Trial Outcomes & Findings for Project Bridge: Peer Health Navigator Intervention (NCT NCT02022462)

NCT ID: NCT02022462

Last Updated: 2024-02-02

Results Overview

Changed score on SF-12 pain items from baseline to 6 months and 12 months in active intervention group and changed score from 6 months to 12 months in the waitlist control group. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more pain. A negative change score indicates less pain. The SF-12 is a widely used preference-based utility measure of health derived from the SF-36.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 151 participants
• Primary outcome timeframe: baseline, 6 months, 12 months
• Results posted on: 2024-02-02

Participant Flow

Participant milestones

Measure	Health Navigation 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Overall Study STARTED	76	75
Overall Study COMPLETED	53	50
Overall Study NOT COMPLETED	23	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Project Bridge: Peer Health Navigator Intervention

Baseline characteristics by cohort

Measure	Health Navigation n=76 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=75 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.	Total n=151 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants	73 Participants n=7 Participants	149 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	44.80 years STANDARD_DEVIATION 11.30 • n=5 Participants	46.47 years STANDARD_DEVIATION 10.59 • n=7 Participants	45.63 years STANDARD_DEVIATION 10.95 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	46 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	29 Participants n=7 Participants	70 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/LatinX	46 Participants n=5 Participants	44 Participants n=7 Participants	90 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 months, 12 months

Population: Sample size changes across cells due to attrition from baseline to 12 month interview.

Changed score on SF-12 pain items from baseline to 6 months and 12 months in active intervention group and changed score from 6 months to 12 months in the waitlist control group. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more pain. A negative change score indicates less pain. The SF-12 is a widely used preference-based utility measure of health derived from the SF-36.

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Score on SF-12 Pain Items From Baseline to 6 Months and 12 Months Baseline to 6 months	-.16 Changed mean z-score Standard Deviation .75	.11 Changed mean z-score Standard Deviation .86
Changed Score on SF-12 Pain Items From Baseline to 6 Months and 12 Months 6 months to 12 months	.19 Changed mean z-score Standard Deviation .91	-.18 Changed mean z-score Standard Deviation .82

PRIMARY outcome

Timeframe: baseline, 6 months, 12 months

Population: There was differential attrition from baseline to 6 months and 6 months to 12 months.

Changed health screenings (e.g., pap smear, diabetes screening, blood pressure) from baseline to 6 months and 12 months for active intervention group and from 6 months to 12 months for waitlist control group. Clients select from a list of 8 possible routine screenings for ones they have completed in the last 6 months or since their last assessment. A higher change score indicates an increased rate of health screenings (which could reflect better care) and a lower score indicates fewer health screenings. Scores ranged from -6 to 7.

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Health Screenings From Baseline to 6 Months and 12 Months Baseline to 6 months	.44 Changed count of health screenings Standard Deviation 2.35	.45 Changed count of health screenings Standard Deviation 2.29
Changed Health Screenings From Baseline to 6 Months and 12 Months 6 months to 12 months	.17 Changed count of health screenings Standard Deviation 1.95	.06 Changed count of health screenings Standard Deviation 2.37

PRIMARY outcome

Timeframe: baseline, 6 months, 12 months

Population: There was different attrition from baseline to 6 months and 6 months to 12 months.

Changed number of Health Complaints from baseline to 6 and 12 months for the active intervention group and from 6 to 12 months by the waitlist control group. Participants will select yes/no whether they currently are experiencing any of 24 common health symptoms in the last 6 months. A count of the number of health complaints will be used in analyses. A negative change score would indicate a reduction in symptoms, which would indicate better health. Change scores ranged from -21 to 7.

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Number of Health Complaints From Baseline to 6 and 12 Months Baseline to 6 months	-1.07 Changed mean of symptoms count Standard Deviation 4.48	-1.35 Changed mean of symptoms count Standard Deviation 4.81
Changed Number of Health Complaints From Baseline to 6 and 12 Months 6 months to 12 months	.78 Changed mean of symptoms count Standard Deviation 3.60	-.94 Changed mean of symptoms count Standard Deviation 4.13

PRIMARY outcome

Timeframe: baseline, 6 months, 12 months

Population: The sample size varied for comparisons overtime due to attrition.

Changed scores on The Health Care Efficacy Scale from baseline to 6 months and 12 months for the active intervention group and for the waitlist control group from 6 months to 12 months. This scale has been adapted from the Mental Health Confidence Scale, which was developed to measure the self-efficacy in individuals with a mental illness. This 14-item scale includes items on skills such as appointment making, pharmacy visits, establishing a medical home, and feeling that healthcare needs were heard and addressed. Participants will estimate the frequency of these experiences on a 3 point scale (1 = 'never' to 3 = '3 or more times'). A positive change score indicates improved health care self-efficacy.

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Scores on Health Care Efficacy Scale From Baseline to 6 Months and 12 Months Baseline to 6 months	.06 Change mean score Standard Deviation .44	.02 Change mean score Standard Deviation .55
Changed Scores on Health Care Efficacy Scale From Baseline to 6 Months and 12 Months 6 month to 12 months	.13 Change mean score Standard Deviation .35	-.02 Change mean score Standard Deviation .36

PRIMARY outcome

Timeframe: baseline, 6 months, 12 months

Population: The sample size varies across the timepoints due to attrition.

Changed ratings of a high-quality relationship with primary care providers from baseline to 6 and 12 months for active intervention group and from 6 months compared to 12 months for waitlist intervention group. Participants will be asked if they have a primary care provider (yes/no). Patients with a routine primary care provider will complete the Engagement with the Healthcare Provider Scale (as done with their navigator) regarding their relationship with their primary care provider. Mean scores range from 1 to 5 and the reported scores reflect the change in those scores from baseline to 6 months and 6 months to 12 months. A negative score indicates fewer issues with their healthcare provider over time in terms of units on a scale.

Outcome measures

Measure	Health Navigation n=44 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=46 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Score on Primary Care Provider Relationship From Baseline to 6 and 12 Months Baseline to 6 months	-0.32 Score on a scale Standard Deviation .81	.08 Score on a scale Standard Deviation .75
Changed Score on Primary Care Provider Relationship From Baseline to 6 and 12 Months 6 months to 12 months	.05 Score on a scale Standard Deviation .66	-.17 Score on a scale Standard Deviation .69

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Population: The sample size varies across time points due to attrition.

Changed ratings of provider stigma from baseline to 6 and 12 months for the immediate treatment group and from 6 months to 12 months for the waitlist control group. Provider-level stigma will be measured with a scale adapted from a provider level stigma scale in individuals with HIV/AIDS. This 7-item scale measures the degree to which clients experience stigma when they interact with health care providers, with items adapted to reflect SMI rather than HIV/AIDS. Participants rate their stigmatizing experiences with their provider on a 5-point scale (1= 'strongly disagree' to 5 = 'strongly agree'). Mean scores range from 1 to 5 with higher scores indicating agreement with experiences of stigma.

Outcome measures

Measure	Health Navigation n=44 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=46 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Scores on Provider Level Stigma From Baseline in Comparison to 6 and 12 Months Baseline to 6 months	.06 Mean change score Standard Deviation .62	-.12 Mean change score Standard Deviation .75
Changed Scores on Provider Level Stigma From Baseline in Comparison to 6 and 12 Months 6 months to 12 months	-.06 Mean change score Standard Deviation .59	.13 Mean change score Standard Deviation .60

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Population: The sample size varies across rows due to attrition over 12 months.

Changed scores of life satisfaction by the immediate treatment group from baseline to 6 and 12 months and from 6 months to 12 months for the waitlist control group. The Satisfaction with Life scale (SWL) is an 18-item Likert scale which measures participants' satisfaction with life in four domains: living situation, social relationship, work, and self and present life. It has shown good inter-item reliability (alpha = .88) and factorial validity in studies of the SMI. Mean scores range from 1 to 5, with higher scores indicating greater satisfaction with life. Change scores ranged from -1.42 to 1.59 with higher scores indicating an improvement over time in life satisfaction.

Outcome measures

Measure	Health Navigation n=58 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=59 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Scores of General Life Satisfaction From Baseline to 6 and 12 Months Baseline to 6 months	.11 Score on a scale Standard Deviation .61	.12 Score on a scale Standard Deviation .54
Changed Scores of General Life Satisfaction From Baseline to 6 and 12 Months 6 months to 12 months	.01 Score on a scale Standard Deviation .48	.04 Score on a scale Standard Deviation .57

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Changed ratings of issues from baseline in comparison to 6 and 12 months assessments for immediate intervention group and from 6 months to 12 months for waitlist control group. The functional outcomes of the clients will be measured with the BASIS-24 (Behavior and Symptom Identification Scale). The 24 items of the BASIS-32 have been designed to assess a client's perception of difficulty due to psychiatric symptoms and problems in functional areas (daily living skills, work, and social) over the past week. Higher scores indicate greater difficulty. Scores range from 0 to 4. Change scores range from -2.18 to 1.58 with a positive score indicating an increase in difficulties.

Outcome measures

Measure	Health Navigation n=60 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=60 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Scores on BASIS-24 From Baseline in Comparison to 6 and 12 Months	-.23 Score on a scale Standard Deviation .50	-.15 Score on a scale Standard Deviation .62

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Population: Exercise changed.

Using 1 item adapted from the National Leisure Time Survey, participants rated on a 7 point scale (0 = 'never' to 7 = 'daily') the frequency that participants exercise and scores were converted into z scores. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more exercise. A negative change score indicates less exercise

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Unhealthy Habits From Baseline to 6 and 12 Months Baseline to 6 months	.18 Changed z-score Standard Deviation .95	.04 Changed z-score Standard Deviation .79
Changed Unhealthy Habits From Baseline to 6 and 12 Months 6 months to 12 months	.07 Changed z-score Standard Deviation 1.03	-.16 Changed z-score Standard Deviation .89

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Population: The sample size changes due to attrition over time.

Lower ratings of internalized stigma from baseline to 6 and 12 months for immediate intervention group and from 6 to 12 months for the waitlist control group. The 'Internalized Stigma of Mental Illness' scale (ISMI) will measure the internalized stigma of the clients along 5 dimensions of internalized stigma-alienation, stereotype endorsement, discrimination experience, social withdrawal and stigma resistance. Mean scores ranged from 1 to 4 with higher scores indicating a higher level of self-stigma. Change scores ranged from -.88 to 1.13, with negative change scores indicating a decrease in internalized stigma and a positive score indicating an increase in internalized stigma.

Outcome measures

Measure	Health Navigation n=60 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=61 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Scores of Internalized Stigma From Baseline to 6 and 12 Months Baseline to 6 months	.07 Score on a scale Standard Deviation .38	.06 Score on a scale Standard Deviation .33
Changed Scores of Internalized Stigma From Baseline to 6 and 12 Months 6 months to 12 months	.01 Score on a scale Standard Deviation .46	.02 Score on a scale Standard Deviation .40

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Population: The sample size changes due to attrition over the study period.

A decrease in medications is expected from baseline to 6 and 12 months for immediate treatment group and for the waitlist control group from 6 months to 12 months. Current medications are recorded for their name, dosage, frequency, timing, dates started, side effects noted, and reasons prescribed. A positive score indicates an increase in medications and a negative change score indicates a reduction in medications.

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
ChangedPrescribed Medications From Baseline to 6 and 12 Months Baseline to 6 months	-.05 changed count of medications Standard Deviation 1.16	.10 changed count of medications Standard Deviation 1.40
ChangedPrescribed Medications From Baseline to 6 and 12 Months 6 months to 12 months	.24 changed count of medications Standard Deviation 2.07	-.04 changed count of medications Standard Deviation 1.03

SECONDARY outcome

Timeframe: baseline, 6 months, 12 months

Population: The sample changes over time due to attrition.

Changed rates of identification of previously undetected chronic health conditions, decreased number of other disorders from baseline to 6 and 12 months in active intervention group and from 6 to 12 months in the waitlist control group. Changes in the number of diagnoses ranged from -3 to 5. Positive changes indicate an increased in diagnosed conditions and negative scores indicate a reduction in diagnoses.

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Number of Health Diagnoses From Baseline to 6 and 12 Months Baseline to 6 months	.23 Changed count of conditions Standard Deviation .69	-.08 Changed count of conditions Standard Deviation .91
Changed Number of Health Diagnoses From Baseline to 6 and 12 Months 6 months to 12 months	.02 Changed count of conditions Standard Deviation 1.00	-.34 Changed count of conditions Standard Deviation 1.26

SECONDARY outcome

Timeframe: baseline, 6 months, and 12 months

Population: The sample size changed over time due to attrition.

Changed rating of Euroqual health score from baseline to 6 and 12 months by active intervention group and from 6 months to 12 months for the waitlist control group. Participants rate their health from highest possible to worst possible from 100 to 0. Change scores ranged from -90 to 100. Positive scores indicate better health and negative scores indicate worsening health.

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Euroqual Health Score From Baseline to 6 and 12 Months Baseline to 6 months	3.70 Changed mean score Standard Deviation 21.78	3.29 Changed mean score Standard Deviation 30.55
Changed Euroqual Health Score From Baseline to 6 and 12 Months 6 months to 12 months	-6.43 Changed mean score Standard Deviation 24.34	7.12 Changed mean score Standard Deviation 20.90

SECONDARY outcome

Timeframe: baseline, 6 months, and 12 months

Population: The sample size differs over time due to attrition.

Changed rating of Euroqual satisfaction with provider score from baseline to 6 and 12 months by active intervention group and from 6 months to 12 months for the waitlist control group. Participants rate their satisfaction from highest possible to worst possible from 100 to 0. Change scores ranged from -90 to 79. Positive scores indicate improved satisfaction and negative scores indicate declines in satisfaction.

Outcome measures

Measure	Health Navigation n=48 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=51 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Euroqual Satisfaction With Provider Score From Baseline to 6 and 12 Months Baseline to 6 months	6.32 Mean change score Standard Deviation 28.76	2.71 Mean change score Standard Deviation 34.43
Changed Euroqual Satisfaction With Provider Score From Baseline to 6 and 12 Months 6 months to 12 months	-1.06 Mean change score Standard Deviation 33.89	7.12 Mean change score Standard Deviation 20.9

SECONDARY outcome

Timeframe: baseline, 6 months, 12 month

Population: Sample changed over time due to attrition

Changed substance use from baseline to 6 and 12 months for the immediate treatment group and for the waitlist control group from 6 months to 12 months (e.g., alcohol, nicotine, cocaine, marijuana, prescription drugs). Scores ranged from 0 to 9, with a higher number indicating a greater variety of substances used. A negative score indicates a reduced variety of substances used and a positive score indicates an increase in the variety of substances used (range from -2 to 2 for change scores).

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Substance Use From Baseline to 6 and 12 Months Baseline to 6 months	-.08 Count of substances Standard Deviation .81	-.13 Count of substances Standard Deviation .84
Changed Substance Use From Baseline to 6 and 12 Months 6 months to 12 months	.04 Count of substances Standard Deviation .55	-.11 Count of substances Standard Deviation .32

SECONDARY outcome

Timeframe: baseline, month 6, month 12

Population: The sample sizes differ over time due to attrition.

Changed score on Self Management Motivation scale from baseline to 6 months and 12 months in active intervention group and changed score from 6 months to 12 months in the waitlist control group. 9 item measure written for this study. Participants rate how important and how confident they are about managing their health (1 = not at all confident to 10 = very confident). Changes in confidence ranged from -4.44 to 4.00. Positive scores indicate an increased confidence and negative scores indicate a decrease in confidence.

Outcome measures

Measure	Health Navigation n=61 Participants 76 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12 month study of Bridge navigation. Randomly assigned and completed three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Health Navigation: Experimental: Immediate peer health navigator intervention vs. waitlist control. The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Part	Waitlist Control n=62 Participants 75 participants with SMI in the El Camino clinic, operated by Pacific Clinics, recruited to participate in a 12-month study of Bridge navigation. Randomly assigned, participants in the waitlist control group completed 3 assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.
Changed Score on Self Management Motivation Baseline to 6 months	.33 Mean change score Standard Deviation 1.65	-.28 Mean change score Standard Deviation .78
Changed Score on Self Management Motivation 6 months to 12 months	.29 Mean change score Standard Deviation 1.67	.57 Mean change score Standard Deviation 1.81

Adverse Events

Health Navigation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Waitlist Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Brekke

University of Southern California

Phone: 213-740-0297

Email: brekke@usc.edu

Results disclosure agreements

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