Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living (NCT05956665), a na na study. The primary outcome is Total Number of Medications That Have Been Deprescribed Since Enrollment.

2. Clinical Question

The study concerns residents with dementia living in an assisted living facility who were exposed to multiple medications. Its stated aim was to evaluate an intervention intended to reduce exposure to medications considered unnecessary or potentially harmful. Deprescribing was defined as stopping a medication or reducing its dose or frequency, with decisions based on clinical criteria and resident or surrogate preferences.

The intervention was Shed-MEDS, described as patient-centered. The registry record says all participants received the intervention, so the study does not compare it with a control group receiving usual care or another treatment. The clinical question is therefore whether medication changes and resident or surrogate reports of quality of life could be assessed during and after the intervention in this setting, rather than whether the intervention outperformed an alternative.

The registry describes medication deprescribing from enrollment at 30, 60, and 90 days, and quality-of-life reports at enrollment and 90 days. The primary outcome listed is the number of medications deprescribed by 30 days. The registry identifies the relevant outcome population as participants who completed the intervention protocol, including medication review, surrogate interview, and provider conversation. How many participants completed that protocol is not reported in the registry record.

The record reports enrollment of 18 and a completed study status. It does not report the primary outcome results, quality-of-life results, or analyses. Consequently, the registry record does not answer how many medications were deprescribed or how quality-of-life reports changed.

3. Trial Design

This was a completed pilot study with a single-group model and an enrollment of 18. The intervention was the Shed-MEDS deprescribing intervention, classified as behavioral. All participants received it; the registry lists no comparison arm. Allocation is recorded as NA, and masking is recorded as none. The study is not a randomized comparison, so there is no like-for-like control group against which to interpret changes.

The study record lists Vanderbilt University as the sponsor. The start date was 2024-01-23, and the primary completion date was 2025-06-27. Phase is listed as NA. The study status is completed. Those design and status details describe the registry entry, but do not establish that outcome data were analyzed or posted.

The intervention description characterizes Shed-MEDS as patient-centered deprescribing based on clinical criteria and patient or surrogate preference. The available arm description also states that participants received a medication review by a research nurse practitioner. Further details of the intervention procedures are not reported in the registry record.

The registry lists five outcome measures and zero analyses. The primary outcome is a median number of medications deprescribed since enrollment, with an inter-quartile range and a 30-day timeframe. The outcome population is participants who completed the intervention protocol. The study summary also describes assessment of medication deprescribing at 30, 60, and 90 days and quality-of-life reports at enrollment and 90 days. Results for these assessments are not reported in the registry record.

Because everyone received the intervention and no control group is listed, changes over time could be described but cannot by themselves separate intervention-related change from other explanations. The record does not report an analysis plan or a sample-size justification.

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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants who completed the intervention protocol (medication review, surrogate interview, and provider conversation).

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.

Population: One participant withdrew consent prior to completing baseline data collection and is therefore excluded from the analysis.

6. Primary Endpoint

The registry lists the primary outcome as Total Number of Medications That Have Been Deprescribed Since Enrollment, measured over 30 days.

The listed primary endpoint is the total number of medications deprescribed since enrollment, assessed at 30 days. A medication counts as deprescribed if it was stopped or its dose or frequency was reduced. The definition covers prescribed and over-the-counter medications, as well as scheduled and as-needed medications. The registry specifies the median and inter-quartile range as the summary statistics.

This endpoint is used to describe medication changes made during the intervention period. Counting both discontinuations and dose or frequency reductions reflects the registry’s broad definition of deprescribing; it does not distinguish the clinical importance of one change from another. The endpoint is a medication-count measure, not a direct measure of whether each change was appropriate, sustained, or associated with a particular health outcome.

The stated outcome population includes participants who completed the medication review, surrogate interview, and provider conversation. The number completing all of these steps is not reported in the registry record. Although the study summary describes medication assessments at 30, 60, and 90 days, the primary outcome listing specifies a 30-day timeframe.

The registry record does not report the observed median, inter-quartile range, or other primary endpoint results. It also does not report a comparison estimate or inferential test for this endpoint. Therefore, the endpoint definition can be described, but its observed value and precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary endpoint as a median with an inter-quartile range. The record does not report an inferential analysis for that endpoint or any other analysis; the number of analyses listed is zero. The explanations below describe general statistical concepts relevant to the stated endpoint and design, not methods confirmed as having been used in this study.

What does a median and inter-quartile range describe?

General: The median is a measure of the center of a distribution. It is the middle value when observations are ordered, and is less influenced by unusually high or low values than a mean. The inter-quartile range describes the spread of the middle portion of the observations. Together, these statistics can summarize a count outcome when the distribution is uneven or includes many repeated values. They do not show every participant’s result, and they do not by themselves quantify uncertainty about the median.

For this study, the endpoint is the number of medications deprescribed, with stopping and dose or frequency reductions both included. The registry specifies a median and inter-quartile range but does not post those values. It is therefore not possible to assess the actual distribution or its spread from the registry record.

What does a single-group design allow?

General: A single-group study can describe what occurred among participants receiving an intervention. If measurements are collected over time, it can also describe within-group changes. Without a concurrent comparison group, those changes cannot isolate the intervention’s contribution from other influences, such as changes in care or the natural course of participants’ circumstances. A before-and-after pattern is not equivalent to a randomized treatment contrast.

The registry lists a single-group model, no masking, and no randomized comparison. It does not list a control arm. Accordingly, an estimate comparing the intervention with an alternative is not available from this design as described in the record.

What does a confidence interval add?

General: A confidence interval is an interval estimate that communicates statistical uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision under those assumptions, while a wider interval indicates less precision. An interval does not correct for bias, missing data, or limitations of the design. No confidence intervals for the clinical outcomes are reported in the registry record.

Why can counts be difficult to summarize?

General: Count outcomes may be concentrated at a small number of values or may have a long upper tail. In such cases, a mean and standard deviation can be sensitive to a few large observations, while a median and inter-quartile range offer a different description of the distribution. The choice of summary does not remove the need to report the denominator, missingness, and methods used to handle incomplete observations. Those details are not reported for the primary endpoint.

General: Over-dispersion occurs when the variation in count data is greater than a chosen statistical model expects. If an analysis assumes less variability than is present, its uncertainty estimates may be too small. Assessing that issue requires the outcome data and a specified model; neither an analysis model nor results that would permit assessment are reported in the registry record.

What do the planning assumptions mean?

The registry describes a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a specified fraction of the observed effect. These are planning assumptions, not evidence that the single-group study used a two-arm design. The registry record does not report the numerical planning results or the observed effect used for that illustration.

General: A sample-size calculation estimates the number of participants needed under stated assumptions to target a chosen level of statistical power for a specified effect. It is not a measure of the probability that a completed study’s result is true, and it is not observed power. Planning illustrations based on an observed effect are particularly dependent on that effect estimate and the assumptions used. The record does not report the study’s own sample-size justification, and no planning illustration should be mistaken for a result from this single-group pilot.

Because no outcome analyses are listed, there is no reported model, test statistic, p-value, or confidence interval to explain. The registry record also does not report whether any interim analyses were planned or conducted. The statistical methods actually used beyond the endpoint’s stated summary measure are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and zero analyses. It does not report an analysis plan, a hierarchy of outcomes, or a procedure for addressing multiplicity. When several outcomes or time points are examined, general statistical practice distinguishes the primary question from additional exploratory questions; repeated testing can increase the chance of a result appearing notable by chance. The registry record does not say whether or how that issue was considered.

The study summary describes medication deprescribing at 30, 60, and 90 days and quality-of-life reports at enrollment and 90 days. The primary endpoint listing specifies medication deprescribing at 30 days. Results for the additional time points and quality-of-life assessments are not reported in the registry record. The record does not identify which of the remaining outcome measures were prespecified as secondary or exploratory.

The primary endpoint population consists of participants who completed medication review, surrogate interview, and provider conversation. The number who completed those steps is not reported. The record does not provide outcome-specific denominators, reasons for missing observations, or the method used to handle missing data. It also does not report whether analyses included all enrolled participants or only those with particular follow-up information.

General: Missing data can affect both the number of observations available and the interpretation of an estimate, especially when missingness is related to participant characteristics or outcomes. A complete-case summary describes those with observed data, but may not represent everyone enrolled. Evaluating this requires information on missingness and the analysis population, which is not reported in the registry record.

The registry’s definition of the primary outcome population should therefore be kept distinct from the enrollment count. Enrollment was 18; the count completing the protocol and the number contributing to each outcome are not reported.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: heart failure (5.6%), chronic kidney disease (5.6%), fall (5.6%).

The registry lists one intervention group, with 18 participants at risk for serious adverse events and 3 participants affected. It also lists 18 participants at risk for other adverse events and 7 affected. The record reports one death. These are descriptive counts from the single-group study, not comparisons with a control group.

The serious-event terms listed are Heart Failure, Chronic Kidney Disease, and Fall, each accompanied by 5.6%. The registry record does not give event counts for each term or further detail on how these terms relate to the participants affected. The terms may not represent distinct participants, and the record does not establish whether categories overlap.

These figures do not, on their own, establish that an event was caused by the intervention or that the intervention changed risk. The registry record does not report a comparator, event timing, seriousness definitions, relatedness assessments, or detailed event narratives. It also does not provide additional context about the death. The figures should therefore be read as the safety counts posted for this group, without causal interpretation.

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

The record establishes that this completed pilot enrolled 18 participants and evaluated a single-group Shed-MEDS intervention in assisted living residents with dementia. It defines the primary endpoint as the number of medications stopped or reduced by 30 days, including prescribed and over-the-counter medications and scheduled and as-needed medications. It also describes planned assessment of medication changes at 30, 60, and 90 days and quality-of-life reports at enrollment and 90 days.

The registry record does not report the primary endpoint result, the quality-of-life results, or analyses. It therefore does not show how many medications were deprescribed, how variable those counts were, or whether quality-of-life reports changed. The absence of posted results in this record should not be interpreted as evidence that there was no change.

The design also does not permit a controlled treatment comparison: the record lists a single group and no control arm. Any observed within-group change, if reported elsewhere, would not by itself establish that the intervention caused it. The registry does not report the study’s own sample-size justification, analysis plan, handling of missing observations, or outcome estimates with statistical uncertainty.

The posted safety counts describe serious and other adverse events among participants in the intervention group, as well as one death. Without a comparison group and further event details, these figures cannot establish whether the intervention increased or decreased risk or whether an event was related to it.

Accordingly, the registry supports a description of the pilot’s aims, design, endpoint definition, and safety counts, but it does not provide enough outcome information to assess the observed medication changes or quality-of-life findings. It also does not provide evidence for a causal effect relative to another approach.

13. Why This Trial Matters Statistically

This study is statistically informative as an example of a pilot evaluated in a setting where a comparative trial is not described. Its single-group design can document intervention delivery and describe outcomes among participants, but it cannot provide a randomized contrast with usual care or another strategy. Keeping that distinction clear helps prevent descriptive changes from being read as causal effects.

The primary endpoint also raises a useful measurement issue. The registry counts both stopping medications and reducing dose or frequency, and includes several medication categories. This definition captures a broad range of changes, while the median and inter-quartile range would describe the center and spread of the resulting count distribution. Those summaries do not convey the clinical significance of each medication change, and the registry does not report the values needed to assess the distribution.

Outcome population definitions matter as well. The stated primary population includes participants who completed three intervention steps, while enrollment was 18. Since the number completing the protocol and the outcome denominators are not reported, readers cannot assess how the analyzed population relates to enrollment or how incomplete follow-up might affect interpretation.

The record names several assessment times and quality-of-life reporting, but lists no analyses. This makes transparent reporting of outcomes, analysis populations, missingness, and uncertainty especially important for interpreting a pilot. The registry supplies a framework for what the investigators intended to measure, but not the results needed to judge the observed patterns.

Finally, the safety counts should be treated as descriptive rather than comparative. A single-group record can report events that occurred among participants, but without a control group and event-level context, it cannot quantify a difference in risk attributable to the intervention. These design and reporting distinctions are central to drawing appropriately limited conclusions from pilot research.

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 interpretation is that the registry record does not report primary or other outcome results, despite the study being marked completed. The primary endpoint is defined, but its median and inter-quartile range are absent. Results for the quality-of-life assessments and medication assessments at the additional time points are also not reported.

The study is single-group, with no randomized comparison or control arm listed. That design limits causal interpretation because there is no concurrent group to distinguish intervention-related changes from other changes over time. Allocation is NA and masking is none in the registry record.

Enrollment was 18, but the primary outcome population is limited to participants who completed medication review, surrogate interview, and provider conversation. The number completing that protocol is not reported. Outcome-specific denominators, missing observations, and reasons for missingness are also not reported, limiting assessment of attrition and the population represented by any outcome summary.

The registry lists five outcome measures but provides no analyses. It does not report the statistical analysis plan, a sample-size justification, methods for multiplicity, or methods for missing data. The sample-size assumptions describe a planning illustration, not the study’s own design rationale. Numeric planning results are not reported in the registry record.

Safety information is limited to group-level counts and listed serious-event terms. The record does not provide event timing, participant-level overlap, relatedness, or further context for the death. The available intervention description is also incomplete, so additional implementation details are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living — NCT05956665.
• Registry record last updated 2025-10-15; status last verified 2025-09.
• Results first posted 2025-10-15.
• 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

NCT05956665 is a completed, single-group pilot study titled Adapting the Shed-MEDS Deprescribing Intervention to Dementia Care in Assisted Living. Vanderbilt University is listed as sponsor. Enrollment was 18; the start date was 2024-01-23 and the primary completion date was 2025-06-27. Phase is listed as NA, allocation as NA, and masking as none.

The intervention was the Shed-MEDS deprescribing intervention. The primary outcome was the number of medications stopped or reduced by 30 days, summarized by median and inter-quartile range among participants completing the intervention protocol. The record lists five outcome measures and zero analyses.

Primary and quality-of-life results are not reported in the registry record. Safety counts include 3 participants affected by serious adverse events, 7 affected by other adverse events, and one death in the intervention group.