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

Primary Purpose

Chronic Mental Illness, Chronic Physical Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-Directed Wellness Account
Health Navigator
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Mental Illness focused on measuring 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

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Florida, Institute for Child Health Policy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Intervention

Control

Comparison

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 22, 2015
Last Updated
October 2, 2017
Sponsor
University of Florida
Collaborators
Centers for Medicare and Medicaid Services, RTI International, Econometrica, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02440906
Brief Title
Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project
Acronym
WIN
Official Title
Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Centers for Medicare and Medicaid Services, RTI International, Econometrica, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1663 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient-Directed Wellness Account
Intervention Description
The intervention group (n=629) continue to receive usual care and receive a financial incentive to use in meeting their health goals.
Intervention Type
Behavioral
Intervention Name(s)
Health Navigator
Intervention Description
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 Outcome Measure Information:
Title
Self-reported physical health related quality of life (HRQOL) using the Short Form-12 (SF-12)
Description
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.
Time Frame
(Change) baseline, 12 months, 24 months and 36 months
Title
Self-reported mental health related quality of life (HRQOL) using the Short Form-12 (SF-12)
Description
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.
Time Frame
(Change) baseline, 12 months, 24 months and 36 months
Secondary Outcome Measure Information:
Title
Change in Total Healthcare expenditures as measured through Medicaid claims data
Description
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.
Time Frame
(Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
Title
Changes in Inpatient Hospitalization expenditures as measured through Medicaid claims data
Description
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.
Time Frame
(Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
Title
Changes in Outpatient expenditures as measured through Medicaid claims data
Description
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.
Time Frame
(Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
Title
Changes in Emergency Department expenditures as measured through Medicaid claims data
Description
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.
Time Frame
(Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Shenkman, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimberly Case, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dena Stoner
Organizational Affiliation
Texas Health and Human Services Commission
Official's Role
Study Director
Facility Information:
Facility Name
University of Florida, Institute for Child Health Policy
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26714845
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.
Results Reference
derived

Learn more about this trial

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

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