Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry (GET-PrEPD)
Primary Purpose
Mental Illness, Shared Decision Making
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaching and Virtual Provider Program Practice
Sponsored by
About this trial
This is an interventional supportive care trial for Mental Illness focused on measuring serious mental illness, shared decision making-psychiatric medications, mental health
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)
Sites / Locations
- Sandra Eskenazi Mental Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Coaching and Virtual Provider Group
Arm Description
Mental Health Coaching and assigned practice with a Virtual Provider Program
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04601194
First Posted
October 19, 2020
Last Updated
January 9, 2023
Sponsor
Indiana University
Collaborators
National Institute of Mental Health (NIMH), University of Florida, Eskenazi Health
1. Study Identification
Unique Protocol Identification Number
NCT04601194
Brief Title
Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry
Acronym
GET-PrEPD
Official Title
Study Title: Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute of Mental Health (NIMH), University of Florida, Eskenazi Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness, Shared Decision Making
Keywords
serious mental illness, shared decision making-psychiatric medications, mental health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coaching and Virtual Provider Group
Arm Type
Experimental
Arm Description
Mental Health Coaching and assigned practice with a Virtual Provider Program
Intervention Type
Behavioral
Intervention Name(s)
Coaching and Virtual Provider Program Practice
Intervention Description
4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice
Primary Outcome Measure Information:
Title
Patient Activation Measure for Mental Health (PAM-MH)
Description
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.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Altarum Consumer Engagement (ACE) Measure
Description
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.
Time Frame
Baseline, 3 months
Title
Perceived Efficacy in Patient-Provider Interactions (PEPPI-5)
Description
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.
Time Frame
Baseline, 3 months
Title
Illness Management and Recovery (IMR) Scale
Description
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.
Time Frame
Baseline, 3 months
Title
Recovery Assessment Scale (Brief Version)
Description
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.
Time Frame
Baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Salyers, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandra Eskenazi Mental Health Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry
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