The wellness incentives and navigation project: design and methods

Abstract

BackgroundAbout 35 % of non-elderly U.S. adult Medicaid enrollees have a behavioral health condition, such as anxiety, mood disorders, substance use disorders, and/or serious mental illness. Individuals with serious mental illness, in particular, have mortality rates that are 2 to 3 times higher as the general population, which are due to multiple factors including inactivity, poor nutrition, and tobacco use. 61 % of Medicaid beneficiaries with behavioral health conditions also have multiple other co-occurring chronic physical health conditions, which further contributes to morbidity and mortality. The Wellness Incentives and Navigation (WIN) project is one of 10 projects under the Centers for Medicare and Medicaid Services “Medicaid Incentives for the Prevention of Chronic Diseases” Initiative, to “test the effectiveness of providing incentives directly to Medicaid beneficiaries of all ages who participate in prevention programs, and change their health risks and outcomes by adopting healthy behaviors.”Methods/DesignWIN is a three-year randomized pragmatic clinical trial designed to examine the comparative effectiveness of the combined use of personal navigators, motivational interviewing, and a flexible wellness account on cardiovascular risk reduction among individuals in Medicaid with co-occurring physical and mental health conditions or serious mental illness alone relative to the usual care provided within Medicaid Managed Care. 1250 individuals, identified through Medicaid claims data, were recruited and randomly assigned to an intervention group or control group with outcomes tracked annually. A comparison group was also recruited to help assess the study’s internal validity.DiscussionThe primary outcomes are physical and mental health related quality-of-life as measured by the SF-12, and BMI, blood pressure, LDL-C, and Hba1c results for those who are diabetic measured clinically. The purpose of this paper is to present the unique design of the WIN trial prior to results becoming available in hopes of assisting other researchers in conducting community-based randomized pragmatic trials. Outcomes will be assessed through the linkage of patient reported outcomes, health care claims, and electronic health record data.Trial RegistrationNCT02440906

Assessing the reliability of the short form 12 (SF-12) health survey in adults with mental health conditions: a report from the wellness incentive and navigation (WIN) study

“…The WIN project is a three-year longitudinal randomized pragmatic clinical trial funded by the Center for Medicare & Medicaid Services’ Medicaid Incentives for the Prevention of Chronic Conditions portfolio [ 4 ]. The WIN project examines the comparative effectiveness of personal navigators, motivational interviewing (MI), and a flexible wellness expense account on health care costs, cardiovascular risk factors, physical health, and HRQOL among individuals in Medicaid with co-occurring physical and mental health conditions or serious mental illness (SMI) or both, relative to usual care provided by a specialized Medicaid Managed Care Program for individuals with disability.…”

“…Since WIN project is a pragmatic trial, our goal is to provide evidence for adopting the intervention to the real world Medicaid population with mental or co-occurred physical and behavioral conditions. The detailed diagnostic criteria with detailed ICD-9 codes for all included/excluded co-morbidities for individuals in the WIN study was published previously [ 4 ]. In brief, eligibility for the WIN trial included the presence of a serious mental illness (SMI) diagnosis (e.g.…”

“…The primary goal of the STAR+PLUS program is to improve quality of care for individuals with disabilities through coordinated and comprehensive care in a cost-efficient way. Details about STAR+PLUS program has been described elsewhere [ 4 , 5 ]. A reliable health-related quality of life (HRQOL) measure is critical for us to assess the well-being of this population and to quantify the efficacy of interventions to further improve the quality of care and reduce medical costs for this chronically ill population.…”

The Wellness Incentive and Navigation intervention improved health‐related quality of life among Medicaid enrollees: A randomized pragmatic clinical trial

“…Full details of the study design and conceptual framework are available in a previously published article . To be eligible for the WIN study, an individual must have the following: (a) a SMI diagnosis (eg, schizophrenia, bipolar disorder, major depressive disorder) alone, (b) diagnosed behavioral health conditions (BHC; eg, anxiety, depression, substance use disorder) coupled with a diagnosed chronic physical health condition (PHC; eg, diabetes, COPD), or (c) all three conditions: a SMI diagnosis, BHC diagnoses, and a chronic PHC diagnosis.…”

“…Full details of the study design and conceptual framework are available in a previously published article. 22 23 Initially, 12 349 individuals were identified as meeting the inclusion and exclusion criteria from the Harris SDA Medicaid enrollment files. Among these eligible individuals, 9044 were randomly selected to contact for potential study participation.…”