Trial Outcomes & Findings for An Evaluation of Innerview™, a Web-based Tool to Support the Integration of Mental Health in the Primary Care Setting (NCT NCT02025647)

NCT ID: NCT02025647

Last Updated: 2015-10-19

Results Overview

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?

• Recruitment status: COMPLETED
• Target enrollment: 139 participants
• Primary outcome timeframe: Immediate
• Results posted on: 2015-10-19

Participant Flow

This study is comprised of a series of 3 study sessions spanning a maximum participation period of 30-45 days. All subjects are intended to complete Study Session 1 and 2, spanning a duration of 24-48 hours. Those subjects who endorsed enough diagnostic symptoms to generate an Individualized Rating Scale will participate through Study Session 3.

Participant milestones

Measure	Innerview MHCDS Innerview, Mental Health Clinical Decision Support tool
Overall Study STARTED	139
Overall Study Session 1 (Narrative Module)	139
Overall Study Immediate Retest (Rating Module: 5 Min)	97
Overall Study Session 2 (Narrative Module: 24-48 Hrs)	117
Overall Study Session 3 (Rating Module: 30-45 Days)	76
Overall Study COMPLETED	139
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Innerview MHCDS n=139 Participants Innerview, Mental Health Clinical Decision Support tool
Age, Customized 18-40 years	46 participants n=5 Participants
Age, Customized 41-60 years	38 participants n=5 Participants
Age, Customized 61+ years	55 participants n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race/Ethnicity, Customized African American	15 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 participants n=5 Participants
Race/Ethnicity, Customized White	117 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=5 Participants
Region of Enrollment United States	139 participants n=5 Participants
Those with and w/o mental health concerns as identified by each investigator With Mental Health Concerns	35 participants n=5 Participants
Those with and w/o mental health concerns as identified by each investigator Without Mental Health Concerns	104 participants n=5 Participants

PRIMARY outcome

Timeframe: 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?

Outcome measures

Measure	Innerview MHCDS n=139 Participants Innerview, Mental Health Clinical Decision Support tool
Accuracy of the Narrative Module	139 participants

PRIMARY outcome

Timeframe: 24-48 hours

What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart?

Outcome measures

Measure	Innerview MHCDS n=117 Participants Innerview, Mental Health Clinical Decision Support tool
Reliability of the Narrative Module	94 percentage of agreement Standard Deviation 5

PRIMARY outcome

Timeframe: approximate 5 minutes between ratings

What is the standard error of measurement (SEM) for test/retest symptom ratings on a 0 - 10 point scale

Outcome measures

Measure	Innerview MHCDS n=97 Participants Innerview, Mental Health Clinical Decision Support tool
Standard Error of Measure for the Individualized Rating Scale (Rating Module)	.9 units on a scale

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more 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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 1)	4.5 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more 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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 2)	4.3 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more 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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 3)	4.3 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more 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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 4)	4.3 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more 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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 5)	3.5 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more 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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 6)	3.7 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects, one investigator did not respond to this item.

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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 7)	4.2 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more 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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 8)	4.2 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more 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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 9)	3.2 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more 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

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 10)	3.5 units on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Administered Innerview session on at least 15 subjects

Population: This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.

On average, how much extra time do you estimate that you spent with your patients evaluating and discussing the information collected through Innerview?

Outcome measures

Measure	Innerview MHCDS n=6 Participants Innerview, Mental Health Clinical Decision Support tool
Provider Survey (Question 11)	15 minutes Interval 3.0 to 30.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=135 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 1)	4.03 units on a scale Standard Deviation .73

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=132 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 2)	3.89 units on a scale Standard Deviation .78

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=132 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 3)	3.89 units on a scale Standard Deviation .92

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=135 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 4)	4.39 units on a scale Standard Deviation .61

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=126 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 5)	4.44 units on a scale Standard Deviation .59

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=132 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 6)	4.25 units on a scale Standard Deviation .72

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=115 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 7)	4.10 units on a scale Standard Deviation .74

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=118 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 8)	3.81 units on a scale Standard Deviation .82

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=128 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 9)	3.95 units on a scale Standard Deviation .75

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Innerview MHCDS n=133 Participants Innerview, Mental Health Clinical Decision Support tool
Subject Survey (Question 10)	4.11 units on a scale Standard Deviation .70

OTHER_PRE_SPECIFIED outcome

Timeframe: Study Duration

On average, the number of minutes taken to complete both the narrative and rating modules?

Outcome measures

Measure	Innerview MHCDS n=97 Participants Innerview, Mental Health Clinical Decision Support tool
Completion Times	15.56 minutes Interval 9.49 to 23.11

POST_HOC outcome

Timeframe: Study Duration

Population: 104 subjects had no known mental health concerns

What is the percentage of subjects where the provider was unaware of any mental health concerns yet Innerview identified them as having hit a rule out or diagnostic consideration for a mental health disorder vs the US 12 Month Prevalence Rate?

US 12 Month Prevalence Rate = 26.2% (http://www.ncbi.nlm.nih.gov/pubmed/15939839)

Outcome measures

Measure	Innerview MHCDS n=104 Participants Innerview, Mental Health Clinical Decision Support tool
Mental Health Prevalence Rates Comparison	27 percentage of subjects

Adverse Events

Innerview MHCDS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul E Williams, Sr. Research Director

NCS Pearson

Phone: 952-681-4553

Email: paul.e.williams@pearson.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place