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

Chronic Mental Illness Clinical Trial

— WIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440906
• Other study ID #: 168-2012
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: October 2, 2017
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1663
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Mental Illness
• Chronic Physical Illness
• Mental Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida, Institute for Child Health Policy	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	Centers for Medicare and Medicaid Services, Econometrica, Inc., RTI International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported physical health related quality of life (HRQOL) using the Short Form-12 (SF-12)	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
Primary	Self-reported mental health related quality of life (HRQOL) using the Short Form-12 (SF-12)	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	Change in Total Healthcare expenditures as measured through Medicaid claims data	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
Secondary	Changes in Inpatient Hospitalization expenditures as measured through Medicaid claims data	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
Secondary	Changes in Outpatient expenditures as measured through Medicaid claims data	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
Secondary	Changes in Emergency Department expenditures as measured through Medicaid claims data	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