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Project Wellness Enhancement: Increasing Health Care Choice and Outcomes for People With Mental Illness (WE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02263742
First Posted: October 13, 2014
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Chyrell Bellamy, Yale University
  Purpose

This project aims to study health outcomes of individuals with mental illness attending a co-located primary health care center in a mental health center. This study uses mixed methods to collect a range of information about who chooses to use what Wellness Center services and in what combinations, with what short and longer-term effects and with what outcomes.

Based on participant interviews, identify barriers to and facilitators of access, service, and improvements in person-centered outcomes and elicit suggestions for enhancing health care outcomes and choice.

Collaborate with persons in recovery in using the data collected through Aims 1 and 2 to develop and pilot the effectiveness of a new peer-led community based intervention in enhancing access and choice and improving person-centered health outcomes.


Condition Intervention
Mental Health Wellness 1 Mental Illnesses Other Diagnoses, Comorbidities, and Complications | Patient Behavioral: Peer whole health intervention Behavioral: EBPs at Wellness Center

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Increasing Health Care Choices and Improving Health Outcomes Among Persons With Serious Mental Illness

Resource links provided by NLM:


Further study details as provided by Chyrell Bellamy, Yale University:

Primary Outcome Measures:
  • Effectiveness of a Co-located Primary Health Care Center in a Local mental health center [ Time Frame: up to 30 months ]
    Use mixed methods to collect a rage of information about who chooses to use Using quantitative and qualitative measures by looking at the number of participants, follow up rates, improvement in health indices


Secondary Outcome Measures:
  • Effectiveness of health care navigation in improving health outcomes for people with mental illness [ Time Frame: up to 30 months ]
    Use mixed methods to collect a rage of information about who chooses to use Using quantitative and qualitative measures by looking at the number of participants, follow up rates, improvement in health indices, including some patient centered measures, and also the number of times they meet with their health care navigators

  • Universal Health screening [ Time Frame: up to 30 months ]
    Look at whether clients of the Wellness Center have improvement in their overall health by looking at their health measurements and lab works from each of their 6 month appointments


Other Outcome Measures:
  • Collaborate with persons in recovery in using data collected to develop and pilot a new peer led, community based intervention in enhancing access and choice [ Time Frame: up to 30 months ]
    48 participants will be in a pilot intervention run by peers on whole health, measures will be both qualitative and quantitative to look for overall health improvement and choices


Enrollment: 204
Study Start Date: April 2014
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peer whole health
Peer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes
Behavioral: Peer whole health intervention
Provide wraparound peer support, education, and navigation to individuals
Active Comparator: EBPs at Wellness Center
EBPs at Wellness Center will be the active comparative to measure healthcare choice and outcomes with the peer whole health intervention
Behavioral: EBPs at Wellness Center
four EBPs: a) on-site primary care; b) screening of clients for modifiable risk factors and medical conditions; c) care coordination; and d) peer health navigation

Detailed Description:

Background: Americans with serious mental illnesses (SMI) die an average of 25 years earlier due to modifiable risk factors, medical conditions, and lack of access to quality, coordinated care. Strategies for addressing this disparity have amassed evidence. What remains to be determined is who will choose to use these evidence-based practices (EBPs) when implemented in routine practice, in what combinations, with what short term effects and health outcomes, and what else might be needed for persons for whom these strategies are not effective.

Objectives: The proposed research builds upon the investigators receipt of a SAMHSA grant that established an integrated Wellness Center (WC) within the local mental health center that provides four EBPs: a) on-site primary care; b) screening of clients for modifiable risk factors and medical conditions; c) care coordination; and d) peer health navigation. Through PCORI, the investigators propose to add a comparative effectiveness dimension and a focus on patient-centered outcomes. The investigators specific aims are:

  1. to assess patient preferences and use of services, short-term effects, and longer term outcomes associated with various practices for the population and subpopulations;
  2. to identify barriers to and facilitators of access, service use, and improvements in traditional and patient-centered health outcomes; and
  3. to develop and pilot a peer-led, community-based intervention in enhancing access and choice, and improving patient-centered health outcomes, among 40 treatment-refractory clients of the WC.

The investigators long-term objectives are to: a) identify which practices work for which persons with SMI in improving health and patient-centered outcomes, and b) provide stakeholders around the nation with the knowledge and tools to replicate this model efficiently, effectively, and broadly.

Methods: The sample includes 360 poor, urban adults with SMI who are at risk for or have co-morbid medical conditions. Using participatory and mixed methodology, the investigators will assess Specific Aims 1 & 2 by collecting health and patient-centered outcome data on patients entering the WC and at 6 month follow-up intervals and analyze the data using Linear Mixed Models and logistic regression. Outcome data from the pilot intervention (Aim 3; N=40) will be compared to outcomes of a propensity matched sample of WC patients. Qualitative data will be collected each year through focus groups (N=48 agency stakeholders, year 1) and individual interviews (50 WC patients, years 2 & 3).

Projected Patient Outcomes: Outcomes include both traditional medical/clinical outcomes (e.g., blood pressure, BMI, fasting plasma glucose, HbGA1c, cholesterol, triglycerides, alcohol and drug use, psychiatric symptoms) and a range of patient-centered outcomes to be identified by key stakeholders in the initial phase of research. The investigators previous research suggests that these outcomes are likely to include self-efficacy, quality of life, employment, citizenship, and social connectedness.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older
  • Clients receiving services from CMHC and the Wellness Center.
  • Research staff will verify with CMHC staff that the potential participant is receiving services currently at CMHC.
  • Provider research subjects will be included if they are a mental health provider at CMHC or if they are members of the staff for the Wellness Center
  • Adults with serious mental illness and physical illness

Exclusion Criteria:

  • Participant research subjects not receiving services at CMHC and the Wellness Center
  • Provider research subjects of other agencies will be excluded
  • Children and youth under 18 years of age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263742


Locations
United States, Connecticut
CT Mental Health Center
New Haven, Connecticut, United States, 06511
Yale University Program for Recovery and Community Health
New Haven, Connecticut, United States, 06513
Sponsors and Collaborators
Yale University
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Chyrell Bellamy, Ph.D. Yale University
Study Director: Kimberly D Antunes, BSW Yale University
  More Information

Responsible Party: Chyrell Bellamy, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT02263742     History of Changes
Other Study ID Numbers: IH-1304-7294
First Submitted: March 31, 2014
First Posted: October 13, 2014
Last Update Posted: January 27, 2017
Last Verified: January 2017

Keywords provided by Chyrell Bellamy, Yale University:
Healthcare choice and outcomes
Peer-led whole health
Mental Illness
Peer Health Navigation
Health care Coordination

Additional relevant MeSH terms:
Mental Disorders