Mental Health
Conditions
Keywords
Mood disorders, Anxiety disorders, Eating concerns, Pain concerns, Alcohol abuse, Self harm, Mental health, Clinical Decision Support
Brief summary
Innerview can address some of the challenges of integrating mental health and primary care by accurately and reliably collecting mental health evidence and activities directly from patients, and then organizing and automating that evidence and activity into reports for providers and care teams that support diagnosis, treatment planning and monitoring of the mental health issues within a practice population.
Detailed description
To deliver integrated quality care, innovative strategies are needed to efficiently collect, understand, monitor and manage mental health evidence and its contribution to the primary care office visit. Computer applications can provide solutions to providers by helping their processes to be feasible, manageable, and sustainable. We hypothesize that by both providing patients the opportunity to reflect on their physical, emotional and behavioral symptoms and functioning, and giving providers accurate, reliable, current, symptom-based mental health evidence in an accessible organized format prior to the face-to-face visit, Innerview will enhance diagnostic and treatment processes from both a patient- and population-based perspective, as well as enhance communication between patient and provider.
Interventions
None listed
Sponsors
Pearson/Clinical Assessment
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Provide signed and dated informed consent form * Be aged 18 or older * Be willing to comply with all study procedures and be available for the duration of the study * Be able to read English at an 8th grade level (as determined by physician) * Have internet access to email with a computer and/or tablet
Exclusion criteria
* Patients are excluded from study participation if they meet any of the following criteria: * Inability to provide consent due to guardianship issues * Currently experiencing psychotic symptoms (as determined by physician) * Anything that, in the opinion of the Investigator, would preclude the subject's full compliance with or completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Error of Measure for the Individualized Rating Scale (Rating Module) | approximate 5 minutes between ratings | What is the standard error of measurement (SEM) for test/retest symptom ratings on a 0 - 10 point scale |
| Accuracy of the Narrative Module | Immediate | Out of 139 subjects using Innerview for the first time, how many subjects approved their initial version of their narrative versus chose to start over? |
| Reliability of the Narrative Module | 24-48 hours | What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider Survey (Question 3) | Administered Innerview session on at least 15 subjects | The information provided by Innerview was well organized in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 4) | Administered Innerview session on at least 15 subjects | The information provided by Innerview was well communicated in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 5) | Administered Innerview session on at least 15 subjects | In my opinion, the Innerview narrative process will help prepare patients for treatment. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 6) | Administered Innerview session on at least 15 subjects | Innerview will help me better identify patients who suffer from a mental health concern. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 7) | Administered Innerview session on at least 15 subjects | Innerview will function well within my current work flow Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 8) | Administered Innerview session on at least 15 subjects | My patients reacted positively to Innerview. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 9) | Administered Innerview session on at least 15 subjects | In my opinion, incorporating Innerview into my practice would require an acceptable amount of time and effort from myself and staff Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 10) | Administered Innerview session on at least 15 subjects | The benefits of Innerview will outweigh the effort to implement and operate it. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 11) | Administered Innerview session on at least 15 subjects | On average, how much extra time do you estimate that you spent with your patients evaluating and discussing the information collected through Innerview? |
| Subject Survey (Question 2) | Immediate | Compared to other health care questionnaires I have taken, I would rate this system highly. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Subject Survey (Question 3) | Immediate | The program was easy to use. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Subject Survey (Question 4) | Immediate | This tool will contribute positively to my health care. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Subject Survey (Question 5) | Immediate | The program included all of the symptoms I wanted to share with my doctor. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Subject Survey (Question 6) | Immediate | I was able to select words and phrases that I normally use to talk about my symptoms. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Subject Survey (Question 7) | Immediate | Q7. I would encourage other doctors to use this system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Subject Survey (Question 8) | Immediate | Telling my story helped me prepare for treatment. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Subject Survey (Question 9) | Immediate | The demonstration showed me how to use the system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Subject Survey (Question 10) | Immediate | It took an acceptable amount of time to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Subject Survey (Question 1) | Immediate | I am satisfied with how I was able to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 1) | Administered Innerview session on at least 15 subjects | The information provided by Innerview is valuable in understanding and treating my patients. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
| Provider Survey (Question 2) | Administered Innerview session on at least 15 subjects | The information provided by Innerview was consistent with my previous observations of my patients. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree |
Other
| Measure | Time frame | Description |
|---|---|---|
| Completion Times | Study Duration | On average, the number of minutes taken to complete both the narrative and rating modules? |
Countries
United States
Participant flow
Recruitment details
This study is comprised of a series of 3 study sessions spanning a maximum participation period of 30-45 days. All subjects are intended to complete Study Session 1 and 2, spanning a duration of 24-48 hours. Those subjects who endorsed enough diagnostic symptoms to generate an Individualized Rating Scale will participate through Study Session 3.
Participants by arm
| Arm | Count |
|---|---|
| Innerview MHCDS Innerview, Mental Health Clinical Decision Support tool | 139 |
| Total | 139 |
Baseline characteristics
| Characteristic | Innerview MHCDS |
|---|---|
| Age, Customized 18-40 years | 46 participants |
| Age, Customized 41-60 years | 38 participants |
| Age, Customized 61+ years | 55 participants |
| Race/Ethnicity, Customized African American | 15 participants |
| Race/Ethnicity, Customized Hispanic | 5 participants |
| Race/Ethnicity, Customized Other | 2 participants |
| Race/Ethnicity, Customized White | 117 participants |
| Region of Enrollment United States | 139 participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 50 Participants |
| Those with and w/o mental health concerns as identified by each investigator With Mental Health Concerns | 35 participants |
| Those with and w/o mental health concerns as identified by each investigator Without Mental Health Concerns | 104 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 139 |
| serious Total, serious adverse events | 0 / 139 |
Outcome results
Primary
Accuracy of the Narrative Module
Out of 139 subjects using Innerview for the first time, how many subjects approved their initial version of their narrative versus chose to start over?
Time frame: Immediate
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Innerview MHCDS | Accuracy of the Narrative Module | 139 participants |
Primary
Reliability of the Narrative Module
What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart?
Time frame: 24-48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Reliability of the Narrative Module | 94 percentage of agreement | Standard Deviation 5 |
Primary
Standard Error of Measure for the Individualized Rating Scale (Rating Module)
What is the standard error of measurement (SEM) for test/retest symptom ratings on a 0 - 10 point scale
Time frame: approximate 5 minutes between ratings
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Innerview MHCDS | Standard Error of Measure for the Individualized Rating Scale (Rating Module) | .9 units on a scale |
Secondary
Provider Survey (Question 1)
The information provided by Innerview is valuable in understanding and treating my patients. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 1) | 4.5 units on a scale |
Secondary
Provider Survey (Question 10)
The benefits of Innerview will outweigh the effort to implement and operate it. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 10) | 3.5 units on a scale |
Secondary
Provider Survey (Question 11)
On average, how much extra time do you estimate that you spent with your patients evaluating and discussing the information collected through Innerview?
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 11) | 15 minutes |
Secondary
Provider Survey (Question 2)
The information provided by Innerview was consistent with my previous observations of my patients. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 2) | 4.3 units on a scale |
Secondary
Provider Survey (Question 3)
The information provided by Innerview was well organized in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 3) | 4.3 units on a scale |
Secondary
Provider Survey (Question 4)
The information provided by Innerview was well communicated in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 4) | 4.3 units on a scale |
Secondary
Provider Survey (Question 5)
In my opinion, the Innerview narrative process will help prepare patients for treatment. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 5) | 3.5 units on a scale |
Secondary
Provider Survey (Question 6)
Innerview will help me better identify patients who suffer from a mental health concern. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 6) | 3.7 units on a scale |
Secondary
Provider Survey (Question 7)
Innerview will function well within my current work flow Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects, one investigator did not respond to this item.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 7) | 4.2 units on a scale |
Secondary
Provider Survey (Question 8)
My patients reacted positively to Innerview. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 8) | 4.2 units on a scale |
Secondary
Provider Survey (Question 9)
In my opinion, incorporating Innerview into my practice would require an acceptable amount of time and effort from myself and staff Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Administered Innerview session on at least 15 subjects
Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Innerview MHCDS | Provider Survey (Question 9) | 3.2 units on a scale |
Secondary
Subject Survey (Question 1)
I am satisfied with how I was able to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 1) | 4.03 units on a scale | Standard Deviation 0.73 |
Secondary
Subject Survey (Question 10)
It took an acceptable amount of time to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 10) | 4.11 units on a scale | Standard Deviation 0.7 |
Secondary
Subject Survey (Question 2)
Compared to other health care questionnaires I have taken, I would rate this system highly. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 2) | 3.89 units on a scale | Standard Deviation 0.78 |
Secondary
Subject Survey (Question 3)
The program was easy to use. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 3) | 3.89 units on a scale | Standard Deviation 0.92 |
Secondary
Subject Survey (Question 4)
This tool will contribute positively to my health care. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 4) | 4.39 units on a scale | Standard Deviation 0.61 |
Secondary
Subject Survey (Question 5)
The program included all of the symptoms I wanted to share with my doctor. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 5) | 4.44 units on a scale | Standard Deviation 0.59 |
Secondary
Subject Survey (Question 6)
I was able to select words and phrases that I normally use to talk about my symptoms. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 6) | 4.25 units on a scale | Standard Deviation 0.72 |
Secondary
Subject Survey (Question 7)
Q7. I would encourage other doctors to use this system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 7) | 4.10 units on a scale | Standard Deviation 0.74 |
Secondary
Subject Survey (Question 8)
Telling my story helped me prepare for treatment. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 8) | 3.81 units on a scale | Standard Deviation 0.82 |
Secondary
Subject Survey (Question 9)
The demonstration showed me how to use the system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Innerview MHCDS | Subject Survey (Question 9) | 3.95 units on a scale | Standard Deviation 0.75 |
Other Pre-specified
Completion Times
On average, the number of minutes taken to complete both the narrative and rating modules?
Time frame: Study Duration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Innerview MHCDS | Completion Times | 15.56 minutes |
Post Hoc
Mental Health Prevalence Rates Comparison
What is the percentage of subjects where the provider was unaware of any mental health concerns yet Innerview identified them as having hit a rule out or diagnostic consideration for a mental health disorder vs the US 12 Month Prevalence Rate? US 12 Month Prevalence Rate = 26.2% (http://www.ncbi.nlm.nih.gov/pubmed/15939839)
Time frame: Study Duration
Population: 104 subjects had no known mental health concerns
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Innerview MHCDS | Mental Health Prevalence Rates Comparison | 27 percentage of subjects |