Mental HealthNCT02025647
An Evaluation of Innerview™, a Web-based Tool to Support the Integration of Mental Health in the Primary Care Setting
An observational study of Mental Health, run by Pearson/Clinical Assessment at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- How many people
- 139 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2014to May 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado
Denver, Colorado, 80045
Intermed, PA
Portland, Maine, 04101
University of Illinois
Rockford, Illinois, 61108
Peter J. Knoblich MD
Roseville, California, 95661
Novant Healthcare
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Mental Health
- Keywords
- Mood disorders, Anxiety disorders, Eating concerns, Pain concerns, Alcohol abuse, Self harm, Mental health, Clinical Decision Support
- Medical subject headings
- Psychological Well-Being, Mood Disorders, Anxiety Disorders, Alcoholism, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Innerview MHCDS | Innerview, Mental Health Clinical Decision Support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: Immediate
Reliability of the Narrative Module
What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart?
Measured: 24-48 hours
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
Measured: approximate 5 minutes between ratings
Secondary outcomes (21)
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
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Administered Innerview session on at least 15 subjects
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?
Measured: Administered Innerview session on at least 15 subjects
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
Measured: Immediate
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
Measured: Immediate
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
Measured: Immediate
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
Measured: Immediate
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
Measured: Immediate
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
Measured: Immediate
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
Measured: Immediate
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
Measured: Immediate
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
Measured: Immediate
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
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearson/Clinical Assessment
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sloan Manning, MD, Principal investigator, Novant HealthcareSherry Falsetti, PhD, Principal investigator, University of Illinois ChicagoDonald Nease, MD, Principal investigator, University of Colorado, DenverPeter J Knoblich, MD, Principal investigator, Peter J. Knoblich MDWilliam Ervin, MD, Principal investigator, Intermed, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025647
- Sponsor's protocol ID
- IV-0022
- Status last verified
- Sep 2015
- First submitted
- 22 Dec 2013
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 9218985Wang 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.
PubMed 16816223
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02025647
- Acronym / sponsor ID
- IV-0022
- Conditions
- Mental Health
- Keywords
- Mood disorders, Anxiety disorders, Eating concerns, Pain concerns, Alcohol abuse, Self harm, Mental health, Clinical Decision Support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Pearson/Clinical AssessmentIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 1 Jan 2014 (estimated)
- Results
- Posted 19 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Innerview MHCDS | – | –Innerview, Mental Health Clinical Decision Support tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Key exclusion criteria (4 listed)
- Patients are excluded from study participation if they meet any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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?
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
21 secondary outcomes
Provider Survey (Question 1)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 2)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 3)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 4)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 5)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 6)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 7)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 8)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 9)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 10)
Time frame: Administered Innerview session on at least 15 subjects
Provider Survey (Question 11)
Time frame: Administered Innerview session on at least 15 subjects
Subject Survey (Question 1)
Time frame: Immediate
Subject Survey (Question 2)
Time frame: Immediate
Subject Survey (Question 3)
Time frame: Immediate
Subject Survey (Question 4)
Time frame: Immediate
Subject Survey (Question 5)
Time frame: Immediate
Subject Survey (Question 6)
Time frame: Immediate
Subject Survey (Question 7)
Time frame: Immediate
Subject Survey (Question 8)
Time frame: Immediate
Subject Survey (Question 9)
Time frame: Immediate
Subject Survey (Question 10)
Time frame: Immediate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9218985Katon 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.
- Background: PubMed 16816223Wang 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.
- Mental Health: A Report of the Surgeon GeneralLink provided by the sponsor.
- Prevalence of serious mental illness among U.S. adults by age, sex, and raceLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sloan Manning, MD principal investigator
Novant Healthcare
Sherry Falsetti, PhD principal investigator
University of Illinois Chicago
Donald Nease, MD principal investigator
University of Colorado, Denver
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health, run by Pearson/Clinical Assessment at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the Narrative Module (time frame: Immediate). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02025647, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.