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Clinical Trials/NCT02025647
NCT02025647
Completed
Not Applicable

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

Pearson/Clinical Assessment5 sites in 1 country139 target enrollmentJanuary 2014
ConditionsMental Health

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health
Sponsor
Pearson/Clinical Assessment
Enrollment
139
Locations
5
Primary Endpoint
Standard Error of Measure for the Individualized Rating Scale (Rating Module)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
May 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pearson/Clinical Assessment
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

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?

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?

Secondary Outcomes

  • Provider Survey (Question 8)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 4)(Immediate)
  • Provider Survey (Question 1)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 5)(Immediate)
  • Subject Survey (Question 6)(Immediate)
  • Subject Survey (Question 7)(Immediate)
  • Provider Survey (Question 2)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 4)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 10)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 3)(Immediate)
  • Provider Survey (Question 3)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 6)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 7)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 8)(Immediate)
  • Subject Survey (Question 9)(Immediate)
  • Subject Survey (Question 10)(Immediate)
  • Provider Survey (Question 5)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 9)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 11)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 1)(Immediate)
  • Subject Survey (Question 2)(Immediate)

Study Sites (5)

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