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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH118314 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of Florida | OTHER |
| Eskenazi Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaching and Virtual Provider Group | Experimental | Mental Health Coaching and assigned practice with a Virtual Provider Program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaching and Virtual Provider Program Practice | Behavioral | 4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months |
| Perceived Efficacy in Patient-Provider Interactions (PEPPI-5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Salyers, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandra Eskenazi Mental Health Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 7 subjects were lost to follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
|
approximately 3 months
Adverse events were not systematically collected for this minimal risk study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Salyers | Indiana University | 317-274-2904 | mpsalyer@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2022 | Nov 17, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 17, 2021 | Nov 17, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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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, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary Mental Health Diagnosis | Count of Participants | Participants |
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| Current Marital Status | Count of Participants | Participants |
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| Highest Level of Education | Count of Participants | Participants |
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| Current Employment Status | Count of Participants | Participants |
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| Current Housing | Count of Participants | Participants |
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| Caretaking responsibilities for a child or children less than 18 years in same household | Count of Participants | Participants |
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| Units | Counts |
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| Participants |
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| Secondary | 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. | 7 subjects were lost to follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
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| Secondary | 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. | 7 subjects were lost to follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
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| Secondary | 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. | 7 subjects were lost to follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
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| Secondary | 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. | 7 subjects were lost to follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months |
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| 29 |
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