Clinical trial NCT02022462: Project Bridge: Peer Health Navigator Intervention
Official title: A Randomized Controlled Trial of "The Bridge", a Peer Health Navigation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Depression
Medical Disorders
Serious Mental Illness
Keywords: Serious mental illnesses
peer navigator
integrated health care
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2013-12-27
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. 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;
2. 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.

151 participants in an Full Service Partnership (FSP) clinic operated by Pacific Clinics were 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: 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 conducted a randomized controlled trial comparing 2 groups: a) a treatment as usual waitlist (n =75), and b) the Bridge peer navigator intervention (n=76). 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 conducted 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 ask each person interviewed for his or her ideas about what are the critical factors for implementation and sustainability. Finally, investigators conducted exit interviews with each patient as part of their final assessment. Exit interviews focused 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 was 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changed Score on SF-12 Pain Items From Baseline to 6 Months and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Health Screenings From Baseline to 6 Months and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Number of Health Complaints From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Scores on Health Care Efficacy Scale From Baseline to 6 Months and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Score on Primary Care Provider Relationship From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Changed Scores on Provider Level Stigma From Baseline in Comparison to 6 and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Scores of General Life Satisfaction From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Scores on BASIS-24 From Baseline in Comparison to 6 and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Unhealthy Habits From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Scores of Internalized Stigma From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: ChangedPrescribed Medications From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Number of Health Diagnoses From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, 12 months
measure: Changed Euroqual Health Score From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, and 12 months
measure: Changed Euroqual Satisfaction With Provider Score From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, and 12 months
measure: Changed Substance Use From Baseline to 6 and 12 Months
timeFrame: baseline, 6 months, 12 month
measure: Changed Score on Self Management Motivation
timeFrame: baseline, month 6, month 12
Other outcomes:
Locations:
city: Santa Fe Springs
country: United States
facility: Pacific Clinics El Camino
state: California
Study officials:
affiliation: Pacific Clinics Corporate Director, East Valley Division and New Initiatives
name: Sharon Duris
role: STUDY_DIRECTOR
References:
citation: DE Hert M, Correll CU, Bobes J, Cetkovich-Bakmas M, Cohen D, Asai I, Detraux J, Gautam S, Moller HJ, Ndetei DM, Newcomer JW, Uwakwe R, Leucht S. Physical illness in patients with severe mental disorders. I. Prevalence, impact of medications and disparities in health care. World Psychiatry. 2011 Feb;10(1):52-77. doi: 10.1002/j.2051-5545.2011.tb00014.x.
citation: Parks J, Svendsen D, Singer P, Foti ME. Morbidity and mortality in people with serious mental illness. Report from the National Association of State Mental Health Program Directors. 2006.
citation: Bazelon Center for Mental Health Law. Get it together. How to integrate physical and mental health care for people with serious mental disorders. Washington DC 2004.
citation: Gelberg L, Andersen RM, Leake BD. The Behavioral Model for Vulnerable Populations: application to medical care use and outcomes for homeless people. Health Serv Res. 2000 Feb;34(6):1273-302.