Clinical trial NCT04601194: Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry
Official title: Study Title: Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Shared Decision Making
Keywords: serious mental illness
shared decision making-psychiatric medications
mental health
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Florida
name: Eskenazi Health
First posted: 2020-10-23
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Patient Activation Measure for Mental Health (PAM-MH)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Altarum Consumer Engagement (ACE) Measure
timeFrame: Baseline, 3 months
measure: Perceived Efficacy in Patient-Provider Interactions (PEPPI-5)
timeFrame: Baseline, 3 months
measure: Illness Management and Recovery (IMR) Scale
timeFrame: Baseline, 3 months
measure: Recovery Assessment Scale (Brief Version)
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Sandra Eskenazi Mental Health Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Michelle Salyers, PhD
role: PRINCIPAL_INVESTIGATOR
References: