CONNECT for Quality: A Study to Reduce Falls in Nursing Homes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for CONNECT for Quality: A Study to Reduce Falls in Nursing Homes (NCT00636675), a randomized na study. The primary outcome is Fall Related Process Measures.

2. Clinical Question

The study also set out to compare fall rates and injurious falls, and listed fall rates and change in weighted average staff interaction scales as secondary outcomes. Those aims provide context for the process measure: the primary endpoint concerns recorded steps to address risk, not the number of falls itself. Whether the added staff intervention changed the process measure, and how any difference related to resident outcomes, cannot be determined from the results reported in the registry record.

3. Trial Design

CONNECT for Quality was a randomized, parallel-group trial in nursing homes. The registry summary describes a cluster-randomized design in which nursing homes, rather than individual residents or staff, were assigned to the study groups. It reports 16 nursing homes randomized. This distinction matters: residents and staff within a home share an organizational setting, while the assigned intervention was delivered at the nursing-home level.

The two groups were Falls quality improvement alone and Connect followed by Falls quality improvement. In the Falls group, nursing-home staff were to receive falls quality-improvement training with support from study personnel. In the Connect plus Falls group, Connect was delivered first, followed by the falls program. The stated purpose of Connect was to encourage staff to build connections and improve interaction, information flow, and care planning and execution.

The registry lists randomized allocation, a parallel model, and single masking. The study summary describes outcome assessment as blinded, but does not specify who was masked in the registry's masking field. The record gives a total enrollment of 1726. Its summary estimates about 800 residents and 576 staff would participate; these figures are described as approximate, and the registry notes that residents assessed for the primary measure were not considered enrolled study participants.

The record gives a start of 2009-09, primary completion of 2016-01, and status of completed. The primary endpoint was the mean number of fall-risk-reduction indicators documented in residents with prior falls, measured at 6 months post intervention. The record identifies the outcome as a continuous measure summarized by a mean and standard deviation. It does not report the group means, standard deviations, treatment contrast, confidence interval, or test result. The statistical analysis plan, including methods for accounting for clustering in the outcome analysis, is not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Residents with prior fall

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.

Population: Participants who completed all follow up measures.

6. Primary Endpoint

The registry lists the primary outcome as Fall Related Process Measures, measured over 6 months post intervention.

The primary endpoint is the mean total number of fall-risk-reduction indicators documented for residents with prior falls who were at high risk. The assessment time is 6 months post intervention. The indicators represent documented steps to reduce risk, including orthostatic blood pressure measurement or intervention; evaluation or intervention for sensory impairment; footwear; exercise or an assistive-device intervention; a toileting schedule; environmental modification; reduction of psychoactive medication; and vitamin D supplements.

This is a continuous process measure: each resident's documented indicators contribute to a count, and the endpoint summarizes those counts with a mean and standard deviation. It is intended to describe whether relevant risk-reduction steps were documented, rather than directly count falls, injuries, or deaths. Process measures can help characterize whether care practices changed, while clinical outcomes address events experienced by residents. Neither type of measure automatically establishes what caused any observed change.

The registry record says that this measure concerns residents, not staff, and that these residents were not considered enrolled study participants. It does not report the number of residents contributing to each group’s endpoint, the group means or standard deviations, or the estimated group difference. As a result, the endpoint’s observed level and the precision of any comparison are not available in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design and outcome description support several general statistical principles, but the registry record does not report the analysis methods used to estimate the primary treatment effect. The explanations below distinguish general concepts from details about the trial. No unreported analysis method should be inferred from the randomized design or the stated outcome format.

Why does cluster randomization matter?

In a cluster-randomized study, groups such as nursing homes are assigned to interventions, while outcomes may be measured on people within those groups. The assignment unit and measurement unit are therefore different. Residents in a shared home can have more similar care environments than residents in different homes. As a general statistical principle, an analysis that treats all resident observations as independent can understate uncertainty when outcomes are correlated within homes. Appropriate analysis usually needs to reflect the cluster allocation and within-cluster dependence. The registry summary says that nursing homes were randomized, but the statistical method for accounting for this structure is not reported in the registry record. The number of residents contributing to the primary endpoint by group and the number of clusters contributing to each comparison are also not reported there.

What does a mean and standard deviation describe?

The primary endpoint is described as a mean of a continuous measure, with a standard deviation. The mean describes the average number of documented indicators in the eligible residents. The standard deviation describes the spread of individual observations around that average. It is not the same as the uncertainty in the estimated mean or in a between-group difference. A confidence interval would describe a range of values compatible with the observed data and analysis assumptions; a narrower interval indicates greater precision than a wider interval. No primary group means, standard deviations, or confidence interval are reported in the registry record, so these features cannot be assessed for this trial from the posted results.

Why is this measure a process endpoint?

The indicators represent documented actions or assessments intended to address fall risk. The endpoint thus concerns recorded care processes. It differs from an outcome such as a fall or an injurious fall, which records an event experienced by a resident. Process and event outcomes answer different questions. A process measure may help describe care delivery, but it cannot be substituted for the event outcome. The registry record does not report the results of the primary process measure or the fall-rate outcomes, so it does not establish whether either changed.

How should statistical tests and intervals be read?

In general, a p-value measures how incompatible the observed data are with a specified null model, under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not describe the size or practical importance of an effect. A confidence interval conveys an estimate and its uncertainty on the outcome scale. For a randomized cluster trial, both a test and an interval need to account for the allocation structure to represent uncertainty appropriately. The registry record does not report a p-value, confidence interval, primary contrast, or test method for the endpoint.

Random assignment supports a comparison of groups as assigned, but it does not remove the need to define an analysis population, handle missing outcome data, or account for clustering. The registry record does not report whether the primary analysis followed an intention-to-treat approach, how deviations from assigned intervention were handled, or how missing observations were addressed. These are important parts of an analysis description, not details that can be reconstructed from the intervention labels.

What do the planning calculations mean?

Planning illustrations use a two-sided significance level of 0.05, equal allocation between the groups, a normal approximation, and an effect defined as a stated fraction of the observed effect. For time-to-event outcomes, the stated convention is to report the total number of events; for other outcomes, it is to report participants per arm. These are planning assumptions, not features that establish the trial’s actual analysis or observed power. A planning calculation asks what sample size would be associated with a chosen target effect and assumptions. It does not show the probability that this completed trial detected an effect, nor does it establish that the target effect was present. The registry record does not report the original sample-size justification or the study’s analysis plan.

When outcomes are over-dispersed relative to a chosen statistical model, their variability exceeds what that model expects; as a general statistical principle, model-based standard errors and tests may then be unreliable unless the model accounts for the extra variability. No over-dispersion assessment or model choice is reported in the registry record. Similarly, the record does not give a cluster correlation estimate, a variance model, or the method used to calculate uncertainty. Those omissions prevent a detailed appraisal of the statistical analysis, but they do not change the descriptive details about the randomization level and endpoint definition.

10. Confidence Intervals for Each Arm

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

R code and output

arm <- c("Fall QI", "Connect & Falls QI")
n   <- c(907, 887)
m   <- c(3.3, 3.2)
sp  <- c(1.6, 1.5)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Fall QI  907  3.300  1.600  3.196  3.404
CARM  Connect & Falls QI  887  3.200  1.500  3.101  3.299

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome, Fall Related Process Measures, and secondary outcomes of fall rates and change in weighted average staff interaction scales. It reports three outcome measures in total. The presence of several outcomes raises a general statistical issue: when many outcomes or comparisons are tested, the chance of at least one apparently unusual result can increase. Prespecified outcome hierarchy and any multiplicity adjustment help readers understand how such results should be interpreted.

The multiplicity strategy, including whether any adjustment was planned or used, is not reported in the registry record. The record also does not provide a complete analysis plan, the planned hierarchy of comparisons, or results for the listed outcomes. No analysis estimates are reported, so it is not possible to assess how outcome selection or multiple testing affected the posted evidence.

The approach to missing observations is not reported in the registry record. It does not describe how missing primary endpoint measurements were handled, whether imputation was used, or what assumptions underpinned any missing-data method. The number of participants or residents with missing measurements is not reported. The analysis population is also not stated: the registry record does not say whether the analysis was based on all randomized clusters, residents with observed outcomes, or another defined population.

These omissions matter because missingness and exclusions can affect the comparison, and because residents were measured within nursing homes while homes were randomized. The record does not report the analysis method used to account for clustering, any sensitivity analyses, or how intervention deviations were handled. Those methods cannot be inferred from the fact that the design was randomized. The reported outcome definitions and design describe the intended question, but the analysis details needed to evaluate multiplicity, missing data, and analysis populations are not reported in the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event entries list Fall QI with 811 participants at risk for serious adverse events and 811 at risk for other adverse events. The recorded number affected is 0 for serious events and 0 for other events, and deaths are listed as 0. For Connect plus Falls QI, 734 are listed at risk for serious adverse events and 734 at risk for other adverse events; the number affected is 0 in both categories, and deaths are listed as 0.

These are the figures recorded in the registry. They should be read as reported counts, not as evidence that no event could have occurred outside the registry’s capture, definitions, or reporting period. The registry record does not specify the adverse-event observation period or provide detailed event definitions in the information reported. No top serious-event terms are listed. The counts at risk are not a substitute for the primary endpoint, and they do not provide the missing fall-rate or injurious-fall results.

The adverse-event entries also do not, by themselves, permit a comparison of risk over time or an assessment of the statistical uncertainty around between-group differences. No event rate, comparative estimate, or uncertainty interval is reported in the registry record. The listed zero affected counts are therefore best described exactly as registry entries, without extending them into a broader safety conclusion.

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

The record identifies a clinically relevant implementation question: whether adding a staff-connection intervention to falls quality-improvement training changes documented steps to reduce fall risk in nursing homes. The cluster-randomized design aligns assignment with the setting in which the behavioral and quality-improvement interventions were intended to operate. The primary measure focuses on residents with prior falls and high fall risk, and it records a mean count of relevant risk-reduction indicators at 6 months post intervention.

What the record does not provide is the primary outcome result. Without group summaries, an estimated contrast, and an uncertainty interval, the direction, magnitude, and precision of any difference are unknown from the registry record. It is therefore not possible to say whether the groups differed on the primary process measure. The recorded design and intervention descriptions explain what was compared, but they are not evidence of an observed effect.

Even if a process result were available, the endpoint would answer a narrower question than whether residents experienced fewer falls or injuries. It counts documented care indicators, not events. The registry lists fall rates and staff interaction scales as secondary outcomes, but outcome estimates for these are not reported. The aims to examine falls and injurious falls likewise do not establish that those outcomes changed or that process changes mediated any event outcomes.

The study is also a comparison of two active approaches: Connect plus Falls quality improvement versus Falls quality improvement alone. The design does not, as described, compare the falls program with no falls-focused intervention. A result would therefore speak to the incremental contribution of Connect in the context of the specified falls program, subject to the analysis and its uncertainty. The registry record does not report those estimates or the statistical methods needed to appraise them.

The most defensible reading is that the registry describes a completed cluster-randomized trial with a defined primary process measure, but does not report the primary analysis result. It does not establish the effectiveness, ineffectiveness, or safety of either approach. Such conclusions would require outcome estimates, a valid cluster-aware analysis, and adequate information about missingness and uncertainty, none of which are reported for the primary comparison in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of a design in which the intervention is assigned to institutions but outcomes are measured among residents. The nursing-home cluster is central to interpretation: the assigned program was implemented within homes, and residents within a home share a care environment. That structure must be represented in the analysis rather than treating every resident as an independently randomized observation. The registry summary identifies the cluster-randomized design, while the analysis method used to account for it is not reported.

The trial also separates a care-process question from an event-outcome question. Its primary endpoint is the mean number of documented risk-reduction indicators, while fall rates and injurious falls are stated aims and fall rates are listed as a secondary outcome. This distinction is useful when interpreting evidence: documentation of care steps and occurrence of falls are different measures, and one cannot stand in for the other without supporting analysis.

The comparison is specifically between Falls quality improvement alone and Connect followed by Falls quality improvement. This makes the scientific question about adding a staff-connection component to an existing falls-focused program. The intended mechanisms described in the summary—staff connection, information flow, and cognitive diversity—provide a rationale for asking the question, but they are not themselves evidence that the intervention changed practice or resident outcomes.

Finally, this record illustrates why trial design information and results information must be kept distinct. Randomization, masking, intervention descriptions, and endpoint definitions clarify what investigators set out to compare. They do not supply the estimated effect or its precision. Since the registry record does not report the primary analysis estimates, readers cannot evaluate the result’s direction, magnitude, or uncertainty. The statistical contribution visible in the record is therefore chiefly the design and measurement framework, not a numerical conclusion about the intervention comparison.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The central limitation for interpreting this trial from the registry record is that the primary endpoint results are not reported. Group means, standard deviations, an estimated difference, a confidence interval, and a p-value are absent. The record also does not report outcome estimates for the listed secondary measures. This prevents assessment of the observed effect and its precision.

The design randomized nursing homes, and the summary reports 16 homes. A cluster-randomized study requires analysis that reflects the assignment of homes and potential similarity among residents within a home. The registry record does not report the method used for the primary analysis, cluster-level variance information, or the extent to which within-home dependence was accounted for. A simple individual-level re-analysis would be misleading for this design.

The outcome is based on documented steps. Documentation may not fully capture whether an intervention was delivered or whether a resident’s risk changed. The registry description does not report validation of the records or the completeness of documentation. The endpoint is also a process measure rather than a direct measure of falls, injuries, or mortality. The registry does not report the primary result or the results needed to connect the process measure to those events.

Other details needed for appraisal are not reported in the registry record, including the statistical analysis plan, missing-data methods, analysis population, multiplicity approach, and original sample-size justification. The summary describes outcome assessment as blinded, while the registry lists single masking without specifying the masked parties in that field. Detailed intervention adherence and implementation results are not reported in the information available. These gaps limit interpretation of both the conduct and analysis; they do not establish that any particular method or problem occurred.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: CONNECT for Quality: A Study to Reduce Falls in Nursing Homes — NCT00636675.
• Registry record last updated 2018-12-11; status last verified 2018-11.
• Results first posted 2018-12-11.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

CONNECT for Quality: A Study to Reduce Falls in Nursing Homes, also titled Outcomes of Nursing Management Practice in Nursing Homes, is a completed randomized, parallel-group trial sponsored by Duke University. The registry lists a start of 2009-09, primary completion of 2016-01, and enrollment of 1726. The summary describes 16 nursing homes randomized, with about 800 residents and 576 staff expected to participate.

The comparison was Falls quality improvement alone versus Connect followed by Falls quality improvement. The primary measure was the mean number of documented fall-risk-reduction indicators among residents with prior falls and high fall risk, assessed at 6 months post intervention. The registry lists fall rates and change in weighted average staff interaction scales as secondary outcomes.

Primary outcome estimates, statistical analysis methods, missing-data methods, and the multiplicity approach are not reported in the registry record. The adverse-event entries list zero affected by serious and other adverse events in both groups, and zero deaths. The design and endpoint are described, but the numerical primary comparison cannot be interpreted from the registry record.