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

NCT ID: NCT04601194

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2022-02-10

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Coaching and Virtual Provider Group

Mental Health Coaching and assigned practice with a Virtual Provider Program

Group Type: EXPERIMENTAL

Coaching and Virtual Provider Program Practice

Intervention Type: BEHAVIORAL

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

Interventions

Coaching and Virtual Provider Program Practice

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: collaborator

Eskenazi Health

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Michelle Salyers

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Salyers, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Sandra Eskenazi Mental Health Center

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34MH118314

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010326129

Identifier Type: -

Identifier Source: org_study_id