Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02022462
Study type Interventional
Source University of Southern California
Contact
Status Completed
Phase N/A
Start date April 2014
Completion date March 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A