Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia (NCT06273917), a na na study. The primary outcome is Participants With Pharmacist Communication of Deprescribing Recommendation.

2. Clinical Question

The study asks whether an emergency-department pharmacist can carry out medication reconciliation and communicate deprescribing recommendations to outpatient prescribers for patients with dementia or mild cognitive impairment who may be using central nervous system active potentially inappropriate medications (CNS PIMs). It is framed as a feasibility study, rather than a controlled test of whether the intervention changes clinical outcomes.

The broader aims are to assess feasibility of medication reconciliation, pharmacist-to-prescriber communication, and collection of outcomes for a future study. Those future outcomes are described as CNS PIM reduction 90 days after an ED visit, outpatient follow-up, repeat ED visits, and hospitalizations. A further aim is to assess outpatient clinicians’ acceptability of PRIDE using the Acceptability of Intervention Measure and qualitative analysis. These aims define the questions the study was designed to address; they do not establish that each outcome was successfully collected or that the intervention changed medication use.

3. Trial Design

The registry describes NCT06273917 as a completed, single-group study of PRIDE, with no masking and allocation listed as not applicable. It lists the phase as not applicable. Because there is no randomized allocation or separate control arm, the study design is suited to documenting whether intervention procedures and outcome collection are feasible, not to estimating a comparative treatment effect.

The registry lists enrollment as 300. The intervention-arm description states an intention to include 290 patients across 3 sites, but that description ends mid-sentence. These entries are not reconciled in the registry record, so they should not be treated as interchangeable descriptions of the final number enrolled or analyzed. The description identifies community-dwelling adults age 18 or older with emergency-department visits, prior outpatient visits within the NM system, and dementia or mild cognitive impairment recorded in the NM electronic health record as eligible.

The listed sponsor is the National Institute on Aging (NIA). The study start date is 2024-07-09, and the primary completion date is 2025-10-31. The record lists the status as completed. These administrative details do not supply participant-level follow-up, an analysis population, or a result for the primary endpoint.

The primary measure concerns pharmacist communication of a deprescribing recommendation to an outpatient prescriber. Other registry outcomes include medication reconciliation completed, participants with deprescribed medications, and participants with repeat ED visits or hospitalization. The study aims also describe later outcome collection and clinician acceptability. The protocol details governing recruitment, implementation across sites, and analysis are not reported in the registry record. In particular, the arm description does not fully explain how the intervention was delivered or how completion was defined.

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: Emergency Department pharmacists approached patients with prior diagnosis of dementia or MCI to perform medication reconciliation

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 Participants With Pharmacist Communication of Deprescribing Recommendation, measured over 24 hours.

The primary endpoint is the count of participants for whom an ED pharmacist sends an electronic message through the electronic health record to the outpatient prescriber with a deprescribing recommendation. The recommendation is intended for patients taking CNS PIMs. The registry gives a timeframe of 24 hours and describes the communication as being performed on Day 0 in the emergency department.

This measure is used to assess a practical step in the intervention pathway: whether a recommendation gets communicated across care settings. A count can describe how many participants had that documented action. To interpret it as a proportion, a defined denominator is also needed, such as the number of eligible participants or the number taking CNS PIMs. The denominator for a proportion is not reported in the registry record, and no numerical primary-endpoint count is listed in the posted results.

Communication is not the same as a prescriber accepting a recommendation, changing a medication, or a patient experiencing a later outcome. The endpoint therefore captures a process measure, not medication reduction or a clinical effect. The record does not state the operational rules used to verify message delivery, determine whether a recommendation qualified, or handle multiple recommendations for one participant. Those details are important for reproducibility and for interpreting the count, but are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Several statistical ideas help distinguish what this study can describe from what it can establish. The design and outcomes are described in the registry, but the statistical analysis plan is not reported in the registry record. The explanations below are general, with the study-specific details identified separately.

What does a single-group design estimate?

In general, a single-group study can describe what happened among participants who received an intervention. For a count outcome, that may be the number of participants with a documented action. A rate or proportion additionally requires a clearly defined denominator. A comparison of outcomes before and after an intervention can describe change, but without a control group it cannot separate the intervention’s contribution from changes in clinical practice, participant characteristics, or other events occurring over the same period.

For this study, the registry lists a single-group model and allocation as not applicable. The primary outcome is a count of participants with pharmacist communication of a deprescribing recommendation. No comparison group is listed, and there are no analysis results reported. Thus, the design and posted information do not support a between-group treatment-effect estimate.

What does a count measure?

A count records how many participants meet a defined event criterion. It does not, by itself, show the chance of that event for an individual participant, because that interpretation depends on the population at risk and the denominator. For a proportion, the numerator and denominator must refer to a clearly defined population and observation period. If some participants are ineligible for the event, have incomplete records, or are not observed for the full period, the handling of those participants can affect the interpretation.

The primary endpoint is described as a count, with a 24-hour timeframe and a Day 0 intervention description. The record does not state a numerical count, denominator, or rules for missing or incomplete communication records. Therefore, the count cannot be converted into a proportion from the registry information available for this analysis.

What does a confidence interval add?

In general, a confidence interval describes the uncertainty around an estimated quantity under a statistical model and its assumptions. A narrow interval indicates greater precision than a wide interval, while neither width nor location alone establishes that an intervention caused an outcome. For a count or proportion, the interval method should match the outcome type and the way participants were observed. No confidence interval for the primary or secondary outcomes is reported in the registry record.

A p-value, when reported, addresses how compatible data are with a specified null model under stated assumptions. It does not measure the size or importance of an effect and does not establish causality. No p-value or inferential analysis is listed for this study. A missing p-value should not be interpreted as evidence that outcomes were equal or that an effect was absent.

How should planning calculations be interpreted?

In general, a sample-size calculation is a planning exercise based on assumptions about the outcome, the target effect, variability, allocation, and statistical procedure. It is not a result observed in participants. A calculation made from an observed effect for illustration is not a trial’s prospective design justification, and it is not observed power. The registry record does not report the protocol’s sample-size justification.

The described planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They also describe the effect to detect as a stated fraction of an observed effect. These are planning assumptions, not a description of the registered single-group design, which has no two-arm allocation. No numerical planning results are included in the registry information used for this analysis. Any resulting sample-size figures should therefore be read as hypothetical planning illustrations, not as observed trial findings or evidence of the study’s ability to detect an effect.

Why can over-dispersion matter?

In general, over-dispersion occurs when observed variability exceeds what a statistical model assumes. For count outcomes, a simple model may understate uncertainty if participants vary substantially in their event rates or if events cluster by site. A model that accounts for such variation can yield more realistic uncertainty estimates. Whether over-dispersion is relevant depends on the outcome structure and model; the registry record does not report a count model, dispersion assessment, or site-level analysis. The primary outcome is described as a participant count, and no model-based estimate is listed.

What is needed to reproduce an analysis?

In general, reproducibility requires definitions for the analysis population, outcome coding, timing, missing data, covariates, and statistical method. This is particularly important when the measure depends on an electronic message: the protocol should specify what qualifies as a completed recommendation and how duplicate or incomplete communications are treated. The registry record does not report those analysis details. It also does not report whether estimates were adjusted, whether site was considered, or how outcome collection was verified. Without these details and numerical results, the statistical findings cannot be independently reconstructed from the registry information.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Patients With CNS PIMs", "PRIDE Patients")
n      <- c(79, 300)
events <- c(78, 299)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Patients With CNS PIMs  79  78  98.7  93.1  100.0  93.2  99.8  93.2  99.7
ARM  PRIDE Patients  300  299  99.7  98.2  100.0  98.1  99.9  98.2  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and describes primary and secondary aims. Considering multiple outcomes raises a general issue of multiplicity: when several statistical hypotheses are tested, the chance of at least one apparently notable result can increase if no adjustment or outcome hierarchy is used. Whether an adjustment is appropriate depends on the study’s goals and analysis plan. Any multiplicity strategy, prespecified hierarchy, or distinction between confirmatory and exploratory analyses is not reported in the registry record.

No statistical analyses are listed, and numerical outcome results are not reported in the registry record for the primary endpoint or the stated secondary outcomes. Therefore, there are no reported estimates to interpret in light of multiplicity, and no adjustment procedure can be identified. A list of outcomes alone does not establish which were analyzed, whether all planned outcomes were collected, or how results were selected for reporting.

Missing-data handling is also not described. The registry record does not report the number of participants with complete medication reconciliation, the number with outcome follow-up, reasons for missing information, or any imputation or sensitivity analysis. For a process measure based on electronic health record messages, missing documentation could reflect either the absence of a communication or incomplete capture; the record does not explain how those possibilities were distinguished.

The analysis population is not reported in the registry record. The enrollment field lists 300, while the intervention-arm description refers to an intention to include 290 patients across 3 sites. The record does not explain which number corresponds to enrollment, eligibility, or analysis. Outcome-specific denominators and exclusions are also absent. The completed status does not, on its own, establish that every participant had complete outcome data or that all outcomes were analyzed.

12. 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 5% reporting threshold.

The registry safety listing records 79 participants at risk for serious adverse events, with 0 affected. It also records 79 participants at risk for other adverse events, with 0 affected. The listing separately reports 2 deaths. These are descriptive counts and should be read as distinct entries rather than as a complete account of all clinical events.

The record does not report the timing, causes, or circumstances of the deaths, whether they occurred in participants included in either adverse-event group, or whether any event was judged related to PRIDE. It also provides no serious adverse event terms. Thus, the listed 0 affected does not establish that no clinically important events occurred, and the deaths cannot be attributed to the intervention from these figures.

The count of 79 at risk should not be assumed to represent the full enrollment or the denominator for every study outcome. The registry record does not explain the safety population definition or follow-up period. Because the study has no comparison group, these figures cannot show whether event occurrence differed from what would have happened without the intervention. The counts describe what the registry lists; they do not establish comparative safety.

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

The study’s stated purpose is feasibility: to assess medication reconciliation and pharmacist communication in an emergency department, the feasibility of collecting outcomes for a subsequent study, and outpatient clinicians’ acceptability of PRIDE. The single-group design is consistent with describing implementation and documenting observed events. It does not provide a randomized or concurrent control comparison.

The primary endpoint focuses on whether an ED pharmacist sends a deprescribing recommendation to an outpatient prescriber through the electronic health record. That is a meaningful process step to document, but it is not equivalent to the prescriber changing a medication, a reduction in CNS PIM use, or a change in later healthcare use. Those are separate outcomes. The registry describes CNS PIM reduction 90 days after an ED visit as a future primary outcome for a subsequent study, alongside outpatient follow-up, repeat ED visits, and hospitalizations.

Numerical findings for the primary endpoint and the listed secondary outcomes are not reported in the registry record. It is therefore not possible to state how often communication or medication reconciliation occurred, how many participants had deprescribed medications, or how often repeat ED visits or hospitalization occurred. The record also does not provide a numerical acceptability result or a qualitative summary of clinician responses.

The posted safety counts include 0 participants affected among 79 at risk for serious adverse events, 0 affected among 79 at risk for other adverse events, and 2 deaths. Without event details, follow-up definitions, and attribution information, these entries cannot establish the cause of the deaths or comparative safety. A lack of a control group also limits safety comparisons.

Accordingly, the registry information identifies the study questions and some safety counts, but it does not permit conclusions about the frequency of the primary process outcome, changes in medication use, or the intervention’s effects. Such conclusions would require outcome estimates, denominators, uncertainty measures, analysis definitions, and appropriate comparison data where causal effects are of interest.

14. Why This Trial Matters Statistically

Feasibility studies address whether a proposed intervention and its measurement procedures can be carried out in the intended setting. For a later definitive study, it matters whether medication histories can be reconciled, whether recommendations can reach outpatient prescribers, and whether outcomes can be collected after an emergency-department visit. The registry’s aims make those implementation questions explicit and distinguish them from the future question of whether CNS PIM use changes.

Statistically, the distinction between process and clinical outcomes is central. A documented pharmacist message is a process measure. Medication deprescribing, CNS PIM reduction at 90 days, and subsequent healthcare use represent different outcomes and require their own definitions and follow-up. Reporting the numerator, denominator, time window, and missingness for each measure would allow readers to assess completeness and precision. Those numerical details are not reported in the registry record for the primary measure.

The single-group design can be useful for describing delivery and data collection, but it cannot isolate the effect of PRIDE from other influences. This matters when results are used to plan a later comparative study: feasibility counts can inform whether procedures were implemented, while comparative estimates are needed to assess differences attributable to an intervention. The registry record does not report a control group or a statistical analysis plan.

The registry’s enrollment entries also illustrate why study flow and analysis populations should be reported clearly. Enrollment is listed as 300, while the arm description states an intention to include 290 patients across 3 sites. Without an explanation of these entries and outcome-specific denominators, readers cannot determine how many participants contributed to each measure. Clearer reporting would support interpretation, reproducibility, and planning for future research.

15. 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 statistical interpretation is the absence of numerical results for the primary endpoint and the stated secondary outcomes in the registry record. The primary measure is defined as a count, but the observed count and denominator are not reported. There are no reported confidence intervals, p-values, or model estimates, and no analyses are listed. Statistical precision and outcome frequencies therefore cannot be assessed.

The single-group design has no concurrent control arm. It can describe intervention implementation but cannot, by itself, distinguish intervention-related changes from other causes. The registry also does not report the statistical analysis plan, sample-size justification, analysis population, missing-data approach, or multiplicity strategy. These omissions constrain reproducibility and interpretation.

The registry lists enrollment as 300, whereas the arm description refers to an intention to include 290 patients across 3 sites. The record does not reconcile these entries. The arm description is incomplete, ending before it fully describes how medication reconciliation would be conducted. Eligibility is described, but recruitment details and outcome-specific denominators are not reported.

For the primary endpoint, the record gives a 24-hour timeframe and states that communication is performed on Day 0. It does not explain the detailed criteria for a completed communication, how duplicate messages are counted, or how missing electronic health record documentation is handled. The safety listing gives counts but not event timing, causes, or attribution. These limitations apply to interpretation of the registry information and do not determine what may be available in other study materials.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Deprescribing Potentially Inappropriate Medications in the Emergency Department for Persons Living With Dementia — NCT06273917.
• Registry record last updated 2026-07-01; status last verified 2026-06.
• Results first posted 2026-07-01.
• 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.

19. Record Summary

NCT06273917 is listed as a completed, single-group study of PRIDE, with no masking and allocation not applicable. The sponsor is the National Institute on Aging (NIA). The record lists enrollment as 300, a start date of 2024-07-09, and a primary completion date of 2025-10-31. Its aims concern feasibility of medication reconciliation and pharmacist communication, feasibility of collecting outcomes for a later study, and clinician acceptability.

The primary measure is the count of participants with pharmacist communication of a deprescribing recommendation to an outpatient prescriber, described as occurring on Day 0 with a 24-hour timeframe. The registry record does not report a numerical primary outcome result, a denominator, or analyses. Safety entries list 0 serious adverse events among 79 at risk, 0 other adverse events among 79 at risk, and 2 deaths. The record does not provide details sufficient to interpret the deaths’ causes or relationship to the intervention.