Project Bridge: Peer Health Navigator Intervention

Study Overview
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Brief Summary
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The mortality rate among people with Serious Mental Illness (SMI) is 2 to 3 times that of the general population, meaning that those with a serious mental illness die, on average, 25 years earlier than those without an SMI. These deaths are largely attributed to preventable medical conditions, many of which are more common in the SMI population. The Bridge intervention is a peer navigator model that was developed to target factors that negatively impact healthcare access, utilization, and outcomes among individuals with serious mental illness (e.g., severe mood disorders and psychotic disorders). This intervention targets male and female, adult consumers across races/ethnicities and has been utilized by Pacific Clinics (Southern California's largest behavioral healthcare agency) and the Department of Mental Health of Los Angeles County to improve the health and quality of life for their consumers. Investigators will test the comparative effectiveness of a peer navigator intervention (the Bridge) to treatment as usual. The Bridge navigator intervention is designed to teach SMI consumers the skills to engage health care providers and to overcome motivational deficits in order to improve their health and healthcare use. The specific aims of this application are: To use randomized methods to examine the effectiveness of the Bridge intervention on the health care utilization, satisfaction with care, health status, and health care self-management for a sample of individuals with severe mental illness receiving public mental health services in the community; To use randomized methods to examine the effectiveness of the Bridge intervention on psychological and social well-being for a sample of individuals with severe mental illness receiving public mental health services in the community. Up to 146 participants in an Full Service Partnership (FSP) clinic operated by Pacific Clinics will be recruited to participate in an approximately 24 month long study of Bridge navigation. Participants will be randomly assigned to either treatment as usual (waitlist) or immediate intervention with the Bridge. Participants in both groups will complete three assessments (baseline, 6 months, 12 months) and statistically compared over time. Staff stakeholders (n = 20) will also be interviewed at baseline and every three months of the study in order to ensure that the intervention is being implemented appropriately.

Detailed Description
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The mortality rate among people with Serious Mental Illness (SMI) is 2 to 3 times that of the general population (DeHert et al., 2011), meaning that those with a serious mental illness die, on average, 25 years earlier than those without a SMI (Parks et al., 2006). There is evidence that these deaths are largely attributed to preventable medical conditions, many of which are more common in the SMI population. System bifurcation, or the separation of mental and physical health services, has been identified as a critical factor that leads to significant health disparities for those with SMI (Bazelon Center for Mental Health Law, 2004). Grounded in patients' experiences, needs, and voices, investigators seek to generate knowledge about effective interventions, use outcomes that are central to patients and caregivers, attend to issues of implementation and dissemination, and may seek to optimize outcomes in the context of factors such as burden, technology, and stakeholder perspectives. Based on pilot work funded by the UniHealth Foundation, the goal of this Patient Centered Outcomes Research Institute (PCORI) proposal is to test the effectiveness of a peer health navigation intervention (The Bridge) in comparison to usual treatment. The Bridge is a peer-staffed comprehensive healthcare engagement and self management model, situated in an outpatient mental health clinic, where clients are taught the skills to access and manage their healthcare for any condition. The investigators' goal is train clients to successfully engage and navigate the primary health care system as well as other needed health care services (specialty care, lab, and pharmacy). Guided by a version of Gelberg, Andersen, and Leake's (2000) Behavioral Model of Health Service Use for Vulnerable Populations that investigators adapted for the seriously mentally ill (Brekke et al., in press), the Bridge combines three approaches: integrated care, patient education, and cognitive-behavioral skill building with an in vivo (real world) focus. Investigators will conduct a randomized controlled trial comparing 2 groups: a) a treatment as usual waitlist (n =73), and b) the Bridge peer navigator intervention (n=73). Investigators will compare these groups across 3 time points (baseline, 6 months, 1 year) to examine the Bridge's effectiveness at improving health care service use, satisfaction with care, health knowledge, health status, health related self-efficacy, and quality of life. Outcomes will be measured through patient self-report and according to objective measures of health (medical records and insurance claims data). In addition, investigators will conduct interviews every three months with selected stakeholders to assess the degree to which the intervention and the study are succeeding and what challenges have occurred. This will allow for corrections as the study proceeds. Investigators will focus on the factors that will contribute to the implementation and sustainability of the health navigator intervention including: cost, training, supervision, billing issues, and how this position will fit into the organizational model of the clinic. To begin the interview, investigators will ask each person interviewed for his or her ideas about what are the critical factors for implementation and sustainability. Finally investigators plan on conducting exit interviews with each patient as part of their final assessment. Exit interviews will focus on the patients' perceptions about the study, how it affected them, what went well, and what challenges they encountered. Each interview should last about 20-30 minutes and will be audio-recorded using an encrypted tape recorder. Investigators will use a semi-structured interview guide so that all interviewees are asked the same questions and data are comparable. Basic demographics such as gender, ethnicity, and age will be recorded for all participants. This PCORI proposal relies on significant stakeholder involvement in the intervention development, project development and management, and in the plans for dissemination and implementation. The ultimate goal is to provide the field a peer-delivered intervention that significantly reduces disparities in the utilization and outcome of health services for the seriously mentally ill and thereby reduce morbidity and mortality in this highly vulnerable population.

Official Title
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A Randomized Controlled Trial of The Bridge, a Peer Health Navigation Intervention

Conditions
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Schizophrenia, Depression, Medical Disorders, Serious Mental Illness

Intervention / Treatment
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* Behavioral: Health Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Client participants will have diagnoses of serious mental illness and be between the ages of 18-65. All participants must be able to complete assessments in English. Staff participants will be between the ages of 18-65 and must be currently employed at Pacific Clinics. All participants must be able to complete assessments in English. Medical providers who serve clients of Pacific Clinics will also be interviewed as stakeholders. They will be between the ages of 18-65 and must be employees of a medical provider serving Pacific Clinics' clients. Exclusion Criteria: Clients who are under the age of 18, over the age of 65, who are under conservatorship, cannot give informed consent themselves, or are not receiving mental health services through Pacific Clinics will not be eligible for participation. Staff participants must be currently employed at Pacific Clinics and have the capacity to give informed consent themselves. Medical providers must be serving Pacific Clinics' clients and have the capacity to give informed consent themselves.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Navigation<br>Up to 151 participants with SMI in the El Camino clinic, operated by Pacific Clinics, will be recruited to participate in a 12 month study of Bridge navigation. Participants will be randomly assigned to either waitlist control (6 month waitlist with treatment as usual) or immediate intervention with the Bridge. Participants in the immediate treatment group will complete three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Participants in the waitlist control group will complete three assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months. | Behavioral: Health Navigation<br>* 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. Participants will receive training in how to self-manage their physical health and healthcare. The intervention is individualized and the number of contacts by the navigator will be determined by their need level. The waitlist control group will complete a baseline assessment and then wait for 6 months before receiving the peer health navigator intervention. They will complete a follow-up assessment after 6 months of the intervention.<br>|
| Other: Waitlist Control<br>Up to 146 participants with SMI in the El Camino clinic, operated by Pacific Clinics, will be recruited to participate in a 12 month study of Bridge navigation. Participants will be randomly assigned to either waitlist control (n = 73, 6 month waitlist with treatment as usual then they will receive the intervention) or immediate intervention with the Bridge (n = 73). Participants in the immediate treatment group will complete three assessments (baseline, 6 months, and 12 months) and, after 6 months, one interview about their health, healthcare, and navigation experiences. Participants in the waitlist control group will complete three assessments (baseline, 6 month, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months. | Behavioral: Health Navigation<br>* 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. Participants will receive training in how to self-manage their physical health and healthcare. The intervention is individualized and the number of contacts by the navigator will be determined by their need level. The waitlist control group will complete a baseline assessment and then wait for 6 months before receiving the peer health navigator intervention. They will complete a follow-up assessment after 6 months of the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changed score on SF-12 items from baseline to 6 months and 12 months | Changed score on SF-12 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. The SF-12 is a widely used preference based utility measure of health derived from the SF-36. The six domains of the SF-12 are physical functioning, role limitations, social functioning, pain, mental health, and vitality. | baseline, 6 months, 12 months | 
| Changed health screenings from baseline to 6 months and 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. | baseline, 6 months, 12 months | 
| Changed number of Health Complaints from baseline to 6 and 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. | baseline, 6 months, 12 months | 
| Changed scores on Health Care Efficacy Scale from baseline to 6 months and 12 months | 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'). | baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changed score on Primary Care Provider Relationship from baseline to 6 and 12 months | 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 who have a routine primary care provider will complete the Weinberger Adjustment Inventory (WAI) and the Engagement with the Healthcare Provider Scale (as done with their navigator) regarding their relationship with their primary care provider. | baseline, 6 months, 12 months | 
| Changed scores on Provider level stigma from baseline in comparison to 6 and 12 months | 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 experiences with their provider on a 5-point scale (1= 'strongly disagree' to 5 = 'strongly agree'). | baseline, 6 months, 12 months | 
| Changed scores of General Life Satisfaction from baseline to 6 and 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. | baseline, 6 months, 12 months | 
| Changed scores on BASIS-32 from baseline in comparison to 6 and 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. Functional outcome of the clients will be measured with the BASIS-32 (Behavior and Symptom Identification Scale). The 32 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. | baseline, 6 months, 12 months | 
| Changed unhealthy habits from baseline to 6 and 12 months | Using 5 items adapted from the National Leisure Time Survey, participants rate on a 7 point scale (0 = 'never' to 7 = 'daily') the frequency that participants engage in unhealthy behaviors. Participants are asked about their engagement in unhealthy behaviors such as smoking, alcohol consumption, consumption of sugary/fatty foods, unsafe/risky sexual practices. | baseline, 6 months, 12 months | 
| Changed scores of Internalized stigma from baseline to 6 and 12 months | 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. | baseline, 6 months, 12 months | 
| ChangedPrescribed Medications from baseline to 6 and 12 months | 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. | baseline, 6 months, 12 months | 
| Changed Number of Health Diagnoses from baseline to 6 and 12 months | 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. | baseline, 6 months, 12 months | 
| Changed Euroqual health score from baseline to 6 and 12 months | 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. | baseline, 6 months, and 12 months | 
| Changed Euroqual satisfaction with provider score from baseline to 6 and 12 months | 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. | baseline, 6 months, and 12 months | 
| Changed substance use from baseline to 6 and 12 months | Changed substance use from baseline to 6 and 12 months for immediate treatment group and for waitlist control group from 6 months to 12 months (e.g., alcohol, nicotine, cocaine, marijuana, prescription drugs). | baseline, 6 months, 12 month | 
| Changed risky sexual behaviors from baseline to 6 and 12 months | Changed risky sexual behaviors from baseline to 6 and 12 months (e.g., using a barrier method of protection, seeing a doctor) for immediate treatment group and from 6 months to 12 months for waitlist control group. | baseline, 6 months, 12 months | 
| Changed score on self management motivation | 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.18 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). | baseline, month 6, month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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integrated health care, Serious mental illnesses, peer navigator