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Completed

NCT Number: NCT02025647

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peter J. Knoblich MD, Roseville, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Accuracy of the Narrative Module

    Time frame: 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?

  2. Reliability of the Narrative Module

    Time frame: 24-48 hours

    What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart?

  3. Standard Error of Measure for the Individualized Rating Scale (Rating Module)

    Time frame: approximate 5 minutes between ratings

    What is the standard error of measurement (SEM) for test/retest symptom ratings on a 0 - 10 point scale

Secondary outcomes

  1. Provider Survey (Question 1)

    Time frame: 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

  2. Provider Survey (Question 2)

    Time frame: 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

  3. Provider Survey (Question 3)

    Time frame: 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

  4. Provider Survey (Question 4)

    Time frame: 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

  5. Provider Survey (Question 5)

    Time frame: 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

  6. Provider Survey (Question 6)

    Time frame: 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

  7. Provider Survey (Question 7)

    Time frame: 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

  8. Provider Survey (Question 8)

    Time frame: 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

  9. Provider Survey (Question 9)

    Time frame: 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

  10. Provider Survey (Question 10)

    Time frame: 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

  11. Provider Survey (Question 11)

    Time frame: 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?

  12. Subject Survey (Question 1)

    Time frame: 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

  13. Subject Survey (Question 2)

    Time frame: 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

  14. Subject Survey (Question 3)

    Time frame: 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

  15. Subject Survey (Question 4)

    Time frame: 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

  16. Subject Survey (Question 5)

    Time frame: 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

  17. Subject Survey (Question 6)

    Time frame: 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

  18. Subject Survey (Question 7)

    Time frame: 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

  19. Subject Survey (Question 8)

    Time frame: 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

  20. Subject Survey (Question 9)

    Time frame: 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

  21. Subject Survey (Question 10)

    Time frame: 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

Other outcomes

  1. Completion Times

    Time frame: Study Duration

    On average, the number of minutes taken to complete both the narrative and rating modules?

Sponsors and collaborators

Lead sponsor

Pearson/Clinical Assessment

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2014
Registry last updated
Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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