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

NCT ID: NCT02440906

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1663 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Mental Illness Chronic Physical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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.

Group Type EXPERIMENTAL

Patient-Directed Wellness Account

Intervention Type 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

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Comparison

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centers for Medicare and Medicaid Services

FED

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

Econometrica, Inc.

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth Shenkman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Kimberly Case, Ph.D.

Role: STUDY_DIRECTOR

University of Florida

Dena Stoner

Role: STUDY_DIRECTOR

Texas Health and Human Services Commission

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida, Institute for Child Health Policy

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26714845 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

168-2012

Identifier Type: -

Identifier Source: org_study_id