Shared Decision Making About Medication Use for People With Multiple Health Problems: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Shared Decision Making About Medication Use for People With Multiple Health Problems (NCT05156073), a na na study. The primary outcome is Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR.

2. Clinical Question

3. Trial Design

This completed study, NCT05156073, is titled “Shared Decision Making About Medication Use for People With Multiple Health Problems.” It is recorded as a single-group study with no masking and no randomized allocation. Enrollment was 22. The registry lists the phase as NA and identifies Johns Hopkins University as the sponsor. The study began on 2023-05-22, reached primary completion on 2023-11-03, and has a completed status.

The intervention is described as educational materials on deprescribing for a patient and care-partner cohort and a primary-care-physician cohort. The study summary describes patient and care-partner education and activation, plus clinician education to increase awareness of deprescribing options and processes. Clinicians were asked to take part in a single, 15-minute educational session; medical residents were to receive a 45-minute lecture. Patients, caregivers, clinicians, and medical assistants were to participate in a one-on-one debriefing interview.

The registry describes clinical documentation from the visit immediately after the patient and care partner received the intervention brochure as the basis for the primary assessment. It also gives a timeframe of 1 year. How that timeframe relates to the immediate post-brochure visit is not explained in the registry record. Secondary outcomes concern acceptability and feasibility, assessed qualitatively from debriefing interviews.

Because there is no separate control group, observed documentation or medication changes cannot by themselves establish what would have happened without the educational intervention. The study is framed around feasibility, acceptability, and preliminary assessment in a defined setting. Details of recruitment procedures, participant characteristics beyond the listed conditions, and the number of people in each cohort are not reported in the registry record.

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: A total of 22 participants were enrolled and received the intervention brochure by mail. Data on clinical documentation was not available for two participants, therefore a total of 20 participants were analyzed in rows 1-4. Additionally, medication data was missing for three more participants in rows 5-6, thus a total of 17 participants were included in the analysis of rows 5-6.

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 Preliminary Efficacy of the Intervention to be Assessed From Primary Care Clinician's Intervention Visit Clinical Notes and EHR, measured over 1 year.

The primary outcome is titled as a preliminary efficacy assessment based on primary care clinician intervention-visit clinical notes and the electronic health record. It concerns what clinicians documented after the patient and care partner received the brochure. The listed measures cover discussion of medication appropriateness, safety, or effectiveness; planned medication changes such as adding, increasing, reducing, or stopping a medication; and the proportions of patients who deprescribed or added one or more medications.

These measures capture clinical processes and recorded medication changes. They are relevant to whether the intervention is followed by discussion or action that can be identified in routine records. They do not, on their own, measure whether a medication change improved health, whether it was sustained, or whether the intervention caused it. Documentation is also an imperfect proxy for what was discussed or done: an activity may not be recorded, and a record may not describe the full context.

The registry specifies a timeframe of 1 year, while its outcome description focuses on documentation at the visit immediately after receipt of the brochure. The relationship between these descriptions is not explained in the registry record. No outcome values for these measures are reported there, so the magnitude or precision of any observed clinical-documentation or medication-change outcome cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends on how outcomes were defined, how participants contributed data, and what analysis was performed. The registry lists the intended measures and some analysis-population information, but it does not report an analysis plan or outcome estimates. The explanations below distinguish general statistical principles from what can be concluded about this study.

What does a single-group design estimate?

In general, a single-group study can describe outcomes observed after an intervention within the enrolled group. A comparative effect asks how outcomes differ between intervention and comparator conditions. Estimating that contrast requires information about both conditions and a design or analysis that makes the comparison interpretable. This study is recorded as single-group, with allocation listed as NA, and has no separate control group. Its observed outcomes, if reported, would therefore be descriptive of this group rather than a controlled estimate of what the intervention changed.

Even when an outcome occurs after an intervention, timing alone does not establish cause. Participants continue to receive clinical care, and records may reflect decisions made for many reasons. A control group can help distinguish intervention-related patterns from background changes, though it does not automatically resolve every source of bias. The registry record does not describe a comparative design in this study.

What do the primary measures capture?

The primary assessment uses clinician documentation and electronic health record information. Its listed domains include discussions of medication appropriateness, safety, or effectiveness; planned medication changes; and participants who deprescribe or add medication. In general, a count records how many people meet a defined outcome, while a proportion expresses that count relative to a specified denominator. The registry gives the outcome unit as participants and describes several measures in terms of counts or proportions, but it does not report the observed values or all outcome-specific denominators.

Record-based measures have practical value because they capture information generated in routine care. They also depend on what clinicians document, how records are extracted, and how the study defines a qualifying discussion or change. In general, absence of documentation is not necessarily evidence that an activity did not occur. The registry record does not describe coding rules, adjudication procedures, or validation of the extracted measures.

How should uncertainty be understood?

General statistical interpretation considers both the estimate and its uncertainty. A confidence interval communicates the range of values compatible with the observed data under a specified model and its assumptions. A narrow interval usually indicates greater precision than a wide interval, but precision is not the same as freedom from bias. A small or incomplete dataset may leave substantial uncertainty. No confidence intervals, standard errors, hypothesis tests, or other uncertainty estimates for the primary outcomes are reported in the registry record.

The registry lists zero analysis entries. This does not reveal which statistical procedures, if any, were used outside the registry record. The analysis methods, rules for choosing denominators, and any adjustment for participant or clinician characteristics are not reported in the registry record. Without those details and the outcome values, it is not possible to reproduce or assess a statistical estimate.

What is over-dispersion, in general?

For count outcomes, a statistical model may assume a particular degree of variation. Over-dispersion means the observed variation is greater than that assumed by a model, which can make uncertainty estimates too small if the model is not adapted. This is a general consideration for count-data analysis, not a reported feature of this study. The registry record does not describe a count model or report the data needed to assess over-dispersion.

How should planning illustrations be read?

In general, sample-size calculations describe how many observations a future design might require under stated assumptions about the effect, variability, significance level, and allocation. They are planning tools, not a summary of what happened in an enrolled study. The registry’s stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a fraction of the observed effect. Those assumptions describe a hypothetical two-arm planning exercise and do not match this single-group design. Any resulting sample sizes should not be interpreted as observed power or as evidence that the study could detect an effect. The actual planning rationale and sample-size justification for the trial are not reported in the registry record.

The registry does not report interim analyses, a prespecified statistical analysis plan, or multiplicity procedures. In general, an interim analysis is an analysis planned before the end of a study, and multiplicity concerns the increased chance of false-positive findings when multiple hypotheses are tested. Without a documented plan, it is not possible to determine whether either issue was relevant to the investigators’ analyses. No inference about an unreported procedure should be made.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome description includes several related measures: clinician discussions about medication appropriateness, safety, or effectiveness; planned medication changes; and whether participants deprescribed or added medication. The registry also lists secondary qualitative outcomes for acceptability and feasibility. Considering multiple outcomes can raise a multiplicity question if formal statistical tests are conducted. In general, testing multiple hypotheses without an appropriate plan can increase the chance of at least one false-positive finding. Whether that issue arose depends on the analyses actually performed. A multiplicity strategy is not reported in the registry record, and the registry lists no analysis entries.

Missing data affect which participants contribute to each outcome and can make denominators differ across measures. The registry says that clinical-documentation data were unavailable for two participants and that 20 participants were analyzed for rows 1–4. It further says medication data were missing for three more participants in a later row, but the description ends before specifying the analysis population for that row. The exact denominator for that medication measure and the reasons for missing data are not reported in the registry record.

In general, complete-case analysis uses participants with observed data for the outcome being analyzed. Whether that approach was used, whether missing values were otherwise handled, and whether any sensitivity analyses were conducted are not reported in the registry record. The registry also does not explain whether missingness was related to participant characteristics or outcomes. These omissions limit assessment of potential bias from incomplete records.

The primary outcome description identifies participants analyzed for some measures, but the registry does not provide a full account of all analysis populations, exclusions, or denominators. Findings should therefore not be generalized beyond the participants contributing data to each specific measure, even if outcome results are reported elsewhere.

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: hospitalization (9.1%), emergency department visit (4.5%).

The registry lists 22 participants at risk for the intervention group and records 3 under serious adverse events, 0 under other adverse events, and 0 deaths. These are the registry’s counts; no comparison group is available to show what event frequency might have occurred without the intervention. The record also lists hospitalization at 9.1% and emergency department visit at 4.5% among the top serious-event terms.

These figures should be read as safety reporting within a small, single-group study, not as estimates of excess risk attributable to the educational intervention. The registry does not explain the causal relationship, if any, between the intervention and the serious events. Nor does it provide event-level timing, duration, severity beyond the serious classification, or additional context for the listed terms. The percentages are reproduced as recorded and should not be treated as mutually exclusive categories unless the record establishes that relationship; it does not.

In general, a zero recorded count does not demonstrate that an event is impossible or that risk is absent. The amount of information available depends on the number of participants observed, how long they were followed, and how events were defined and collected. The registry gives a primary-outcome timeframe of 1 year, but the safety reporting timeframe is not specified in the registry record. These data support a description of events recorded in this study, not a definitive safety comparison.

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

The registry describes a completed evaluation of educational materials about deprescribing for people with mild cognitive impairment or dementia and/or multiple chronic conditions, their care partners, and primary care clinicians. Its planned primary assessment focused on clinician documentation and medication changes. Secondary outcomes concerned qualitative assessments of feasibility and acceptability. The intervention and outcomes address practical questions about whether deprescribing education can be incorporated into primary care and what activities are recorded afterward.

The registry record does not report the outcome values for the primary measures or the findings from debriefing interviews. It therefore does not establish how often medication discussions or changes occurred, whether participants found the intervention acceptable, or whether implementation was feasible. It also does not provide estimates of uncertainty for these outcomes. No claim about the direction, size, or precision of an intervention effect can be supported from the posted results described in the registry record.

The single-group design is an important boundary on interpretation. Without a separate comparison group, any observed post-intervention activity would not show what would have happened in the absence of the intervention. The design can generate descriptive observations and inform questions for further study, but it cannot by itself establish that the educational materials caused a change in documentation or medication use.

“Preliminary efficacy” is part of the registry’s outcome title, not a reported finding. It should not be read as evidence that the intervention was effective. Likewise, a record of serious adverse events does not establish that the intervention caused those events. The registry does not report enough information to make either causal claim.

The main conclusion is about the limits of the available record: it documents the study’s purpose, design, intervention, planned outcomes, enrollment, and some missing-data and safety information, but does not provide the clinical outcome results needed to assess the observed patterns or their precision.

13. Why This Trial Matters Statistically

This study illustrates a statistical distinction between evaluating implementation and estimating a comparative effect. Feasibility and acceptability can be central questions when an intervention is being introduced in primary care. Interviews and routine clinical records can help describe how participants and clinicians engage with an intervention and what activity is documented. Those questions differ from whether an intervention changes an outcome relative to usual care or another comparator.

The single-group structure makes that distinction especially important. A before-and-after or post-intervention description can be useful for understanding what happened among participants, but without a comparator it cannot isolate the intervention’s contribution. Clear language about the estimand—the specific quantity an analysis aims to estimate—helps prevent descriptive evidence from being mistaken for a causal effect. The registry does not report a formal estimand or analysis plan.

The study also highlights the role of outcome measurement. Electronic records provide information from routine practice, but documentation depends on recording behavior and extraction rules. If documentation is used as a proxy for discussion or medication action, the interpretation should remain tied to what the record captures. Missing records can further change which participants contribute to each outcome.

Finally, labels such as preliminary efficacy do not replace outcome estimates, uncertainty measures, or a clear account of analysis populations. Statistical interpretation requires the observed values and methods as well as the design. In this record, the absence of reported primary results and analysis details limits what can be concluded, while still leaving the study’s implementation-focused questions relevant to future research design.

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 principal limitation for interpretation is the single-group design. There is no separate control group, so the study cannot provide a direct comparison with participants not receiving the intervention. Any post-intervention documentation or medication changes, if observed, could reflect factors other than the educational materials. This constrains causal interpretation regardless of the size of an observed change.

The registry record does not report the primary outcome values, qualitative interview findings, or uncertainty estimates. It also does not describe the statistical analysis methods, a prespecified analysis plan, or procedures for addressing multiple outcomes. The primary outcome title refers to preliminary efficacy, but the record’s described measures are process and medication-change measures, and no results are available for judging their magnitude or precision.

Incomplete outcome information is another limitation. The registry reports unavailable clinical-documentation data for two participants and analysis of 20 participants for rows 1–4. It then notes missing medication data for three more participants, but the outcome description is incomplete about the resulting analysis population. Reasons for missingness and methods for handling it are not reported in the registry record.

The registry gives the primary outcome timeframe as 1 year while describing the assessment as documentation from the visit immediately after the brochure was received; the relationship between these descriptions is unclear. Details on recruitment, the distribution of participants among cohorts, and record-extraction or outcome-adjudication procedures are also not reported in the registry record. These gaps limit assessment of measurement quality and generalizability.

Safety interpretation is constrained by the absence of a comparison group and by limited context about event timing and ascertainment. The record does not report a sample-size justification or interim-analysis plan. These limitations do not negate the study’s descriptive purpose, but they define what its registry record can support.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Shared Decision Making About Medication Use for People With Multiple Health Problems — NCT05156073.
• Registry record last updated 2024-11-27; status last verified 2024-11.
• Results first posted 2024-11-27.
• 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

NCT05156073 is a completed, single-group study sponsored by Johns Hopkins University. Enrollment was 22; the study began on 2023-05-22 and reached primary completion on 2023-11-03. The intervention used educational materials about deprescribing for patient and care-partner and primary-care-physician cohorts, with additional clinician education described in the study summary.

The primary outcome concerned clinician documentation and medication changes, with a registry timeframe of 1 year. Secondary outcomes concerned qualitative assessments of feasibility and acceptability. The record states that clinical-documentation data were unavailable for two participants and that 20 participants were analyzed for rows 1–4; it also notes additional missing medication data without fully specifying the resulting analysis population.

Serious adverse events are recorded for 3 of 22 at risk, other adverse events for 0, and deaths for 0. Primary outcome results, interview findings, statistical analysis methods, and uncertainty estimates are not reported in the registry record. The single-group design does not provide a randomized or like-for-like control comparison.