Chronic Mental IllnessWINNCT02440906
Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project
A study testing Patient-Directed Wellness Account and Health Navigator in people with Chronic Mental Illness and Chronic Physical Illness, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Chronic Mental Illness, Chronic Physical Illness
- What is being tested?
- Patient-Directed Wellness Account and Health Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,663 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Institute for Child Health Policy
Gainesville, Florida, 32608
About this study
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.
Read the 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.
- Conditions
- Chronic Mental Illness, Chronic Physical Illness
- Being tested
- Patient-Directed Wellness Account, Health Navigator
- 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
- Medical subject headings
- Asthma, Cerebrovascular Disorders, Neoplasms, Heart Failure, Acquired Immunodeficiency Syndrome, Neuritis, Arthritis, Rheumatoid, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Directed Wellness AccountBehavioural
The intervention group (n=629) continue to receive usual care and receive a financial incentive to use in meeting their health goals.
Health NavigatorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient-Directed Wellness Account; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (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.
Measured: (Change) baseline, 12 months, 24 months and 36 months
Secondary outcomes (4)
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.
Measured: (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
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.
Measured: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
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.
Measured: (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
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.
Measured: (Change) baseline, 12 months, 24 months, 36 months, and 1 year after month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Mental IllnessStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,663 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, RTI International, Econometrica, Inc.
- Responsible party
- Sponsor
- Investigators
- Elizabeth Shenkman, Ph.D., Principal investigator, University of FloridaKimberly Case, Ph.D., Study director, University of FloridaDena Stoner, Study director, Texas Health and Human Services Commission
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440906
- Sponsor's protocol ID
- 168-2012
- Acronym
- WIN
- Status last verified
- Oct 2017
- First submitted
- 22 Apr 2015
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26714845
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Texas Wellness Incentives and Navigation (WIN) Project
- ClinicalTrials.gov ID
- NCT02440906
- Acronym / sponsor ID
- WIN / 168-2012
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,663 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, RTI International, Econometrica, Inc.
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Patient-Directed Wellness Account, Behavioral: Health NavigatorA 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 | 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. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Directed Wellness AccountThe intervention group (n=629) continue to receive usual care and receive a financial incentive to use in meeting their health goals. | Behavioural | Intervention |
| Health NavigatorThe 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. | Behavioural | Intervention |
Primary outcome
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
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)
Time frame: (Change) baseline, 12 months, 24 months and 36 months
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Derived from this study: PubMed 26714845Shenkman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Shenkman, Ph.D. principal investigator
University of Florida
Kimberly Case, Ph.D. study director
University of Florida
Dena Stoner study director
Texas Health and Human Services Commission
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Directed Wellness Account and Health Navigator in people with Chronic Mental Illness and Chronic Physical Illness, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.