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 Pilot Study of Patient Navigation to Promote Smoking Cessation (NCT01414036), a randomized na study. The primary outcome is Engagement in Smoking Cessation Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01414036 |
| Phase | NA |
| Condition | Cigarette Smoking |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 47 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Boston University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns low-income and minority patients who smoke in a primary-care setting. The registry record describes this intended population, but detailed eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
Patient navigation from a trained navigator, alongside a low-literacy smoking-cessation brochure and a list of hospital and community resources. The intervention description states that participants could receive up to 4 hours of navigation; further delivery details are not reported in the registry record.
Comparator
Enhanced traditional care: a low-literacy smoking-cessation brochure, a list of hospital and community cessation resources, and usual care.
Primary question
At 3 months, how many participants in each group engaged in smoking-cessation treatment, as defined by the registry endpoint? The posted counts are 7 of 14 in the control group and 9 of 19 in the patient-navigation group among participants who completed the survey.
The clinical question is about engagement with treatment, not smoking abstinence or a direct measure of smoking behavior. Engagement is defined using self-report and, for some components, medical-record review. The endpoint counts whether a participant met at least one of its specified treatment-contact criteria. The registry record does not report a statistical estimate of the between-group difference or its uncertainty, so the counts alone do not establish how precisely the groups differed.
3. Trial Design
The registry identifies this as a randomized, single-masked, parallel-group pilot trial. It reports 47 participants enrolled. The study is marked completed, with a start date of 2011-10 and a primary completion date of 2012-12. The sponsor is Boston University. Further details about the masking procedure, including who was masked, are not reported in the registry record.
Participants were assigned to enhanced traditional care or patient navigation. Both groups were described as receiving a low-literacy smoking-cessation brochure and a list of hospital and community resources. The navigation group was also assigned a trained navigator. The control group was described as receiving usual care alongside the written materials and resource list. The intervention description mentions up to 4 hours of navigation and an in-person option; other delivery details are not reported in the registry record.
The primary endpoint is assessed at 3 months. The registry reports survey completion for 14 of 23 participants in the control group and 19 of 24 in the patient-navigation group. These are the denominators for the posted primary-outcome counts. The safety record lists 23 and 24 participants at risk in the respective groups, consistent with the group totals recorded there. Details of sequence generation, allocation concealment, recruitment procedures, eligibility criteria, and the intended sample-size justification are not reported in the registry record.
The pilot label describes the study as an initial trial, but the registry record does not state a formal feasibility objective or progression criteria. It also does not describe whether the design was intended to test a confirmatory treatment effect. Accordingly, the posted results are best read as limited descriptive evidence about treatment engagement in this trial, rather than as a definitive estimate 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.
Received Allocated Intervention
| Stage | Enhanced Traditional Care Control | Patient Navigation |
|---|---|---|
| STARTED | 23 | 24 |
| COMPLETED | 23 | 11 |
| NOT COMPLETED | 0 | 13 |
Completed 3 Month Survey
| Stage | Enhanced Traditional Care Control | Patient Navigation |
|---|---|---|
| STARTED | 23 | 24 |
| COMPLETED | 14 | 19 |
| NOT COMPLETED | 9 | 5 |
Analysis population for the primary outcome, as defined in the registry: 14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Enhanced Traditional Care Control | Patient Navigation | Total |
|---|---|---|---|---|
| Participants analysed | 23 | 24 | 47 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 23 | 24 | 47 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 10 | 14 | 24 |
| Sex: Female, Male: Male | Participants | 13 | 10 | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Engagement in Smoking Cessation Treatment, measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participant |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint, “Engagement in Smoking Cessation Treatment,” is a dichotomous participant-level measure assessed at 3 months. A participant is classified as meeting the endpoint if at least one listed treatment-contact condition is met: more than one quit-line counseling session, based on self-report; more than one primary-care visit in which smoking-cessation treatment is discussed, based on participant report and medical-record review of progress notes; or more than one session of a BMC smoking-cessation group, based on medical-record review. The registry describes the endpoint as yes or no.
This type of endpoint captures whether participants made contact with specified treatment services. It is different from measuring whether a participant stopped smoking, how much they smoked, or whether their health changed. The registry record does not post those outcomes as the primary endpoint. The use of more than one qualifying contact also means the endpoint represents a specific threshold of engagement, rather than any contact with a service.
A dichotomous endpoint can be summarized by the number meeting its definition and the number assessed. In the posted results, the counts are 7 of 14 in enhanced traditional care and 9 of 19 in patient navigation. The registry reports survey completion as the basis for these denominators. Whether additional outcome information was available from records for non-completers, or how such information was handled, is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary-outcome counts are 7 participants meeting the engagement definition among 14 survey completers in enhanced traditional care, and 9 among 19 survey completers in patient navigation. These are descriptive counts within the observed survey-completer groups. They do not by themselves quantify the uncertainty around a difference between assigned groups. The registry record does not report a two-arm effect estimate, confidence interval, or p-value for this endpoint.
The distinction between enrolled participants and participants included in the posted endpoint counts matters. The registry reports 47 participants enrolled, while the outcome population is described as 14 of 23 in the control group and 19 of 24 in patient navigation completing the 3-month survey. The posted counts therefore describe those survey completers, not necessarily every randomized participant. The reasons for non-completion and the approach to missing outcome data are not reported in the registry record.
The endpoint also has a specific meaning: it records whether participants met one of the listed service-engagement criteria. It does not directly report smoking cessation. Thus, the registry results address engagement as defined in the record, not whether participants quit smoking or whether the intervention changed smoking behavior. No result for those questions should be inferred from these counts.
There are no posted statistical analyses for a two-arm comparison; the registry record indicates that values were missing or not estimable for this count outcome. A numerical contrast, interval estimate, or significance test should therefore not be reconstructed from the counts for this interpretation. Without a reported inferential analysis, the direction and precision of any population-level difference remain undetermined by the registry record. The absence of a reported comparison is not evidence that the groups were equivalent.
The small pilot enrollment and the smaller survey-completer groups constrain the amount of information in the posted result. General statistical principle: estimates based on limited observations are often imprecise, and a confidence interval would communicate the range of values compatible with the observed data under the analysis assumptions. No such interval is reported for this endpoint. The record also does not report an analysis plan that would clarify whether any adjustment, alternative analysis, or planned handling of missing outcomes was intended.
For the safety outcomes, the registry reports no serious adverse events and no other adverse events in either group. This is a count of reported events in the recorded groups; it does not establish that no unrecorded events occurred or establish comparative safety. Death counts are not reported in the registry record. Overall, the results available for interpretation are descriptive primary-outcome counts and adverse-event counts, without a reported statistical comparison of engagement.
9. Statistical Methods Explained
The record identifies a randomized parallel-group pilot design and posts a dichotomous primary endpoint. It does not report an analysis plan, a named statistical test, an adjusted model, or a confidence interval for the primary outcome. The explanations below distinguish general statistical principles from what is documented for this trial.
What does a dichotomous endpoint represent?
In general, a dichotomous endpoint assigns each assessed participant to one of two categories, such as meeting or not meeting a prespecified definition. For this trial, the registry says the endpoint is yes or no and defines engagement through specified smoking-cessation service contacts. The counts of participants meeting the endpoint can be described alongside the number assessed in each group. Those counts do not, on their own, provide an estimate of the uncertainty around a between-group contrast.
The registry record posts 7 of 14 for enhanced traditional care and 9 of 19 for patient navigation. These counts should be interpreted according to the registry’s stated survey-completer population. They should not be silently treated as counts for all 47 enrolled participants. How outcomes for people who did not complete the survey were handled is not reported in the registry record.
What would an inferential comparison add?
In general, an inferential comparison would estimate a difference or another contrast between groups and describe uncertainty, commonly with a confidence interval and, if planned, a hypothesis test. A confidence interval is a range of values that reflects sampling uncertainty under the method’s assumptions; it is not a guarantee that the true value lies within that range. A p-value, when reported, addresses compatibility of the observed data with a specified null hypothesis under a statistical model. Neither statistic alone measures clinical importance.
No such two-arm comparison is posted for this primary count outcome. The registry record indicates that values were missing or not estimable for a two-arm comparison and lists no posted analyses. Consequently, there is no trial-specific test or interval to interpret. Calculating a contrast independently from the posted counts would not replace the sponsor’s analysis, and the registry record gives no sponsor analysis for this endpoint to take precedence.
What does randomization contribute?
In general, random assignment is intended to support a fair comparison by allocating participants to groups without choosing assignment according to participant characteristics. The registry identifies the allocation as randomized, but it does not describe the sequence-generation or allocation-concealment methods. Randomization does not ensure that every observed characteristic is balanced, particularly in a pilot with limited enrollment, and it does not address missing outcome data by itself. The registry record does not report a baseline comparison or an adjusted analysis.
The parallel-group structure means the two assigned groups are followed as separate groups rather than as a crossover. The single-masked designation does not identify who was masked or how masking was maintained. These details matter for understanding the conduct of an outcome based partly on participant reports, but they are not reported in the registry record.
How should planning calculations be understood?
The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. They also describe planning for a stated fraction of the observed effect. These assumptions concern a planning illustration, not the trial’s original design rationale. The registry record does not report the trial’s own sample-size justification. Any participant counts generated for a planning exercise are prospective illustrations, not observed power and not evidence that the trial had a particular probability of detecting an effect.
In general, power is a design-stage probability defined for a specified effect, sample size, variability, and analysis. It is not a property that can be established after observing a result by labeling the study “powered” or “underpowered.” A planning calculation based on an observed effect can be especially sensitive to uncertainty in that observed effect. It cannot substitute for a prespecified design calculation. The registry record does not report a sample-size target rationale or a formal power calculation for this pilot.
The endpoint is a count outcome rather than a continuous measurement. The registry does not report a model for it, so assumptions about a normal approximation, over-dispersion, or another count-data method cannot be attributed to the trial’s analysis. General principle: over-dispersion occurs when count variability exceeds what a chosen model expects, potentially making standard errors too small if the model does not account for it. That concept does not establish that over-dispersion applies to this binary participant-level endpoint or that a count model was used.
What analysis details remain unknown?
The statistical analysis plan, inferential method, effect measure, confidence level for any interval, covariate adjustment, interim-analysis plan, and treatment of missing data are not reported in the registry record. The registry lists two secondary outcomes—stage of change with regard to smoking cessation and use of other tobacco-treatment support—but does not post their results in the registry record for this analysis. Whether multiplicity procedures were planned or applied is also not reported. These omissions limit what can be said about the intended statistical framework and prevent a fuller assessment of the robustness of the results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two secondary outcomes: stage of change with regard to smoking cessation and use of other tobacco-treatment support. The record does not post results for these outcomes in the information available for interpretation. It reports three outcome measures in total, but the statistical analysis record lists no analyses. Whether the primary endpoint was designated in a prespecified analysis plan, and whether secondary outcomes were planned as confirmatory or exploratory, are not reported in the registry record.
Multiplicity arises when several outcomes, time points, or statistical tests are considered. In general, conducting many tests can increase the chance of obtaining at least one apparently notable result under a null hypothesis. Methods to address multiplicity depend on the study’s aims and analysis plan. No multiplicity adjustment or strategy is reported in the registry record, so it cannot be determined whether such an approach was planned or used.
Survey completion is reported for 14 of 23 participants in control and 19 of 24 in patient navigation. The reasons for non-completion, the availability of endpoint information from other sources for non-completers, and any missing-data method are not reported in the registry record. The posted primary counts should therefore be read in the stated survey-completer population. The record does not establish that missingness was unrelated to treatment assignment or to the endpoint.
The analysis population is also not defined beyond the endpoint’s reported completion counts. Whether the primary analysis was intended to include all randomized participants, only participants with observed endpoint data, or another population is not reported in the registry record. No sensitivity analysis for missing outcomes is reported. These limitations leave uncertainty about how the observed counts would compare with results under different assumptions about participants without completed surveys.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Enhanced Traditional Care Control | 0 | 23 | 0.0% |
| Patient Navigation | 0 | 24 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Enhanced Traditional Care Control | 0 of 23 |
| Patient Navigation | 0 of 24 |
The registry reports zero serious adverse events and zero other adverse events in both groups. The at-risk group counts are 23 for enhanced traditional care and 24 for patient navigation. These figures describe the recorded adverse-event counts; they do not provide an inferential comparison or establish that no event went unrecorded.
The registry does not list any serious adverse-event terms. Death counts are not reported in the registry record. It also does not describe how adverse events were solicited, defined, assessed, or followed over time. Without those details, the zero counts should be read narrowly as the events recorded in this registry entry, rather than as a complete account of all possible harms or as proof that the groups had identical safety experience.
In general, an event count is interpreted in the context of how many participants were monitored, the observation period, and the event-collection procedures. The record provides group counts at risk but does not provide enough detail to assess event ascertainment or comparative uncertainty. These safety figures therefore support only a descriptive statement about what was recorded.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized pilot comparing patient navigation plus written smoking-cessation resources with enhanced traditional care. Its primary endpoint concerns engagement with specified cessation-treatment services at 3 months. Among survey completers, the posted counts are 7 of 14 in control and 9 of 19 in patient navigation. These are the principal interpretable primary-outcome observations in the record.
Those counts do not show whether navigation changed smoking behavior. The primary endpoint is service engagement, not abstinence, smoking intensity, or a health outcome. Nor do the counts alone establish the size or precision of a group difference. A two-arm effect estimate, confidence interval, and p-value are not reported, and the registry indicates that a comparison was not estimable from the posted result.
The findings also do not establish equivalence between the groups. A lack of a reported statistical comparison is not evidence that any difference is absent. The result is limited to the participants represented in the endpoint denominators, and the record does not explain why some participants did not complete the 3-month survey or how their outcome status was handled.
The study is identified as a pilot, and its enrollment was 47. This makes the evidence available in the registry limited in scope, but it does not justify a claim about the study’s intended power or its design rationale; those details are not reported in the registry record. The record also does not supply posted results for the listed secondary outcomes or a detailed analysis plan.
The appropriate reading is therefore descriptive and bounded: the record reports engagement counts for survey completers, along with zero recorded serious and other adverse events in both groups. It does not, on its own, establish a causal effect, clinical benefit, absence of effect, or comparative safety. Any broader conclusion would require information and analyses not reported in the registry record.
13. Why This Trial Matters Statistically
This trial raises a statistical question about what counts as success for an intervention designed to connect patients with care. The primary endpoint measures contact with smoking-cessation treatment services, using a defined combination of participant report and medical-record review. That choice is distinct from measuring smoking cessation itself. Clear separation of process outcomes from behavioral or health outcomes is important when interpreting an intervention’s results.
The record also illustrates the difference between enrollment and the population contributing to an outcome count. Although 47 participants were enrolled, the primary result is reported among the 3-month survey completers: 14 of 23 in control and 19 of 24 in patient navigation. Readers need the endpoint definition and denominators to understand what the counts represent. The handling of participants without completed surveys is not reported, which leaves an important uncertainty about the analysis population.
For statistical interpretation, counts alone are not a substitute for a contrast and its uncertainty. The registry does not post an estimable two-arm comparison, interval estimate, or p-value for the primary outcome. This means that the result can be described but not used to judge the precision of a group difference from the registry entry alone. It is also a useful reminder that planning illustrations, when present, do not amount to observed power or establish what the original sample-size rationale was.
Finally, the record lists secondary outcomes but does not report their results or explain how multiple outcomes were handled. These gaps show why interpretation depends not only on the outcome counts, but also on analysis plans, missing-data methods, and transparent reporting of uncertainty. Those methodological details 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.
The primary result is reported for participants who completed the 3-month survey, not for all enrolled participants. The record gives completion counts by group but does not report reasons for non-completion, whether other sources posted endpoint information for non-completers, or how missing outcomes were handled. This limits interpretation of the observed counts as a comparison of all randomized participants.
The endpoint combines several kinds of treatment contact and data sources. Some criteria rely on self-report, while others involve medical-record review. The registry record does not describe how discrepancies between sources were handled, whether outcome assessors were masked, or how consistently the criteria were applied. The description says more than one qualifying contact is needed, but does not provide further operational detail.
Details of the randomization process, allocation concealment, masking, eligibility criteria, baseline characteristics, and analysis population are not reported in the registry record. The single-masked designation is not accompanied by information identifying who was masked. The statistical analysis plan, adjustment strategy, interim analyses, and sample-size justification are also not reported.
The registry does not post an inferential comparison for the primary endpoint, and it does not provide results for the two listed secondary outcomes. Adverse-event collection procedures and death counts are not reported. These limitations mean the record supports a narrow descriptive reading, rather than a complete evaluation of intervention effects, uncertainty, or safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pilot Study of Patient Navigation to Promote Smoking Cessation — NCT01414036.
- Registry record last updated 2016-03-21; status last verified 2016-02.
- Results first posted 2016-03-21.
- 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 NCT01414036, “Pilot Study of Patient Navigation to Promote Smoking Cessation,” as a completed, randomized, single-masked, parallel-group pilot. It reports 47 participants enrolled and compares patient navigation with enhanced traditional care. The primary endpoint is engagement in smoking-cessation treatment at 3 months.
Among 3-month survey completers, the posted engagement counts are 7 of 14 in enhanced traditional care and 9 of 19 in patient navigation. The registry does not report an estimable two-arm comparison, confidence interval, or p-value. It lists two secondary outcomes without posted results in the available record. Zero serious and zero other adverse events are recorded in each group; death counts are not reported in the registry record.
Details of the statistical plan, missing-data handling, sample-size justification, and several trial procedures are not reported in the registry record. The available results are descriptive and do not establish a treatment effect or equivalence.