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

NCT04601194 | Completed Results

• 2 other identifiers: 20103261291R34MH118314
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Mental Illness; Shared Decision Making

Keywords

serious mental illness; shared decision making-psychiatric medications; mental health

Outcome Measures

Primary Outcomes (1)

• Patient Activation Measure for Mental Health (PAM-MH)

  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.

  Baseline, 3 months

Secondary Outcomes (4)

• Altarum Consumer Engagement (ACE) Measure

  Baseline, 3 months

• Perceived Efficacy in Patient-Provider Interactions (PEPPI-5)

  Baseline, 3 months

• Illness Management and Recovery (IMR) Scale

  Baseline, 3 months

• Recovery Assessment Scale (Brief Version)

  Baseline, 3 months

Study Arms (1)

Coaching and Virtual Provider Group

EXPERIMENTAL

Mental Health Coaching and assigned practice with a Virtual Provider Program

Behavioral: Coaching and Virtual Provider Program Practice

Interventions

Coaching and Virtual Provider Program Practice BEHAVIORAL

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

Coaching and Virtual Provider Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Sandra Eskenazi Mental Health Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Results Point of Contact

• Title: Michelle Salyers
• Organization: Indiana University

mpsalyer@iu.edu

317-274-2904

Study Officials

• Michelle Salyers, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: April 20, 2021
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: January 26, 2023
• Results First Posted: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)