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Completed

NCT Number: NCT02440906

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

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.

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Key information

Conditions

Chronic Mental Illness Acquired Immunodeficiency Syndrome Anxiety Disorders Arthritis Arthritis, Rheumatoid Asthma Autoimmune Diseases Blood-Borne Infections Brain Diseases Bronchial Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Physical Illness Communicable Diseases Connective Tissue Diseases Genital Diseases HIV Infections Heart Diseases Heart Failure Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Infections Joint Diseases Lentivirus Infections Lung Diseases Lung Diseases, Obstructive Mental Disorders Musculoskeletal Diseases Neoplasms Nervous System Diseases Neuritis Neuromuscular Diseases Neurotic Disorders Peripheral Nervous System Diseases RNA Virus Infections Respiratory Hypersensitivity Respiratory Tract Diseases Retroviridae Infections Rheumatic Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Paranoid Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin and Connective Tissue Diseases Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Institute for Child Health Policy

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Patient-Directed Wellness Account

Behavioral

The intervention group (n=629) continue to receive usual care and receive a financial incentive to use in meeting their health goals.

Health Navigator

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Centers for Medicare and Medicaid Services
  • Econometrica, Inc.
  • RTI International

Registry information

Acronym: WIN

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
May 12, 2015
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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