Project Bridge: Peer Health Navigator Intervention

NCT02022462 | Completed Results

• 2 other identifiers: Bridge2014PCORI
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Schizophrenia; Depression; Medical Disorders; Serious Mental Illness

Keywords

Serious mental illnesses; peer navigator; integrated health care

Outcome Measures

Primary Outcomes (5)

• Changed Score on SF-12 Pain Items From Baseline to 6 Months and 12 Months

  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.

  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. 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.

  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. A negative change score would indicate a reduction in symptoms, which would indicate better health. Change scores ranged from -21 to 7.

  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'). A positive change score indicates improved health care self-efficacy.

  baseline, 6 months, 12 months

• 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 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.

  baseline, 6 months, 12 months

Secondary Outcomes (11)

• Changed Scores on Provider Level Stigma From Baseline in Comparison to 6 and 12 Months

  baseline, 6 months, 12 months

• Changed Scores of General Life Satisfaction From Baseline to 6 and 12 Months

  baseline, 6 months, 12 months

• Changed Scores on BASIS-24 From Baseline in Comparison to 6 and 12 Months

  baseline, 6 months, 12 months

• Changed Unhealthy Habits From Baseline to 6 and 12 Months

  baseline, 6 months, 12 months

• Changed Scores of Internalized Stigma From Baseline to 6 and 12 Months

  baseline, 6 months, 12 months

Study Arms (2)

Health Navigation

EXPERIMENTAL

151 participants with SMI in the El Camino clinic, operated by Pacific Clinics, were recruited to participate in a 12-month study of Bridge navigation. Participants were 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 completed 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 completed three assessments (baseline, 6 months, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.

Behavioral: Health Navigation

Waitlist Control

OTHER

151 participants with SMI in the El Camino clinic, operated by Pacific Clinics, were recruited to participate in a 12-month study of Bridge navigation. Participants were randomly assigned to either waitlist control (n = 75, 6-month waitlist with treatment as usual then they received the intervention) or immediate intervention with the Bridge (n = 76). Participants in the immediate treatment group completed 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 completed three assessments (baseline, 6 months, 12 months) and one interview about their health, health care, and their experiences using health navigation after 12 months.

Behavioral: Health Navigation

Interventions

Health Navigation BEHAVIORAL

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.

Health Navigation; Waitlist Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Pacific Clinics El Camino

Santa Fe Springs, California, 90670, United States

Location

Related Publications (4)

• 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.

  PMID: 21379357 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10654830 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Depression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Limited to a single mental health agency.

Results Point of Contact

• Title: Dr. John Brekke
• Organization: University of Southern California

brekke@usc.edu

213-740-0297

Study Officials

• Sharon Duris

  Pacific Clinics Corporate Director, East Valley Division and New Initiatives

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 27, 2013
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2020
• Last Updated: February 2, 2024
• Results First Posted: February 2, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)