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SchizophreniaBridgeNCT02022462

Project Bridge: Peer Health Navigator Intervention

A study testing Health Navigation in people with Schizophrenia and Depression, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia, Depression, Medical Disorders
What is being tested?
Health Navigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
1 siteUnited States
Study dates
Apr 2014to Mar 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pacific Clinics El Camino

    Santa Fe Springs, California, 90670

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of "The Bridge", a Peer Health Navigation Intervention

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.

Read more

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.

Read the 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.

Being tested
Health Navigation
Keywords
Serious mental illnesses, peer navigator, integrated health care
Medical subject headings
Schizophrenia, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health NavigationBehavioural

    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.

Study groups in NCT02022462
Study groupRoleWhat they receive
Health NavigationExperimental151 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.
Receives: Behavioral: Health Navigation
Waitlist ControlOther151 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.
Receives: Behavioral: Health Navigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, 6 months, 12 months

  2. 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.

    Measured: baseline, 6 months, 12 months

  3. 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.

    Measured: baseline, 6 months, 12 months

  4. 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.

    Measured: baseline, 6 months, 12 months

  5. 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.

    Measured: baseline, 6 months, 12 months

Secondary outcomes (11)

  1. 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 stigmatizing experiences with their provider on a 5-point scale (1= 'strongly disagree' to 5 = 'strongly agree'). Mean scores range from 1 to 5 with higher scores indicating agreement with experiences of stigma.

    Measured: baseline, 6 months, 12 months

  2. 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. Mean scores range from 1 to 5, with higher scores indicating greater satisfaction with life. Change scores ranged from -1.42 to 1.59 with higher scores indicating an improvement over time in life satisfaction.

    Measured: baseline, 6 months, 12 months

  3. Changed Scores on BASIS-24 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. The functional outcomes of the clients will be measured with the BASIS-24 (Behavior and Symptom Identification Scale). The 24 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. Higher scores indicate greater difficulty. Scores range from 0 to 4. Change scores range from -2.18 to 1.58 with a positive score indicating an increase in difficulties.

    Measured: baseline, 6 months, 12 months

  4. Changed Unhealthy Habits From Baseline to 6 and 12 Months

    Using 1 item adapted from the National Leisure Time Survey, participants rated on a 7 point scale (0 = 'never' to 7 = 'daily') the frequency that participants exercise and scores were converted into z scores. 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 exercise. A negative change score indicates less exercise

    Measured: baseline, 6 months, 12 months

  5. 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. Mean scores ranged from 1 to 4 with higher scores indicating a higher level of self-stigma. Change scores ranged from -.88 to 1.13, with negative change scores indicating a decrease in internalized stigma and a positive score indicating an increase in internalized stigma.

    Measured: baseline, 6 months, 12 months

  6. 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. A positive score indicates an increase in medications and a negative change score indicates a reduction in medications.

    Measured: baseline, 6 months, 12 months

  7. 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. Changes in the number of diagnoses ranged from -3 to 5. Positive changes indicate an increased in diagnosed conditions and negative scores indicate a reduction in diagnoses.

    Measured: baseline, 6 months, 12 months

  8. 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. Change scores ranged from -90 to 100. Positive scores indicate better health and negative scores indicate worsening health.

    Measured: baseline, 6 months, and 12 months

  9. 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. Change scores ranged from -90 to 79. Positive scores indicate improved satisfaction and negative scores indicate declines in satisfaction.

    Measured: baseline, 6 months, and 12 months

  10. Changed Substance Use From Baseline to 6 and 12 Months

    Changed substance use from baseline to 6 and 12 months for the immediate treatment group and for the waitlist control group from 6 months to 12 months (e.g., alcohol, nicotine, cocaine, marijuana, prescription drugs). Scores ranged from 0 to 9, with a higher number indicating a greater variety of substances used. A negative score indicates a reduced variety of substances used and a positive score indicates an increase in the variety of substances used (range from -2 to 2 for change scores).

    Measured: baseline, 6 months, 12 month

  11. 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. 9 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). Changes in confidence ranged from -4.44 to 4.00. Positive scores indicate an increased confidence and negative scores indicate a decrease in confidence.

    Measured: baseline, month 6, month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2013 (estimated)
  2. Study startApr 2014
  3. Primary completionSep 2015
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022462
Sponsor's protocol ID
Bridge2014
Other IDs
PCORI
Acronym
Bridge
Status last verified
May 2023
First submitted
11 Dec 2013
Last updated
2 Feb 2024
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21379357

  • 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.

  • 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.

  • 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.

    PubMed 10654830

Questions about this trial

What is this clinical trial studying?

A study testing Health Navigation in people with Schizophrenia and Depression, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changed Score on SF-12 Pain Items From Baseline to 6 Months and 12 Months (time frame: baseline, 6 months, 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02022462, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.

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