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

Mental Health Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025647
• Other study ID #: IV-0022
• Status: Completed
• Phase: N/A
• First received: December 22, 2013
• Last updated: September 21, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Pearson/Clinical Assessment
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mental Health

Locations

Country	Name	City	State
United States	University of Colorado	Denver	Colorado
United States	Intermed, PA	Portland	Maine
United States	University of Illinois	Rockford	Illinois
United States	Peter J. Knoblich MD	Roseville	California
United States	Novant Healthcare	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pearson/Clinical Assessment

Country where clinical trial is conducted

United States, 

References & Publications (2)

Katon W, Von Korff M, Lin E, Unützer J, Simon G, Walker E, Ludman E, Bush T. Population-based care of depression: effective disease management strategies to decrease prevalence. Gen Hosp Psychiatry. 1997 May;19(3):169-78. Review. — View Citation

Wang PS, Demler O, Olfson M, Pincus HA, Wells KB, Kessler RC. Changing profiles of service sectors used for mental health care in the United States. Am J Psychiatry. 2006 Jul;163(7):1187-98. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Completion Times	On average, the number of minutes taken to complete both the narrative and rating modules?	Study Duration	No
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?	Immediate	No
Primary	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	No
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	approximate 5 minutes between ratings	No
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	Administered Innerview session on at least 15 subjects	No
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	Administered Innerview session on at least 15 subjects	No
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	Administered Innerview session on at least 15 subjects	No
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	Administered Innerview session on at least 15 subjects	No
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	Administered Innerview session on at least 15 subjects	No
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	Administered Innerview session on at least 15 subjects	No
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	Administered Innerview session on at least 15 subjects	No
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	Administered Innerview session on at least 15 subjects	No
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	Administered Innerview session on at least 15 subjects	No
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	Administered Innerview session on at least 15 subjects	No
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?	Administered Innerview session on at least 15 subjects	No
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	Immediate	No
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	Immediate	No
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	Immediate	No
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	Immediate	No
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	Immediate	No
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	Immediate	No
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	Immediate	No
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	Immediate	No
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	Immediate	No
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	Immediate	No

External Links

•   Mental health care services by family physisicans (position paper)
•   Mental Health: A Report of the Surgeon General
•   Prevalence of serious mental illness among U.S. adults by age, sex, and race