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

Primary Purpose

Mental Health Wellness 1, Mental Illnesses, Other Diagnoses, Comorbidities, and Complications | Patient

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer whole health intervention
EBPs at Wellness Center
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health Wellness 1 focused on measuring Healthcare choice and outcomes, Peer-led whole health, Mental Illness, Peer Health Navigation, Health care Coordination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CT Mental Health Center
  • Yale University Program for Recovery and Community Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peer whole health

EBPs at Wellness Center

Arm Description

Peer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes

EBPs at Wellness Center will be the active comparative to measure healthcare choice and outcomes with the peer whole health intervention

Outcomes

Primary Outcome Measures

Effectiveness of a Co-located Primary Health Care Center in a Local mental health center
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
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
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

Full Information

First Posted
March 31, 2014
Last Updated
January 12, 2018
Sponsor
Yale University
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02263742
Brief Title
Project Wellness Enhancement: Increasing Health Care Choice and Outcomes for People With Mental Illness
Acronym
WE
Official Title
Increasing Health Care Choices and Improving Health Outcomes Among Persons With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: to assess patient preferences and use of services, short-term effects, and longer term outcomes associated with various practices for the population and subpopulations; to identify barriers to and facilitators of access, service use, and improvements in traditional and patient-centered health outcomes; and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1, Mental Illnesses, Other Diagnoses, Comorbidities, and Complications | Patient
Keywords
Healthcare choice and outcomes, Peer-led whole health, Mental Illness, Peer Health Navigation, Health care Coordination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer whole health
Arm Type
Experimental
Arm Description
Peer whole health intervention will be compared to the treatment as usual at Wellness Center to assess healthcare choice and outcomes
Arm Title
EBPs at Wellness Center
Arm Type
Active Comparator
Arm Description
EBPs at Wellness Center will be the active comparative to measure healthcare choice and outcomes with the peer whole health intervention
Intervention Type
Behavioral
Intervention Name(s)
Peer whole health intervention
Intervention Description
Provide wraparound peer support, education, and navigation to individuals
Intervention Type
Behavioral
Intervention Name(s)
EBPs at Wellness Center
Intervention Description
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
Primary Outcome Measure Information:
Title
Effectiveness of a Co-located Primary Health Care Center in a Local mental health center
Description
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
Time Frame
up to 30 months
Secondary Outcome Measure Information:
Title
Effectiveness of health care navigation in improving health outcomes for people with mental illness
Description
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
Time Frame
up to 30 months
Title
Universal Health screening
Description
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
Time Frame
up to 30 months
Other Pre-specified Outcome Measures:
Title
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
Description
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
Time Frame
up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chyrell Bellamy, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimberly D Antunes, BSW
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
CT Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Yale University Program for Recovery and Community Health
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06513
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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