Overview

This trial is active, not recruiting.

Conditions schizophrenia, depression, medical disorders, serious mental illness
Treatment health navigation
Sponsor University of Southern California
Collaborator University of California, Los Angeles
Start date April 2014
End date September 2015
Trial size 151 participants
Trial identifier NCT02022462, Bridge2014, PCORI

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.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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. 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.
(Other)
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.
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. 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.

Primary Outcomes

Measure
Changed score on SF-6D from baseline to 6 months and 12 months
time frame: baseline, 6 months, 12 months
Increased health screenings from baseline to 6 months and 12 months
time frame: baseline, 6 months, 12 months
Reduced number of Health Complaints from baseline to 6 and 12 months
time frame: baseline, 6 months, 12 months
Higher scores on Health Care Efficacy Scale from baseline to 6 months and 12 months
time frame: baseline, 6 months, 12 months

Secondary Outcomes

Measure
Increased score on Primary Care Provider Relationship from baseline to 6 and 12 months
time frame: baseline, 6 months, 12 months
Decreased scores on Provider level stigma from baseline in comparison to 6 and 12 months
time frame: baseline, 6 months, 12 months
Increased scores of General Life Satisfaction from baseline to 6 and 12 months
time frame: baseline, 6 months, 12 months
Decreased scores on BASIS-32 from baseline in comparison to 6 and 12 months
time frame: baseline, 6 months, 12 months
Decreased unhealthy habits from baseline to 6 and 12 months
time frame: baseline, 6 months, 12 months
Decreased scores of Internalized stigma from baseline to 6 and 12 months
time frame: baseline, 6 months, 12 months
Decreased Prescribed Medications from baseline to 6 and 12 months
time frame: baseline, 6 months, 12 months
Number of Health Diagnoses from baseline to 6 and 12 months
time frame: baseline, 6 months, 12 months
Increased Euroqual health score from baseline to 6 and 12 months
time frame: baseline, 6 months, and 12 months
Increased Euroqual satisfaction with provider score from baseline to 6 and 12 months
time frame: baseline, 6 months, and 12 months
Decreased substance use from baseline to 6 and 12 months
time frame: baseline, 6 months, 12 monthd
Decreased risky sexual behaviors from baseline to 6 and 12 months
time frame: baseline, 6 months, 12 months
Changed score on self management motivation
time frame: baseline, month 6, month 12

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title A Randomized Controlled Trial of "The Bridge", a Peer Health Navigation Intervention
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Southern California.