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NCT04601194 · ClinicalTrials.gov registry record · NA

Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry

A NA study, sponsored by Indiana University.

Completed
Registry status
NA
Development phase
29
Enrollment target

NCT04601194: Completed NA study, sponsored by Indiana University.

NCT04601194 is a NA study that has completed, run by Indiana University. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04601194, a NA study, has completed, sponsored by Indiana University.

COMPLETED
Registry status
NA
Development phase
29 participants
Enrollment target

Study Summary

GET PrEPD-Psychiatry is a mixed-methods, developmental study to adapt a shared decision making (SDM) intervention to be specific for psychiatry decisions (Aim 1, previously completed), evaluate its feasibility and acceptability (Aim 2), and examine potential mechanisms of change and preliminary outcomes (Aim 3) of this innovative intervention to increase SDM and self-management for adults with serious mental illness (SMI). In line with National Institute of Mental Health (NIMH) priorities, we are examining whether GET PrEPD-Psychiatry engages the target mechanisms that putatively underlie the intervention (i.e., patient activation and communication self-efficacy; Aim 3). Aim 1 used approximately 200 deidentified transcripts from our prior study of SDM in psychiatry to cull language used in decision-making. These conversations were then used to program the Virtual Provider to represent common interactions and decisions in psychiatric visits. Iterative testing of the use of the Virtual Provider has been completed and feedback was obtained from our psychiatry consultants to refine the program. For Aim 2, we will recruit up to 40 patients to participate in GET PrEPD-Psychiatry (4 weekly goal setting/coaching sessions, coupled with Virtual Provider training and practice). We will assess participant satisfaction and utility ratings, as well as track their use (frequency and time-on-task) of the Virtual Provider program. For Aim 3, we will follow enrolled patient participants, interviewing them at baseline and approximately 3 months later. We hypothesize that participants will have significantly 1) improved mechanisms of change, demonstrated by increases in self-reported activation and communication self-efficacy, 2) improved SDM, and 3) improved self-management and recovery attitudes. The Narrative Evaluation of Intervention Interview (NEII), completed at approximately 3 months, will be used as a qualitative interview guide to understand the acceptability and impact of th

Primary Outcome

The 13-item Patient Activation Measure for Mental Health (PAM-MH) assesses patient knowledge, skill, and confidence for self-managing one's chronic health condition. Scores range from 0 to 100, with higher numbers indicating greater activation.

Interventions

  • BEHAVIORAL Coaching and Virtual Provider Program Practice

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2021-04-20
Est. Completion 2022-02-10
Phase NA
Indiana University

890 total trials

What the finished NCT04601194 record still lists

NCT04601194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Coaching and Virtual Provider Program Practice is the first listed.

NCT04601194 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04601194 about?

NCT04601194 is a clinical study titled "Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry". GET PrEPD-Psychiatry is a mixed-methods, developmental study to adapt a shared decision making (SDM) intervention to be specific for psychiatry decisions (Aim 1, previously completed), evaluate its feasibility and acceptability (Aim 2), and examine potential mechanisms of change and preliminary outc...

What is the current status of trial NCT04601194?

This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2021-04-20. Estimated completion is 2022-02-10.

What interventions are being tested in trial NCT04601194?

The interventions under investigation include: Coaching and Virtual Provider Program Practice (BEHAVIORAL).

Who is sponsoring clinical trial NCT04601194?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04601194's enrollment target sits among peer trials

29 1702nd of 2000 higher than 297 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04601194, the US trial registry maintained by the National Library of Medicine. NCT04601194 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.