Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry (NCT04601194), a na na study. The primary outcome is Patient Activation Measure for Mental Health (PAM-MH).

2. Clinical Question

The study, titled GET PrEPD-Psychiatry, was designed as a mixed-methods developmental project. Its aims included adapting a shared decision-making intervention to psychiatric decisions, evaluating feasibility and acceptability, and examining potential mechanisms of change and preliminary outcomes. Patient activation and communication self-efficacy were identified as potential mechanisms.

The clinical question is therefore exploratory rather than a direct comparison of treatments. With no control group, any change over time could not by itself distinguish an intervention effect from other explanations, such as changes in participants or circumstances during follow-up. The registry record does not report the observed PAM-MH scores or an estimate of change. It therefore does not establish the direction or size of any change in activation.

3. Trial Design

The registry record describes a completed, single-group behavioral study sponsored by Indiana University. Its recorded start date is 2021-04-20, and its primary completion date is 2022-02-10. The phase and allocation are listed as NA, and masking is listed as none. Enrollment is recorded as 29. The study does not have a like-for-like control arm, so it is not structured as a randomized comparison of intervention and control.

The intervention is called Coaching and Virtual Provider Program Practice. The arm description specifies mental health coaching and assigned practice with a Virtual Provider Program. The study summary describes 4 weekly goal-setting and coaching sessions, coupled with training and practice using the Virtual Provider. The stated purpose of this work was to adapt shared decision making for psychiatry and assess feasibility, acceptability, potential mechanisms, and preliminary outcomes. Aim 1, adaptation of the intervention, is described as previously completed.

The study summary says the researchers planned to recruit up to 40 patients for Aim 2 and describes participant satisfaction and utility ratings, along with tracking Virtual Provider use by frequency and time-on-task. That planned recruitment target should not be confused with the recorded enrollment. The summary also describes follow-up for Aim 3, but the registry record does not report detailed follow-up procedures or a complete statistical analysis plan.

The intervention was intended to support shared decision making and self-management for adults with serious mental illness. The summary describes earlier development work using approximately 200 deidentified transcripts from a prior study to identify language used in psychiatric decision-making and program a Virtual Provider. Those transcripts are background to intervention development, not participants in the current single-group evaluation.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 7 subjects were lost to follow-up.

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 Patient Activation Measure for Mental Health (PAM-MH), measured over Baseline, 3 months.

The primary outcome is the Patient Activation Measure for Mental Health (PAM-MH), a 13-item measure of a person's knowledge, skill, and confidence for managing a chronic health condition. The registry record gives its range as 0 to 100 and states that higher scores indicate greater activation. The listed unit is units on a scale, and the outcome is characterized as a continuous measure summarized by a mean and standard deviation.

Patient activation is relevant to this developmental study because its stated aims include examining whether the intervention engages potential mechanisms that may support shared decision making and self-management. A measure of knowledge, skill, and confidence can describe this aspect of participants' experience; it does not, on its own, establish that communication or health outcomes changed because of the intervention.

The recorded timeframe is baseline and 3 months. The registry record does not report the PAM-MH means, standard deviations, change estimate, confidence interval, or test result. It also does not report a threshold for interpreting a change as clinically important. The record notes that 7 subjects were lost to follow-up, but does not state how those missing observations were handled in the primary outcome analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record characterizes the primary outcome as a continuous measure reported as a mean with a standard deviation. These summaries answer different descriptive questions. A mean describes the average score among the observations included in a calculation. A standard deviation describes how spread out individual scores are around that average. Neither summary alone gives the full distribution or indicates how precisely an average estimates a broader population value.

What would a mean change describe?

For a measure recorded at baseline and follow-up, a change estimate can describe how scores differ across the recorded time points. In a single-group study, such a change is descriptive unless the analysis and design justify a stronger interpretation. It does not automatically isolate an intervention effect, because there is no control group against which to compare changes over the same period. The registry record does not report the means, standard deviations, or change estimate for PAM-MH.

How should uncertainty be understood?

In general, a confidence interval describes a range of values compatible with the data and the assumptions of the statistical procedure. A narrower interval indicates greater precision under those assumptions; a wider interval indicates less precision. A confidence interval is not a guarantee that the true value lies in the interval. No confidence interval for the primary outcome is reported in the registry record, so the precision of any observed mean or change cannot be evaluated from this entry.

What does the design allow?

The record identifies a single-group model, allocation listed as NA, and no masking. These details describe a study without a separate randomized control group. A before-and-after comparison within one group may be useful for describing observed scores, but it does not control for changes over time that could occur independently of the intervention. The record does not describe an adjusted model, a prespecified hypothesis test, or an analysis plan for estimating change.

The primary measure is continuous and bounded, with scores ranging from 0 to 100. In general, a mean and standard deviation can be informative for a continuous measure, but interpretation also depends on the observed score distribution, missingness, and the number of observations at each time point. Those outcome details are not reported in the registry record. No additional distributional checks or alternative summaries are described.

What do the planning assumptions mean?

A planning illustration is described as using 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 fraction of the observed effect. The stated illustration is not the trial's original design. It is a hypothetical planning exercise rather than evidence that the completed study had a randomized two-arm structure. The sample-size outputs are planning illustrations, not observed power, and cannot replace a report of the actual outcome estimates and their uncertainty.

More generally, sample-size planning depends on the chosen outcome, target effect, variability assumptions, statistical test, and design. Changing an assumed effect changes the planning question. A calculation under equal allocation between two arms does not describe the precision achieved in this single-group study. The registry record does not report a sample-size justification for the original study or establish that the planning assumptions were part of its protocol.

What is not documented?

The registry record lists no analyses, and does not report a detailed statistical analysis plan, hypothesis tests, confidence intervals, adjusted estimates, or a model specification. It also does not report interim analyses. Their absence from the registry entry should be read as a lack of documentation, not as evidence about what may or may not have occurred outside the record. Without outcome estimates and analysis details, a reader cannot independently assess the statistical evidence for change.

General statistical interpretation also depends on how observations are handled when follow-up data are missing. Different methods can lead to different estimates when the chance of missingness relates to participant characteristics or outcomes. The registry record notes loss to follow-up but does not describe an imputation method, a complete-case approach, a sensitivity analysis, or the population included in any primary analysis. It therefore does not permit an assessment of whether missingness might affect the reported result.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists PAM-MH as the primary outcome and names four secondary measures: the Altarum Consumer Engagement (ACE) Measure, Perceived Efficacy in Patient-Provider Interactions (PEPPI-5), Illness Management and Recovery (IMR) Scale, and Recovery Assessment Scale (Brief Version). It also describes satisfaction, utility, and Virtual Provider use as matters to assess. Results for these outcomes are not reported in the registry record.

When a study examines several outcomes, time points, or analytic comparisons, the chance of at least one apparently notable result can increase. This is the general reason multiplicity can matter. A prespecified hierarchy or adjustment method can help clarify how multiple tests are to be interpreted, but the registry record does not report a multiplicity procedure or detailed analysis plan. It is not possible to determine from this entry whether multiplicity was addressed in another document or in analyses not recorded.

The registry record states that 7 subjects were lost to follow-up. It does not report the timing or reasons for loss, which measures were missing, or how missing observations were treated. The analysis population for PAM-MH and the secondary outcomes is not reported in the registry record. There is no stated imputation method, missing-data assumption, or sensitivity analysis with which to evaluate the influence of missing follow-up.

These gaps limit interpretation independently of whether a particular statistical test was used. A result without a clear account of the analysis population and missing-data handling may not represent all enrolled participants in the same way. Because the outcome estimates and methods are not reported, neither the extent of missing data for each measure nor the impact of analytic choices can be assessed.

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.

The registry record lists 29 participants at risk for serious adverse events and 0 affected by serious adverse events in the Coaching and Virtual Provider Group. It also lists 29 at risk for other adverse events and 0 affected by other adverse events. Deaths are recorded as 0. No top serious adverse event terms are listed.

These entries describe the safety counts recorded for the intervention group. A zero count means that no event in that category was entered as affecting a participant in this registry record; it does not establish that every possible event was actively excluded, or that no event occurred outside the record's reporting process. The record does not provide additional details about safety monitoring, event definitions, severity grading, or the period during which participants were considered at risk.

Because this is a single-group study, the safety entries do not provide a comparative estimate against a control group. The counts should not be interpreted as evidence that the intervention is risk-free. They are a limited description of recorded events in this study, alongside the absence of further safety details in the registry record.

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

The registry record supports a clear description of the study's design and intended question: a completed, single-group developmental study of coaching and Virtual Provider practice, with patient activation assessed at baseline and 3 months. The measure is described as assessing knowledge, skill, and confidence for self-management, and higher PAM-MH scores represent greater activation. The record also identifies feasibility, acceptability, potential mechanisms, and preliminary outcomes as aims.

It does not report the primary outcome values, a change estimate, or statistical uncertainty. Therefore, no conclusion about the direction, size, or precision of change in patient activation can be drawn from the registry record. The listed outcome measure and timeframe do not substitute for observed results. The record likewise does not report results for its secondary measures or participant satisfaction and program-use assessments.

The single-group design also limits what an observed change, if reported elsewhere, could establish. Without a concurrent comparison group, change over time would not by itself show that the intervention caused the change. The entry does not offer a randomized treatment contrast, and its status as completed does not resolve that limitation.

The safety counts are a separate part of the record: zero serious adverse events, zero other adverse events, and zero deaths are recorded, with 29 at risk in each adverse-event category. Those entries are informative as registry data but do not establish the absence of all harms. Missing follow-up and the absence of details about analytic populations and missing-data methods also limit interpretation of any outcome estimates that may be reported elsewhere.

In short, the record describes a pilot intended to develop and evaluate a psychiatry-focused shared decision-making intervention, but does not supply the numerical outcome findings needed to judge changes in PAM-MH or other outcomes. It supports interpretation of the study's scope and design, not a quantitative claim about intervention effects.

13. Why This Trial Matters Statistically

This study is statistically notable for the difference between a developmental, single-group evaluation and a controlled treatment comparison. Its stated aims span intervention adaptation, feasibility and acceptability, and exploration of potential mechanisms and preliminary outcomes. Those aims call for careful separation of descriptive evidence about implementation from evidence that would estimate a causal treatment effect.

The primary measure is specified in a way that identifies its construct, scale, direction, and timing. That information helps readers understand what an eventual result would represent. At the same time, the absence of the observed means, variability, and change estimate means that the primary statistical question cannot be answered from the registry record. A measure can be well described while its results remain unavailable in the entry.

The study also illustrates why design and analysis details matter alongside results. A before-and-after pattern in one group would not have the same interpretation as a difference between randomized groups. The record's missing follow-up note makes it important to know which observations entered any analysis and how missing data were handled. Those details are not reported.

Finally, planning calculations should be distinguished from the design that generated the study data. The stated sample-size illustration assumes equal allocation between two arms and is explicitly described as a planning exercise, whereas the study itself is recorded as single-group. This is a useful reminder that planning outputs are conditional on their assumptions and are not observed evidence or observed power. The record is therefore informative about statistical design constraints, while leaving the principal outcome result unreported.

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 central limitation of the registry record for statistical interpretation is that it does not report the numerical results for the primary endpoint. There are no PAM-MH means, standard deviations, change estimates, confidence intervals, or test results in the entry. Without these, neither the observed pattern nor its precision can be assessed. The listed secondary measures also have no reported results in the registry record.

The single-group design has no concurrent control arm. Consequently, any change observed between baseline and follow-up would not, on its own, identify an intervention effect. The registry record does not describe a randomized comparison, and it does not provide an adjusted analysis that could address this design limitation.

Loss to follow-up is acknowledged: 7 subjects were lost. The entry does not explain reasons or timing, specify which outcomes were missing, identify the primary analysis population, or describe how missing observations were handled. These omissions prevent assessment of whether missing data could affect the estimates.

The registry record does not report a detailed statistical analysis plan, multiplicity procedure, interim analysis details, or the method used to analyze change over time. It also does not state a clinically important threshold for PAM-MH change. Safety information is limited to event counts and at-risk counts, without further details on event definitions or monitoring. These are limitations of what is documented in the registry record and should not be treated as proof that unreported procedures or information do not exist elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry — NCT04601194.
• Registry record last updated 2023-01-26; status last verified 2023-01.
• Results first posted 2023-01-26.
• 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

NCT04601194 is a completed, single-group behavioral study sponsored by Indiana University. The intervention combined mental health coaching with assigned Virtual Provider Program practice. The study summary describes 4 weekly goal-setting and coaching sessions with training and practice, and states that the project aimed to adapt a shared decision-making intervention for psychiatry and assess feasibility, acceptability, potential mechanisms, and preliminary outcomes.

The primary outcome is PAM-MH, a 13-item measure scored from 0 to 100, with higher scores indicating greater activation. Its timeframe is baseline and 3 months. Enrollment is recorded as 29, and the primary outcome description notes that 7 subjects were lost to follow-up. Numerical primary and secondary outcome results, analysis details, and missing-data methods are not reported in the registry record.

The safety entries record 0 serious adverse events, 0 other adverse events, and 0 deaths. The study has no control group, so it does not provide a randomized comparison of intervention and control outcomes.