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

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04601194
Collaborator
National Institute of Mental Health (NIMH) (NIH), University of Florida (Other), Eskenazi Health (Other)
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Study Details

Study Description

Brief 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 those 40 participants, interviewing them and observing SDM in sessions with their providers 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 based on coded audio-recorded clinic visits, and 3) improved self-management and recovery attitudes.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Coaching and Virtual Provider Program Practice
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study Title: Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion - Pilot Study
Actual Study Start Date :
Apr 20, 2021
Actual Primary Completion Date :
Feb 10, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Coaching and Virtual Provider Group

Mental Health Coaching and assigned practice with a Virtual Provider Program

Behavioral: Coaching and Virtual Provider Program Practice
4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice

Outcome Measures

Primary Outcome Measures

  1. Change in Shared Decision Making [Change from baseline to 3 months]

    The Shared Decision Making (SDM) Scale includes 9 items (scored as absent, partial, or complete) and is used for coding transcripts of audio from the subject's appointment with their mental health medication prescriber. Scores range from 0 to 27, with higher scores indicating more shared decision-making.

Secondary Outcome Measures

  1. Narrative Evaluation of Intervention Interview (NEII) [3 months]

    This acceptability assessment consists of 16 questions that focus on participant feedback on the whole intervention as well as specific components that were most and least helpful to them (e.g., goal setting, coaching sessions, Virtual Provider).

  2. Change in Patient Activation Measure for Mental Health (PAM-MH) [Change from baseline to 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.

  3. Change in Altarum Consumer Engagement (ACE) Measure [Change from baseline to 3 months]

    The 13-item Altarum Consumer Engagement (ACE) Measure assesses commitment, informed choice, and navigation. Scores range from 0 to 100, with higher scores indicating greater engagement.

  4. Change in Perceived Efficacy in Patient-Provider Interactions (PEPPI-5) [Change from baseline to 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 5 to 25, with higher scores indicating greater perceived efficacy.

  5. Change in Illness Management and Recovery (IMR) Scale [Change from baseline to 3 months]

    Illness self management will be assessed with the consumer-rated IIllness 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.

  6. Change in Recovery Assessment Scale (brief version) [Change from baseline to 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • At least 18 years of age

  • Current patient at the participating mental health center

  • Current patient at the time of screening of a prescriber who has consented to allow audio recording of clinical visits

  • English speaking

  • Willingness to participate in weekly coaching sessions, engage in practice with the Virtual Provider program, and for prescriber appointments to be audio recorded

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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sandra Eskenazi Mental Health Center Indianapolis Indiana United States 46202

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Michelle Salyers, PhD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michelle Salyers, Professor, Indiana University
ClinicalTrials.gov Identifier:
NCT04601194
Other Study ID Numbers:
  • 2010326129
  • 1R34MH118314
First Posted:
Oct 23, 2020
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michelle Salyers, Professor, Indiana University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2022