Implementation and Impact of an Online Tool Used in Primary Care to Improve Income Security: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Implementation and Impact of an Online Tool Used in Primary Care to Improve Income Security (NCT02959866), a na na study. The primary outcome is Awareness of Financial Benefits.

2. Clinical Question

The central statistical question is descriptive: what outcomes were recorded among participants who used the tool, and how precisely were those outcomes estimated? Without a comparison group, the record cannot establish whether any change was caused by the tool rather than other influences. Nor does the available record show the size or direction of any change. It establishes the planned focus and study structure, not the numerical findings needed to answer whether awareness or income changed.

3. Trial Design

The registry describes a completed, single-group study of an online income tool used within primary care. The intervention is listed as “online income tool,” and the group description says patients completed the tool with their health provider during the study period. The registry records 59 participants enrolled. It does not establish that every enrolled participant completed the tool; the primary outcome description refers specifically to people who did complete it with a provider.

The study’s stated focus was implementation and short-term impact. Its summary describes evaluation at six clinic sites over a three month period and asks whether the tool was acceptable and feasible to clinicians, could be integrated into regular clinic workflow, and was viewed positively by patients. The study also set out to assess short-term impact. The record does not report detailed recruitment procedures, eligibility criteria, clinic-level enrollment, or participant characteristics.

Allocation is recorded as NA, masking as none, and the model as single group. No randomized allocation or concurrent control group is described. The listed phase is NA. The sponsor is Unity Health Toronto. The record gives a start date of 2016-05, primary completion of 2017-06, and status of completed. These dates identify the study record’s timing but do not specify how long each participant was followed.

A single-group design can describe what happened among participants observed in the study, but it does not by itself separate the intervention’s contribution from changes over time, other services, or differences between people who did and did not complete the tool. The registry record does not describe a comparison strategy, adjustment for other factors, or a statistical analysis plan. Those details are 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.

Before assignment: Clinicians will be encouraged to screen patients for poverty and use the online tool with every eligible patient during 3-months. It is difficult to estimate how many patients will be seen during the 3-month time period, the number who will be living in poverty, the number who agree to the intervention and be consented to the study for follow-up.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: This the the number of people who used the tool to completion with their healthcare provider

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: This is the sample of people who were enrolled in this research by participating in one-month follow-up interviews after using the tool with their healthcare provider.

6. Primary Endpoint

The registry lists the primary outcome as Awareness of Financial Benefits, measured over 4 weeks.

The primary endpoint is titled “Awareness of Financial Benefits.” It is a count of participants, with the description specifying self-reported awareness of at least one financial benefit. The registry gives a timeframe of 4 weeks and defines the relevant population as people who used the tool to completion with their healthcare provider. Thus, the endpoint concerns whether participants reported awareness of one or more benefits, rather than the number or monetary value of benefits identified.

This kind of endpoint is relevant to the intervention’s stated purpose: helping patients identify financial benefits. Self-reported awareness can capture whether participants recognize a benefit after using the tool, but it does not by itself establish that a participant qualified for a benefit, applied for it, received it, or gained income. Those are distinct outcomes. Increase in income is listed separately as a secondary outcome, and its measurement details and results are not reported in the registry record.

For a binary outcome, a count can be accompanied by a proportion to describe how common the response was in the observed group. General statistical interpretation should also consider the denominator: the count is meaningful only alongside the number of participants with outcome data. The registry record does not report the primary endpoint count, its denominator, or an estimate of uncertainty. Therefore, it is not possible to quantify the observed level of awareness from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry classifies the primary outcome as a binary count: participants either report awareness of at least one financial benefit or do not. The stated measure is the count of participants, and the assessment timeframe is 4 weeks. This is a direct way to describe how many participants met the stated criterion, but the count needs an outcome denominator to show how common the response was among those assessed. Neither the outcome count nor its denominator is reported in the registry record.

What does a count measure?

A count is the number of observations meeting a defined condition. For this endpoint, the condition is self-reported awareness of at least one financial benefit. A count does not indicate how many benefits were identified by each person, whether a benefit was received, or the amount of any financial change. Those distinctions matter because awareness, eligibility, application, receipt, and income are different concepts. The registry lists increase in income as a separate secondary outcome, but does not state its measurement details or result.

General statistical explanation: when the outcome is binary, an analysis may report both the count meeting the criterion and the proportion among participants with observed data. A proportion makes the denominator explicit. Uncertainty can be expressed with a confidence interval, which gives a range of values compatible with the observed data under the method’s assumptions. Its width is affected by the amount of information and the variability in the data. These are general concepts; the registry record does not report a proportion, confidence interval, or method for estimating one.

What can a single-group design estimate?

The study is identified as single group, with no comparator listed. A single-group study can describe outcomes among the people observed, such as the number reporting awareness after using the tool. If measurements are collected at more than one time, a within-person change may also be described, but the registry record does not report a baseline awareness measurement or such an analysis. In general, a comparison over time does not by itself show that the intervention caused the change. Other events, services, or time trends could also contribute. A concurrent comparison group can help address some competing explanations, but none is listed for this study.

The registry records allocation as NA and masking as none. There is no randomized allocation described. Randomization, in general, is used to create comparable groups on average, while masking can reduce the influence of knowledge about group assignment on some measurements. Neither should be presumed in a single-group study. Participant self-report may also be affected by how a question is understood or recalled; the registry does not report details of the questionnaire or measurement validation.

What do the analysis fields tell us?

The record lists 2 outcome measures and 0 analyses. It does not report a statistical analysis plan, an inferential test, an adjusted estimate, or a method for handling repeated observations. Those analysis details are not reported in the registry record. The absence of a listed analysis means the record does not provide a basis to assess model choice, covariate adjustment, or the handling of outcome data beyond the stated measurement description.

General statistical explanation: if a binary outcome is analyzed as a proportion, the method should reflect the sample size and the structure of the data. If participants are grouped within clinics, observations may be more alike within a clinic than across clinics. Accounting for clustering can affect estimated uncertainty. The study summary names six clinic sites, but the record does not state whether clustering was included in an analysis or how site was handled. No inference should be made about the actual analysis from this general consideration.

General statistical explanation: over-dispersion occurs when observed variation exceeds what a chosen statistical model expects. It can make standard errors and confidence intervals too small if ignored. Whether over-dispersion is relevant depends on the outcome and model. The registry record does not report a model, a dispersion assessment, or an analysis for the primary endpoint, so it is not possible to say whether over-dispersion was assessed.

How should planning assumptions be read?

The record describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It specifies that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a description of the observed study design: the registered study is single group and does not list two allocated arms. The record does not report a trial-specific sample-size justification or a statistical plan connecting those assumptions to this study. Any planning illustration is hypothetical, not observed power, and cannot substitute for reported outcome estimates. No planning sample-size result is stated in the registry record.

General statistical explanation: a sample-size calculation asks how much information a hypothetical design may need to detect a specified effect under stated assumptions. It is not an estimate of what the study found. “Observed power” calculated after a study from an estimated effect does not provide an independent measure of evidential strength; the estimate and its uncertainty are more informative. For this study, the registry record does not provide an observed effect on which to base an interpretation.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Online Income Tool")
n      <- c(59)
events <- c(59)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Online Income Tool  59  59  100.0  93.9  100.0  93.9  100.0  94.0  100.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures: awareness of financial benefits as the primary outcome and increase in income as a secondary outcome. It reports 0 analyses. No analysis plan, outcome-specific results, p-values, confidence intervals, or adjustment for multiple comparisons is reported in the registry record. It is therefore not possible to determine whether the outcomes were analyzed as planned or whether any multiplicity procedure was used.

General statistical explanation: when several outcomes or hypotheses are examined, the chance of at least one apparently unusual finding can increase if each is assessed independently using the same threshold. Researchers may identify one primary endpoint in advance and use a prespecified approach to handle additional outcomes. The registry identifies a primary endpoint and a secondary outcome, but does not report an inferential strategy or multiplicity adjustment. No conclusion about statistical significance can be drawn because no test results are reported.

The record gives 59 participants enrolled, but it does not report the number with data for each outcome, the number completing the tool, or the number assessed at 4 weeks. It does not describe missing-data rates, reasons for missingness, imputation, or sensitivity analyses. Those details are not reported in the registry record. Without an outcome-specific denominator, even a reported count would be difficult to interpret as a proportion of the relevant population.

The analysis population is not defined beyond the endpoint description referring to people who completed the tool with a healthcare provider. The record does not state whether all enrolled participants, only tool completers, or another group was intended for each analysis. Interim analyses are not reported in the registry record. These omissions limit assessment of attrition, analysis choices, and the relationship between the stated outcome population and the enrolled group.

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 registry lists 59 participants at risk in the Online Income Tool group. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious adverse-event terms are listed. These figures are descriptive safety counts in the registry record; they do not provide an estimate of the primary awareness outcome or the secondary income outcome.

A zero count means that no events of the specified category are recorded among the listed participants at risk in this record. It does not mean that the true risk is known to be zero. General statistical explanation: when few people are observed, uncommon events may not occur in the observed group even if they can occur in a broader population. The precision of a risk estimate depends on the amount of follow-up and on how completely events are captured.

The registry does not report the safety observation period, event-collection procedures, severity definitions beyond the serious and other categories, or whether events were assessed for relation to the tool. These details are not reported in the registry record. The 4-week timeframe belongs to the primary awareness endpoint and should not be assumed to define the safety follow-up period.

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

The record establishes that a completed single-group study evaluated an online income tool used with a health provider in primary care. Its primary endpoint was self-reported awareness of at least one financial benefit at 4 weeks among people who completed the tool with their provider. Increase in income was listed as a secondary outcome. The study summary also describes questions about clinician acceptability and feasibility, clinic workflow, patient perspectives, and short-term impact.

The record does not report outcome values for awareness or income, outcome-specific denominators, or statistical analyses. It therefore does not show how many participants reported awareness, whether awareness changed, whether income increased, or how precisely either outcome was estimated. The enrollment figure of 59 cannot be treated as the number with complete outcome data because completion and follow-up counts are not reported.

The design also limits what the study could establish about cause and effect. There is no control group or randomized comparison listed. Even if the record contained a post-use outcome, a single-group observation alone would not show what would have happened without the tool. Changes could reflect other circumstances or services, and the registry does not report an approach to distinguish those possibilities.

The posted adverse-event counts are 0 serious events, 0 other events, and 0 deaths among 59 listed at risk. They describe the events recorded in this study, not a guarantee about safety in other populations or settings. The safety follow-up period and event ascertainment details are not reported.

Accordingly, the registry record is informative about the study’s aims, design, and outcome definitions, but it does not provide the results needed to judge the observed awareness or income outcomes. No claim about the tool’s effectiveness, lack of effectiveness, or causal impact can be drawn from the information reported.

14. Why This Trial Matters Statistically

This study raises a statistical distinction that is important in implementation research: describing whether a tool was used and how participants responded is not the same as estimating what the tool caused. The registry sets out questions about acceptability, feasibility, workflow integration, patient perspectives, and short-term impact. Those questions cover both implementation and outcome measurement, but each requires its own operational definition and data. The record does not report results for those questions.

The primary endpoint focuses on self-reported awareness of at least one financial benefit. This is conceptually close to the purpose of an information tool, yet it is not interchangeable with benefit receipt or increased income. Listing increase in income as a separate secondary outcome recognizes that distinction. Without outcome definitions and results for both, readers cannot assess whether reported awareness corresponded to a subsequent financial change.

The study also illustrates why denominators matter. The enrollment count is 59, while the endpoint is defined for people who completed the tool with a provider. The number who completed the tool and the number with 4-week outcome data are not reported. Those quantities determine which group an outcome count describes and how much information supports an estimate.

Finally, the single-group design and absence of reported analyses restrict causal and precision claims. A descriptive result, even if present, would not on its own establish a treatment effect. Statistical interpretation depends on the design, the outcome data, and the analysis method together. The registry record identifies the intended evaluation but does not provide the numerical outcomes or analysis needed to complete that assessment.

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 main limitation for interpretation is that outcome results are not reported in the registry record. The primary awareness endpoint is defined, and increase in income is listed as a secondary outcome, but neither has a posted result or uncertainty estimate. The record therefore cannot support a quantitative assessment of either outcome.

The study is single group and has no listed comparator. This prevents a like-for-like comparison within the registered design and limits conclusions about whether any observed outcome would be attributable to the tool. The record does not describe a baseline measure for awareness, a concurrent comparison, or adjustment for other influences.

Although 59 participants were enrolled, the number who completed the tool and the number with data at the 4-week assessment are not reported. The outcome denominator, missing-data handling, and analysis population are also not reported. This makes it impossible to assess attrition or determine how representative any outcome count would be of all enrolled participants.

The primary endpoint relies on self-reported awareness. The record does not describe the question wording, measurement instrument, or how the response was verified. Awareness does not necessarily mean that a person applied for or received a benefit. The secondary income outcome is named, but its definition, measurement period, and result are not reported.

The summary describes six clinic sites and a three month evaluation period, but does not provide site-specific results, recruitment details, or participant characteristics. The extent to which findings would apply to other clinics or populations therefore cannot be assessed from the record. Safety follow-up and event-capture procedures are also not described. These limitations concern what the registry record reports; they do not establish that unreported procedures or analyses did not occur.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Implementation and Impact of an Online Tool Used in Primary Care to Improve Income Security — NCT02959866.
• Registry record last updated 2019-09-27; status last verified 2019-09.
• Results first posted 2019-09-27.
• 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

The registry record for NCT02959866 describes a completed, single-group evaluation of an online income tool used with a health provider in primary care. It lists 59 participants enrolled, no masking, allocation recorded as NA, and a study start of 2016-05 with primary completion in 2017-06. The sponsor is Unity Health Toronto.

The primary endpoint is self-reported awareness of at least one financial benefit at 4 weeks among people who completed the tool with their healthcare provider. Increase in income is listed as a secondary outcome. The summary describes evaluation at six clinic sites over a three month period and questions about feasibility, acceptability, workflow, patient perspectives, and short-term impact.

The record lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 59 participants at risk. It reports 2 outcome measures and 0 analyses. Outcome results, outcome-specific denominators, missing-data procedures, and statistical analysis details are not reported in the registry record. As a result, the record describes the intended evaluation and its design but does not provide numerical findings for the primary or secondary outcome.