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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04601194

Acronym

GET-PrEPD

Enrollment

Registered

2020-10-23

Start date

2021-04-20

Completion date

2022-02-10

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Illness, Shared Decision Making

Keywords

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

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.

Interventions

BEHAVIORALCoaching and Virtual Provider Program Practice

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Patient Activation Measure for Mental Health (PAM-MH)	Baseline, 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.

Secondary

Measure	Time frame	Description
Altarum Consumer Engagement (ACE) Measure	Baseline, 3 months	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)	Baseline, 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 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	Baseline, 3 months	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)	Baseline, 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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Coaching and Virtual Provider Group Mental Health Coaching and assigned practice with a Virtual Provider Program Coaching and Virtual Provider Program Practice: 4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice	29
Total	29

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	7

Baseline characteristics

Characteristic	Coaching and Virtual Provider Group
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	29 Participants
Age, Continuous	45 years STANDARD_DEVIATION 13
Caretaking responsibilities for a child or children less than 18 years in same household No	24 Participants
Caretaking responsibilities for a child or children less than 18 years in same household Yes	5 Participants
Current Employment Status Casual Work	2 Participants
Current Employment Status Disabled	13 Participants
Current Employment Status Other: Retired and Disabled	1 Participants
Current Employment Status Paid Employment	5 Participants
Current Employment Status Student	1 Participants
Current Employment Status Unemployed and looking for work	5 Participants
Current Employment Status Unemployed and not looking for work	2 Participants
Current Housing Homeless (includes in shelter)	3 Participants
Current Housing Living with family (not spouse)	4 Participants
Current Housing Own apartment or house-alone	4 Participants
Current Housing Own apartment or house-with spouse, living as married, with friends	10 Participants
Current Housing Semi-independent living (staff member lives on site or foster family care)	1 Participants
Current Housing Staying with friends or family temporarily	5 Participants
Current Housing Structured congregate living (e.g., nursing home, group home, residential facility)	2 Participants
Current Marital Status Currently married or living with a partner	2 Participants
Current Marital Status Separated or divorced	6 Participants
Current Marital Status Single, never married	20 Participants
Current Marital Status Widowed	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Highest Level of Education Bachelors degree	3 Participants
Highest Level of Education High school degree/GED	9 Participants
Highest Level of Education Less than high school/GED	5 Participants
Highest Level of Education Some college coursework	12 Participants
Primary Mental Health Diagnosis Anxiety Disorders (Anxiety Disorder, Panic Disorder, Post-traumatic Stress Disorder)	4 Participants
Primary Mental Health Diagnosis Bipolar Disorder	4 Participants
Primary Mental Health Diagnosis Major Depressive Disorder	7 Participants
Primary Mental Health Diagnosis Other (Difficulty Controlling Anger, Adjustment Disorder)	2 Participants
Primary Mental Health Diagnosis Schizophrenia (Schizophrenia, Schizoaffective Disorder, Chronic Schizophrenia)	12 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	19 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	9 Participants
Region of Enrollment United States	29 participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	15 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 29
other Total, other adverse events	0 / 29
serious Total, serious adverse events	0 / 29

Outcome results

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.