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 Improving Native American Elder Access to and Use of Healthcare (NCT03550404), a registered phase not stated study. The primary outcome is User Evaluation Survey.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03550404 |
| Phase | Phase not stated |
| Condition | Access to Health Care |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pacific Institute for Research and Evaluation |
| Results posted | Yes |
2. Clinical Question
Population
American Indian elders in New Mexico and the navigators and healthcare providers or staff involved in their healthcare experiences. The registry lists enrollment of 16, but does not report how participants were distributed across these stakeholder groups.
Intervention
The behavioral intervention was the Seasons of Care app, used by American Indian elder navigators in outreach and encountered by elders when they sought navigation assistance. Healthcare providers and staff could encounter the app through navigators and their patients.
Comparator
No like-for-like control comparison is described. The registry does not state an allocation method, and the listed groups represent different stakeholder roles and forms of exposure rather than comparable treatment and control arms.
Primary question
The planned user evaluation asked about the experiences and perceived effects of the app among elders and healthcare providers who interacted with a navigator using it, and sought suggestions for improvement. No data were collected for this outcome because tribal communities closed during the COVID-19 pandemic.
The broader study aimed to examine help-seeking behavior and healthcare experiences and to develop and evaluate a tailored approach intended to support knowledge of, access to, and use of insurance and available services. Its community-driven, participatory design included qualitative and quantitative interviews, concept mapping, and focus groups with American Indian elders and other stakeholders. Those aims describe the study’s purpose; they are not evidence that the intervention changed access, service use, or health outcomes.
3. Trial Design
NCT03550404 is listed as a completed study with an enrollment of 16. The registry gives a start date of 2018-08-01 and a primary completion date of 2021-11-30. It describes a mixed-method, participatory study rather than a randomized clinical comparison. The allocation method is not stated, and the record specifically cautions that the arms are not a like-for-like control comparison.
The intervention was the behavioral Seasons of Care app. Navigators were to use it during everyday outreach with American Indian elders over two four-month intervention periods, P1 and P2. Elders were exposed to the app when they sought help from navigators, while healthcare providers and staff were exposed through navigators and their patients. These different routes of exposure matter: the groups have distinct roles and are not interchangeable arms for estimating a treatment contrast.
The primary outcome was planned as a user evaluation at the end of P2, described as Month 8 of 8. It was to be a semi-structured, in-person interview or a focus group, depending on availability, with elders and healthcare providers who had interacted with a navigator using the app. The study status is completed, but the registry states that no data were collected for this outcome because of the complete closure of tribal communities during the COVID-19 pandemic. Completion status therefore does not imply that the primary outcome was measured or analyzed.
The record identifies a Navigator Pre- and Post-Evaluation Interview as a secondary outcome. Four outcome measures are listed, but details and results for the other measures are not reported in the registry record. A statistical analysis plan, allocation details, and a sample-size justification are also 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: Due to the complete closure of tribal communities during the COVID-19 pandemic, zero participants were enrolled and assigned in the "American Indian Elders (AIEs)" and "Healthcare Providers/Staff" Arms/Groups, respectively.
Phase 1
| Stage | Navigators | American Indian Elders (AIEs) | Healthcare Providers/Staff |
|---|---|---|---|
| STARTED | 8 | 0 | 0 |
| COMPLETED | 8 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
Phase 2
| Stage | Navigators | American Indian Elders (AIEs) | Healthcare Providers/Staff |
|---|---|---|---|
| STARTED | 8 | 0 | 0 |
| COMPLETED | 4 | 0 | 0 |
| NOT COMPLETED | 4 | 0 | 0 |
Reasons for not completing this period:
| Reason | Navigators | American Indian Elders (AIEs) | Healthcare Providers/Staff |
|---|---|---|---|
| Unable to complete due to other duties during COVID-19 pandemic | 3 | 0 | 0 |
| Vacated position | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Due to the complete closure of tribal communities during the COVID-19 pandemic, no data were collected for this outcome measure.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Due to complete closure of tribal communities during the COVID-19 pandemic, we were unable to complete baseline measures with any American Indian Elders or healthcare providers/staff
| Characteristic | Unit | Navigators | American Indian Elders (AIEs) | Healthcare Providers/Staff | Total |
|---|---|---|---|---|---|
| Participants analysed | 16 | 0 | 0 | 16 | |
| Age, Continuous | years | 36 (21 to 70) | — | — | 36 (21 to 70) |
| Sex: Female, Male: Female | Participants | 12 | — | — | 12 |
| Sex: Female, Male: Male | Participants | 4 | — | — | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 | — | — | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 12 | — | — | 12 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | — | — | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 12 | — | — | 12 |
| Race (NIH/OMB): Asian | Participants | 0 | — | — | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | — | — | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | — | — | 0 |
| Race (NIH/OMB): White | Participants | 3 | — | — | 3 |
| Race (NIH/OMB): More than one race | Participants | 1 | — | — | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | — | — | 0 |
| Confidence communicating with Elders: Comfortable communicating with AIEs about health and healthcare issues | Participants | 16 | — | — | 16 |
| Confidence communicating with Elders: Comfortable communicating with AIEs about health insurance | Participants | 11 | — | — | 11 |
| Confidence communicating with Elders: Uncomfortable communicating AIEs about insurance due to lack of knowledge | Participants | 3 | — | — | 3 |
| Confidence communicating with Elders: Experienced language barriers communicating with AIEs | Participants | 5 | — | — | 5 |
| Confidence communicating with Elders: Experienced challenges communicating with AIEs about difficult or taboo topics | Participants | 4 | — | — | 4 |
| Confidence communicating with healthcare providers: Comfortable communicating with healthcare providers due to regular experience doing so | Participants | 12 | — | — | 12 |
| Confidence communicating with healthcare providers: Comfortable communicating with healthcare providers when receiving referrals to help AIE | Participants | 7 | — | — | 7 |
| Comfort using Seasons of Care Guide: Comfortable using the Seasons of Care Guide in their work | Participants | 10 | — | — | 10 |
| Comfort using Seasons of Care Guide: Confident that they would become comfortable with the Seasons of Care Guide over time | Participants | 5 | — | — | 5 |
| Comfort using Seasons of Care Guide: Felt that the Seasons of Care Guide was no different than other resources they already used | Participants | 1 | — | — | 1 |
6. Primary Endpoint
The registry lists the primary outcome as User Evaluation Survey, measured over Once at the end of P2 (Month 8 of 8).
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint, called the User Evaluation Survey, was intended to capture how American Indian elders and healthcare providers experienced the Seasons of Care app after interacting with a navigator who used it. The planned interview or focus group would also elicit perceived effects and suggestions for improving the app. The registry specifies collection at the end of P2, Month 8 of 8.
This kind of endpoint is suited to questions about experience, acceptability, and possible areas for refinement: participants can describe what they encountered rather than expressing their views only through a numerical score. That is a general reason to use interviews or focus groups in an intervention evaluation; the registry does not describe a scoring system, a quantitative endpoint definition, or a validation procedure for this measure. The endpoint’s unit, parameter, and dispersion are not reported in the registry record.
Most importantly, the registry states that no data were collected for this outcome because tribal communities closed during the COVID-19 pandemic. There is therefore no reported endpoint result to interpret. The planned questions indicate what researchers intended to learn, but they cannot be treated as findings about users’ experiences or the app’s effects.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central result for interpretation is the absence of primary endpoint data. The planned user evaluation was not conducted because of the complete closure of tribal communities during the COVID-19 pandemic. Consequently, the registry record does not provide an observed outcome, effect estimate, confidence interval, or p-value for that endpoint. It is not possible to infer from the record whether users found the app useful, what effects they perceived, or what changes they would have recommended.
The study’s completed status and enrollment of 16 do not fill this evidentiary gap. Enrollment describes the registered study size, not the number who completed the user evaluation or the number contributing data to any particular outcome. The distribution of enrollment across stakeholder groups, outcome-specific denominators, and analysis populations are not reported in the registry record. No analysis results are listed.
Interpretation of comparisons would also be limited by the design information. The registry does not state an allocation method and identifies the arms as not being a like-for-like control comparison. Navigators, elders, and healthcare providers or staff have different roles and encounter the app in different ways. A difference between stakeholder groups, if one had been reported, would not by itself isolate an app effect. Differences could reflect group composition, access to navigation, or other contextual factors; the registry does not provide data to assess such possibilities.
The study’s participatory and mixed-method approach was intended to examine experiences and help-seeking in context. That approach can be useful for understanding how an intervention is encountered and for generating ideas for refinement. However, the registry record does not report findings from the planned primary evaluation, and the stated aims should not be read as results. It also does not report estimates for changes in insurance knowledge, access to services, service use, or healthcare disparities.
Statistical precision cannot be judged for the primary question because there are no outcome observations or estimates. There is no reported confidence interval to show how compatible the data are with different effect sizes, and no reported test to assess evidence against a statistical null hypothesis. This absence is not evidence of no effect; it means the registry record does not contain the outcome data needed to estimate an effect. Conclusions should remain bounded to the design and the missing primary endpoint rather than extending to effectiveness or lack of effectiveness.
9. Statistical Methods Explained
The registry describes a mixed-method, participatory study. In general, mixed methods combine numerical information with qualitative accounts, while participatory approaches involve community members or stakeholders in shaping the questions or process. The record identifies qualitative and quantitative interviews, concept mapping, and focus groups as study components. It does not report the results of those components or explain how qualitative and quantitative findings were integrated.
What can an endpoint estimate?
A quantitative endpoint needs a defined outcome and observations from participants. An estimate describes a feature of the observed data, while uncertainty measures such as a confidence interval indicate the range of values that remain compatible with the data under the statistical model. A p-value, when used, addresses compatibility with a specified null hypothesis under stated assumptions; it does not measure the size or importance of an effect. These are general statistical concepts. For the primary user evaluation, the registry reports no collected data and no effect estimate, confidence interval, or p-value.
The planned endpoint was an interview or focus group, not a reported numeric score. Qualitative analysis can organize participants’ accounts into themes or describe variation in experience. Quantitative analysis would require numerical outcomes and a defined analysis approach. Neither a qualitative coding approach nor a quantitative statistical method for the primary endpoint is reported in the registry record. The record lists zero analyses, so there are no reported analysis results to interpret.
Why does the comparison structure matter?
In a randomized comparison, allocation is intended to make groups comparable in expectation, which supports interpreting a between-group contrast as an intervention effect, subject to study conduct and assumptions. In a nonrandomized or otherwise non-comparable design, group differences may reflect more than the intervention. This is a general principle, not a description of an allocation procedure in this study: the registry does not state how allocation occurred. It also cautions that the arms are not a like-for-like control comparison. The groups represent navigators, American Indian elders, and healthcare providers or staff, with different relationships to the app.
For this reason, the study should not be interpreted as a conventional controlled treatment-effect estimate based on the listed groups. The registry record does not report a prespecified contrast, adjustment strategy, baseline comparability assessment, or model used to account for differences among participants. Such details are not reported in the registry record.
What do the planning assumptions mean?
The registry’s sample-size assumptions describe planning illustrations, not the study’s own design justification. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of an observed effect. The record also distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. These assumptions do not establish that the trial used equal allocation or had a corresponding comparison. Sample-size illustrations are planning quantities, not observed power, and they do not substitute for outcome data or an analysis result. A sample-size justification for the registered study is not reported in the registry record.
More generally, planning calculations depend on the endpoint, variability, allocation, target effect, and analysis assumptions. A mismatch between those assumptions and the actual design can make an illustration inapplicable. The registry does not report a statistical analysis plan that would allow readers to assess the planned treatment of the study’s stakeholder groups, outcome measures, or qualitative material.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures, names the User Evaluation Survey as primary, and identifies a Navigator Pre- and Post-Evaluation Interview as a secondary outcome. It does not report results for the primary outcome, and the record lists no analyses. Details for the remaining outcome measures are not reported in the registry record.
When a study assesses multiple outcomes or performs multiple statistical tests, the chance of a false-positive finding can increase if each test is interpreted separately without accounting for multiplicity. This is a general statistical concern. Whether and how it applies depends on the planned analyses and the role of each outcome. A multiplicity strategy, hierarchy among secondary outcomes, or distinction between confirmatory and exploratory analyses is not reported in the registry record. With no reported analyses, there are no p-values or outcome findings for which an adjustment can be evaluated.
The primary outcome has a specific missing-data explanation: no data were collected because tribal communities closed during the COVID-19 pandemic. This is not the same as a partial response rate or a set of missing values among completed interviews. The registry does not report whether other outcome measures were collected, how much data may be missing for them, or whether any imputation or sensitivity analysis was planned or performed.
Analysis populations, participant flow by stakeholder group, and outcome-specific denominators are not reported in the registry record. It is therefore not possible to determine which enrolled participants contributed to any other outcome analysis. The record also does not describe exclusions, adherence definitions, or a method for handling incomplete observations.
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 |
|---|---|---|---|
| Navigators | 0 | 16 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Navigators | 0 of 16 |
| American Indian Elders (AIEs) | 0 of 0 |
| Healthcare Providers/Staff | 0 of 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 |
|---|---|
| Navigators | 0 of 16 |
| American Indian Elders (AIEs) | 0 of 0 |
| Healthcare Providers/Staff | 0 of 0 |
The registry reports adverse-event counts separately for navigators, American Indian elders, and healthcare providers or staff. Among navigators, 16 were listed as at risk for serious adverse events and 16 for other adverse events; zero were affected in either category. Deaths were recorded as zero. For American Indian elders and healthcare providers or staff, the listed number at risk was zero for both adverse-event categories, the number affected was zero, and deaths were recorded as zero.
These figures should be read with their denominators. The zero affected count among navigators is reported alongside 16 at risk. For elders and healthcare providers or staff, a zero at-risk count does not provide an observed safety denominator for those groups; it should not be interpreted as evidence that no events occurred among an exposed group. The record does not report additional detail about adverse-event monitoring, collection methods, or event timing.
Zero recorded events in the listed categories is a registry count, not a statistical estimate that risk is absent. Sparse or absent safety observations cannot establish that an intervention has no risk. The figures describe only what the registry reports for these groups and categories.
12. What the Result Does, and Does Not, Mean
The registry record supports a clear conclusion about the availability of evidence: the planned primary user evaluation has no collected data reported. As a result, it provides no empirical estimate of users’ experiences with the Seasons of Care app, perceived effects, or suggestions for improvement. The study’s completed status does not change that limitation.
The record does describe the intervention’s intended setting and the study’s broader purpose. Navigators were to use the app in outreach, elders could encounter it when seeking navigation help, and healthcare providers or staff could encounter it through navigators and their patients. The study aimed to examine help-seeking and healthcare experiences and to develop and evaluate a tailored intervention. These descriptions establish what the study set out to do; they do not establish that knowledge, access, service use, or disparities changed.
The design also does not support treating the listed stakeholder groups as a randomized intervention group and control group. Allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison. There are no reported analyses or effect estimates that could be used to quantify a contrast. Even if a numerical difference had been presented, interpreting it as an intervention effect would require a defensible comparison and relevant design and analysis information.
The absence of primary outcome data should not be interpreted as evidence that the app had no effect, just as the study’s aims should not be interpreted as evidence that it did have an effect. It means the primary question remains unanswered in the registry record. The adverse-event counts describe the recorded categories and denominators; they do not establish the absence of risk, particularly for groups listed with zero at risk.
Statistically, the main boundary is between a planned evaluation and an observed result. The registry documents the former but does not provide the primary outcome observations needed for the latter. Claims about effectiveness, precision, or subgroup differences are not supported by the posted results.
13. Why This Trial Matters Statistically
This study raises a statistically important distinction between designing an evaluation and obtaining data that can answer its question. The registry describes a community-driven intervention and a user evaluation tailored to the people who would encounter the app. It also records that the planned primary evaluation did not collect data because tribal communities closed during the COVID-19 pandemic. That disruption leaves the primary question without an observed endpoint result.
The design also highlights why comparison groups must be understood in context. Navigators, elders, and healthcare providers or staff have different roles and different routes of exposure. Treating them as if they were interchangeable treatment and control groups would obscure those distinctions. The registry itself cautions that the arms are not a like-for-like control comparison and does not state an allocation method. A valid statistical interpretation depends on matching the analysis to the design, rather than assuming a controlled contrast from group labels.
Mixed-method and participatory research can address questions about experiences, context, and implementation that a single numerical outcome may not capture. In general, combining qualitative and quantitative evidence can broaden the questions an evaluation addresses. But the record must still report how the evidence was collected and analyzed for readers to assess findings. For the primary evaluation, the registry reports no data; for other measures, analysis details and results are not reported.
The case is therefore informative about the limits of registry-based conclusions. A completed study record can document intervention plans and study aims without providing an analyzable result for its primary question. Statistical rigor includes recognizing that boundary and avoiding claims stronger than the available outcome evidence.
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 most consequential trial-specific limitation is that no data were collected for the primary User Evaluation Survey. The registry attributes this to the complete closure of tribal communities during the COVID-19 pandemic. With no primary outcome observations, there is no estimate of experience, perceived effect, or suggested improvement to assess.
The registry does not state the allocation method and warns that the arms are not a like-for-like control comparison. The listed groups are different stakeholder populations with distinct exposure pathways. Enrollment is 16, but the record does not report the distribution among groups or outcome-specific denominators. This prevents assessment of how many participants contributed to any given measure.
Although four outcome measures are listed, the record describes only the primary User Evaluation Survey and the Navigator Pre- and Post-Evaluation Interview by name. Results and analysis details for the other measures are not reported in the registry record. A statistical analysis plan, sample-size justification, methods for handling missing data, and multiplicity procedures are also not reported in the registry record.
The adverse-event information lists zero at risk for elders and healthcare providers or staff, so the zero affected counts for those groups do not supply a safety observation among an at-risk denominator. The record does not provide further detail on adverse-event ascertainment. Overall, the available registry information is insufficient to estimate intervention effects, assess their precision, or draw conclusions about effects across stakeholder groups.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Improving Native American Elder Access to and Use of Healthcare — NCT03550404.
- Registry record last updated 2024-07-10; status last verified 2024-07.
- Results first posted 2024-07-10.
- 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
NCT03550404, Improving Native American Elder Access to and Use of Healthcare, is listed as completed, with enrollment of 16. The study used a community-driven, mixed-method, participatory design to examine help-seeking and healthcare experiences and to develop and evaluate a tailored navigation intervention.
The behavioral intervention was the Seasons of Care app. Navigators were to use it in outreach, while elders and healthcare providers or staff could encounter it through navigation interactions. The planned primary User Evaluation Survey was an interview or focus group at the end of P2, Month 8 of 8. The registry states that no data were collected for this outcome because tribal communities closed during the COVID-19 pandemic.
The registry does not report analyses or primary outcome estimates. It does not state an allocation method and cautions that the listed groups are not a like-for-like control comparison. Thus, the record documents study aims and intervention plans but does not provide a primary result from which to estimate the app’s effects.