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 Technology Assisted Care Transition Intervention for Veterans With CHF or COPD (NCT02632552), a randomized na study. The primary outcome is Pre-post Change in Combined Emergency and Urgent Care Service Utilization.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02632552 |
| Phase | NA |
| Condition | CHF, COPD |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 140 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
The trial asks whether a technology-assisted program supporting the transition from hospital to home is associated with a different pattern of combined emergency and urgent care use than an active attention control. The focus is Veterans with CHF and/or COPD. The intervention begins during the inpatient stay with a virtual nurse and continues after discharge through text messages. The control also includes an inpatient tutorial and outpatient texting, so the comparison is between two behavioral approaches rather than between the intervention and no contact.
Population
Enrolled Veterans with CHF and/or COPD who had complete data for the primary utilization measure. Eligibility details beyond this description are not reported in the registry record.
Intervention
An inpatient virtual nurse delivered through an onscreen touchscreen, followed by outpatient virtual-nurse follow-up by text message.
Comparator
An active attention control consisting of an inpatient brief animated, presentation-style tutorial about core care-transition concepts and brief outpatient texting.
Primary question
How does the mean total number of VA emergency department and urgent care visits change across the stated pre-enrollment and post-discharge periods in the intervention and control arms?
The registry frames the outcome as a comparison between arms across time, not simply as a post-discharge count. The intended interpretation would therefore depend on the reported group estimates and the statistical contrast used to compare them. Those estimates and the contrast are not reported in the registry record. The record does not establish whether any observed difference is attributable to the intervention.
3. Trial Design
The registry describes a randomized, parallel trial with single masking and behavioral interventions. It lists enrollment as 140 and status as completed. The listed study start is 2018-05-01, and the primary completion date is 2020-06-30. The sponsor is the VA Office of Research and Development. The record does not identify who was masked, describe the randomization sequence or allocation concealment, or report the procedures used to maintain masking.
The two arms differ in their care-transition content. The technology-assisted arm uses an inpatient virtual nurse on a touchscreen and outpatient virtual-nurse follow-up by text. The active attention control uses a brief animated, presentation-style inpatient tutorial about care-transition concepts and brief outpatient texting. Both arms therefore include inpatient and post-discharge contact, although the content and delivery differ. The record does not specify the timing, number, or duration of individual contacts.
The clinical conditions are CHF and COPD, and the population is described as Veterans. The registry’s primary-outcome population is enrolled Veterans with complete data for that measure. Further eligibility criteria, participant characteristics, arm-specific enrollment, and the number included in the primary analysis are not reported in the registry record. The phase is listed as NA.
Random assignment can support a causal comparison when allocation, follow-up, and analysis preserve the randomized groups, but the registry information does not provide enough detail to assess those conditions. The record also does not report protocol deviations, crossovers, treatment adherence, or whether analyses followed assigned groups. The design description alone is not evidence of an intervention effect.
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 | Intervention | Active Attention Control |
|---|---|---|
| STARTED | 80 | 60 |
| COMPLETED | 57 | 50 |
| NOT COMPLETED | 23 | 10 |
Reasons for not completing this period:
| Reason | Intervention | Active Attention Control |
|---|---|---|
| Lost to Follow-up | 14 | 8 |
| Withdrawal by Subject | 2 | 0 |
| Did not receive allocated protocol (did not enroll in texting program) | 7 | 2 |
Analysis population for the primary outcome, as defined in the registry: Enrolled Veterans who had complete data for this measure
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 | Technology-assisted Care Transition Arm | Active Attention Control | Total |
|---|---|---|---|---|
| Participants analysed | 80 | 60 | 140 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 25 | 18 | 43 |
| Age, Categorical: >=65 years | Participants | 55 | 42 | 97 |
| Age, Continuous | years | 69.01 (SD 8.40) | 68.40 (SD 7.70) | 68.705 (SD 8.05) |
| Sex: Female, Male: Female | Participants | 2 | 1 | 3 |
| Sex: Female, Male: Male | Participants | 78 | 59 | 137 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 2 | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 77 | 58 | 135 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 8 | 10 | 18 |
| Race (NIH/OMB): White | Participants | 66 | 42 | 108 |
| Race (NIH/OMB): More than one race | Participants | 5 | 7 | 12 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 80 | 60 | 140 |
| Problems learning about medical conditions: Always | Participants | 2 | 6 | 8 |
| Problems learning about medical conditions: Often | Participants | 3 | 1 | 4 |
| Problems learning about medical conditions: Sometimes | Participants | 2 | 9 | 11 |
| Problems learning about medical conditions: Occasionally | Participants | 14 | 5 | 19 |
| Problems learning about medical conditions: Never | Participants | 57 | 39 | 96 |
| Problems learning about medical conditions: No response | Participants | 2 | 0 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Pre-post Change in Combined Emergency and Urgent Care Service Utilization, measured over 18 months prior to enrollment and 12 months post-discharge.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | care utilization events |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the pre-post change in combined emergency and urgent care service utilization. It is defined as the total number of VA emergency department visits and VA urgent care visits for each participant during the study period. The stated comparison concerns Veterans with CHF and/or COPD in the intervention and control arms across time. The time frame is 18 months prior to enrollment and 12 months post-discharge.
The endpoint represents a count of service-use events, summarized using a mean and standard deviation. A mean describes the average event count in a group; the standard deviation describes variation among participants around that average. As a general statistical point, a mean can be influenced by participants with unusually high counts, so the distribution and the analysis model can matter when interpreting an average count. The registry record does not report the distribution of counts or the model used.
Utilization is used to assess whether the care-transition approaches are accompanied by different patterns of emergency and urgent care use. It is distinct from a direct measure of a patient’s experience, self-management, or health status. The record identifies complete-data participants as the primary-outcome population, but does not provide the endpoint estimates, a treatment contrast, or its uncertainty. The clinical meaning of the comparison therefore cannot be determined from the posted outcome description alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the primary outcome and how it is defined, but does not report the intervention and control estimates for the primary outcome. It also does not report a difference or other treatment-effect estimate, a confidence interval, or a p-value for that outcome. Consequently, the posted record does not show the direction, size, or precision of the primary comparison. The absence of a reported estimate is not evidence that the arms were equal, nor does it establish that a difference was present.
The outcome is a comparison across the pre-enrollment and post-discharge periods, with utilization measured as combined VA emergency department and urgent care visits. A statistical interpretation would require knowing how the pre- and post-period counts were summarized and how the comparison across arms and time was estimated. Those details are not reported in the registry record. The record also does not say whether the analysis adjusted for baseline utilization or other characteristics.
The record lists nine outcome measures and nine analyses. Named secondary measures include care-transition experience, medication adherence, health distress, self-efficacy, heart-failure self-care, COPD self-management, and self-efficacy for managing symptoms, medications, and treatments. Their outcome estimates and uncertainty are not reported in the registry record. Their presence indicates that the study addressed more than utilization, but the available information does not support conclusions about any of these outcomes.
For safety, the registry lists zero serious adverse events and zero other adverse events in each arm, alongside deaths recorded for each arm. These are descriptive counts, not a statistical comparison of risk. The record does not report event timing, attribution, follow-up completeness, or a formal analysis of safety differences. The death counts should not be treated as a treatment effect without information about the analysis population, time at risk, and circumstances.
Thus, the posted record supports a description of the trial question, intervention contrast, endpoint definition, and selected safety counts. It does not provide the numerical outcome results needed to estimate an intervention effect or judge its precision. No conclusion that the intervention improves, worsens, or leaves utilization unchanged follows from the information reported.
9. Statistical Methods Explained
The registry describes the primary endpoint as a continuous measure analyzed as a mean, with standard deviation as the dispersion measure. The underlying participant-level quantity is a count of combined emergency and urgent care events. The record does not describe the statistical model or the specific method used to compare arms and time periods. The methods below explain general statistical considerations; they are not a description of methods confirmed for this trial.
What does a mean describe?
In general, a mean is the sum of measured values divided by the number of observations. It gives an average across participants, but it does not show how values are distributed. With a utilization count, a few participants with many events can pull the mean upward. The standard deviation describes how spread out values are around the mean, but it does not fully communicate the shape of the distribution or the presence of unusually high values. The registry record does not report the observed means, standard deviations, or count distributions for this endpoint.
Why does the comparison across time matter?
The endpoint is described as a pre-post change, with one period before enrollment and another after discharge, and as a comparison between randomized arms. A treatment contrast could be framed in different ways: for example, by comparing changes between arms or by modeling the measurements across periods. These approaches can answer related but not necessarily identical statistical questions. The registry record does not identify the contrast, model, covariates, or assumptions used. It would therefore be inappropriate to infer a particular analysis from the outcome title alone.
How should uncertainty be assessed?
In general, a confidence interval gives a range of values compatible with the observed data under the assumptions of the analysis. Its width conveys precision: wider intervals indicate less precision, while narrower intervals indicate greater precision. A p-value addresses compatibility with a specified null hypothesis under a statistical model; it does not measure the size or clinical importance of an effect. Neither a confidence interval nor a p-value for the primary comparison is reported in the registry record. Without an estimate and uncertainty measure, the magnitude and precision of any difference cannot be assessed.
Why can count data need special attention?
As a general matter, counts are nonnegative and may be concentrated at low values, with a smaller number of larger values. A normal-based method may not represent such a distribution well in some settings. Count models can be considered when their assumptions fit the data. Over-dispersion occurs when variation exceeds what a chosen model expects; if ignored, uncertainty estimates can be misleading. These are general considerations only. The registry record does not report the distribution of utilization counts, whether over-dispersion was evaluated, or whether a count model or another method was used.
What does the planning illustration mean?
The described sample-size illustration uses a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It is based on a stated fraction of the observed effect, with the relevant effect fraction determining the size used for planning. The record does not report the trial’s own design justification or a sample-size calculation established before the study. A calculation based on an observed effect is a planning illustration, not observed power and not evidence that the study had a particular probability of detecting an effect. The actual illustration values are not reported in the registry record.
The assumptions matter: changing the target effect, allocation, significance level, or statistical approximation can change a planning result. An illustration also cannot repair the absence of a reported treatment estimate or uncertainty interval. The registry record does not report interim analyses, a prespecified statistical analysis plan, or the methods used for the primary and secondary comparisons. Those details are not reported in the registry record, so the general explanations above should not be read as claims about the trial’s actual analysis.
10. Multiplicity, Missing Data and Analysis Populations
The record lists nine outcome measures and nine analyses. The primary measure itself concerns a comparison across two periods and two arms, while the secondary measures cover several domains. When researchers examine multiple outcomes or contrasts, the chance of at least one apparently notable result can increase. General approaches to this issue include prespecifying a primary contrast, controlling a family-wise error rate, or treating secondary findings as exploratory. The registry record does not report a multiplicity adjustment or a hierarchy among the secondary outcomes. No claim about how multiplicity was handled can be made from the outcome list alone.
The primary outcome population is described as enrolled Veterans with complete data for that measure. The record does not say how many participants had complete data, how much information was missing, why data were missing, or whether missingness differed between arms. It also does not report imputation, sensitivity analyses, or another method for handling missing observations. Complete-case results can be affected if the participants with observed outcomes differ systematically from those without observed outcomes; this is a general concern, not a finding about this trial.
The record does not state whether participants were analyzed according to randomized assignment, whether exclusions occurred after randomization, or how protocol deviations were handled. Therefore, the analysis population beyond the stated complete-data description is not reported in the registry record. Without these details, the impact of missing data and analysis choices on the reported outcomes cannot be evaluated.
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 |
|---|---|---|---|
| Technology-assisted Care Transition Arm | 0 | 80 | 0.0% |
| Active Attention Control | 0 | 60 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Technology-assisted Care Transition Arm | 24 of 80 |
| Active Attention Control | 21 of 60 |
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 |
|---|---|
| Technology-assisted Care Transition Arm | 0 of 80 |
| Active Attention Control | 0 of 60 |
The registry lists 80 at risk in the technology-assisted care-transition arm and 60 at risk in the active attention control. It reports zero serious adverse events and zero other adverse events in each arm. It also reports 24 deaths in the technology-assisted arm and 21 deaths in the active attention control. These are descriptive registry counts; they are not adjusted estimates or evidence of a difference between arms.
The at-risk counts are the denominators associated with the posted safety figures. The record does not explain whether these denominators represent all randomized participants, participants followed for safety, or another analysis set. It does not report the duration of individual safety follow-up, event timing, event definitions, causes of death, or whether events were considered related to an intervention. It also does not state how incomplete safety information was handled.
Zero recorded events in a category means that no events in that category were listed in the registry results; it does not establish that the underlying risk is zero. Similarly, the death counts alone cannot establish a comparative safety effect. Interpretation would require a defined follow-up period and an analysis that accounts for the relevant population and time at risk. Those analyses are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a randomized, parallel comparison of a technology-assisted care-transition program with an active attention control among Veterans with CHF and/or COPD. It also defines a primary utilization endpoint that combines VA emergency department and urgent care visits, and describes measurement before enrollment and after discharge. These details clarify what the trial set out to compare.
The record does not report the primary outcome estimates or a statistical comparison between the arms. It therefore does not establish whether utilization was higher, lower, or similar in either arm, nor how precise an estimated difference might be. The same limitation applies to the listed secondary measures: the outcome names are present, but numerical findings are not reported in the registry record.
The safety entries show zero recorded serious adverse events and zero other adverse events in each arm, as well as the reported death counts. Those entries are not accompanied by information on timing, attribution, or a comparative analysis. They should be read as posted counts rather than proof of safety, harm, or a difference in risk.
More generally, a randomized design can help distinguish intervention effects from differences that arise because participants chose their own treatment, but randomization by itself does not ensure that the reported analysis is unbiased. Follow-up, missing outcomes, adherence, analysis populations, and statistical methods also matter. The registry information does not describe these sufficiently to evaluate them.
The appropriate conclusion is limited: the trial addressed a relevant care-transition question and the registry defines several outcomes, but the posted results do not permit an estimate of the primary treatment effect. This is not evidence that the intervention does or does not change utilization, self-management, or other outcomes.
13. Why This Trial Matters Statistically
Care after a hospital stay can involve both inpatient preparation and support after discharge. This trial’s design reflects that transition by pairing an inpatient virtual-nurse interaction with outpatient texting, while also giving the active attention control inpatient and outpatient contact. Statistically, that makes the comparison more specific than a contrast between a supported group and no additional attention: it concerns the relative outcomes of two behavioral approaches.
The primary endpoint is also a practical health-service measure. Combining emergency department and urgent care visits captures a defined form of acute service use over a pre-enrollment and post-discharge period. Such outcomes can be useful for studying patterns of care, but interpretation depends on the exact contrast, the count distribution, completeness of follow-up, and the analysis method. The registry record does not report those methods or the primary estimates, so the statistical evidence for a difference cannot be assessed.
The record includes a range of secondary domains, from care-transition experience and medication adherence to self-efficacy and condition-specific self-management. Together, these measures describe distinct questions that should not be collapsed into a single claim. Their presence also makes clear why prespecified outcome priorities and transparent multiplicity methods matter in interpreting a trial with several analyses. Those methods are not reported in the registry record.
The trial is statistically informative as a clearly described comparison and endpoint framework, but the available results are incomplete for evaluating effects. Distinguishing a well-defined research question from an answer supported by reported estimates is central to responsible interpretation. Here, the question and outcome definitions are visible; the estimates needed to quantify the findings are not reported in the registry record.
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.
A central limitation is that the registry record does not report numerical results for the primary utilization comparison. There is no reported arm estimate, treatment-effect estimate, confidence interval, or p-value with which to assess direction, magnitude, or precision. The endpoint description therefore cannot be translated into an estimate of how the arms differed.
The record states that the primary population included enrolled Veterans with complete data for the measure, but it does not report the number analyzed or the amount and pattern of missing data. It does not describe the handling of missing outcomes, exclusions, adherence, or deviations from assigned intervention. These omissions limit assessment of whether the analyzed participants represent the randomized groups.
Several design and analysis details are also absent. The record does not identify who was masked, explain allocation concealment, describe the statistical model or covariate adjustment, or state how the comparison across periods was constructed. It does not report whether multiplicity was addressed across the nine listed outcome measures and analyses. The number of participants in each analyzed arm and participant characteristics are not reported in the registry record.
The primary outcome combines emergency department and urgent care events, but the record does not describe their separate contributions or the distribution of total counts. It also does not report safety follow-up duration or details that would support interpretation of the death counts and zero adverse-event counts. Finally, the population is described broadly as Veterans with CHF and/or COPD; further eligibility and clinical-characteristic details are not reported in the registry record. These limits prevent a detailed assessment of generalizability and statistical robustness.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Technology Assisted Care Transition Intervention for Veterans With CHF or COPD — NCT02632552.
- Registry record last updated 2023-07-27; status last verified 2023-07.
- Results first posted 2021-11-04.
- 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
The registry describes a completed randomized, parallel trial sponsored by the VA Office of Research and Development. It compares an inpatient and post-discharge technology-assisted care-transition intervention with an active attention control among Veterans with CHF and/or COPD. The listed enrollment is 140.
The primary outcome is the pre-post change in combined VA emergency department and urgent care utilization, measured over 18 months prior to enrollment and 12 months post-discharge. The measure is summarized as a mean with standard deviation, and the stated primary population consists of enrolled Veterans with complete data for the measure. The registry also lists nine outcome measures and nine analyses.
Safety entries include zero serious adverse events and zero other adverse events in each arm, with deaths recorded in both arms. Numerical estimates for the primary outcome and details of the statistical analysis are not reported in the registry record. The available information describes the research question and outcome definitions but does not establish the size or precision of an intervention effect.