Social Determinants of Health Screening and Interventions: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Social Determinants of Health Screening and Interventions (NCT03661359), a na na study. The primary outcome is Correlation Co-efficient Between Patient Satisfaction Assessed Using HCAHPS and the Domains at Risk.

2. Clinical Question

The study also described objectives involving patient satisfaction, physician-patient communication, surgery department HCAHPS scores, and correlations between satisfaction and social determinants of health. Its stated hypotheses concerned directed screening and intervention, patient advocacy, social determinants of health, and the possible relationship of traumatic injury and acute surgery to perceptions of care. These are research aims and hypotheses, not findings. The registry record does not report results establishing whether any of these relationships were observed.

3. Trial Design

This was a completed, single-group study of Social Determinants of Health Referrals, sponsored by the University of Toledo Health Science Campus. The registry record lists phase as NA, allocation as NA, and masking as none. Enrollment was 35. The study dates recorded were 2018-05-14 for the start and 2019-08-20 for primary completion. These design details describe the registered study; they do not indicate that a controlled comparison was conducted.

The intervention description identifies referrals related to social determinants of health. The stated primary objective was to connect patients with community resources. Secondary objectives included improving patient satisfaction within the trauma and general surgery service, enhancing physician-patient communication, bettering surgery department HCAHPS scores, and increasing understanding of correlations between patient satisfaction and social determinants of health. The objectives and hypotheses specify what investigators intended to examine, not what the results demonstrated.

Because the design is single group, the study does not provide a randomized, concurrent comparison between people receiving referrals and people not receiving referrals. Allocation is listed as NA, and the registry record explicitly does not describe a like-for-like control comparison. Baseline HCAHPS data are named among the secondary outcomes, but the record does not say that these data formed a prespecified control group or explain how they were used in analysis. The timing and structure of any before-and-after comparison are not reported in the registry record.

The primary outcome concerned a correlation coefficient between HCAHPS-assessed patient satisfaction and domains at risk related to social determinants of health, with assessment within 15 days of discharge. The record lists five outcome measures and three analyses, but the details of all analyses are not reported in the registry record. It also does not report a statistical analysis plan, a sample-size justification, or whether any analyses were planned in advance. Accordingly, the design supports describing the intervention and the intended association question, but the registry entry alone does not establish 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.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Correlation Co-efficient Between Patient Satisfaction Assessed Using HCAHPS and the Domains at Risk, measured over Within 15 days of discharge.

The primary endpoint is a correlation coefficient relating patient satisfaction assessed using HCAHPS to domains at risk related to social determinants of health. The scheduled assessment was within 15 days of discharge. A correlation coefficient is a way of describing how two measured characteristics vary together: its direction indicates whether higher values tend to occur together or in opposite directions, while its magnitude describes the strength of the association. This is a general explanation of the statistic, not a result from this study.

The registry description says the abbreviated HCAHPS assessment included 9 questions about positive or negative patient responses to hospital care. Positive responses were coded as 1 and negative responses as 2, with lower numbers corresponding to higher hospital satisfaction. It also included a hospital rating from 1-10, where 1 was the lowest score and 10 the highest; higher ratings corresponded to higher patient satisfaction. Because these scoring directions differ, an association involving a particular score needs to be interpreted with its coding in mind. The registry record does not explain exactly how the question responses and hospital rating were combined, or which measure entered the correlation analysis.

An association endpoint is relevant to the stated question of whether satisfaction varies with social determinants of health risk domains. It does not, by itself, establish that referrals caused a change in satisfaction. The coefficient, its uncertainty, the number of observations contributing to it, and any significance test are not reported in the registry record. The outcome description therefore explains what investigators intended to relate, but does not permit an assessment of the observed association or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

A correlation coefficient describes the direction and degree to which two measured variables vary together. As a general statistical concept, a positive association means higher values of one variable tend to accompany higher values of the other; a negative association means higher values of one tend to accompany lower values of the other. The coefficient is not, on its own, evidence that one variable causes the other. For this study, the registered primary question concerns satisfaction and domains at risk related to social determinants of health. The actual coefficient and the method used to calculate it are not reported in the registry record.

What does the outcome coding mean?

The registry describes an abbreviated HCAHPS questionnaire with 9 questions based on positive or negative responses to hospital care. A positive response was coded as 1 and a negative response as 2, so a lower number corresponds to higher satisfaction for these responses. The same description includes a hospital rating from 1-10, with 1 as the lowest and 10 as the highest rating; higher values correspond to higher satisfaction for that rating. These different coding directions mean that a coefficient's sign cannot be interpreted without knowing which measure or coding was used. The record does not state how the responses were combined, whether an overall score was calculated, or which score was used in the primary analysis.

What would an uncertainty interval add?

In general, a confidence interval describes a range of estimates compatible with the data and the method's assumptions. It helps readers assess how precisely an association has been estimated; a point estimate alone cannot show that precision. No confidence interval for the primary endpoint is reported in the registry record. Nor does the entry report a standard error, a p-value, or enough information to reproduce the analysis. It is therefore not possible to characterize the statistical uncertainty around the intended correlation from the registry entry.

What does the design allow?

The study is registered as single group, with allocation listed as NA and masking as none. In general, a concurrent control group can help distinguish an intervention-related difference from changes that might also occur without the intervention. A single-group design does not supply that randomized contrast. It may describe outcomes among participants receiving the intervention, but causal interpretation requires assumptions and supporting design or analysis details. The registry record does not report a comparison group, a defined pre-intervention assessment for the primary endpoint, or an analysis plan that would support a particular causal interpretation.

The stated primary question is correlational, which differs from a treatment-effect question. Even a clearly estimated correlation would describe co-variation, not the effect of referral on satisfaction. The record also includes hypotheses about patient advocacy, social determinants of health, traumatic injury, and acute surgery. These hypotheses do not identify which variables were included together in a statistical model, whether adjustment was used, or how any relationships were tested. Those methods are not reported in the registry record.

How should planning calculations be understood?

General sample-size planning asks how many observations may be needed to detect a prespecified effect under chosen assumptions. The planning illustration associated with this study assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect described as a fraction of the observed effect. For time-to-event planning, the illustration concerns total events; for other planning, it concerns participants per arm. These are planning assumptions, not a description of the single-group study's registered design. They should not be confused with an observed comparison or interpreted as observed power.

The registry record does not report the trial's own sample-size justification or a target effect used when planning enrollment. It also does not provide the numerical planning outputs in the registry record describing the study. Planning examples based on an observed effect are especially distinct from a prospective justification: they illustrate hypothetical requirements under stated assumptions and do not establish that the study was designed to meet those requirements. The enrolled total of 35 describes enrollment, not evidence that a chosen level of precision or power was achieved.

What analysis details are unavailable?

The registry lists five outcome measures and three analyses. It does not describe the tests or models, define the analysis populations, say whether analysis was adjusted, or explain how repeated or incomplete questionnaire responses were treated. It also does not state whether the correlation used a particular statistical formulation or whether assumptions were checked. These details matter because different methods, score definitions, and available-case rules can affect an estimate and its uncertainty. In the absence of those details, readers should not infer a specific statistical procedure from the outcome label alone.

Multiplicity is another general concern when a study assesses several outcomes or analyses. Testing multiple questions can increase the chance of at least one apparently notable finding if no adjustment or interpretation plan is specified. The record does not report how multiple outcomes or analyses were handled, so it is not possible to determine whether any multiplicity approach was planned or used. This uncertainty does not establish that the results are invalid; it limits how specifically they can be interpreted.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and three analyses, but it does not report a statistical analysis plan identifying a primary testing hierarchy beyond the named primary outcome. It does not say whether secondary outcomes were confirmatory or exploratory, whether any adjustment for multiple testing was planned, or how results across the analyses were to be interpreted. When several outcomes or tests are considered, multiplicity can make an isolated small p-value less informative unless the analysis plan accounts for the number and role of comparisons. This is a general statistical consideration; the registry record does not establish which approach, if any, was used.

Missing-data handling is not reported in the registry record. In particular, it does not state how unanswered HCAHPS questions, incomplete questionnaires, or unavailable risk-domain assessments were handled. The number of participants contributing to each outcome is also not reported. These omissions prevent assessment of whether the analyzed participants differed from those without usable data, and whether missingness could have influenced the estimated association. No imputation or complete-case approach should be assumed.

The analysis populations are also not defined. Although enrollment is listed as 35, the record does not state whether all enrolled participants were included in each analysis, whether participants had to complete particular assessments, or whether any exclusions occurred. The registry does not report whether analyses followed an intention-to-treat principle or another population definition. Such labels should not be inferred for a single-group study without a stated analysis rule.

The primary outcome result itself is not reported in the registry record, and there is no posted estimate or uncertainty measure to evaluate. Consequently, multiplicity, missingness, and population-definition concerns cannot be resolved by examining the reported effect. They remain limitations on interpreting the registered study information.

11. 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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: death (2.9%).

The safety record lists 35 participants at risk for serious adverse events and 2 participants affected. It separately lists 35 at risk for other adverse events and 0 affected. The record also lists 2 deaths and identifies death as a top serious adverse event term, with 2.9% displayed for that term. These are registry-reported counts and the displayed term percentage; they should be read as recorded categories, not as evidence about why events occurred.

The registry information does not provide a safety observation period, event narratives, severity details beyond the serious-event categorization, or an assessment of whether events were related to the intervention. It does not explain the relation between the death count and the serious-event listing, or provide additional detail on how the displayed percentage was derived. No causal attribution should be inferred from the counts alone. In particular, the presence of deaths in the record does not establish that referrals caused them, and the absence of reported other adverse events does not establish that no other events occurred outside the registry's recorded categories or reporting process.

These safety figures describe what the registry record reports for the study group. They do not constitute a comparison of safety between intervention and control groups, because the study is single group and no like-for-like control is registered. Interpretation is limited by the lack of timing, context, and event-level details.

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

The record establishes that a completed, single-group study of Social Determinants of Health Referrals enrolled 35 participants and planned to examine patient satisfaction in relation to social determinants of health risk domains. It identifies an HCAHPS-based primary endpoint, an assessment window within 15 days of discharge, and secondary outcomes involving communication and baseline HCAHPS data. These details describe the research question and registered study structure.

The primary correlation result is not reported in the registry record. There is no estimate, confidence interval, or p-value from which to describe the observed direction, magnitude, or precision of the relationship. Nor are results for the listed secondary outcomes reported in the registry record. It is not possible to say whether satisfaction and risk domains were associated, whether satisfaction changed, or whether communication or HCAHPS outcomes differed.

Even if results were available, a correlation would describe association rather than prove that social determinants of health caused a change in satisfaction. The single-group design also has no registered concurrent control group, so it does not support a randomized comparison of referral versus no referral. The listed hypotheses and objectives express what investigators expected to examine; they are not evidence that the expected outcomes occurred.

The study's enrollment and completion status should not be treated as evidence that the intervention achieved its objectives or that the endpoint was estimated precisely. The registry does not report a sample-size justification, analysis population, handling of incomplete data, or a detailed statistical plan. Those omissions further limit interpretation. The most defensible reading is that the registry documents a study of referrals and patient-perception measures, while the posted results needed to assess the primary question are not reported in the registry record.

13. Why This Trial Matters Statistically

This study raises a statistically distinct question from a straightforward comparison of two treatments. Its primary endpoint is the correlation between patient satisfaction and domains at risk related to social determinants of health. That focus can help describe whether patient perceptions vary alongside reported social needs, but an association is not automatically an intervention effect. Keeping that distinction clear is important when interpreting studies that combine a service intervention with patient-reported outcomes.

The design details also matter. A single-group study can document a program and collect measurements among participants, but without a like-for-like concurrent control comparison it offers no randomized contrast for separating intervention effects from other explanations. The record lists allocation as NA and masking as none. The absence of a comparator is especially relevant when the stated objectives include improvement in satisfaction, communication, and HCAHPS scores: those are aims, not demonstrated changes.

Measurement direction is another practical statistical issue. In the HCAHPS description, lower numeric values for positive or negative question responses correspond to higher satisfaction, while higher values on the hospital rating correspond to higher satisfaction. Understanding that coding is necessary to interpret the sign of any association. The registry record does not specify exactly how those measures were constructed for analysis, and it does not report the primary coefficient.

Finally, transparency about estimates, uncertainty, missing data, analysis populations, and multiplicity is essential for judging how much a result can support. Those details are not reported in the registry record. The entry therefore offers useful information about the question, intervention, and intended measures, while illustrating why design description alone cannot substitute for posted outcome results and analysis details.

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 main limitation for interpreting this particular study is that the primary result is not reported in the registry record. The outcome is named and described, but the coefficient, its direction, its precision, and the number of observations used are absent. Without those items, the central association question cannot be answered from the registered information.

The study is single group, with allocation listed as NA and no like-for-like control comparison. Thus, even a reported change in an outcome would not by itself isolate the contribution of referrals. The record does not specify a pre-intervention measurement for the primary endpoint or describe a before-and-after analysis. It also does not state how participants were identified, what determined referral eligibility, which community resources were available, or whether referrals were completed.

Outcome measurement is not fully specified. The registry describes response coding and a hospital rating, but does not report how these measures were combined or which score was used for the primary correlation. It does not describe the domains at risk in detail or explain how risk status was measured. The timing is stated as within 15 days of discharge, but the record does not provide more specific assessment procedures.

Analysis details are also limited: missing-data methods, analysis populations, adjustment for other factors, multiplicity handling, and the statistical tests or models are not reported in the registry record. The safety information gives counts but lacks event timing and clinical context. These limitations concern what can be learned from the registry entry; they do not establish that a particular method was or was not used outside the information recorded.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Social Determinants of Health Screening and Interventions — NCT03661359.
• Registry record last updated 2025-01-27; status last verified 2025-01.
• Results first posted 2025-01-27.
• 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.

18. Record Summary

NCT03661359, titled Social Determinants of Health Screening and Interventions, is a completed, single-group study sponsored by the University of Toledo Health Science Campus. The registered intervention was Social Determinants of Health Referrals, and enrollment was 35. Allocation is listed as NA and masking as none.

The primary outcome was a correlation coefficient between HCAHPS-assessed patient satisfaction and domains at risk related to social determinants of health, assessed within 15 days of discharge. The registry describes an abbreviated HCAHPS measure and lists communication and baseline HCAHPS data as secondary outcomes. It also lists five outcome measures and three analyses.

The primary outcome result and the detailed analysis methods are not reported in the registry record. The entry therefore describes the study's aims, intervention, and planned measurement, but does not provide the estimate needed to assess the primary association.