Trial Outcomes & Findings for Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry (NCT NCT04601194)
NCT ID: NCT04601194
Last Updated: 2023-01-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Baseline, 3 months
Results posted on
2023-01-26
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
Baseline Characteristics
Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry
Baseline characteristics by cohort
| Measure |
Coaching and Virtual Provider Group
n=29 Participants
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
|
|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
|
Primary Mental Health Diagnosis
Anxiety Disorders (Anxiety Disorder, Panic Disorder, Post-traumatic Stress Disorder)
|
4 Participants
n=5 Participants
|
|
Primary Mental Health Diagnosis
Bipolar Disorder
|
4 Participants
n=5 Participants
|
|
Primary Mental Health Diagnosis
Schizophrenia (Schizophrenia, Schizoaffective Disorder, Chronic Schizophrenia)
|
12 Participants
n=5 Participants
|
|
Primary Mental Health Diagnosis
Major Depressive Disorder
|
7 Participants
n=5 Participants
|
|
Primary Mental Health Diagnosis
Other (Difficulty Controlling Anger, Adjustment Disorder)
|
2 Participants
n=5 Participants
|
|
Current Marital Status
Single, never married
|
20 Participants
n=5 Participants
|
|
Current Marital Status
Currently married or living with a partner
|
2 Participants
n=5 Participants
|
|
Current Marital Status
Separated or divorced
|
6 Participants
n=5 Participants
|
|
Current Marital Status
Widowed
|
1 Participants
n=5 Participants
|
|
Highest Level of Education
Less than high school/GED
|
5 Participants
n=5 Participants
|
|
Highest Level of Education
High school degree/GED
|
9 Participants
n=5 Participants
|
|
Highest Level of Education
Some college coursework
|
12 Participants
n=5 Participants
|
|
Highest Level of Education
Bachelors degree
|
3 Participants
n=5 Participants
|
|
Current Employment Status
Paid Employment
|
5 Participants
n=5 Participants
|
|
Current Employment Status
Casual Work
|
2 Participants
n=5 Participants
|
|
Current Employment Status
Student
|
1 Participants
n=5 Participants
|
|
Current Employment Status
Unemployed and looking for work
|
5 Participants
n=5 Participants
|
|
Current Employment Status
Unemployed and not looking for work
|
2 Participants
n=5 Participants
|
|
Current Employment Status
Disabled
|
13 Participants
n=5 Participants
|
|
Current Employment Status
Other: Retired and Disabled
|
1 Participants
n=5 Participants
|
|
Current Housing
Homeless (includes in shelter)
|
3 Participants
n=5 Participants
|
|
Current Housing
Staying with friends or family temporarily
|
5 Participants
n=5 Participants
|
|
Current Housing
Structured congregate living (e.g., nursing home, group home, residential facility)
|
2 Participants
n=5 Participants
|
|
Current Housing
Semi-independent living (staff member lives on site or foster family care)
|
1 Participants
n=5 Participants
|
|
Current Housing
Living with family (not spouse)
|
4 Participants
n=5 Participants
|
|
Current Housing
Own apartment or house-with spouse, living as married, with friends
|
10 Participants
n=5 Participants
|
|
Current Housing
Own apartment or house-alone
|
4 Participants
n=5 Participants
|
|
Caretaking responsibilities for a child or children less than 18 years in same household
Yes
|
5 Participants
n=5 Participants
|
|
Caretaking responsibilities for a child or children less than 18 years in same household
No
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: 7 subjects were lost to follow-up.
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.
Outcome measures
| Measure |
Coaching and Virtual Provider Group
n=29 Participants
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
|
|---|---|
|
Patient Activation Measure for Mental Health (PAM-MH)
Baseline
|
59.8 units on a scale
Standard Deviation 17.1
|
|
Patient Activation Measure for Mental Health (PAM-MH)
3 Months
|
61.6 units on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: 7 subjects were lost to follow-up.
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.
Outcome measures
| Measure |
Coaching and Virtual Provider Group
n=29 Participants
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
|
|---|---|
|
Altarum Consumer Engagement (ACE) Measure
Baseline
|
2.4 units on a scale
Standard Deviation 0.7
|
|
Altarum Consumer Engagement (ACE) Measure
3 Months
|
2.4 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: 7 subjects were lost to follow-up.
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.
Outcome measures
| Measure |
Coaching and Virtual Provider Group
n=29 Participants
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
|
|---|---|
|
Perceived Efficacy in Patient-Provider Interactions (PEPPI-5)
Baseline
|
7.6 units on a scale
Standard Deviation 2.1
|
|
Perceived Efficacy in Patient-Provider Interactions (PEPPI-5)
3 Months
|
7.4 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: 7 subjects were lost to follow-up.
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.
Outcome measures
| Measure |
Coaching and Virtual Provider Group
n=29 Participants
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
|
|---|---|
|
Illness Management and Recovery (IMR) Scale
Baseline
|
3.4 units on a scale
Standard Deviation 0.5
|
|
Illness Management and Recovery (IMR) Scale
3 Months
|
3.5 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: 7 subjects were lost to follow-up.
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.
Outcome measures
| Measure |
Coaching and Virtual Provider Group
n=29 Participants
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
|
|---|---|
|
Recovery Assessment Scale (Brief Version)
Baseline
|
4.0 units on a scale
Standard Deviation 0.6
|
|
Recovery Assessment Scale (Brief Version)
3 Months
|
3.9 units on a scale
Standard Deviation 0.5
|
Adverse Events
Coaching and Virtual Provider Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place