An Evaluation of Innerview™, a Web-based Tool to Support the Integration of Mental Health in the Primary Care Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open, Non-Randomized, Evaluation of Innerview™, an MHCDS Tool Used to Report Symptoms and Functioning Related to Common Mental Health Disorders in the Primary Care Setting

Conditions
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Mental Health

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Innerview MHCDS<br>Innerview, Mental Health Clinical Decision Support tool | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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? | Immediate | 
| Reliability of the Narrative Module | What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart? | 24-48 hours | 
| 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 | approximate 5 minutes between ratings | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Administered Innerview session on at least 15 subjects | 
| 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 | Administered Innerview session on at least 15 subjects | 
| 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 | Administered Innerview session on at least 15 subjects | 
| 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 | Administered Innerview session on at least 15 subjects | 
| 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 | Administered Innerview session on at least 15 subjects | 
| 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 | Administered Innerview session on at least 15 subjects | 
| 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 | Administered Innerview session on at least 15 subjects | 
| 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 | Administered Innerview session on at least 15 subjects | 
| 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 | Administered Innerview session on at least 15 subjects | 
| 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 | Administered Innerview session on at least 15 subjects | 
| 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? | Administered Innerview session on at least 15 subjects | 
| 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 | Immediate | 
| 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 | Immediate | 
| 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 | Immediate | 
| 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 | Immediate | 
| 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 | Immediate | 
| 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 | Immediate | 
| 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 | Immediate | 
| 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 | Immediate | 
| 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 | Immediate | 
| 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 | Immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mood disorders, Anxiety disorders, Eating concerns, Pain concerns, Alcohol abuse, Self harm, Mental health, Clinical Decision Support