Living With Multimorbidity: CO-ORDINATE Program: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Living With Multimorbidity: CO-ORDINATE Program (NCT05985044), a na na study. The primary outcome is Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Pain.

2. Clinical Question

The broader rationale is that symptoms can affect quality of life for people managing multiple chronic conditions, and hospitalization may offer an opportunity to begin supportive care. Those statements describe the motivation for the program, not evidence that it changed symptoms or quality of life. The primary outcome listed is the ESAS pain score; the listed secondary outcomes concern health-care utilization, including emergency department visits, hospitalization, and critical care admission.

3. Trial Design

The record describes the CO-ORDINATE Program as a completed, single-group study sponsored by Johns Hopkins University. It lists an enrollment of 27 and dates of 2022-11-16 for study start and 2024-03-02 for primary completion. The phase is recorded as NA, allocation as NA, and masking as NONE. These entries describe a study that is not presented as a randomized, masked comparison.

The intervention is identified as a patient-centered care coordination and symptom management program. The summary characterizes its intended approach as nurse-led support before discharge, augmented by telephone support. The record does not provide enough detail to establish how consistently each component was delivered, how much contact participants received, or whether the intervention was adapted during the study.

With a single group and no control arm identified, outcome patterns over time can describe participants’ reported scores, if those results are available, but cannot isolate an intervention effect from other explanations. Changes could coincide with recovery, usual care, changes in health status, or other influences. The registry record does not report a comparator against which those explanations could be assessed.

The primary outcome is pain measured with the ESAS at baseline, 6-weeks post intervention, and 3 months post intervention. The record specifies median and inter-quartile range as the summary format. It also lists 21 outcome measures, including health-care utilization outcomes. Numerical outcome values and analysis results are not reported in the registry record. The registry status is COMPLETED, but completion status alone does not supply evidence about outcome changes or their precision.

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: Out of the 27 participants who signed the informed consent, 25 completed the baseline survey and received the intervention. Two participants did not complete the baseline data collection and could not be reached after signing the consent form.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participants who competed the survey at each time point are reported.

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 Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Pain, measured over Baseline, 6-weeks post intervention, 3 months post intervention.

The primary endpoint is symptom burden assessed using the pain item of the Edmonton Symptom Assessment System (ESAS). The questionnaire rates common symptoms, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. For the listed pain score, the scale runs from 0 (none, best) to 10 (worst). The registry names pain, rather than an aggregate of all symptom items, as the primary outcome.

Pain ratings can describe participants’ experience at a particular assessment time. Repeated measurement at baseline, 6-weeks post intervention, and 3 months post intervention can describe how reported scores vary over the specified follow-up period. The registry specifies median and inter-quartile range, which can summarize the center and spread of scores without assuming a symmetric distribution. This is a reporting format, not evidence of a change.

Symptom measurement is relevant to the program’s stated focus on symptom management and quality of life. However, the primary endpoint is a pain score, not a direct measure of the program’s overall effect on quality of life. The registry record does not report the actual median or inter-quartile range at any assessment, the number of respondents at each time, or a statistical comparison across time. The magnitude and precision of any change therefore cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a single-group design show?

In general, a single-group study follows participants who receive an intervention without a concurrent control group. Repeated measurements can describe the group’s outcomes at different times. They do not, on their own, separate an intervention effect from natural changes, usual care, or other influences occurring during follow-up. The registry lists a single-group model and does not identify a control arm or randomized allocation.

That distinction matters when interpreting a change from baseline. A change is a description of what happened to measured scores; attributing that change to the intervention requires a basis for considering what would have happened without it. A control comparison can help address that question, but one is not reported in this registry record. The available description therefore supports discussion of the study’s intended measurements, not an estimate of a controlled treatment effect.

What do the median and inter-quartile range describe?

In general, the median is the middle value when observations are ordered. It describes the center of the observed scores and is less affected by extreme values than the arithmetic mean. The inter-quartile range describes the spread of the middle portion of the score distribution. These summaries can be useful when scores are skewed or contain outlying observations, although they do not show every feature of the distribution.

The registry specifies median and inter-quartile range for the ESAS pain score. That choice tells readers how the outcome was intended to be summarized; it does not provide the actual summaries. The medians, inter-quartile ranges, and participant counts at each time are not reported in the registry record. A numerical change between time points cannot be inferred from the measurement schedule alone.

What would a confidence interval contribute?

In general, a confidence interval describes the uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater statistical precision for that estimate, while a wider interval indicates less precision. An interval around a change estimate can help readers distinguish a well-resolved estimate from one compatible with a broad range of values.

No confidence interval for the primary outcome is reported in the registry record. Since the outcome estimates themselves are also absent, neither the size nor the precision of a change can be evaluated. A confidence interval would not resolve the absence of a control group: it can quantify uncertainty around an estimate, but it cannot by itself remove design limitations or establish causation.

Why do the analysis population and missing data matter?

In general, the interpretation of a repeated-measure outcome depends on who contributes data at each assessment. When some participants do not complete follow-up surveys, the observed participants may not represent all enrolled participants. The amount and pattern of missing data, reasons for nonresponse, and methods used to handle missing measurements help readers assess this risk.

The registry says that participants who completed the survey at each time point are reported. It does not report the completion counts, reasons for missing surveys, or a missing-data method. It also does not specify whether the same participants were included in each time-point summary or whether a paired analysis was planned. Without those details, the relationship between the reported population and all enrolled participants cannot be assessed.

What does the analysis record establish?

The registry lists 21 outcome measures and 0 analyses. It provides an outcome description and time frame for the primary pain measure, but it does not report numerical estimates or inferential analysis results. An outcome listing identifies what was measured or intended to be measured; it is not equivalent to a report of the resulting data.

General statistical interpretation would normally consider the estimate, its uncertainty, the analysis population, and the assumptions used. Here, those elements are not reported for the primary outcome. No statistical method for assessing change, no test statistic, and no p-value are reported in the registry record. It would be speculative to fill in a planned model, inferential procedure, or adjustment based only on the endpoint description.

How should sample-size illustrations be read?

In general, a sample-size illustration asks how many participants might be needed under stated assumptions to detect an effect of a specified size with a chosen error rate and power. Such a calculation depends on the assumed effect, variability, design, allocation, and statistical test. It is not a description of the number actually analyzed, nor does it demonstrate that a study had a particular probability of finding a result after completion.

Any planning illustration associated with this record is explicitly based on the observed effect and a hypothetical two-arm calculation, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. That framework does not match the listed single-group design. Such illustrations should be understood only as hypothetical planning scenarios, not as the study’s design justification, observed power, or evidence of a controlled effect. The registry record does not report the study’s sample-size justification or a prospective power calculation.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 21 outcome measures, spanning symptom and health-care utilization topics, but records 0 analyses. That combination does not establish whether analyses were performed outside the registry; it indicates that analysis results are not reported in the registry entry. No analysis plan describing primary or secondary hypothesis tests, outcome hierarchy, or adjustment for multiple comparisons is reported in the registry record.

In general, testing many outcomes can increase the chance of at least one apparently notable result arising by chance. Statistical methods can address that issue in different ways, but the appropriate approach depends on the prespecified questions and analysis plan. Because no such plan or reported analyses are recorded, it is not possible to assess how multiplicity was handled. The existence of 21 listed outcomes should not be read as 21 statistically tested findings.

For missing data, the primary outcome description says that participants who completed the survey at each time point are reported. The registry does not report completion counts, reasons for noncompletion, the amount or pattern of missing data, or any imputation or other missing-data method. It also does not describe an analysis population beyond the survey-completer wording. Thus, the extent to which outcome summaries represent all enrolled participants cannot be assessed.

Details about prespecified interim analyses, stopping rules, and a statistical analysis plan are not reported in the registry record. Their absence from the record should not be taken as evidence that particular procedures were or were not used; it means their use cannot be evaluated from the registry entry.

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.

The registry lists one intervention group for safety. It records 25 participants at risk for serious adverse events and 0 affected, and 25 at risk for other adverse events and 0 affected. It also lists 6 deaths. These figures are counts as recorded; the safety entry does not report event details or a time frame that would explain how the counts relate to each other.

The safety denominator is 25, while overall enrollment is listed as 27. The registry record does not explain the difference between those figures, so the safety population should not be assumed to include every enrolled participant. Zero affected is a count in the listed safety category, not proof that no event could have occurred outside the recorded population or reporting period.

The listed deaths should not be attributed to the intervention on the basis of these counts. The record does not report causes, timing, relatedness assessments, or circumstances for the deaths. Nor does it explain how deaths relate to the adverse-event categories. The figures describe what is entered in the registry, not a causal safety comparison: there is no control group identified for comparison, and event-level information is not reported.

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

The registry record establishes that the completed CO-ORDINATE study enrolled 27 participants and focused its primary outcome on pain measured with the ESAS. It specifies assessment at baseline, 6-weeks post intervention, and 3 months post intervention, with median and inter-quartile range as the reporting format. It also describes the study as single-group and lists health-care utilization outcomes as secondary measures.

It does not establish how pain scores changed. The numerical scores, their inter-quartile ranges, the number of survey respondents at each time, and inferential results are not reported in the registry record. Consequently, the direction, magnitude, and precision of any change cannot be determined from the recorded information. The study’s completion status is not a substitute for outcome results.

The design also does not support a controlled causal comparison. A single-group study can describe outcomes among observed participants, but any change could reflect influences other than the program. No control group or randomized allocation is identified, and the registry does not report a strategy that would address those alternative explanations.

The intervention’s rationale and intended components are described, including coordination and symptom management support. Those descriptions explain the study question; they do not demonstrate that symptoms or quality of life improved. Although quality of life appears among the conditions and rationale, the primary endpoint named in the record is the ESAS pain score. Numerical results for that endpoint and for the secondary utilization outcomes are not reported in the registry record.

Accordingly, the record is informative about the population of interest, intervention concept, outcome schedule, and broad design. It does not provide enough statistical evidence to quantify an outcome effect, evaluate uncertainty, or determine whether any observed pattern would be attributable to the intervention.

13. Why This Trial Matters Statistically

This study addresses a measurement and design challenge common in research on multimorbidity: patients may experience several symptoms while also navigating care across chronic conditions. The CO-ORDINATE concept focuses on care coordination and symptom management, and the registry identifies pain as the primary symptom outcome. Keeping the outcome and measurement times explicit helps clarify what the study sought to assess.

Statistically, however, a stated question and a completed study are not the same as a reported result. The record lists a single-group design, 27 enrolled participants, and a survey-completer population at each time point, but it does not give the numerical pain summaries or analysis results. This makes the study useful as an example of why endpoint descriptions, respondent counts, and estimates with uncertainty are all needed for interpretation.

The study also highlights how design constrains the claims that can be made. Repeated measurement can describe the trajectory of scores among respondents, but an uncontrolled pattern cannot on its own distinguish intervention-related change from other changes over time. The lack of a recorded comparator is therefore central to interpreting any possible before-and-after results.

Finally, multiple listed outcomes and unspecified missing-data handling matter for transparency. Readers need to know which outcomes were analyzed, how incomplete follow-up was addressed, and how uncertainty was quantified. Those details are not reported in the registry record. The statistical importance of the study lies not in an effect estimate that the record does not provide, but in the clear separation between a plausible intervention question and the evidence needed to answer it.

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.

Several limitations specific to this record constrain interpretation. It describes a single-group study with no control arm or randomized allocation identified. As a result, outcome patterns over time cannot be compared with a concurrent group, and changes cannot be attributed to the intervention on the basis of this design description alone.

The primary outcome is specified, but the numerical ESAS pain results are not reported in the registry record. Neither the median and inter-quartile range at each assessment nor any estimate of change is available. The number of participants completing each survey is also not reported, despite the outcome population being defined by survey completion at each time point. This prevents assessment of follow-up completeness and the size of the outcome-specific population.

The registry lists 21 outcomes and 0 analyses, but does not report an analysis plan, inferential methods, uncertainty estimates, or multiplicity procedures. Missing-data handling and analysis-population definitions beyond the survey-completer wording are not reported. These omissions preclude appraisal of how the outcome data were analyzed and how robust the results might be.

The intervention description identifies a patient-centered program and gives a broad account of its intended components. Details about delivery, adherence, and variation in implementation are not reported in the registry record. The secondary health-care utilization outcomes also lack numerical results and detailed definitions in the entry.

Safety information is limited to group-level counts. The record does not explain the safety denominator, describe the listed deaths, report event timing or relatedness, or identify a comparator. These limitations mean that the safety counts cannot establish causality or support a comparative safety assessment.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Living With Multimorbidity: CO-ORDINATE Program — NCT05985044.
• Registry record last updated 2025-01-28; status last verified 2025-01.
• Results first posted 2025-01-28.
• 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

NCT05985044 is a completed, single-group study of the CO-ORDINATE program, sponsored by Johns Hopkins University. The record lists 27 enrolled participants, with a study start date of 2022-11-16 and primary completion date of 2024-03-02. Allocation is recorded as NA and masking as NONE.

The primary outcome is ESAS pain score, specified as a median with inter-quartile range at baseline, 6-weeks post intervention, and 3 months post intervention. The registry lists 21 outcome measures and 0 analyses. Numerical primary and secondary outcome results, analysis methods, and missing-data procedures are not reported in the registry record.

The safety entry lists 25 at risk and 0 affected for serious adverse events, 25 at risk and 0 affected for other adverse events, and 6 deaths. Event details and the relationship of the deaths to the intervention are not reported. The study record describes the intended intervention and its measurement schedule, but does not provide statistical results sufficient to estimate an outcome effect.