Clinical trial NCT02123251: Hawaii Patient Reward And Incentives to Support Empowerment
Official title: A Randomized Incentive-Based Diabetes Self-Management Study (Hawaii Patient Reward And Incentives to Support Empowerment Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Incentives,
Diabetes,
Medicaid,
Health behavior,
Cost effectiveness
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: Centers for Medicare and Medicaid Services
name: Hawaii Department of Human Services (DHS)
name: Kaiser Permanente
name: RTI International
name: IMPAQ International, LLC.
name: Econometrica, Inc.
First posted: 2014-04-25
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. 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.
2. 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).
3. 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

Eligibility criteria: Inclusion Criteria:

1. Clinically diagnosed with diabetes mellitus
2. 18 years of age or older
3. Medicaid recipient
4. At recruitment has an HbA1c level of ≥ 6.5
5. At recruitment is receiving care coordination at Kaiser Permanente Hawaii

Exclusion Criteria:

1. Current pregnancy - gestational diabetes
2. End-stage Renal Disease
3. Does not speak English

Primary outcomes:
measure: Changes in HbA1c From Baseline to the End of Intervention (December 2015)
timeFrame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
measure: Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015)
timeFrame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
measure: Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015)
timeFrame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
measure: Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015)
timeFrame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
measure: Changes in Triglycerides From Baseline to the End of Intervention (December 2015)
timeFrame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
measure: Changes in LDL From Baseline to the End of Intervention (December 2015)
timeFrame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
measure: Changes in HDL From Baseline to the End of Intervention (December 2015)
timeFrame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Secondary outcomes:
measure: Changes in Health Utilization Cost Before and During Intervention - Amount Paid by Service Providers
timeFrame: Before intervention (3 years prior to baseline) and during intervention (2 years from baseline to end of intervention)
measure: Change From Baseline to End of Intervention (December 2015) in General Diet Subscale of The Summary of Diabetes Self-Care Activities (SDSCA) Measure
timeFrame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
measure: Change From Baseline to End of Intervention (December 2015) in Physical Component Summary Measure of the Short Form (SF-36v2) Health Survey
timeFrame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Ritabelle Fernandes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unversity of Hawaii - Center on Disability Studies
name: Rebecca R. Ozaki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Organisation for Economic Co-Operation and Development (OECD), "Health Status: Life Expectancy at Birth, in Health at a Glance 2013: available at http://www.oecd.org/els/health-systems/Health-at-a-Glance-2013.pdf.
citation: Office of Minority Health 2010. Diabetes Data/Statistics. Retrieved from http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=3&lvlid=62
citation: Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
citation: Mitchell MS, Goodman JM, Alter DA, John LK, Oh PI, Pakosh MT, Faulkner GE. Financial incentives for exercise adherence in adults: systematic review and meta-analysis. Am J Prev Med. 2013 Nov;45(5):658-67. doi: 10.1016/j.amepre.2013.06.017.
citation: Cahill K, Perera R. Competitions and incentives for smoking cessation. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD004307. doi: 10.1002/14651858.CD004307.pub3.