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 Value of Technology to Transfer Discharge Information (NCT00101868), a randomized na study. The primary outcome is Hospital Readmission, at Least One.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00101868 |
| Phase | NA |
| Condition | Information Dissemination, Interprofessional Relations |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 631 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Agency for Healthcare Research and Quality (AHRQ) |
| Results posted | Yes |
2. Clinical Question
Population
Patients recently discharged from an acute care hospital, described in the registry summary as high-risk patients. The trial enrolled 631 participants. The primary outcome analysis was described as intention to treat, including all participants assigned to interventions.
Intervention
A discharge communication software application intended to support information transfer at hospital discharge. The description includes required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. It identifies patients, retail pharmacists, and community physicians as intended recipients of discharge information.
Comparator
The usual care discharge process. Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The described form topics include diagnoses, medications and instructions, post-discharge activities and restrictions, diet, and diagnostic or therapeutic follow-up.
Primary question
How did the assigned discharge communication approach compare with usual care on the number of participants with at least one hospital readmission within 6 months after discharge from the index hospital visit? The registry record names this outcome but does not report an outcome result.
The study addresses communication during the transition from hospital to home. Its stated motivation is that discharge information may be incomplete, inaccurate, delayed, illegible, or not delivered. The comparison therefore concerns a software-supported information-transfer process versus the handwritten process described for usual care. The registry record does not establish whether any difference in readmission was observed, how large it may have been, or how precisely it was estimated.
3. Trial Design
The registry record describes a randomized, single-masked, parallel-group trial. It lists 631 participants as enrolled and records the study status as completed. The phase is listed as NA. The sponsor is the Agency for Healthcare Research and Quality (AHRQ). The recorded study start is 2004-12, and the primary completion date is 2007-08.
In a parallel-group design, participants are assigned to one of the compared approaches and the groups are followed as distinct arms. Random allocation is intended to make the groups comparable, on average, with respect to factors that could affect outcomes. That is a general design principle, not a claim that all participant characteristics were balanced in this trial. Baseline characteristics and details of the allocation procedure are not reported in the registry record.
The two interventions were discharge communication software and the usual care discharge process. The software is described as facilitating communication at discharge, with features such as required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. The usual care description refers to handwritten discharge forms completed by hospital physicians and ward nurses on the day of discharge. The registry record does not give a complete account of how often the software was used, whether adherence was measured, or whether other care differed between arms.
Single masking is recorded, but the registry record does not identify who was masked or explain how masking was maintained. It also does not report the randomization method, allocation concealment, a sample-size justification, interim analyses, or a detailed statistical analysis plan. Those omissions limit how fully the trial’s conduct and planned inference can be assessed from the registry record alone.
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 | Discharge Communication Software | Usual Care Discharge Process |
|---|---|---|
| STARTED | 316 | 315 |
| COMPLETED | 287 | 283 |
| NOT COMPLETED | 29 | 32 |
Reasons for not completing this period:
| Reason | Discharge Communication Software | Usual Care Discharge Process |
|---|---|---|
| Death | 10 | 10 |
| Withdrawal by Subject | 8 | 9 |
| Protocol Violation | 3 | 0 |
| Lost to Follow-up | 8 | 13 |
Analysis population for the primary outcome, as defined in the registry: Analysis was intention to treat. All 631 patient participants assigned to interventions were analyzed
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 | Discharge Communication Software | Usual Care Discharge Process | Total |
|---|---|---|---|---|
| Participants analysed | 316 | 315 | 631 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 233 | 245 | 478 |
| Age, Categorical: >=65 years | Participants | 83 | 70 | 153 |
| Sex: Female, Male: Female | Participants | 180 | 168 | 348 |
| Sex: Female, Male: Male | Participants | 136 | 147 | 283 |
| Region of Enrollment: United States | participants | 316 | 315 | 631 |
| Hospital admissions during year prior to index admission: zero or one admission | participants | 247 | 224 | 471 |
| Hospital admissions during year prior to index admission: 2 or more admissions | participants | 69 | 91 | 160 |
| Emergency department visits during 6 months before index admission: zero or one | participants | 194 | 168 | 362 |
| Emergency department visits during 6 months before index admission: 2 or more | participants | 122 | 147 | 269 |
| Heart failure: present | participants | 80 | 67 | 147 |
| Heart failure: absent | participants | 236 | 248 | 484 |
6. Primary Endpoint
The registry lists the primary outcome as Hospital Readmission, at Least One, measured over within 6 months after discharge.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with at least one readmission within 6 months after discharge from the index hospital visit. It is a binary participant-level outcome: each participant either had at least one readmission during the stated follow-up period or did not. The endpoint focuses on whether any readmission occurred, rather than the total number of readmissions per participant.
As a general statistical rationale, readmission can serve as an observable measure of healthcare use after discharge and may capture part of the patient’s subsequent course. The registry record identifies the endpoint and its follow-up window, but does not state why this particular outcome was selected or whether the window was chosen for a specific clinical or statistical reason. It also does not report the number of participants with readmission in either group, an estimated comparison, or uncertainty around that comparison.
The primary outcome description says that analysis was intention to treat and that all 631 participants assigned to interventions were analyzed. That describes the analysis population, not the outcome findings. Without arm-specific outcome counts or an effect estimate, the registry record does not establish the direction, magnitude, or precision of any difference in readmission.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive limitation is that the registry record names a primary outcome but does not post its results. It specifies hospital readmission, defined as at least one readmission within 6 months after discharge from the index hospital visit. It does not give the number of participants meeting that outcome in either assigned group, a between-group estimate, a confidence interval, or a test result. As a result, the comparative effect on readmission cannot be described from this record.
The record states that the primary outcome analysis was intention to treat and included all 631 patient participants assigned to interventions. In general, intention-to-treat analysis retains participants in their assigned groups, regardless of whether they received or adhered to the assigned approach. This approach aims to preserve the advantages of random allocation. The registry entry does not provide enough detail to assess outcome ascertainment, missing outcomes, or how the stated analysis population was implemented.
The study objective was to compare software-supported discharge communication with usual care. The intervention description suggests a process focused on organizing and transferring discharge information; the comparator description refers to handwritten forms. Those descriptions clarify what was being compared, but they do not show whether the software was used as intended or whether the quality of information transfer changed. No results for those process measures are reported in the listed outcomes.
The registry record lists 13 outcome measures, including patient perceptions, pharmacist clarification and satisfaction, adverse events, and primary care physician perceptions. It does not report analysis entries. Without results for these outcomes, it is not possible to assess whether the trial found differences in patient experience, communication with pharmacists or physicians, or adverse events. Nor is it possible to evaluate whether any outcomes were consistent with the primary endpoint.
Interpretation should therefore remain at the level of study question and design. Randomization supports a planned comparison between assigned approaches, but it does not by itself establish an effect. An outcome estimate would need to be considered together with its uncertainty, the completeness of outcome follow-up, and the analysis methods. Those results and details are not reported in the registry record. No conclusion about the direction or size of the readmission comparison can be drawn from the enrollment count or the intervention descriptions alone.
9. Statistical Methods Explained
General explanation of randomized comparisons. Random assignment creates a basis for comparing groups because assignment is not intentionally determined by a participant’s prognosis. In a well-conducted trial, this can reduce systematic differences in measured and unmeasured characteristics at the start of follow-up. Chance imbalances can still occur. The registry record identifies the study as randomized but does not report the allocation sequence, concealment procedures, or baseline characteristics, so those aspects cannot be evaluated from the record.
General explanation of a binary endpoint. The primary outcome is whether a participant had at least one readmission within the stated follow-up period. A binary outcome records the presence or absence of an event for each participant. A comparison could be expressed using group event proportions or an effect measure, with a confidence interval to describe uncertainty. A confidence interval is a range of values compatible with the observed data under the statistical model and its assumptions; it is not a guarantee that the true effect lies within that range. The registry record does not post the event counts or an estimate, so no such comparison can be interpreted for this trial.
General explanation of statistical tests. A test of a treatment-group comparison evaluates how compatible the observed data are with a specified null hypothesis under the test’s assumptions. A p-value is not the probability that the null hypothesis is true, and it does not describe the size or practical importance of an effect. The registry record does not give a p-value or identify the test used for the primary outcome. The statistical analysis plan, including any adjustment or modeling choices, is not reported in the registry record.
General explanation of the intention-to-treat principle. The record states that the primary analysis was intention to treat and included all 631 participants assigned to interventions. Under this principle, participants are analyzed according to their assigned group, rather than being reassigned based on treatment received. This preserves the comparison created by randomization and estimates the effect of assignment to the intervention strategy. The record does not describe treatment adherence, crossovers, withdrawals, or how missing outcome information was handled, so the practical completeness of the analysis cannot be assessed.
General explanation of masking. Masking can reduce the influence of knowledge about assignment on aspects of trial conduct or outcome assessment, depending on who is masked and how outcomes are measured. The record labels the trial single masked but does not specify the masked party. It also does not say whether readmission ascertainment was independent of treatment assignment. Those details matter when considering possible measurement or assessment bias.
General explanation of multiplicity. When a study measures several outcomes or performs several comparisons, the chance of at least one apparently unusual finding can increase if each is interpreted separately. A statistical plan may specify which outcome is primary, how secondary outcomes will be interpreted, and whether adjustments will be made. The registry record lists 13 outcome measures but does not report an adjustment strategy or analysis entries. It is therefore not possible to determine whether multiplicity was addressed in the trial’s analysis.
General explanation of planning illustrations. Sample-size calculations are planning tools that depend on assumptions about the effect to detect, the significance level, allocation, and statistical method. An illustration based on an observed effect is not a report of the trial’s original design justification and is not observed power. The record does not report the trial’s sample-size justification or planned effect size. It states general assumptions for planning illustrations, including a two-sided significance level of 0.05, equal allocation, and a normal approximation, but the registry record does not provide a primary-outcome result from which to interpret a planning illustration for this comparison.
General explanation of model assumptions. Statistical methods rely on assumptions about the data and the way observations relate to one another. For example, over-dispersion matters in count models when variability exceeds what a chosen model assumes; it can lead to uncertainty estimates that are too small if not addressed. The primary endpoint in this trial is described as a participant-level binary outcome, not a count of repeated readmissions. The registry record does not identify a model or report whether model diagnostics were performed. General modeling considerations should not be mistaken for methods documented as used in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 13 outcome measures. Along with the primary readmission outcome, the listed outcomes cover patient perceptions of the discharge process, satisfaction and preparedness, pharmacist clarification and satisfaction, adverse events, patient satisfaction with drug information, and primary care physician perceptions. Listing an outcome does not establish that results were analyzed or reported.
The record reports zero analysis entries. It does not provide outcome-level estimates, confidence intervals, p-values, or a description of which comparisons were conducted. A multiplicity strategy, such as identifying a hierarchy of outcomes or adjusting interpretation for multiple comparisons, is not reported in the registry record. Without that information, secondary findings could not be assessed for the potential impact of multiple testing even if results were available.
Missing-data handling is also not reported in the registry record. The primary analysis is described as intention to treat and includes all 631 assigned participants, but that statement does not explain whether all participants had outcome information, how incomplete follow-up was handled, or whether any imputation or sensitivity analysis was used. The record does not report reasons for missing data or losses to follow-up.
The registry record does not report a detailed analysis population for each secondary outcome, an analysis plan, or interim analyses. These omissions make it difficult to judge whether analyses followed prespecified procedures or how robust any findings would be to alternative assumptions. They do not demonstrate that a particular procedure was or was not used; they indicate that the information is not reported in the registry record.
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 |
|---|---|---|---|
| Discharge Communication Software | 10 | 316 | 3.2% |
| Usual Care Discharge Process | 10 | 315 | 3.2% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Discharge Communication Software | 17 of 316 |
| Usual Care Discharge Process | 17 of 315 |
Most frequent serious adverse event terms
| Event term | Organ system | Discharge Communication Software | Usual Care Discharge Process |
|---|---|---|---|
| Death | General disorders | 10 of 316 | 10 of 315 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Discharge Communication Software | Usual Care Discharge Process |
|---|---|---|---|
| adverse drug event | General disorders | 17 of 316 | 17 of 315 |
Serious events with the highest arm-level rate: death (3.2%).
The adverse-event figures list the discharge communication software group with 316 participants at risk and 10 affected for serious adverse events. For other adverse events, the same group has 316 at risk and 17 affected. The usual care discharge process group has 315 participants at risk and 10 affected for serious adverse events, and 315 at risk and 17 affected for other adverse events. These are the posted counts; they do not by themselves establish whether the groups differ in safety.
The registry record also lists Death as a top serious adverse-event term at 3.2%. It does not specify arm-specific attribution for that term in the reported entry. The term and percentage should therefore not be treated as a comparison between groups or linked to a particular arm based on this record alone.
As a general interpretive point, event counts need context, including the event definitions, observation period, completeness of reporting, and uncertainty around comparisons. The registry record does not provide those details for these adverse-event figures. It also does not report deaths by group in the displayed adverse-event entry. These figures should be read as registry-listed counts rather than as evidence that one discharge approach caused or prevented an event.
12. What the Result Does, and Does Not, Mean
The trial record describes a randomized comparison of discharge communication software with a handwritten usual care process. It identifies a specific primary outcome: whether a participant had at least one readmission within 6 months after discharge from the index hospital visit. It also states that the primary analysis was intention to treat and included all 631 assigned participants. These details define the study question and its stated analysis population.
The record does not report the primary outcome counts or a comparative estimate. It therefore cannot establish whether readmission was more or less common in either group, how large a difference might have been, or how precise an estimate would be. A completed study status and an enrolled participant count are not substitutes for outcome results.
The registry describes the software’s features and the usual care process, but those descriptions do not show whether information transfer improved or whether any such change affected readmission. The record lists patient, pharmacist, and primary care physician outcomes, but does not report their results. No conclusion about those outcomes or the consistency of findings across outcomes can be drawn from the registry record.
In general, a randomized comparison can inform the effect of assignment when outcomes are measured and analyzed appropriately. The strength of that interpretation depends on details such as allocation procedures, follow-up completeness, outcome ascertainment, and prespecified analyses. Several of these details are not reported in the registry record. The defensible conclusion is limited to what was planned and recorded: the trial compared two discharge processes and designated readmission within the stated period as its primary outcome, but the posted record does not supply results that answer the comparative question.
13. Why This Trial Matters Statistically
This trial raises a statistical question about how to evaluate a care-process intervention using a patient-level outcome after hospital discharge. The intervention was designed to support transfer of information among patients, retail pharmacists, and community physicians. The primary endpoint was not a measure of software use or document completeness; it was the occurrence of at least one readmission within 6 months. That distinction matters because an intervention can target a process while the primary outcome reflects a later event that may have multiple contributing influences.
The design is recorded as randomized and parallel group, with an intention-to-treat primary analysis. In general, those features provide a framework for estimating the effect of assignment while retaining participants in their assigned groups. The registry record does not report the outcome estimate or the methods needed to assess its precision, so the design cannot be translated into a quantitative conclusion about readmission from this record alone.
The record also lists outcomes across several perspectives: patients, pharmacists, primary care physicians, and adverse events. This breadth makes multiplicity and interpretation important statistical considerations. A prespecified outcome hierarchy and transparent reporting of estimates would help distinguish the primary question from exploratory or secondary comparisons. Such analysis details and results are not reported in the registry record.
Finally, the record illustrates the difference between a completed trial registration and a report of trial findings. A clear intervention description, enrollment count, and named primary endpoint document the study’s scope, but they do not provide evidence about the comparative result. Statistical interpretation requires outcome data and uncertainty estimates, along with enough methodological detail to understand how those data were analyzed.
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 main trial-specific limitation for interpretation is the absence of posted primary outcome results. The registry record identifies readmission within 6 months as the primary endpoint but gives no arm-specific outcome counts, effect estimate, confidence interval, or test result. The comparative effect cannot be assessed from this record.
Important design and conduct details are also not reported. The record does not describe the randomization sequence or allocation concealment, identify who was masked despite recording single masking, or give baseline characteristics. It does not report adherence to the software intervention, crossover between approaches, or how consistently the software was used. These omissions limit assessment of implementation and possible differences between assigned treatment and treatment received.
The record states that all 631 assigned participants were analyzed for the primary outcome, but does not describe outcome completeness, losses to follow-up, or missing-data methods. It also does not report the analysis model, prespecified statistical plan, multiplicity approach, or interim analyses. The original sample-size justification is not reported in the registry record.
The intervention and usual care descriptions provide useful outlines, but some text is incomplete in the registry record. The degree to which the intervention changed communication quality, the fidelity of the usual care process, and any co-interventions are not reported. These limitations do not establish that the trial was poorly conducted; they identify information that is unavailable in the registry record and restrict what can be concluded from the posted information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Value of Technology to Transfer Discharge Information — NCT00101868.
- Registry record last updated 2012-05-15; status last verified 2012-04.
- Results first posted 2012-05-15.
- 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 record describes a completed, randomized, single-masked, parallel-group trial sponsored by the Agency for Healthcare Research and Quality (AHRQ). It lists 631 enrolled participants, a start date of 2004-12, and a primary completion date of 2007-08. The comparison was discharge communication software versus the usual care discharge process, which used handwritten forms.
The primary outcome was the number of participants with at least one readmission within 6 months after discharge from the index hospital visit. The primary analysis was described as intention to treat and included all 631 participants assigned to interventions. The record lists 13 outcome measures but no analysis entries and does not report primary outcome results. The adverse-event entry lists counts by group, but does not provide enough context for a comparative safety conclusion.