Hawaii Patient Reward And Incentives to Support Empowerment

NCT ID: NCT02123251

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-09-30

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

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Financial Incentives Group

Participants (159) 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.

Group Type: EXPERIMENTAL

Financial Incentives

Intervention Type: BEHAVIORAL

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

Control Group

Participants (161) 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Medicare and Medicaid Services

FED

Sponsor Role: collaborator

Hawaii Department of Human Services (DHS)

UNKNOWN

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

IMPAQ International, LLC.

INDUSTRY

Sponsor Role: collaborator

Econometrica, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Rude Ozaki

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ritabelle Fernandes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii

Rebecca R. Ozaki, PhD

Role: PRINCIPAL_INVESTIGATOR

Unversity of Hawaii - Center on Disability Studies

Locations

Kaiser Permanente Hawaii

Honolulu, Hawaii, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Office of Minority Health 2010. Diabetes Data/Statistics. Retrieved from http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=3&lvlid=62

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 19102784 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24139781 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18646105 (View on PubMed)

Other Identifiers

1B1CMS330884-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDFA93.536 -CMS-MIPCD-HI

Identifier Type: -

Identifier Source: org_study_id