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

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.
 
ClinicalTrials.gov Identifier: NCT02440906
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : October 3, 2017
Sponsor:
Collaborators:
Centers for Medicare and Medicaid Services
RTI International
Econometrica, Inc.
Information provided by (Responsible Party):
University of Florida

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Mental Illness Chronic Physical Illness Behavioral: Patient-Directed Wellness Account Behavioral: Health Navigator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1663 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project
Study Start Date : June 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016

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.
Behavioral: Patient-Directed Wellness Account
The intervention group (n=629) continue to receive usual care and receive a financial incentive to use in meeting their health goals.

Behavioral: Health Navigator
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

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): NCT02440906


Locations
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United States, Florida
University of Florida, Institute for Child Health Policy
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Centers for Medicare and Medicaid Services
RTI International
Econometrica, Inc.
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02440906    
Other Study ID Numbers: 168-2012
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: October 2017
Keywords provided by University of Florida:
Asthma
Cerebrovascular Disease
Intracranial Injury
Neoplasms
Heart Failure
HIV/AIDs
Hereditary and Degenerative Diseases of the Central Nervous System
Disorders of the Peripheral Nervous System
Rheumatoid Arthritis and Other Inflammatory Polyarthropathies
History of hepatitis C
Schizophrenia
Episodic Mood Disorders
Delusional Disorders
Other Non-Organic Psychoses
Organic Psychotic Conditions
Neurotic Disorders
Other Non-Psychotic Mental Disorders
Additional relevant MeSH terms:
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Mental Disorders