Trial Outcomes & Findings for Integrated Care & Patient Navigators for Latinos With Serious Mental Illness (NCT NCT02469714)

NCT ID: NCT02469714

Last Updated: 2024-03-15

Results Overview

This scale represents the total achieved appointments and total scheduled appointments. Data was collected weekly and added up per month.The minimum is 0 ( no appointments ) with no maximum (participants were not limited to the number of appointments per week).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

Every week for up to 52 weeks

Results posted on

2024-03-15

Participant Flow

Recruitment began 8/24/2015 to 11/20/2015. Locations for recruitment included: Trilogy, National Alliance on Mental Illness Chicago, social service providers, community coalitions, religious organizations, health fairs, and health centers that provided free or sliding scale access to care.

No enrolled participants (from Baseline) were excluded from the study before or after assignment to groups

Participant milestones

Participant milestones
Measure
Peer Navigator Intervention
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Overall Study
STARTED
55
55
Overall Study
4 Month Follow-Up
50
51
Overall Study
8 Month Follow-Up
49
50
Overall Study
COMPLETED
47
50
Overall Study
NOT COMPLETED
8
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integrated Care & Patient Navigators for Latinos With Serious Mental Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Peer Navigator Intervention
n=55 Participants
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
n=55 Participants
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Total
n=110 Participants
Total of all reporting groups
Age, Continuous
48.56 years
STANDARD_DEVIATION 9.927 • n=5 Participants
42.67 years
STANDARD_DEVIATION 11.918 • n=7 Participants
45.62 years
STANDARD_DEVIATION 11.311 • n=5 Participants
Sex/Gender, Customized
Female
28 participants
n=5 Participants
36 participants
n=7 Participants
64 participants
n=5 Participants
Sex/Gender, Customized
Male
26 participants
n=5 Participants
18 participants
n=7 Participants
44 participants
n=5 Participants
Sex/Gender, Customized
Transgender
1 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
55 Participants
n=5 Participants
55 Participants
n=7 Participants
110 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
17 Participants
n=5 Participants
16 Participants
n=7 Participants
33 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
34 Participants
n=5 Participants
35 Participants
n=7 Participants
69 Participants
n=5 Participants
Language
Preferred English
16 participants
n=5 Participants
25 participants
n=7 Participants
41 participants
n=5 Participants
Language
Preferred Spanish
39 participants
n=5 Participants
30 participants
n=7 Participants
69 participants
n=5 Participants
Education
Less than High School or GED
23 participants
n=5 Participants
16 participants
n=7 Participants
39 participants
n=5 Participants
Education
High School or GED
13 participants
n=5 Participants
15 participants
n=7 Participants
28 participants
n=5 Participants
Education
Some College
9 participants
n=5 Participants
15 participants
n=7 Participants
24 participants
n=5 Participants
Education
Associate's Degree
3 participants
n=5 Participants
3 participants
n=7 Participants
6 participants
n=5 Participants
Education
Bachelor's Degree
5 participants
n=5 Participants
3 participants
n=7 Participants
8 participants
n=5 Participants
Education
More than a Bachelor's Degree
2 participants
n=5 Participants
3 participants
n=7 Participants
5 participants
n=5 Participants
Employment
Yes
16 participants
n=5 Participants
19 participants
n=7 Participants
35 participants
n=5 Participants
Employment
No
39 participants
n=5 Participants
36 participants
n=7 Participants
75 participants
n=5 Participants
Diagnosis
Major Depression
32 participants
n=5 Participants
40 participants
n=7 Participants
72 participants
n=5 Participants
Diagnosis
Bipolar Disorder
2 participants
n=5 Participants
6 participants
n=7 Participants
8 participants
n=5 Participants
Diagnosis
Anxiety Disorder
17 participants
n=5 Participants
6 participants
n=7 Participants
23 participants
n=5 Participants
Diagnosis
Post Traumatic Stress
1 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants
Diagnosis
Schizophrenia
3 participants
n=5 Participants
0 participants
n=7 Participants
3 participants
n=5 Participants
Diagnosis
Schizoaffective
0 participants
n=5 Participants
1 participants
n=7 Participants
1 participants
n=5 Participants
Diagnosis
Adult ADD
0 participants
n=5 Participants
1 participants
n=7 Participants
1 participants
n=5 Participants
Sexual Orientation
Heterosexual
46 participants
n=5 Participants
46 participants
n=7 Participants
92 participants
n=5 Participants
Sexual Orientation
Homosexual
2 participants
n=5 Participants
2 participants
n=7 Participants
4 participants
n=5 Participants
Sexual Orientation
Bisexual
4 participants
n=5 Participants
3 participants
n=7 Participants
7 participants
n=5 Participants
Sexual Orientation
Queer
2 participants
n=5 Participants
3 participants
n=7 Participants
5 participants
n=5 Participants
Sexual Orientation
Other
1 participants
n=5 Participants
0 participants
n=7 Participants
1 participants
n=5 Participants
Sexual Orientation
Refuse to answer
0 participants
n=5 Participants
1 participants
n=7 Participants
1 participants
n=5 Participants

PRIMARY outcome

Timeframe: Every week for up to 52 weeks

This scale represents the total achieved appointments and total scheduled appointments. Data was collected weekly and added up per month.The minimum is 0 ( no appointments ) with no maximum (participants were not limited to the number of appointments per week).

Outcome measures

Outcome measures
Measure
Peer Navigator Intervention
n=55 Participants
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
n=55 Participants
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Weekly Health Appointment Measure
Total Achieved Month 1
4.55 appointments
Standard Deviation 3.07
2.14 appointments
Standard Deviation 3.02
Weekly Health Appointment Measure
Total Achieved Month 9
4.8 appointments
Standard Deviation 5.09
2.91 appointments
Standard Deviation 5.64
Weekly Health Appointment Measure
Total Scheduled Month 1
6.33 appointments
Standard Deviation 4.25
3.42 appointments
Standard Deviation 4.31
Weekly Health Appointment Measure
Total Scheduled Month 2
8.64 appointments
Standard Deviation 5.59
4.65 appointments
Standard Deviation 5.62
Weekly Health Appointment Measure
Total Scheduled Month 3
8.09 appointments
Standard Deviation 6.26
4.67 appointments
Standard Deviation 5.32
Weekly Health Appointment Measure
Total Scheduled Month4
7.65 appointments
Standard Deviation 5.69
5.6 appointments
Standard Deviation 6.12
Weekly Health Appointment Measure
Total Scheduled Month 5
6.31 appointments
Standard Deviation 6.36
4.33 appointments
Standard Deviation 5.56
Weekly Health Appointment Measure
Total scheduled Month 6
8.04 appointments
Standard Deviation 7.35
5.11 appointments
Standard Deviation 6.88
Weekly Health Appointment Measure
Total Scheduled Month 7
7.8 appointments
Standard Deviation 7.40
5.85 appointments
Standard Deviation 7.31
Weekly Health Appointment Measure
Total Scheduled Month 8
8.58 appointments
Standard Deviation 7.07
5.8 appointments
Standard Deviation 7.79
Weekly Health Appointment Measure
Total Scheduled Month 9
7.72 appointments
Standard Deviation 7.04
4.69 appointments
Standard Deviation 7.41
Weekly Health Appointment Measure
Total Scheduled Month 10
8.27 appointments
Standard Deviation 7.36
5.15 appointments
Standard Deviation 7.14
Weekly Health Appointment Measure
Total Scheduled Month11
7.05 appointments
Standard Deviation 7.49
5.22 appointments
Standard Deviation 7.01
Weekly Health Appointment Measure
Total Scheduled Month 12
6.95 appointments
Standard Deviation 7.36
5.6 appointments
Standard Deviation 7.44
Weekly Health Appointment Measure
Total Scheduled Month 13
7.53 appointments
Standard Deviation 7.22
5.42 appointments
Standard Deviation 8.09
Weekly Health Appointment Measure
Total Achieved Month 2
4.33 appointments
Standard Deviation 3.42
2.29 appointments
Standard Deviation 2.74
Weekly Health Appointment Measure
Total Achieved Month 3
4.05 appointments
Standard Deviation 4.21
2 appointments
Standard Deviation 2.39
Weekly Health Appointment Measure
Total Achieved Month 4
3.93 appointments
Standard Deviation 2.69
2.31 appointments
Standard Deviation 2.73
Weekly Health Appointment Measure
Total Achieved Month 5
4.13 appointments
Standard Deviation 4.32
2.38 appointments
Standard Deviation 3.16
Weekly Health Appointment Measure
Total Achieved Month 6
5.16 appointments
Standard Deviation 5.38
2.95 appointments
Standard Deviation 4.66
Weekly Health Appointment Measure
Total Achieved Month 7
4.67 appointments
Standard Deviation 5.39
3 appointments
Standard Deviation 4.82
Weekly Health Appointment Measure
Total Achieved Month 8
5.07 appointments
Standard Deviation 5.36
3.09 appointments
Standard Deviation 5.47
Weekly Health Appointment Measure
Total Achieved Month 10
4.53 appointments
Standard Deviation 4.70
2.84 appointments
Standard Deviation 5.54
Weekly Health Appointment Measure
Total Achieved Month 11
3.81 appointments
Standard Deviation 4.56
2.84 appointments
Standard Deviation 4.68
Weekly Health Appointment Measure
Total Achieved Month 12
3.55 appointments
Standard Deviation 4.22
3.13 appointments
Standard Deviation 5.55
Weekly Health Appointment Measure
Total Achieved Month 13
4.09 appointments
Standard Deviation 4.47
2.91 appointments
Standard Deviation 6.05

SECONDARY outcome

Timeframe: Baseline (0), 4, 8, and 12 months

ATSPPH is a 29 item scale that has been used in more than 150 studies. The scale ranges from 1 (disagreement) to 4 (agreement). Higher overall scores reflect more positive attitudes towards help seeking. Subscales were summed to get the total of each scale. Total scores range from 29-116.

Outcome measures

Outcome measures
Measure
Peer Navigator Intervention
n=55 Participants
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
n=55 Participants
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)
Baseline
90.18 units on a scale
Standard Deviation 13.42
91.15 units on a scale
Standard Deviation 12.31
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)
4 Month
89.77 units on a scale
Standard Deviation 10.36
89.7682 units on a scale
Standard Deviation 11.65
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)
8 Month
89.62 units on a scale
Standard Deviation 10.80
88.74 units on a scale
Standard Deviation 11.67
Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)
12 Month
91.04 units on a scale
Standard Deviation 10.39
87.85 units on a scale
Standard Deviation 13.07

SECONDARY outcome

Timeframe: Baseline (0), 4, 8, and 12 months

This widely used scale examines multiple dimensions of perceived personal empowerment in people with serious mental illness. The scale ranges from 1 (strongly agree) to 4 (strongly disagree). The lower the score, the higher level of empowerment. The total scores range from a minimum value of 4 to a maximum value of 16.

Outcome measures

Outcome measures
Measure
Peer Navigator Intervention
n=55 Participants
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
n=55 Participants
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Empowerment Scale (EMP)
Baseline
11.66 units on a scale
Standard Deviation 1.29
11.12 units on a scale
Standard Deviation 1.22
Empowerment Scale (EMP)
4 Month
11.12 units on a scale
Standard Deviation 1.53
10.79 units on a scale
Standard Deviation 1.39
Empowerment Scale (EMP)
8 Month
10.82 units on a scale
Standard Deviation 1.31
10.96 units on a scale
Standard Deviation 1.39
Empowerment Scale (EMP)
12 Month
10.91 units on a scale
Standard Deviation 1.19
10.99 units on a scale
Standard Deviation 1.40

SECONDARY outcome

Timeframe: Baseline (0), 4, 8, and 12 months

The RAS assesses five factors related to recovery from mental illness including hope and goals. The scale ranges from 1 (strongly disagree) to 5 (strongly agree). A higher score reflects greater attitudes towards recovery. The total score range is 22-110.

Outcome measures

Outcome measures
Measure
Peer Navigator Intervention
n=55 Participants
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
n=55 Participants
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Recovery Assessment Scale (RAS)
8 Month
87.37 units on a scale
Standard Deviation 9.91
85.52 units on a scale
Standard Deviation 10.54
Recovery Assessment Scale (RAS)
12 Month
88.27 units on a scale
Standard Deviation 9.80
85.28 units on a scale
Standard Deviation 11.47
Recovery Assessment Scale (RAS)
Baseline
78.87 units on a scale
Standard Deviation 10.62
85.33 units on a scale
Standard Deviation 10.85
Recovery Assessment Scale (RAS)
4 Month
85.97 units on a scale
Standard Deviation 10.23
85.79 units on a scale
Standard Deviation 10.47

SECONDARY outcome

Timeframe: Baseline (0), 4, 8, and 12 months

This a 36 item short form that is widely adopted measure of medical health outcomes in mental health services research. Each item is scored on a 0 to 100 range. Items in same scale are averaged together to create the 8 scale scores. Higher scores indicate better health. In the current study, the total score it the sum of all scales scores. The total score can range from 0 to 800.

Outcome measures

Outcome measures
Measure
Peer Navigator Intervention
n=54 Participants
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
n=55 Participants
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Medical Outcome Study (SF-36)
Baseline
319.84 units on a scale
Standard Deviation 149.41
379.97 units on a scale
Standard Deviation 165.37
Medical Outcome Study (SF-36)
4 Month
420.23 units on a scale
Standard Deviation 143.29
432.43 units on a scale
Standard Deviation 171.31
Medical Outcome Study (SF-36)
8 Month
427.52 units on a scale
Standard Deviation 140.36
422.91 units on a scale
Standard Deviation 176.97
Medical Outcome Study (SF-36)
12 Month
444.91 units on a scale
Standard Deviation 163.58
454.81 units on a scale
Standard Deviation 168.48

SECONDARY outcome

Timeframe: Baseline (0), 4, 8, and 12 months

The QLS is highly used in services research and comprises 6 items of various domains of independent living. The scale ranges from 1 (terrible) to 7 (delighted). The lower the score the less quality of life. The total scores range 6-42.

Outcome measures

Outcome measures
Measure
Peer Navigator Intervention
n=55 Participants
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
n=55 Participants
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Quality of Life Scale (QLS)
Baseline
23.5 units on a scale
Standard Deviation 6.92
26.01 units on a scale
Standard Deviation 6.23
Quality of Life Scale (QLS)
4 Month
25.93 units on a scale
Standard Deviation 5.19
27.12 units on a scale
Standard Deviation 6.47
Quality of Life Scale (QLS)
8 Month
26.35 units on a scale
Standard Deviation 5.56
26.39 units on a scale
Standard Deviation 7.46
Quality of Life Scale (QLS)
12 Month
27.39 units on a scale
Standard Deviation 5.81
26.37 units on a scale
Standard Deviation 7.12

SECONDARY outcome

Timeframe: Baseline (0), 4, 8, and 12 months

The scale measures the availability of health services. The scale ranges from 1 (Not at all) to 9 (Very much). The lower the score the less availability of a service. Items were summed to get the total of each scale. Score totals range from 26-234.

Outcome measures

Outcome measures
Measure
Peer Navigator Intervention
n=49 Participants
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
n=53 Participants
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Availability Health Service Scale (AHSS)
Baseline
159.85 units on a scale
Standard Deviation 42.41
157.46 units on a scale
Standard Deviation 50.27369
Availability Health Service Scale (AHSS)
4 Month
185.72 units on a scale
Standard Deviation 44.02
166.24 units on a scale
Standard Deviation 49.62
Availability Health Service Scale (AHSS)
8 Month
189.18 units on a scale
Standard Deviation 39.52
171.34 units on a scale
Standard Deviation 46.29
Availability Health Service Scale (AHSS)
12 Month
195.23 units on a scale
Standard Deviation 33.64
183.85 units on a scale
Standard Deviation 45.17

SECONDARY outcome

Timeframe: Baseline (0), 4, 8, and 12 months

Assesses physical health in the last 4 months and Emotional/Mental Health in the last 30 days.The scale ranges from 1 (None of the time) to 5 (All of the time). The higher the score, the more health problems. Score totals on the physical health scale range 14-70.

Outcome measures

Outcome measures
Measure
Peer Navigator Intervention
n=55 Participants
Integrated care with a peer navigator to be provided for one year, where data will be collected at baseline, 4, 8 and 12 months. Peer Navigator Intervention: Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
Controlled
n=55 Participants
Integrated care without a peer navigator, where data will be collected at baseline, 4, 8 and 12 months
Texas Christian University Health Form- Physical Health Subscale
Baseline
48.40 units on a scale
Standard Deviation 11.37
43.15 units on a scale
Standard Deviation 11.92
Texas Christian University Health Form- Physical Health Subscale
4 Month
41.67 units on a scale
Standard Deviation 10.94
40.47 units on a scale
Standard Deviation 10.58
Texas Christian University Health Form- Physical Health Subscale
8 Month
42.62 units on a scale
Standard Deviation 11.96
41.31 units on a scale
Standard Deviation 11.74
Texas Christian University Health Form- Physical Health Subscale
12 Month
40.59 units on a scale
Standard Deviation 11.47
40.49 units on a scale
Standard Deviation 12.85

Adverse Events

Peer Navigator Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Controlled

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

Patrick Corrigan

Illinois Institute of Technology

Phone: (312)567-6751

Results disclosure agreements

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