Clinical trial NCT02440906: Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project
Official title: Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Mental Illness
Chronic Physical Illness
Keywords: 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
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
name: RTI International
name: Econometrica, Inc.
First posted: 2015-05-12
Enrollment: 1663
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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).

Primary outcomes:
measure: Self-reported physical health related quality of life (HRQOL) using the Short Form-12 (SF-12)
timeFrame: (Change) baseline, 12 months, 24 months and 36 months
measure: Self-reported mental health related quality of life (HRQOL) using the Short Form-12 (SF-12)
timeFrame: (Change) baseline, 12 months, 24 months and 36 months
Secondary outcomes:
measure: Change in Total Healthcare expenditures as measured through Medicaid claims data
timeFrame: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
measure: Changes in Inpatient Hospitalization expenditures as measured through Medicaid claims data
timeFrame: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
measure: Changes in Outpatient expenditures as measured through Medicaid claims data
timeFrame: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
measure: Changes in Emergency Department expenditures as measured through Medicaid claims data
timeFrame: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida, Institute for Child Health Policy
state: Florida
Study officials:
affiliation: University of Florida
name: Elizabeth Shenkman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Kimberly Case, Ph.D.
role: STUDY_DIRECTOR
affiliation: Texas Health and Human Services Commission
name: Dena Stoner
role: STUDY_DIRECTOR
References:
citation: Shenkman E, Muller K, Vogel B, Nixon SJ, Wagenaar AC, Case K, Guo Y, Wegman M, Aric J, Stoner D. The wellness incentives and navigation project: design and methods. BMC Health Serv Res. 2015 Dec 29;15:579. doi: 10.1186/s12913-015-1245-x.