Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project (WIN)

October 2, 2017 updated by: University of Florida

The Wellness Incentives and Navigation (WIN) project is designed to help improve health self-management and reduce the incidence and consequences of chronic disease among non-elderly adult Medicaid Supplemental Security Income (SSI) beneficiaries. WIN targets SSI beneficiaries with behavioral health (mental health and substance abuse) diagnoses. Research demonstrates that these individuals are more likely to suffer chronic physical co-morbidities, experience debilitating chronic illnesses earlier in life and have elevated healthcare costs.

WIN uses person-centered wellness planning and navigation facilitated by trained, professional health Navigators, dedicated specifically to the WIN project, who use Motivational Interviewing (MI) techniques, and a personal wellness account. Participants with more serious mental illnesses will be offered additional support in the form of Wellness Recovery Action Planning (WRAP) to enable them to take full advantage of person-centered wellness planning.

Study Overview

Detailed Description

The Texas based Wellness Incentives and Navigation (WIN) project uses a continuum of evidence-based "whole person" interventions that take into account clinical, environmental, and social risk factors and co-morbidities. Unlike more traditional didactic approaches to health management, WIN addresses individual behavioral, social, and economic barriers to health and wellness, and promotes continued engagement in achieving, internalizing, and maintaining healthy behaviors.

The study is focused on non-dual eligible adult STAR+PLUS (a Texas Medicaid managed care program for people with chronic illnesses) members (ages 21-55) with a behavioral health disorder including serious mental illness (SMI - e.g., schizophrenia, bipolar disorder or major depressive disorder) or other behavioral health conditions (e.g., anxiety disorder or substance abuse). Key features of the program include the use of professional health navigators, working in collaboration with the three STAR+PLUS plans in the Harris Service Area (SA) (United-Evercare, Amerigroup, and Molina), the use of motivational interviewing (MI) techniques to help members develop and meet personal wellness goals, and a flexible wellness account for the participant to use in meeting his/her goals.

Study Type

Interventional

Enrollment (Actual)

1663

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida, Institute for Child Health Policy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be a resident of the Harris service area
  • Be a non-dual eligible member of STAR+PLUS;
  • Be 21 to 55 years of age; and
  • Have an SMI Diagnosis (schizophrenia, bi-polar disorder, major depressive disorder); or
  • Other behavioral health diagnoses (e.g., anxiety, depression, substance use disorder) coupled with a chronic health diagnosis (physical health condition).

Exclusion Criteria:

  • Intellectual or cognitive diagnoses indicative of severe cognitive impairment. These could include diagnoses such as 290.X (dementia) and 318-319 (moderate to severe mental retardation).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
A person-centered wellness intervention that includes a patient-directed wellness account. Enrollees meet with a patient Navigator to develop a wellness plan. The enrollee can then use the flexible wellness account to make purchases that are consistent with the goals of the wellness plan. Health Navigators have monthly phone contact with enrollees and meet quarterly with them to discuss goals and spending with the express goal of improving self-management, use of preventive services, satisfaction with care, healthcare utilization and expenditures and quality of care.
The intervention group (n=629) continue to receive usual care and receive a financial incentive to use in meeting their health goals.
The intervention group (n=629) will work with a health navigator on a monthly basis to develop and refine patient-centered health goals. Motivational interviewing techniques are used to establish the wellness goals.
No Intervention: Control
Control group participants receive a monthly mailing requesting updated contact information. They can send this card via mail, or by calling the toll free number.
No Intervention: Comparison
These are STAR+PLUS enrollees who meet the same enrollment criteria as the intervention and control but reside outside of the Harris Service Area. The purpose of the comparison group is to follow them and their outcomes. This group will help us to better compare the outcomes we see with those enrolled in the WIN Project to a comparable group for whom we already house data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported physical health related quality of life (HRQOL) using the Short Form-12 (SF-12)
Time Frame: (Change) baseline, 12 months, 24 months and 36 months
The SF-12 has been validated across a number of chronic diseases and conditions. The survey consists of 12 questions measuring functional health and well-being. Patients answer questions related to daily functioning, difficulties in physical tasks, and disruptions in life due to mental illness (e.g. depression, anxiety). The overall score can be further classified into two summary scores for physical and mental health.
(Change) baseline, 12 months, 24 months and 36 months
Self-reported mental health related quality of life (HRQOL) using the Short Form-12 (SF-12)
Time Frame: (Change) baseline, 12 months, 24 months and 36 months
The SF-12 has been validated across a number of chronic diseases and conditions. The survey consists of 12 questions measuring functional health and well-being. Patients answer questions related to daily functioning, difficulties in physical tasks, and disruptions in life due to mental illness (e.g. depression, anxiety). The overall score can be further classified into two summary scores for physical and mental health.
(Change) baseline, 12 months, 24 months and 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Healthcare expenditures as measured through Medicaid claims data
Time Frame: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
We will use Medicaid claims and enrollment expenditure data to examine changes in total medical expenditures between the three groups of participants across baseline, 12 months, 24 months and 36 months.
(Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
Changes in Inpatient Hospitalization expenditures as measured through Medicaid claims data
Time Frame: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
We will use Medicaid claims and enrollment expenditure data to examine changes in inpatient hospitalization expenditures between the three groups of participants across baseline, 12 months, 24 months and 36 months.
(Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
Changes in Outpatient expenditures as measured through Medicaid claims data
Time Frame: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
We will use Medicaid claims and enrollment expenditure data to examine changes in outpatient expenditures between the three groups of participants across baseline, 12 months, 24 months and 36 months.
(Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
Changes in Emergency Department expenditures as measured through Medicaid claims data
Time Frame: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
We will use Medicaid claims and enrollment expenditure data to examine changes in emergency department expenditures between the three groups of participants across baseline, 12 months, 24 months and 36 months.
(Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elizabeth Shenkman, Ph.D., University of Florida
  • Study Director: Kimberly Case, Ph.D., University of Florida
  • Study Director: Dena Stoner, Texas Health and Human Services Commission

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

October 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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