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Completed

NCT Number: NCT04601194

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 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 the intervention.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sandra Eskenazi Mental Health Center

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Current patient at the participating mental health center
  • English speaking
  • Willingness to participate in weekly coaching sessions, engage in practice with the Virtual Provider program

Exclusion criteria

  • Under 18 years of age
  • No reasonable access to use of internet on a computer
  • Inability or unwillingness to use a computer (necessary for Virtual Provider Program practice)
  • Never or rarely uses a computer or similar device (based on self-report)
  • Very or somewhat uncomfortable using a computer or similar device (based on self-report)

Treatment and study plan

Coaching and Virtual Provider Program Practice

Behavioral

4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice

Primary outcomes

  1. Patient Activation Measure for Mental Health (PAM-MH)

    Time frame: Baseline, 3 months

    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.

Secondary outcomes

  1. Altarum Consumer Engagement (ACE) Measure

    Time frame: Baseline, 3 months

    The 12-item Altarum Consumer Engagement (ACE) Measure assesses commitment, informed choice, and navigation. Scores range from 0-4, with higher scores indicating more engagement.

  2. Perceived Efficacy in Patient-Provider Interactions (PEPPI-5)

    Time frame: Baseline, 3 months

    The 5-item Perceived Efficacy in Patient-Provider Interactions (PEPPI-5) measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit; scores range from 1-10. The questionnaire is rated on a 10-point Likert scale, with higher scores indicating higher perceived efficacy in the interactions.

  3. Illness Management and Recovery (IMR) Scale

    Time frame: Baseline, 3 months

    Illness self management will be assessed with the consumer-rated Illness Management and Recovery (IMR) Scale; items are rated on a 5-point behaviorally anchored scale and averaged. Scores range from 1 to 5, with higher number reflecting greater self-management.

  4. Recovery Assessment Scale (Brief Version)

    Time frame: Baseline, 3 months

    Recovery attitudes will be assessed using the total score of the 20-item Brief version of the Recovery Assessment Scale. Using the average score, the scale ranges from 1 to 5, with 5 indicating greater self-reported recovery.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Eskenazi Health
  • National Institute of Mental Health (NIMH)
  • University of Florida

Registry information

Official study title

Study Title: Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion - Pilot Study

Acronym: GET-PrEPD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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