A Randomized Incentive-Based Diabetes Self-Management Study (Hawaii Patient Reward And Incentives to Support Empowerment Project)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- University of Hawaii
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Changes in HbA1c From Baseline to the End of Intervention (December 2015)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this randomized controlled trial (RCT) study is to examine the extent that financial incentives when combined with diabetes evidence-based practices, improve self-management and biometric measures for adult diabetic Medicaid recipients with an HbA1c of ≥ 6.5 at enrollment. The study will also evaluate the cost-effectiveness of the program.
Specific Aims:
- Evaluate whether financial incentives for completing American Diabetes Association (ADA) recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve primary biometric outcomes.
- Evaluate whether financial incentives for completing ADA recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve diabetes patients' self-management as assessed by Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF36v2).
- Evaluate the extent to which financial incentives for healthy behaviors reduce the cost of health care utilization.
Detailed Description
Diabetes is the seventh leading cause of death in the United States (OECD 2013). It is also known that certain populations are at greater risk for diabetes. In Hawaii, diabetes disproportionally affects Native Hawaiians and Pacific Islanders as they are three times more likely to be diagnosed with diabetes. In addition, in 2010 the U.S. Department of Health and Human Services Office of Minority Health reported that Native Hawaiians/Pacific Islanders in Hawaii were 5.7 times as likely as Caucasians living in Hawaii to die from diabetes(Office of Minority Health, 2010). In order to address the challenges that chronic diseases impose on individuals and the health care system the Centers for Medicare \& Medicaid Services (CMS) is assessing the impact of incentivizing patients to increase self-care and disease management. Previous studies have demonstrated that monetary incentives have been associated with an improvement in behavioral outcomes, most notably when the incentive is received immediately following the targeted behavior (Volpp, K.G., et.al., 2008; Mitchell, M.S., et.al., 2013). Cahill et al. (2008) showed that economic incentives were tied to smoking cessation and led to a decrease in relapse within a year. Our study seeks to build on these findings and determine whether financial incentives may provide a way to improve diabetes self-management. Data: Electronic data (Labs, Outcomes) - January 1st, 2013 through December 31, 2015 Electronic data (Claims) - January 1st, 2011 through December 31, 2015
Investigators
Rebecca Rude Ozaki
Associate Professor
University of Hawaii
Eligibility Criteria
Inclusion Criteria
- •Clinically diagnosed with diabetes mellitus
- •18 years of age or older
- •Medicaid recipient
- •At recruitment has an HbA1c level of ≥ 6.5
- •At recruitment is receiving care coordination at Kaiser Permanente Hawaii
Exclusion Criteria
- •Current pregnancy - gestational diabetes
- •End-stage Renal Disease
- •Does not speak English
Outcomes
Primary Outcomes
Changes in HbA1c From Baseline to the End of Intervention (December 2015)
Time Frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in Hemoglobin A1c from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015)
Time Frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in systolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015)
Time Frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in diastolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in Triglycerides From Baseline to the End of Intervention (December 2015)
Time Frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in triglycerides from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015)
Time Frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in total cholesterol from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in LDL From Baseline to the End of Intervention (December 2015)
Time Frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in LDL from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in HDL From Baseline to the End of Intervention (December 2015)
Time Frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in HDL from baseline to end of study. Change = (End of Intervention score - Baseline score)
Secondary Outcomes
- Changes in Health Utilization Cost Before and During Intervention - Amount Paid by Service Providers(Before intervention (3 years prior to baseline) and during intervention (2 years from baseline to end of intervention))
- Change From Baseline to End of Intervention (December 2015) in Physical Component Summary Measure of the Short Form (SF-36v2) Health Survey(Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment)
- Change From Baseline to End of Intervention (December 2015) in General Diet Subscale of The Summary of Diabetes Self-Care Activities (SDSCA) Measure(Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment)