Clinical trial NCT02025647: An Evaluation of Innerview™, a Web-based Tool to Support the Integration of Mental Health in the Primary Care Setting
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health
Keywords: Mood disorders
Anxiety disorders
Eating concerns
Pain concerns
Alcohol abuse
Self harm
Mental health
Clinical Decision Support
Lead sponsor: Pearson/Clinical Assessment
Sponsor class: INDUSTRY
First posted: 2014-01-01
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Accuracy of the Narrative Module
timeFrame: Immediate
measure: Reliability of the Narrative Module
timeFrame: 24-48 hours
measure: Standard Error of Measure for the Individualized Rating Scale (Rating Module)
timeFrame: approximate 5 minutes between ratings
Secondary outcomes:
measure: Provider Survey (Question 1)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 2)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 3)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 4)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 5)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 6)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 7)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 8)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 9)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 10)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Provider Survey (Question 11)
timeFrame: Administered Innerview session on at least 15 subjects
measure: Subject Survey (Question 1)
timeFrame: Immediate
measure: Subject Survey (Question 2)
timeFrame: Immediate
measure: Subject Survey (Question 3)
timeFrame: Immediate
measure: Subject Survey (Question 4)
timeFrame: Immediate
measure: Subject Survey (Question 5)
timeFrame: Immediate
measure: Subject Survey (Question 6)
timeFrame: Immediate
measure: Subject Survey (Question 7)
timeFrame: Immediate
measure: Subject Survey (Question 8)
timeFrame: Immediate
measure: Subject Survey (Question 9)
timeFrame: Immediate
measure: Subject Survey (Question 10)
timeFrame: Immediate
Other outcomes:
measure: Completion Times
timeFrame: Study Duration
Locations:
city: Roseville
country: United States
facility: Peter J. Knoblich MD
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Rockford
country: United States
facility: University of Illinois
state: Illinois
city: Portland
country: United States
facility: Intermed, PA
state: Maine
city: Winston-Salem
country: United States
facility: Novant Healthcare
state: North Carolina
Study officials:
affiliation: Novant Healthcare
name: Sloan Manning, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Sherry Falsetti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Donald Nease, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peter J. Knoblich MD
name: Peter J Knoblich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermed, PA
name: William Ervin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katon W, Von Korff M, Lin E, Unutzer 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. doi: 10.1016/s0163-8343(97)00016-9.
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. doi: 10.1176/ajp.2006.163.7.1187.