NCT02440906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,663

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 3, 2017

Status Verified

October 1, 2017

Enrollment Period

3.5 years

First QC Date

April 22, 2015

Last Update Submit

October 2, 2017

Conditions

Keywords

AsthmaCerebrovascular DiseaseIntracranial InjuryNeoplasmsHeart FailureHIV/AIDsHereditary and Degenerative Diseases of the Central Nervous SystemDisorders of the Peripheral Nervous SystemRheumatoid Arthritis and Other Inflammatory PolyarthropathiesHistory of hepatitis CSchizophreniaEpisodic Mood DisordersDelusional DisordersOther Non-Organic PsychosesOrganic Psychotic ConditionsNeurotic DisordersOther Non-Psychotic Mental Disorders

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Change in Total Healthcare expenditures as measured through Medicaid claims data

    (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

    (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36

  • Changes in Outpatient expenditures as measured through Medicaid claims data

    (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

    (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36

Study Arms (3)

Intervention

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.

Behavioral: Patient-Directed Wellness AccountBehavioral: Health Navigator

Control

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.

Comparison

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.

Interventions

The intervention group (n=629) continue to receive usual care and receive a financial incentive to use in meeting their health goals.

Intervention

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

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida, Institute for Child Health Policy

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AsthmaCerebrovascular DisordersNeoplasmsHeart FailureAcquired Immunodeficiency SyndromeNeuritisArthritis, RheumatoidSchizophreniaSchizophrenia, ParanoidNeurotic Disorders

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHeart DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental DisordersAnxiety Disorders

Study Officials

  • Elizabeth Shenkman, Ph.D.

    University of Florida

    PRINCIPAL INVESTIGATOR
  • Kimberly Case, Ph.D.

    University of Florida

    STUDY DIRECTOR
  • Dena Stoner

    Texas Health and Human Services Commission

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 12, 2015

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

October 3, 2017

Record last verified: 2017-10

Locations