NCT04601194: GET-PrEPD

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

Completed NA Results posted Last updated 26 January 2023

What this trial tests

NA trial testing Coaching and Virtual Provider Program Practice in Mental Illness in 29 participants. Completed in 10 February 2022.

Timeline

20 April 2021

Primary endpoint
10 February 2022

10 February 2022

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	29
Start date	20 April 2021
Primary completion	10 February 2022
Estimated completion	10 February 2022
Sites	1 location across United States

Drugs / interventions tested

• Coaching and Virtual Provider Program Practice

Conditions studied

• Mental Illness — all drugs for Mental Illness →
• Shared Decision Making — all drugs for Shared Decision Making →

Sponsor

Indiana University

Who can join

18 and older, any sex, with Mental Illness or Shared Decision Making. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Activation Measure for Mental Health (PAM-MH) Primary · 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.

Baseline

Group	Value	95% CI
Coaching and Virtual Provider Group	59.8	± 17.1

3 Months

Group	Value	95% CI
Coaching and Virtual Provider Group	61.6	± 12.1

Altarum Consumer Engagement (ACE) Measure Secondary · 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.

Baseline

Group	Value	95% CI
Coaching and Virtual Provider Group	2.4	± 0.7

3 Months

Group	Value	95% CI
Coaching and Virtual Provider Group	2.4	± 0.6

Perceived Efficacy in Patient-Provider Interactions (PEPPI-5) Secondary · 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.

Baseline

Group	Value	95% CI
Coaching and Virtual Provider Group	7.6	± 2.1

3 Months

Group	Value	95% CI
Coaching and Virtual Provider Group	7.4	± 2.1

Illness Management and Recovery (IMR) Scale Secondary · 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.

Baseline

Group	Value	95% CI
Coaching and Virtual Provider Group	3.4	± 0.5

3 Months

Group	Value	95% CI
Coaching and Virtual Provider Group	3.5	± 0.5

Recovery Assessment Scale (Brief Version) Secondary · 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.

Baseline

Group	Value	95% CI
Coaching and Virtual Provider Group	4.0	± 0.6

3 Months

Group	Value	95% CI
Coaching and Virtual Provider Group	3.9	± 0.5

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Shared decision-making interventions for people with mental health conditions.
   Aoki Y, Yaju Y, Utsumi T, Sanyaolu L, et al · · 2022 · cited 34× · PMID 36367232 · DOI 10.1002/14651858.cd007297.pub3