Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025647
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : October 19, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Pearson/Clinical Assessment

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Mental Health

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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 139 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Innerview MHCDS
Innerview, Mental Health Clinical Decision Support tool


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Completion Times [ Time Frame: Study Duration ]
    On average, the number of minutes taken to complete both the narrative and rating modules?


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Innerview will be given universally / as indicated to 150 non-randomly selected subjects aged 18 and over seeking primary care in selected primary care study sites.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025647


Locations
Layout table for location information
United States, California
Peter J. Knoblich MD
Roseville, California, United States, 95661
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80045
United States, Illinois
University of Illinois
Rockford, Illinois, United States, 61108
United States, Maine
Intermed, PA
Portland, Maine, United States, 04101
United States, North Carolina
Novant Healthcare
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Pearson/Clinical Assessment
Investigators
Layout table for investigator information
Principal Investigator: Sloan Manning, MD Novant Healthcare
Principal Investigator: Sherry Falsetti, PhD University of Illinois at Chicago
Principal Investigator: Donald Nease, MD University of Colorado, Denver
Principal Investigator: Peter J Knoblich, MD Peter J. Knoblich MD
Principal Investigator: William Ervin, MD Intermed, PA
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Pearson/Clinical Assessment
ClinicalTrials.gov Identifier: NCT02025647    
Other Study ID Numbers: IV-0022
First Posted: January 1, 2014    Key Record Dates
Results First Posted: October 19, 2015
Last Update Posted: October 19, 2015
Last Verified: September 2015
Keywords provided by Pearson/Clinical Assessment:
Mood disorders
Anxiety disorders
Eating concerns
Pain concerns
 Alcohol abuse
Self harm
Mental health
Clinical Decision Support