US PRECISION Implementation Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for US PRECISION Implementation Study (NCT04891978), a na na study. The primary outcome is Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Overall Ease of Implementing AIRQ Into Clinical Practice..

2. Clinical Question

The study’s broader objective was to assess the process and potential benefits of integrating AIRQ, the Asthma Checklist and educational resources into clinical practice. Its secondary objectives concerned patients’ clinic-visit experiences when the program was used during in-person or telehealth visits, and changes in AIRQ scores from the initial visit to follow-up visits when available.

These objectives span implementation and patient-reported outcomes. The primary endpoint is an HCP survey measure of implementation experience, not a direct measure of asthma control or a comparison of clinical outcomes between treatment groups. The secondary outcomes listed in the registry record include changes in AIRQ scores and control levels, as well as responses to items on the ACE Questionnaire. The record does not report results for these outcomes.

3. Trial Design

The US PRECISION Implementation Study is registered as a completed, single-group community program intervention study for asthma. It began on 2021-04-20, had primary completion on 2023-04-30, and lists enrollment of 857. The registry record does not report a trial phase or a randomized allocation scheme. Masking is listed as none.

All participants were to receive the AIRQ tool, the Asthma Checklist tool and the PRECISION educational resources. These are classified as behavioral interventions. The program was integrated into clinical practice through either in-person or telehealth visits. The registry record identifies primary care sites, specialty care sites and novel care sites in its adverse-event group listings, but does not report the number of sites in each category.

The design is important for interpreting the study’s purpose. With a single group and no like-for-like control group, the primary outcome describes HCPs’ reported experience implementing the program; it does not estimate a comparative effect against usual care or another intervention. A single-group design can describe implementation in the settings studied, but it cannot separate changes associated with the program from other influences using a concurrent randomized comparison.

The primary outcome is based on a post-study HCP survey. The registry describes the survey as completed between 5 weeks and 50.6 weeks after the last patient ended follow-up across sites. End of follow-up was defined as 36 weeks from the last patient enrolled at a site, or 6 weeks for the novel care site. These timing details indicate that survey timing varied across sites; the record does not describe how that variation was handled in analysis.

The registry lists 25 outcome measures. It gives no analysis entries, and it does not report the statistical plan, sample-size justification, or interim analyses. Those details should not be inferred from the study’s completed status or enrollment listing.

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.

Baseline

Reasons for not completing this period:

Follow-up

Analysis population for the primary outcome, as defined in the registry: Number of site HCPs who responded to the post-study HCP survey (one HCP responded per site)

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: Baseline patient population from primary care, specialty care and novel sites who completed the AIRQ

6. Primary Endpoint

The registry lists the primary outcome as Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Overall Ease of Implementing AIRQ Into Clinical Practice., measured over Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site)..

The primary endpoint is the percentage endorsement of responses by site HCPs for each categorical item on the post-study survey relating to the overall ease of implementing AIRQ into clinical practice. The survey includes questions about implementation of the PRECISION program, including a question about ease of using AIRQ in clinical practice with a telehealth platform. The endpoint population is site HCPs who responded to the survey, with one HCP respondent per site.

This endpoint is intended to describe implementation experience from the perspective of HCPs. In general, categorical survey responses can provide an organized account of how respondents select among defined options. Reporting the share endorsing each response can make the distribution of views easier to interpret than a single overall summary, especially when responses represent different levels or aspects of ease. The registry record does not give the response categories, their wording, or the observed endorsement percentages.

The endpoint is not a measure of patient clinical benefit. It does not, by itself, quantify changes in AIRQ scores, asthma control, or clinic-visit experience. Those topics appear among the study’s secondary objectives or outcomes, but their results are not reported in the registry record. The number of HCP respondents and the number of sites are also not reported, so the precision and representativeness of the endpoint cannot be assessed from the record. No observed endpoint percentages or confidence intervals are reported.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation begins by identifying the unit being measured. The primary endpoint is expressed as percentage endorsement of categorical survey responses by site HCPs, and its unit is sites. The respondent population is described as HCPs who completed the post-study survey, with one HCP per site. This is different from a patient-level outcome: the primary measure describes site HCP responses, not the number or proportion of patients with a particular clinical result. The registry record does not report the number of responding HCPs or the observed response percentages.

What does a percentage of endorsements describe?

General explanation: a percentage for a response category expresses how common that response was among the observations included in its denominator. To interpret it, a reader needs the category wording, the number of responses in that category, the denominator used, and information about missing or unanswered items. When a survey asks several categorical questions, each item may have its own response distribution and potentially its own denominator if responses are incomplete. The registry record describes the endpoint as endorsement by site HCPs for each categorical item, but does not report the response options, counts, percentages, or item-level missingness.

A percentage describes the observed respondents; it does not automatically characterize all HCPs who could have used the program. If respondents differ from nonrespondents, their answers may not represent the views of all sites or HCPs. General statistical practice therefore distinguishes the observed response distribution from broader claims about a target population. Here, the number of sites and the number of survey respondents are not reported, which limits assessment of how broadly the responses can be interpreted.

What would a confidence interval add?

General explanation: a confidence interval conveys the statistical uncertainty around an estimate under the assumptions of the method used. A narrow interval indicates greater precision under those assumptions; a wide interval indicates less precision. The interval does not remove possible bias from nonresponse, measurement, site selection, or other features of study conduct. No confidence interval for the primary survey endpoint is reported in the registry record, and no method for calculating one is described.

The endpoint is site-based, with one HCP response per site. If responses from sites are analyzed as individual site observations, the interpretation concerns variation among the responding sites. The statistical plan would need to specify how that structure and any incomplete responses were handled. The registry record does not report such details. No adjustment, weighting approach, or model for the primary survey outcome is described, so none should be assumed.

Why does the single-group design matter?

General explanation: random assignment to comparison groups can help balance measured and unmeasured influences, on average, for a treatment comparison. This study is listed as single-group, with allocation listed as NA and masking as none. Its primary outcome is a post-study implementation survey, not a between-group contrast. Consequently, there is no control-group estimate in the registry record against which to compare HCP responses. A descriptive survey can characterize reported experiences, but it does not by itself identify the causal effect of the program.

The registry describes use of both in-person and telehealth visits, but does not report a randomized comparison between these platforms. The primary survey description includes a question about ease using AIRQ with a telehealth platform. The record does not provide results by platform, site type, or other subgroup. Comparisons among such groups should not be inferred from the existence of multiple settings.

How should the AIRQ outcomes be understood?

The secondary outcomes include mean AIRQ scores and standard deviations at each visit, mean differences and confidence intervals, changes in AIRQ control level, and ACE Questionnaire response endorsement. General explanation: a mean summarizes the arithmetic center of a numeric measure, while a standard deviation describes dispersion among observed values. A mean difference expresses the contrast between two means, and a confidence interval describes uncertainty around that contrast under a specified analysis. The registry record does not report the actual values, the visit-specific analysis populations, or the methods used to calculate these summaries.

When follow-up is available for some participants but not others, the observed follow-up data may represent a selected subset. General statistical methods for incomplete follow-up depend on why data are missing and on the assumptions made about missingness. The record’s description that follow-up visits were included when available does not specify a missing-data method or whether all eligible follow-up observations contributed. Those analytic choices are not reported in the registry record.

The registry lists 25 outcome measures but no analysis entries. It does not report a statistical analysis plan, adjustment for multiple outcomes, or interim analyses. No particular model, hypothesis test, adjustment, or analysis population can therefore be attributed to the study based on the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 25 outcome measures, including the primary HCP survey endpoint and secondary outcomes concerning AIRQ scores, AIRQ control levels, and ACE Questionnaire responses. When a study evaluates many outcomes or multiple response categories, the chance of at least one apparently notable result can increase if each is examined separately. General approaches to multiplicity include defining a primary outcome in advance, specifying a hierarchy, or adjusting inference across selected comparisons. The registry record does not report whether any such approach was planned or used. It also lists no analysis entries, so the treatment of multiple outcomes cannot be established from the record.

Missing-data methods and analysis populations are not reported. The primary endpoint is defined among HCPs who responded to the post-study survey, one HCP per site, but the number of eligible sites, number of respondents, response rate, and item-level completeness are not reported. Without these details, it is not possible to assess how nonresponse may affect the survey summaries or how missing answers might affect item-specific percentages.

For secondary outcomes, the stated objective includes follow-up visits “when available.” The registry record does not explain how unavailable visits or incomplete AIRQ data were handled, whether participants needed measurements at both baseline and follow-up to contribute to a change estimate, or how the analysis population was defined for each outcome. It does not describe imputation, exclusion rules, or sensitivity analyses. These matters are especially relevant when interpreting mean changes and confidence intervals, because the observations included in an analysis determine the population to which its summary applies.

These are reporting gaps, not evidence that a particular method was or was not used outside the registry record. The posted record does not permit a judgment about the robustness of missing-data handling or multiplicity control.

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

The study’s registry description identifies a practical implementation question: how site HCPs endorsed categorical survey responses about integrating AIRQ into clinical practice as part of the PRECISION program. It also identifies patient-oriented secondary questions about clinic-visit experiences and changes in AIRQ measures. The record establishes that the program included AIRQ, the Asthma Checklist and educational resources and was intended for use in telehealth or in-person practice.

The registry record does not report the observed primary survey results. It therefore does not show the distribution of HCP responses, the number of respondents, or the precision of any estimate. Nor does it report the outcomes needed to characterize patient experiences, AIRQ score changes, control-level changes, or ACE Questionnaire responses. The description of study objectives should not be mistaken for evidence that an outcome changed in a particular direction.

Even with reported survey results, this single-group design would primarily support descriptive statements about responding HCPs and participating sites. It would not provide a randomized estimate comparing the program with a control condition. General statistical reasoning cautions that observed responses in an implementation study may reflect the program as well as setting, respondent selection, local practice, and other influences. The record does not report analyses that could separate those influences.

The enrollment listing of 857 does not represent the primary endpoint denominator: that outcome concerns site HCP respondents, one per site. The numbers of sites and respondents are not reported. Enrollment also does not establish how many participants contributed to each secondary outcome or follow-up time point.

Accordingly, the registry record describes what the study set out to evaluate and how the intervention was intended to be used. It does not, on its own, establish the size, direction, or certainty of observed implementation or patient-outcome results. No medical conclusion should be drawn from the design description in the absence of the reported outcome data.

12. Why This Trial Matters Statistically

Implementation studies address a different statistical question from trials designed primarily to compare clinical outcomes between randomized groups. They can examine how a program is integrated into practice and how participating HCPs describe that process. The US PRECISION Implementation Study’s primary endpoint reflects this focus: it concerns post-study HCP survey responses about ease of implementing AIRQ, including use through a telehealth platform.

That distinction matters when interpreting endpoints. A survey of implementation experience can identify reported perceptions and may help describe how a program is received in participating settings. It is not interchangeable with a measure of patient health, and it does not itself estimate a comparative clinical effect. The study also had secondary objectives concerning patient experiences and AIRQ scores, but their results are not reported in the registry record.

The design illustrates why a clear account of the unit of analysis is essential. Enrollment is listed as 857, while the primary outcome is measured through HCPs, one respondent per site. The patient enrollment figure cannot be used as the HCP survey denominator. The number of sites and responding HCPs is not reported, so readers cannot assess the primary endpoint’s precision or response coverage from the record.

The study used both telehealth and in-person platforms, and included primary care, specialty care and novel care sites. Such variation is relevant to implementation questions because practice contexts may differ. However, the registry record does not report subgroup results or comparative analyses by platform or site type. Those distinctions are part of the study context, not evidence of differences between settings.

Statistically, this record demonstrates the value of separating an intervention’s intended objectives from reported results. A detailed description of an implementation question can clarify what a study was designed to assess, while missing outcome estimates prevent conclusions about what respondents actually reported. That separation is important for accurate reading of clinical research.

13. 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 principal limitation for interpreting the registry record is that it does not report the primary endpoint results. Although the outcome is defined as percentage endorsement for each categorical survey item, the record gives no response counts, percentages, confidence intervals, or category wording. The number of HCP respondents and the number of sites are also not reported. As a result, neither the distribution nor the precision of HCP responses can be evaluated.

The single-group design has no randomized control comparison. Consequently, the study description cannot support an estimate of how implementation responses or patient outcomes would differ under another condition. The registry record does not report a comparator, and the program was assigned to all participants. Masking is listed as none.

There is variation in the survey timing described across sites: completion occurred between 5 weeks and 50.6 weeks after the last patient ended follow-up. End of follow-up was defined as 36 weeks from the last patient enrolled at a site, or 6 weeks for the novel care site. The record does not explain whether the timing variation was considered in analysis or whether it affected responses.

The registry does not report the results for the secondary outcomes, including changes in AIRQ scores and control levels, patient visit experiences, or ACE Questionnaire responses. It also does not report the analysis populations, handling of missing data, multiplicity procedures, statistical plan, or sample-size justification. These omissions limit assessment of both the methods and the precision of any outcome conclusions. They should be understood as limitations of the information reported in the registry record, not as proof that no additional analyses or documentation exist elsewhere.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: US PRECISION Implementation Study — NCT04891978.
• Registry record last updated 2025-07-08; status last verified 2025-06.
• Results first posted 2025-07-08.
• 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.

17. Record Summary

The US PRECISION Implementation Study is a completed, single-group community program intervention study for asthma. The registry lists enrollment of 857, a start date of 2021-04-20, and primary completion on 2023-04-30. The intervention consisted of AIRQ, the Asthma Checklist and PRECISION educational resources, used in clinical practice through in-person or telehealth visits.

The primary endpoint concerns site HCP endorsement of categorical responses on a post-study survey about ease of implementing AIRQ. The survey was completed between 5 weeks and 50.6 weeks after the last patient ended follow-up across sites. The record lists 25 outcome measures and describes secondary questions about patient experiences and AIRQ outcomes.

Observed endpoint results, respondent and site counts, analysis methods, missing-data procedures, multiplicity handling, and analysis populations are not reported in the registry record. With no randomized comparator, the design is descriptive rather than a like-for-like treatment comparison.