This trial is active, not recruiting.

Condition diabetes mellitus
Treatments financial incentives, control
Sponsor University of Hawaii
Collaborator Centers for Medicare and Medicaid Services
Start date May 2014
End date December 2015
Trial size 313 participants
Trial identifier NCT02123251, 1B1CMS330884-01, CDFA93.536 -CMS-MIPCD-HI


The purpose of this randomized controlled trial 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 ADA recommended tests, exams and vaccinations will improve compliance rates.

2. Evaluate whether financial incentives for health education and biometric outcomes will improve diabetes patients' self-management.

3. Evaluate the extent to which financial incentives for healthy behaviors reduce health care utilization.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Participants in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys.
financial incentives
This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle
Participants in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives.

Primary Outcomes

Changes in key biometric measures of diabetes
time frame: Baseline, 9 months, end of intervention (18 months), 6 months post-intervention

Secondary Outcomes

Changes in percentage of participants who are concordant with American Diabetes Association recommended guidelines.
time frame: Baseline, 9 months, end of intervention (18 months), 6 months post-intervention
Changes in the cost expenditures for emergency room and hospital visits
time frame: Two years prior to enrollment - 6 months post-intervention

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Incentive-Based Diabetes Self-Management Study (Hawaii Patient Reward And Incentives to Support Empowerment Project)
Principal investigator Ritabelle Fernandes, MD
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 economic incentives may provide a way to improve diabetes self-management. Data: Electronic data (Labs, Outcomes) - January 1st, 2013 through June 30, 2016 Electronic data (Claims) - January 1st, 2011 through June 30, 2016
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by University of Hawaii.