This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Comparative Effectiveness Trial of Optimal Patient-Centered Care (NCT02274688), a randomized na study. The primary outcome is Change in Post Traumatic Concerns Over the Course of the Six Months After Injury.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02274688 |
| Phase | NA |
| Condition | Post Traumatic Concerns, Post Traumatic Stress Disorder, Depression and Suicide Ideation |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 171 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
People receiving care in trauma care systems after traumatic injury. The registry record concerns post-traumatic concerns and lists post-traumatic stress disorder, depression and suicide ideation, and alcohol and drug use among its conditions. Age criteria and other detailed eligibility characteristics are not reported in the registry record.
Intervention
Patient-centered care transition, described as case management, information technology and mHealth innovations, and stepped-up psychopharmacology and psychotherapy elements.
Comparator
Enhanced usual care with nurse notification of patient concerns.
Primary question
How did endorsement of one or more severe post-traumatic concerns change over the six months after injury in the two randomized groups? The outcome was assessed at baseline and at 1-, 3-, and 6-month follow-up. A single numerical comparison of change is not reported in the registry record.
The trial addresses a care-delivery question: whether a patient-centered transition approach is associated with a different pattern of post-injury concerns than enhanced usual care. The registry describes the broader challenge as fragmented care across hospital, emergency department, outpatient, and community settings, and care that may not be individualized to patients’ concerns and preferences. Those statements provide context for the intervention; they are not findings from the trial.
The primary outcome focuses on severe post-traumatic concerns rather than a single named diagnosis. The record also lists secondary outcomes concerning alcohol use problems, drug use problems, functional status, suicidal ideation, weapon carrying, and emergency department visits. However, outcome-specific estimates and comparisons for these measures are not reported in the registry record. The available information therefore identifies the question and the outcomes of interest, but does not establish how the groups differed on them.
3. Trial Design
This was a randomized, parallel-group trial with single masking, listed as completed. The registry records enrollment of 171. The start is recorded as 2014-03 and primary completion as 2016-12. The sponsor is the University of Washington, and the trial phase is listed as NA. The meaning of the masking procedure and who was masked are not reported in the registry record.
The two groups were enhanced usual care with nurse notification of patient concerns and patient-centered care transition. The latter is described as case management, information technology and mHealth innovations, and stepped-up psychopharmacology and psychotherapy elements. Both group descriptions state that participants were randomized and would be blindly assessed. Details about how randomization was implemented, concealment of assignment, and the precise assessment procedures are not reported in the registry record.
The primary outcome was assessed at baseline and at 1-, 3-, and 6-month follow-up. The listed primary outcome is endorsement of one or more severe post-traumatic concerns. The record characterizes the primary question as change over the six months after injury, but a single comparison is not available because the outcome has several categories or time points and was not reduced to one comparison in the posted results.
The listed secondary outcomes include alcohol use problems, drug use problems, functional status, suicidal ideation, carrying a weapon, and emergency department visits over time. The registry reports nine outcome measures and nine analyses, but the analysis-to-outcome mapping and detailed statistical procedures are not reported in the registry record. Although the record is marked completed, the available primary-outcome information does not provide a numerical estimate of the treatment contrast.
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
| Stage | Enhanced Usual Care - Nurse Notification of Patient Concerns | Patient-centered Care Transition |
|---|---|---|
| STARTED | 86 | 85 |
| COMPLETED | 72 | 72 |
| NOT COMPLETED | 14 | 13 |
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.
| Characteristic | Unit | Enhanced Usual Care - Nurse Notification of Patient Concerns | Patient-centered Care Transition | Total |
|---|---|---|---|---|
| Participants analysed | 86 | 85 | 171 | |
| Age, Categorical: <=18 years | Participants | 2 | 1 | 3 |
| Age, Categorical: Between 18 and 65 years | Participants | 74 | 77 | 151 |
| Age, Categorical: >=65 years | Participants | 10 | 7 | 17 |
| Age, Continuous | years | 43.6 (SD 16) | 41.2 (SD 16.1) | 42.4 (SD 16.0) |
| Sex: Female, Male: Female | Participants | 47 | 50 | 97 |
| Sex: Female, Male: Male | Participants | 39 | 35 | 74 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 6 | 9 | 15 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 80 | 76 | 156 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 10 | 5 | 15 |
| Race (NIH/OMB): Asian | Participants | 2 | 7 | 9 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 4 | 5 |
| Race (NIH/OMB): Black or African American | Participants | 13 | 8 | 21 |
| Race (NIH/OMB): White | Participants | 51 | 47 | 98 |
| Race (NIH/OMB): More than one race | Participants | 5 | 10 | 15 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 | 4 | 8 |
| Region of Enrollment: United States | participants | 86 | 85 | 171 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Post Traumatic Concerns Over the Course of the Six Months After Injury, measured over The investigators assessed at baseline, 1-, 3-, and 6-month..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the endorsement of one or more severe post-traumatic concerns. The registry describes it as a participant count and states that it was assessed at baseline and at 1-, 3-, and 6-month follow-up. Its stated purpose is to capture change in concerns during the six months after injury. The record does not report the specific concerns included in the severity classification, how severity was determined, or the precise rule for combining concern categories into the endpoint.
A concern-based endpoint can reflect experiences that matter to injured patients, rather than focusing only on a particular diagnosis. In general, repeated assessments can describe whether the proportion of participants endorsing an outcome changes over time, and whether that pattern differs between randomized groups. Those are general statistical interpretations; they do not establish that such a difference occurred in this trial.
The primary outcome is described across several time points and categories, and the registry record does not reduce it to one comparison. No numerical primary outcome results, effect estimate, confidence interval, or p-value are reported in the registry record. Accordingly, the endpoint definition and assessment schedule can be described, but the magnitude and precision of any group difference cannot be evaluated from the available record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of patient-centered care transition with enhanced usual care, but it does not provide a single numerical primary-outcome comparison. The primary outcome is change in endorsement of one or more severe post-traumatic concerns, assessed at baseline and at 1-, 3-, and 6-month follow-up. Because the outcome spans multiple categories or time points, the posted results do not reduce it to one comparison. A treatment effect, its direction, and its precision therefore cannot be described from the primary-outcome information reported in the registry record.
This distinction matters: a trial’s design and outcome definitions are not results. The trial is marked completed, and enrollment is recorded as 171, but neither fact supplies an estimate of how the randomized groups compared on the primary outcome. Nor does the presence of secondary outcomes establish that one group had better or worse results. Numerical results for the named secondary outcomes are not reported in the registry record.
The record lists nine outcome measures and nine analyses, but does not give enough detail to connect each analysis to a specific estimate, model, or hypothesis. It also does not report confidence intervals or p-values for the primary outcome. A confidence interval, in general, expresses the range of effect values compatible with the data and the assumptions of the analysis; without an estimate and interval, statistical precision cannot be assessed. A p-value, in general, evaluates how compatible data are with a specified null model, but no primary-outcome p-value is reported.
The serious adverse event entries are descriptive counts, not evidence by themselves of a causal effect. The enhanced usual care group has 1 serious event among 86 at risk, while the patient-centered care transition group has 2 among 85 at risk. Deaths are recorded as 0 and 2, respectively. These entries should be read in the context of how events were collected and classified; further details about attribution, timing, and event-level circumstances are not reported in the registry record. The listed serious term “Suicide Attempt” is recorded as 2.4%.
Overall, the record supports a description of the trial question, randomized design, intervention groups, assessment schedule, and posted safety counts. It does not support a conclusion about the size or statistical significance of a primary-outcome difference, or about whether the intervention changed any secondary outcome. These are limits of the information recorded, not evidence that the groups were equivalent.
9. Statistical Methods Explained
The registry describes the study as randomized, parallel, and single-masked. In a randomized trial, assignment is intended to create groups that can be compared without choosing treatment according to participants’ characteristics. In general, randomization can reduce systematic differences in measured and unmeasured characteristics at the start of a study. It does not guarantee identical groups, and interpretation still depends on how assignment, follow-up, and analysis were carried out. The method of sequence generation, allocation concealment, and the identity of the masked parties are not reported in the registry record.
What does the repeated assessment schedule imply?
The primary outcome was assessed at baseline and at 1-, 3-, and 6-month follow-up. Repeated measurements can describe the course of an outcome, not only its value at one point. In general, observations from the same participant over time may be related to one another. Analyses that account for this within-participant correlation can produce appropriate uncertainty estimates for change over time. The statistical model used for this endpoint, and how it handled repeated measurements, are not reported in the registry record.
The primary endpoint is described as a count of participants endorsing one or more severe post-traumatic concerns. For an outcome recorded as whether a participant does or does not meet a definition, general approaches can model event probabilities or compare proportions. But the registry’s primary outcome also involves multiple categories or time points, and no single comparison is posted. The particular model, effect scale, and contrast are therefore not reported in the registry record. No new estimate can be reconstructed from the endpoint description alone.
Why does over-dispersion matter?
For count outcomes, a statistical model may assume a particular relationship between the average count and its variability. In general, over-dispersion means the observed variability is greater than that assumed by a model. If present and ignored, uncertainty estimates can be too small, making results appear more precise than they are. This is a general consideration for count data; the primary outcome is described as a participant count, and the registry does not report a dispersion estimate or a count model. There is no basis in the record for saying that over-dispersion was present or that a specific adjustment was used.
What do the planning assumptions mean?
The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also says that the effect to detect is expressed as a stated fraction of the observed effect. Such calculations are prospective planning illustrations: they describe sample sizes under assumptions and are not observed power. In general, planning results depend on the assumed effect, variability, design, and analysis. The numerical planning estimates are not reported in the registry record, and the record does not report the trial’s own sample-size justification. No conclusion about whether the trial was adequately sized follows from the available information.
The assumptions described for planning do not establish the analysis actually used. A planned significance threshold does not tell the reader which endpoint contrast was tested, whether covariates were included, or whether the analysis followed randomized assignment. The statistical analysis plan and the exact primary test are not reported in the registry record. No recalculated estimates are available for the primary outcome, and no discrepancy between a sponsor analysis and a recalculation is reported.
How should uncertainty be interpreted?
In general, a point estimate describes the observed contrast on a chosen scale, while a confidence interval describes uncertainty around that estimate under the model. The interval’s width is affected by the amount and variability of data, and by the analysis assumptions. A p-value addresses compatibility with a null hypothesis under a specified analysis; it is not a measure of the size or practical importance of an effect. Here, primary-outcome estimates, confidence intervals, and p-values are not reported in the registry record. Thus neither statistical evidence for a difference nor the precision of an estimated difference can be assessed.
The record lists nine outcome measures and nine analyses. In general, examining multiple outcomes or multiple contrasts raises a multiplicity question: when many hypotheses are tested, the chance of at least one apparently unusual result may increase. Methods can address this by prespecifying a primary contrast, adjusting inference, or treating secondary analyses as exploratory. The registry does not report whether multiplicity was considered or how the analyses correspond to the outcomes. Therefore no claim about adjustment or confirmatory status can be made.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists nine outcome measures and nine analyses. The primary outcome is assessed at multiple time points and is described as having several categories, but the posted results do not reduce it to one comparison. The record does not report a hierarchy of hypotheses, multiplicity adjustment, or whether secondary analyses were considered confirmatory or exploratory. In general, multiple outcomes and comparisons can increase the chance of finding an apparently notable result by chance, so the analysis plan is important for interpreting a collection of tests. The available record does not establish which approach was used.
Missing-data handling is not reported in the registry record. The number of participants with outcome data at each assessment, reasons for missingness, and methods for handling incomplete follow-up are also not reported. In general, missing outcomes can affect estimates when the availability of data is related to participant characteristics or outcomes. Different assumptions and methods for incomplete data can lead to different results, so readers cannot evaluate that issue without the study’s details.
The record does not report analysis populations, such as whether the primary analysis followed randomized assignment or included only participants with particular follow-up data. It does not specify exclusions, treatment of protocol deviations, or how participants who discontinued care were handled. The randomized design is documented, but the population used for each reported analysis is not. These omissions limit assessment of the analysis and of how directly its results, if reported, would reflect the randomized comparison.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | 1 | 86 | 1.2% |
| Patient-centered Care Transition | 2 | 85 | 2.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | 0 of 86 |
| Patient-centered Care Transition | 2 of 85 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | 39 of 86 |
| Patient-centered Care Transition | 39 of 85 |
Most frequent serious adverse event terms
| Event term | Organ system | Enhanced Usual Care - Nurse Notification of Patient Concerns | Patient-centered Care Transition |
|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | 1 of 86 | 2 of 85 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Enhanced Usual Care - Nurse Notification of Patient Concerns | Patient-centered Care Transition |
|---|---|---|---|
| PHQ-9 Score of >0 | Psychiatric disorders | 39 of 86 | 39 of 85 |
Serious events with the highest arm-level rate: suicide attempt (2.4%).
The registry records serious and other adverse event counts separately for the two groups. For enhanced usual care with nurse notification, 1 serious event is recorded among 86 at risk, and 39 other events are recorded among 86 at risk. For patient-centered care transition, 2 serious events are recorded among 85 at risk, and 39 other events are recorded among 85 at risk. Deaths are recorded as 0 in the enhanced usual care group and 2 in the patient-centered care transition group. The listed serious adverse event term is “Suicide Attempt,” recorded as 2.4%.
These are descriptive registry entries. They do not, by themselves, show whether an event was caused by an intervention or establish a comparative safety effect. The registry record does not provide event-level timing, severity definitions, attribution, or details about whether participants experienced more than one event. The serious and other event counts should not be combined or treated as equivalent categories.
General interpretation of safety counts requires attention to the definition of an event, the observation period, and how events were gathered and reviewed. Those details are not reported in the registry record. The counts should therefore be read as the posted adverse-event information, without inferring causation or making a broader safety claim.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group trial compared patient-centered care transition with enhanced usual care in the context of trauma care systems. It identifies the primary endpoint as endorsement of one or more severe post-traumatic concerns, assessed from baseline through 6-month follow-up. It also describes the intervention components, the comparator, several secondary outcomes, and adverse-event counts. Those details clarify the question the trial was designed to address.
The record does not establish whether the primary outcome differed between groups. It does not provide a single primary comparison, numerical effect estimate, confidence interval, or p-value. It also does not report numerical results for the named secondary outcomes. Consequently, the posted information cannot show the direction, size, or precision of any group difference. Absence of a reported comparison is not evidence that there was no difference, and it is not evidence that the groups were equivalent.
Likewise, enrollment and completion status describe the trial record but do not answer its clinical question. The serious adverse event figures are counts and should not be treated as proof that one group caused more or fewer events. Details needed to interpret the safety counts, including event timing and attribution, are not reported in the registry record.
In general, a well-interpreted trial result requires a clearly defined contrast, an estimate on a meaningful scale, and information about uncertainty and analysis choices. For this record, the endpoint and assessment schedule are stated, but the key comparative outcome information is not. Readers can assess the design question and identify the limitations of the posted results; they cannot determine from this record whether the intervention changed post-traumatic concerns or other listed outcomes.
13. Why This Trial Matters Statistically
This trial is statistically notable for the structure of its primary question: it concerns change in post-traumatic concerns across repeated assessments, rather than a single isolated measurement. Repeated outcome data can describe how participants’ reported concerns evolve over follow-up. General analysis of such data must account for the relationship among observations from the same participant and specify which time contrast or trajectory is of interest. The registry record does not report the model or the primary contrast, so the central statistical target is not fully specified in the posted results.
The outcome also reflects a patient-centered concern rather than a single diagnosis. This makes the endpoint relevant to the stated care-delivery question, while placing importance on how concerns and severity were defined. The registry states that the endpoint is endorsement of one or more severe concerns, but the detailed classification rule is not reported. Such definitions affect what a count represents and how its change should be interpreted.
The record also illustrates why trial completion and trial results are separate pieces of information. Randomization and the assessment schedule describe how the study was structured; they do not supply an estimate of the treatment contrast. Without the primary comparison and its uncertainty, the data’s precision and the strength of evidence cannot be evaluated. The multiple outcomes and analyses make clarity about prespecification and multiplicity relevant, yet those details are not reported.
Finally, the adverse-event figures provide a separate descriptive view of events recorded in each group, not a replacement for outcome analysis or a causal safety comparison. The trial’s statistical contribution cannot be judged from counts alone. The record’s main value for interpretation is the clear outline of the clinical question and the corresponding gaps in the posted comparative results.
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 primary outcome is framed as change over several assessment times and categories, but the registry record does not report a single comparison. It also does not state the exact statistical model, the scale of the treatment contrast, or how the severe-concern definition was operationalized. These omissions prevent assessment of how the endpoint was analyzed and what a numerical difference would mean.
Participant characteristics, detailed eligibility criteria, setting-level information, and the distribution of participants across sites are not reported in the registry record. The available description therefore does not establish how broadly the trial population represents people treated in other trauma care systems. Details of intervention delivery, adherence, and uptake are also not reported, limiting interpretation of how the described care components were implemented.
The registry identifies the trial as single-masked and says participants would be blindly assessed, but it does not specify who was masked or how masking was maintained. The randomization procedure and allocation concealment are not reported. These details would help readers assess possible sources of bias in a behavioral care-transition study.
Missing-data methods, analysis populations, protocol deviations, multiplicity procedures, and the statistical analysis plan are not reported. The record gives adverse-event counts but not event-level context, attribution, or timing. It is therefore not possible to determine from the available information whether follow-up completeness, analytical decisions, or safety-event classification materially affected the results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Comparative Effectiveness Trial of Optimal Patient-Centered Care — NCT02274688.
- Registry record last updated 2017-11-21; status last verified 2017-11.
- Results first posted 2017-07-24.
- 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.
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18. Record Summary
NCT02274688 is a completed randomized, parallel-group trial sponsored by the University of Washington. Enrollment is recorded as 171; the start is 2014-03 and primary completion is 2016-12. The two groups were patient-centered care transition and enhanced usual care with nurse notification of patient concerns. The trial is listed as single-masked, with phase NA.
The primary outcome is endorsement of one or more severe post-traumatic concerns, assessed at baseline and at 1-, 3-, and 6-month follow-up. The registry record does not provide a single primary-outcome comparison or numerical results for the listed secondary outcomes. Serious and other adverse-event counts and deaths are recorded by group, but details needed for causal interpretation are not reported. The record lists nine outcome measures and nine analyses; multiplicity, missing-data methods, analysis populations, and the detailed statistical plan are not reported.