Overview

This trial is active, not recruiting.

Conditions chronic mental illness, chronic physical illness
Treatments patient-directed wellness account, health navigator
Sponsor University of Florida
Collaborator Centers for Medicare and Medicaid Services
Start date June 2012
End date December 2015
Trial size 1663 participants
Trial identifier NCT02440906, 168-2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
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.
(No Intervention)
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)
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 Outcomes

Measure
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
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

Secondary Outcomes

Measure
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
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
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
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

Eligibility Criteria

Male or female participants from 21 years up to 55 years old.

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).

Additional Information

Official title Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project
Principal investigator Elizabeth Shenkman, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of Florida.