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

Mental Illness Clinical Trial

— GET-PrEPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601194
• Other study ID #: 2010326129
• Secondary ID: 1R34MH118314
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: January 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness
• Shared Decision Making

Intervention

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

Locations

Country	Name	City	State
United States	Sandra Eskenazi Mental Health Center	Indianapolis	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University	Eskenazi Health, National Institute of Mental Health (NIMH), University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Altarum Consumer Engagement (ACE) Measure	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.	Baseline, 3 months
Secondary	Perceived Efficacy in Patient-Provider Interactions (PEPPI-5)	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.	Baseline, 3 months
Secondary	Illness Management and Recovery (IMR) Scale	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.	Baseline, 3 months
Secondary	Recovery Assessment Scale (Brief Version)	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.	Baseline, 3 months