Implementation of Multidisciplinary Assessments for Geriatric Patients in an ED Observation Unit: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Implementation of Multidisciplinary Assessments for Geriatric Patients in an ED Observation Unit (NCT04068311), a non-randomized na study. The primary outcome is Health Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2.

2. Clinical Question

The registry frames the primary outcome as change in health-related quality of life at 90 days. It says that each participant’s score change was calculated using the day 0 and day 90 T scores, and that the mean and standard deviation of change were reported for both cohorts. However, the cohort-specific change values and a numerical between-cohort comparison are not reported in the registry record. The record therefore identifies the question and outcome definition, but does not give the result needed to characterize the size or precision of the observed difference.

The setting is an emergency department observation unit, and the project concerns implementation of multidisciplinary assessment for geriatric patients. The registry also lists functional status, receipt of home resources or services, new diagnoses of geriatric syndromes, and geriatric screening rates among secondary outcomes. Those measures give context to the evaluation, but their results are not reported in the registry record. The central comparison remains a before-and-after cohort comparison of the defined PROMIS change measure.

3. Trial Design

This is a completed, non-randomized study using sequential pre-implementation and post-implementation cohorts. The registry describes the allocation as non-randomized and the model as sequential. These design features mean that the cohorts represent periods before and after implementation rather than groups assigned at random to receive different approaches. The posted record lists enrollment as 373 and identifies Ohio State University as the sponsor.

The population in both arm descriptions is adult patients >65 years of age in the Emergency Department Observation Unit. The pre-implementation cohort represents the period before implementation, and the post-implementation cohort represents the period after implementation. The record describes the intervention as “Geriatric Screening tools” and the project summary refers to a two-step protocol for multidisciplinary geriatric assessment. It does not report the detailed content of the steps, the timing or duration of implementation, or the extent to which each component was delivered.

The registry lists single masking, but the identity of the masked party and the procedure used to maintain masking are not reported in the registry record. The phase is listed as not applicable. The recorded study start is 2019-09-27, primary completion is 2023-12-30, and status is completed. These registry entries describe study administration; they do not establish that the cohorts were comparable on measured or unmeasured characteristics.

Because assignment followed a sequence over time, changes between cohorts could reflect implementation, differences in the patients enrolled in each period, or other changes occurring over time. The registry does not report a randomized allocation procedure, so the comparison should not be read as if randomization had balanced those factors. The sample-size assumptions described in the record are for planning illustrations based on an observed effect, rather than the study’s own design justification. The protocol’s sample-size justification is 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: Change in HRQoL at 90 days was obtained by subtracting the t-score from day 0 to day 90 for each participant and comparing both cohorts. Therefore we changed the t scores to a delta in scores and report mean and standard deviation of the change.

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 Health Related Quality of Life (HRQoL) Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2, measured over 90 days.

The primary endpoint is health-related quality of life measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale v1.2. The registry describes it as a 10-item patient-reported questionnaire assessing overall health and well-being. It produces Global Physical Health and Global Mental Health summary scores, each standardized to the general US population, with a mean of 50 and a standard deviation of 10. Higher scores indicate better physical or mental health.

The primary outcome is not simply a score at one visit. The registry defines it as change in the T score between day 0 and day 90, then describes reporting the mean and standard deviation of that change in each cohort. Change scores can describe how a measure differs over a follow-up interval, while reporting both cohort summaries allows a before-and-after comparison. The record does not specify a direction convention for the subtraction beyond describing the day 0 and day 90 scores as the basis for the change.

The measure is reported in raw scores of 4 to 20 and T scores of 16.2 - 67.7. Standardization can make score interpretation more consistent with the stated reference population, while the two summaries distinguish physical and mental health dimensions. The registry does not report the observed day 0 or day 90 scores, the cohort mean changes, or a between-cohort estimate. Thus, the endpoint’s definition is available, but the posted results do not establish the direction, magnitude, or precision of the cohort comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary outcome summarized using a mean and standard deviation. A continuous measure can take values across a scale rather than representing only categories or event counts. The PROMIS outcome is expressed as T scores, and the primary measure is the change in score from day 0 to day 90. The mean describes the average change in a cohort; the standard deviation describes how spread out individual changes are around that average. They answer different questions: a similar mean can occur with different amounts of participant-to-participant variation.

The registry says that day 0 and day 90 scores were used to form a change score for each participant, after which the mean and standard deviation of change were reported for both cohorts. It does not state the subtraction direction beyond referring to the scores from the two time points. It also does not report the cohort means or standard deviations. Without those values, a reader cannot determine whether the average change was positive or negative, how variable the changes were, or how far apart the cohort averages were.

What does a confidence interval communicate?

In general, a confidence interval expresses uncertainty around an estimated quantity. A narrower interval indicates greater statistical precision under the assumptions of the method; a wider interval indicates less precision. It is not a guarantee that the true effect lies within a particular realized interval. For a comparison between cohorts, an interval around the estimated difference would help show which values are compatible with the data and analysis. No confidence interval for the primary comparison is reported in the registry record.

A p-value, when reported, summarizes how compatible the observed data are with a specified null hypothesis under the statistical model. It does not measure the probability that the null hypothesis is true, and it does not describe the size or clinical importance of a difference. The registry record does not report a primary-outcome p-value or the test used to calculate one. No test choice, covariate adjustment, or model specification for the primary comparison is reported in the registry record.

Why do the cohorts require cautious comparison?

The design is sequential and non-randomized. In general, a comparison of groups formed at different times can reflect both the intervention and differences in the groups or setting over time. Randomization is one way to reduce systematic differences at baseline, but it was not used according to this record. An adjusted analysis can sometimes account for measured characteristics, but it cannot automatically remove bias from unmeasured factors. The registry does not report baseline characteristics or an adjustment plan for the primary outcome, so the extent of cohort comparability cannot be evaluated from this record.

The registry describes sample-size calculations as planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect and that the illustration is not the trial’s own design. The registry does not report the numerical planning outputs or the observed effect used for such illustrations. These calculations, where presented, should be understood as planning scenarios, not as observed power or evidence about the outcome.

Why can over-dispersion matter?

In general, over-dispersion occurs when the variability in data is greater than a statistical model assumes. If a model understates variability, standard errors can be too small and intervals too narrow, making estimates appear more precise than they are. This issue is especially relevant to outcomes such as counts when their variation exceeds the model’s assumptions. The primary outcome in this record is a continuous change measure, and the registry does not report whether over-dispersion was assessed or whether a model requiring that assessment was used. It is therefore a general statistical consideration, not a reported feature of this analysis.

The registry lists four outcome measures and four analyses, but does not describe the analysis methods for each measure. The secondary outcomes include functional status using the OARS summary scale, participants receiving home resources or services or new diagnoses of geriatric syndromes, and geriatric screening rates. Their exact analysis populations, statistical models, and results are not reported in the registry record. The available information supports describing the measurement plan, but not reconstructing a complete statistical analysis.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Pre-Implementation Cohort", "Post-Implementation Cohort")
n   <- c(111, 161)
m   <- c(-0.73, -0.33)
sp  <- c(6.98, 5.46)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Pre-Implementation Cohort  111  -0.730  6.980  -2.043  0.583
CARM  Post-Implementation Cohort  161  -0.330  5.460  -1.180  0.520

11. Multiplicity, Missing Data and Analysis Populations

The record lists a primary outcome and secondary outcomes, but does not report a multiplicity plan. When a study examines multiple outcomes or makes multiple comparisons, the chance of at least one apparently unusual result can increase if each result is interpreted independently. In general, a prespecified approach to multiple testing can clarify which comparisons are confirmatory and how inference should be interpreted. Whether such an approach was used in this study is not reported in the registry record. The number of listed outcomes alone does not establish that all were tested in the same way or that any particular adjustment was applied.

Missing data are also consequential for a day 0 to day 90 change measure, because both time points are relevant to forming the change. The registry does not report how many participants had scores at each time point, how missing values were handled, whether incomplete cases were excluded, or whether any imputation method was used. It also does not report reasons for missing assessments or compare participants with and without follow-up data. The possible effect of missingness on the estimated cohort changes therefore cannot be evaluated.

The analysis populations are not defined in the registry record. It is not reported whether all enrolled participants, only those with available outcome measurements, or another defined group contributed to each analysis. The number of participants contributing to the primary and secondary outcome analyses is also not reported. Consequently, the enrollment figure should not be treated as the denominator for every endpoint, and the posted information does not allow the analysis population to be reconstructed.

The registry does not report an interim-analysis plan, a statistical analysis plan, or procedures for handling multiple time points or outcomes. These omissions do not establish that such procedures were absent; they mean their use cannot be assessed from the registry record.

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 0% reporting threshold.

The registry reports safety counts separately for the pre-implementation and post-implementation cohorts. For the pre-implementation cohort, 143 were listed as at risk for serious adverse events and zero serious adverse events were reported; 143 were listed for other adverse events and zero other adverse events were reported. Three deaths were recorded. For the post-implementation cohort, 230 were listed as at risk for serious adverse events and zero serious adverse events were reported; 230 were listed for other adverse events and zero other adverse events were reported. Three deaths were recorded.

These are descriptive counts in the registry categories. Zero reported serious or other adverse events does not mean that every possible adverse experience was assessed or that no event occurred outside the registry’s reporting definitions. The record does not report the safety follow-up period, event ascertainment procedures, or whether deaths were considered related to the intervention. It also does not report a statistical comparison of safety outcomes between cohorts.

The deaths should be read separately from the serious and other adverse event counts because the registry displays them as a distinct count. The counts do not establish a causal relationship with implementation, nor do they demonstrate equivalent risk between cohorts. Differences in cohort size and the non-randomized sequential design further limit direct comparisons. The registry record does not provide the detail needed to assess the circumstances or timing of these deaths.

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

This record is informative about the study’s purpose and structure. It describes a project to implement multidisciplinary assessment for geriatric patients in an emergency department observation unit, identifies sequential pre-implementation and post-implementation cohorts, and defines a patient-reported quality-of-life outcome at 90 days. It also lists secondary outcomes related to function, services or diagnoses, and screening. These details clarify what the evaluation was intended to examine.

However, the primary outcome results are not reported in the registry record. Without cohort-specific mean changes, measures of variability, and a between-cohort estimate with its uncertainty, the size, direction, and precision of the primary comparison cannot be determined. The same limitation applies to the listed secondary outcomes, whose results are not reported. A completed status and a stated enrollment figure do not substitute for outcome estimates.

Even if an observed difference were reported, the design would require cautious interpretation. Because allocation was non-randomized and cohorts were sequential, a difference could reflect the implementation, differences in the patients, or changes in the setting over time. The record does not report enough information about baseline comparability, adjustment, or missing outcomes to assess those explanations. Thus, this evaluation can describe a before-and-after implementation comparison, but the registry information does not establish that implementation caused any change in quality of life or other outcomes.

The safety counts are likewise descriptive and do not establish that risk was the same in both cohorts or that implementation affected safety. The main conclusion supported by the registry record is about what was evaluated and how the primary outcome was defined, not about whether the intervention changed patient outcomes. Further interpretation would require outcome estimates and details of the statistical and missing-data methods that are not reported in the registry record.

14. Why This Trial Matters Statistically

Implementation studies address whether a care approach can be incorporated into practice, a question that differs from whether an intervention produces an effect under controlled conditions. This study concerns multidisciplinary geriatric assessment in an emergency department observation unit and uses cohorts before and after implementation. The setting and implementation focus make the design relevant to real-world service delivery, while also creating statistical challenges in separating implementation-related changes from changes over time.

The primary endpoint is a change measure based on patient-reported PROMIS scores at day 0 and day 90. Using a defined measure and follow-up interval gives the evaluation a clear outcome framework. The PROMIS scale distinguishes physical and mental health summaries and expresses them as T scores standardized to the general US population. Yet a well-defined outcome is not enough to judge a comparison: estimates, variability, and uncertainty are needed, and those results are not reported in the registry record.

The sequential non-randomized comparison illustrates why design and analysis must be read together. In general, estimates from before-and-after cohorts can be affected by baseline differences and concurrent changes in care or case mix. Describing the design plainly helps prevent a reader from treating the comparison as randomized evidence. The registry does not report the information needed to assess cohort balance or determine whether adjustment was used.

The registry also lists functional status, home resources or services and new geriatric syndrome diagnoses, and screening rates. Those measures could describe different dimensions of implementation and patient outcomes, but their results are not reported. The record is therefore valuable for identifying the evaluation’s scope and its primary measurement approach, while leaving the central statistical findings unavailable for interpretation.

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 most direct limitation is that the registry does not report the primary outcome values or the comparison estimate. Cohort means and standard deviations for change, an uncertainty interval, and a test result are not reported in the registry record. Without them, neither the magnitude nor the precision of the quality-of-life comparison can be described. Results for the listed secondary outcomes are also not reported.

The non-randomized sequential design limits causal interpretation. Cohort membership is linked to the implementation period, so time and implementation are not separated by random assignment. The registry does not report baseline characteristics, evidence about cohort comparability, or an adjustment strategy. It is not possible to judge whether differences between cohorts were addressed analytically.

The intervention description is limited. The record names geriatric screening tools and describes a two-step protocol for multidisciplinary assessment, but the detailed steps, implementation fidelity, and uptake are not reported. The registry also does not report how the masked party was selected or how masking was maintained, despite listing single masking.

Important outcome-analysis details are absent. The number contributing to each outcome, missing-data handling, analysis populations, and statistical methods are not reported in the registry record. These omissions limit assessment of possible bias and precision. Safety follow-up duration and event ascertainment details are also not reported, so the adverse-event and death counts cannot be interpreted as a complete account of safety over a defined period.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Implementation of Multidisciplinary Assessments for Geriatric Patients in an ED Observation Unit — NCT04068311.
• Registry record last updated 2026-01-09; status last verified 2026-01.
• Results first posted 2026-01-09.
• 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

The registry record describes a completed, non-randomized sequential evaluation of multidisciplinary geriatric assessment in an Emergency Department Observation Unit. The cohorts comprise adults >65 years of age before and after implementation. Ohio State University is listed as sponsor, enrollment is 373, and the primary outcome is change in PROMIS Global Health T scores from day 0 to day 90.

The record lists functional status, home resources or services and new diagnoses of geriatric syndromes, and geriatric screening rates as secondary outcomes. It reports zero serious and zero other adverse events in each cohort, with three deaths recorded in each. Numerical primary and secondary outcome results, the statistical analysis methods, and details of missing-data handling are not reported in the registry record. The non-randomized sequential design also limits causal interpretation of any cohort differences.