mean with standard deviation and defines the follow-up window as the final 45 days of the four-month period. The baseline window was the 45 days before intervention. The record lists one outcome measure and no analyses. It does not report the number randomized to each arm, the number with outcome data at follow-up, or the participant flow between enrollment and analysis. The adverse-event record lists 68 participants at risk in the no-tool group and 61 in the educational-nudge group; those safety denominators should not be treated as a complete account of randomization or outcome availability.

The registry record does not report the rationale for the enrollment target, an allocation ratio, details of sequence generation, concealment procedures, or a detailed statistical analysis plan. It also does not report interim analyses. Those details should not be inferred from the randomized, parallel design description alone.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Individuals in the Clinicians arm did not receive an intervention.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change in Total Standardized Daily Dosage (TSDD) of CNS-Active Medications From Baseline to 4 Months, as Measured in the EHR, measured over 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).

The primary endpoint is change in total standardized daily dosage (TSDD) of CNS-active medications from baseline to four months, measured in the EMR. The baseline period is the 45 days before intervention, and the follow-up measurement uses the final 45 days of the four-month period. Change is defined as TSDD at four months minus baseline TSDD. By that definition, a negative change represents a lower measured TSDD at follow-up than at baseline; the registry record does not report the observed change.

TSDD places doses from different medication classes on a common scale using each medication’s Minimal Effective Geriatric Daily Dose (MEGDD). For each period, the record describes summing the supply of each CNS-active medication and dividing by 45 days to obtain a daily dose. That dose is divided by the medication’s MEGDD to give its standardized daily dose, and the medication-specific values are summed for each participant. The registry’s illustration states that citalopram 20mg daily with an MEGDD of 10mg corresponds to 2 TSDD units.

This measure is used to represent the combined dosage burden across multiple CNS-active medication classes, rather than treating each medication dose as directly interchangeable. It is a medication-use measure, not a direct measure of symptoms, function, or clinical benefit. The record does not report the mean change, standard deviation, confidence interval, or an arm-to-arm estimate.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, parallel-group design with no masking. Random allocation is intended to create groups that are comparable, on average, at the start of a study. A parallel design means participants are assigned to one group rather than crossing between the intervention and comparator. General explanation: randomization can reduce systematic differences between groups, but it does not guarantee exact balance in every characteristic, especially in a finite study. The registry record does not report the allocation ratio, sequence-generation method, concealment procedures, or baseline characteristics needed to assess balance.

What does the endpoint quantify?

TSDD is a continuous outcome expressed in doses per day. The registry describes standardizing the prescribed daily dose for each medication by its MEGDD, then summing across CNS-active medications for each participant. This approach makes the component doses additive on the stated standardized scale. The outcome is measured in two defined windows: the 45 days before intervention and the final 45 days of the four-month period. The primary quantity is the follow-up value minus the baseline value.

General explanation: continuous outcomes can be summarized by a mean and standard deviation. The mean gives the central average, while the standard deviation describes variation among observations. A mean change near zero would indicate little average shift on the chosen scale, but an estimate’s precision and the distribution of individual changes would also matter. No numerical mean, standard deviation, or distributional summary for the primary outcome is reported in the registry record.

Why distinguish a change from a group comparison?

Change from baseline can be calculated separately for each group, but the randomized comparison is the contrast between groups. General explanation: a between-group contrast helps distinguish change associated with assignment to the intervention from changes that may also occur over time in the comparator group. Possible analysis approaches include comparing participant-level changes or modeling follow-up values with baseline adjustment. These approaches can have different assumptions and estimates. The registry record does not report which approach was used, any covariate adjustment, or any primary outcome analysis.

The record describes the outcome as a mean and standard deviation, but that alone does not identify a test or model. It does not report whether assumptions were checked, how skewed or extreme TSDD values were handled, or whether the analysis accounted for baseline values. No confidence interval or p-value is reported. The absence of a listed analysis means those inferential details cannot be reconstructed from the registry description.

What do planning illustrations mean?

The registry describes a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. Such values are planning illustrations, not observed power and not evidence that the study was designed around a particular clinically meaningful difference. The registry record does not report numerical planning estimates or a sample-size justification. It also does not report the target effect used in the trial’s original design.

General explanation: a sample-size calculation estimates how many participants may be needed to detect a specified effect under stated assumptions. Its interpretation depends on the assumed effect, variability, allocation, and statistical method. If the assumed effect differs from the true effect, the operating characteristics may differ from the illustration. A planning calculation cannot replace the observed estimate and its uncertainty, and it cannot establish that a study’s result is conclusive.

How should uncertainty be assessed?

General explanation: a confidence interval communicates the range of estimates compatible with the data under a chosen method. A narrow interval indicates greater precision than a wide interval, all else equal. A p-value, when reported, quantifies how unusual the data would be under a specified null model and assumptions; it does not measure the size or importance of an effect. These tools are most informative alongside the effect estimate and its scale. The registry record does not report a confidence interval, p-value, or inferential estimate for TSDD change.

The sample-size assumptions mention a normal approximation. General explanation: a normal approximation can be useful when the sampling distribution of an estimate is adequately represented by a normal distribution. The registry record does not provide information about the outcome distribution or diagnostics, so the suitability of any particular approximation cannot be assessed. Dispersion matters because greater variability generally makes an estimate less precise for a given amount of information. No numerical variability estimate for the primary outcome is reported.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and no analyses. It does not report a statistical analysis plan, a hierarchy of outcomes, or a multiplicity adjustment. Multiplicity concerns the increased chance of at least one false-positive finding when several hypotheses are tested. General explanation: prespecifying a primary comparison and any adjustment strategy helps clarify how multiple tests are interpreted. With no reported analyses or multiplicity plan, it is not possible to determine how multiple comparisons, if any, were handled. The record’s listing of one outcome measure does not establish that only one statistical test was conducted.

Missing-data handling is not reported in the registry record. The record does not give the number of participants with baseline and follow-up TSDD, reasons for missing observations, imputation procedures, or sensitivity analyses. General explanation: missing outcome data can affect estimates if the participants with observed measurements differ systematically from those without them. The effect depends on why data are missing and on the analysis assumptions; the missingness count alone would not resolve that issue.

The analysis population is also not reported. The registry does not state whether the primary analysis included all randomized participants, only participants with observed measurements, or another defined group. It does not report exclusions or adherence-related restrictions. Consequently, the relation between the registered enrollment of 129, the safety denominators, and the population used for any primary outcome analysis is not established by the record.

Interim analyses are not reported. No details are given about stopping rules, data monitoring, or decisions to modify the study. These omissions do not show that any particular procedure was or was not used; they mean those procedures are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: death (6.6%).

The adverse-event record lists 68 participants at risk in the “No Educational Tool” group and 61 in the “Educational Nudge Intervention” group. Serious adverse events affected 2 participants in the no-tool group and 4 in the educational-nudge group. The record lists 2 deaths in the no-tool group and 4 in the educational-nudge group. Other adverse events affected 0 participants in each group. The clinicians group has 0 participants at risk and 0 events recorded.

“Death” is listed among the top serious adverse-event terms at 6.6%. The registry entries do not specify the denominator used for that percentage. The serious-event counts and death counts are recorded separately by group; the record does not provide event narratives, timing, severity details beyond the serious classification, or an assessment of whether events were related to the intervention.

These counts are descriptive. They do not by themselves establish a causal difference between groups, particularly without an account of follow-up time, event ascertainment, or statistical comparison. Safety figures also do not answer the primary question about TSDD change. No medical conclusion should be drawn from these counts alone.

12. What the Result Does, and Does Not, Mean

The study addresses a measurable question: whether the total standardized daily dosage of CNS-active medications changed between the baseline and four-month periods among people living with dementia in a randomized study of a mailed educational brochure. The registry specifies how TSDD was constructed and identifies a no-tool comparator. That description gives readers a basis for understanding the intended outcome and comparison.

What the registry record does not provide is the primary outcome result. There is no reported mean change, between-group estimate, uncertainty interval, or statistical test. As a result, the size and direction of any difference between the randomized groups cannot be stated, and the precision of an estimate cannot be evaluated. The registered hypothesis is not a result; it records what the study expected to observe.

Even if a numerical change were available, TSDD would represent standardized medication dosage, not all aspects of CNS-active polypharmacy or the lived experience of participants. It would not by itself describe symptoms, function, quality of life, or whether medication changes were appropriate for an individual. The registry record does not report these outcomes as primary measures.

The randomized design is relevant because a comparison between groups can help address whether outcomes differed with assignment to the educational nudge. But the record does not report the analysis method, analysis population, missing-data approach, or primary estimates. Those gaps prevent a full assessment of how the registered comparison was conducted and how well its uncertainty was quantified.

The safety counts should be read as event summaries, not as proof that the intervention caused or prevented any event. The record does not provide an attribution assessment or detailed event context. In short, the registry establishes the trial’s question, intervention, comparator, endpoint definition, and selected safety counts. It does not report enough primary outcome evidence to quantify an intervention-related difference or judge its precision.

13. Why This Trial Matters Statistically

This study is statistically notable for translating medication use across multiple CNS-active classes into a common, standardized dosage measure. TSDD uses each medication’s MEGDD as a reference, then combines the standardized daily doses. That creates a continuous endpoint intended to capture overall dosage burden across medication classes rather than focusing on one drug at a time. The definition matters because interpretation depends on what is counted and how the scale is constructed.

The endpoint also uses repeated periods for each participant: a 45-day baseline window and the final 45 days of the four-month follow-up period. A change score makes the time comparison explicit, while randomization creates the basis for comparing the intervention group with a no-tool group. General explanation: within-person change and between-group contrast answer related but distinct questions. Reporting both the definition and the actual contrast would help readers understand what the trial estimates.

The registry also illustrates why an outcome definition is not a substitute for results. The record gives the unit, time windows, and calculation but does not report the observed mean changes or their uncertainty. Without those estimates, readers cannot evaluate effect size, precision, or how the randomized groups differed on the endpoint. The registered hypothesis should therefore be distinguished from evidence about the observed data.

Finally, this record connects an educational intervention with an EMR-based medication measure and includes a separate qualitative component involving clinician interviews. Keeping the trial components distinct is important: the focus groups informed intervention development, while the registered clinical-trial aims involved mailing the brochure and interviewing clinicians. The registry does not report analysis results for either the primary medication endpoint or the qualitative interviews.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The main limitation for interpreting the trial from the registry record is the absence of primary outcome results. Although the endpoint and its measurement windows are described, the record does not report the mean change, variability, between-group estimate, confidence interval, or p-value. The effect’s magnitude and precision therefore cannot be assessed.

The registry does not report the statistical analysis method, analysis population, handling of missing measurements, or the number of participants contributing to the primary endpoint. The total enrollment is 129, while the adverse-event groups list 68 and 61 participants at risk. Those safety denominators do not establish the numbers randomized or analyzed for TSDD. Without participant flow and outcome completeness, it is not possible to assess whether missing data or exclusions could affect interpretation.

Details that would help evaluate the randomized design are also not reported, including the allocation ratio, sequence generation, concealment, and baseline characteristics. The record lists no masking, but it does not describe how the EMR outcome was extracted or whether outcome assessment was conducted without knowledge of group assignment. It also does not report adherence to the mailed brochure or engagement with the educational tool.

The registry does not report the original sample-size justification, the target effect, a statistical analysis plan, multiplicity procedures, or interim analyses. The planning assumptions described in the record are illustrations based on an observed effect, not a substitute for these design details. Finally, the safety record gives counts but not event-level context, attribution, or the denominator for the listed 6.6% serious-event term. These limitations concern what is reported in the registry and should not be treated as evidence that an unreported procedure was absent.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Patient-facing Tool to Reduce Opioid-Psychotropic Polypharmacy in People Living With Dementia (PLWD) — NCT05628181.
• Registry record last updated 2025-07-24; status last verified 2025-07.
• Results first posted 2025-07-24.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT05628181 is a completed, randomized, parallel-group study sponsored by the University of Michigan, with no masking and a recorded enrollment of 129. The registered intervention was a mailed educational brochure for people living with dementia; the comparator received no educational tool. The primary endpoint was change in TSDD of CNS-active medications from baseline to four months, measured in the EMR using a 45-day baseline period and the final 45 days of follow-up.

The record describes an earlier focus-group aim used to inform intervention development, and registered trial components involving the mailed intervention and qualitative clinician interviews. It lists one outcome measure and no analyses. Primary outcome estimates and analysis details are not reported in the registry record. Safety entries list serious adverse events affecting 2 participants in the no-tool group and 4 in the educational-nudge group, with deaths recorded as 2 and 4, respectively.