Mental IllnessGET-PrEPDNCT04601194
Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry
A study testing Coaching and Virtual Provider Program Practice in people with Mental Illness and Shared Decision Making, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness, Shared Decision Making
- What is being tested?
- Coaching and Virtual Provider Program Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Sandra Eskenazi Mental Health Center
Indianapolis, Indiana, 46202
About this study
Official title: Study Title: Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion - Pilot Study
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.
- Conditions
- Mental Illness, Shared Decision Making
- Being tested
- Coaching and Virtual Provider Program Practice
- Keywords
- serious mental illness, shared decision making-psychiatric medications, mental health
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching and Virtual Provider Program PracticeBehavioural
4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice
| Study group | Role | What they receive |
|---|---|---|
| Coaching and Virtual Provider Group | Experimental | Mental Health Coaching and assigned practice with a Virtual Provider Program Receives: Behavioral: Coaching and Virtual Provider Program Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months
Secondary outcomes (4)
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.
Measured: Baseline, 3 months
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start20 Apr 2021
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Florida, Eskenazi Health
- Responsible party
- Principal investigator, Michelle Salyers, Indiana University
- Investigators
- Michelle Salyers, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601194
- Sponsor's protocol ID
- 2010326129
- Other IDs
- 1R34MH118314
- Acronym
- GET-PrEPD
- Status last verified
- Jan 2023
- First submitted
- 19 Oct 2020
- Last updated
- 26 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Title: Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion - Pilot Study
- ClinicalTrials.gov ID
- NCT04601194
- Acronym / sponsor ID
- GET-PrEPD / 2010326129
- Conditions
- Mental Illness, Shared Decision Making
- Keywords
- serious mental illness, shared decision making-psychiatric medications, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Florida, Eskenazi Health
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Posted 26 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coaching and Virtual Provider Group | Experimental | Behavioral: Coaching and Virtual Provider Program PracticeMental Health Coaching and assigned practice with a Virtual Provider Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching and Virtual Provider Program Practice4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice | Behavioural | Coaching and Virtual Provider Group |
Primary outcome
Patient Activation Measure for Mental Health (PAM-MH)
Time frame: 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.
4 secondary outcomes
Altarum Consumer Engagement (ACE) Measure
Time frame: Baseline, 3 months
Perceived Efficacy in Patient-Provider Interactions (PEPPI-5)
Time frame: Baseline, 3 months
Illness Management and Recovery (IMR) Scale
Time frame: Baseline, 3 months
Recovery Assessment Scale (Brief Version)
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Salyers, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching and Virtual Provider Program Practice in people with Mental Illness and Shared Decision Making, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Activation Measure for Mental Health (PAM-MH) (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.