Hawaii Patient Reward And Incentives to Support Empowerment

NCT02123251 | Completed Results

• 2 other identifiers: CDFA93.536 -CMS-MIPCD-HI1B1CMS330884-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus

Keywords

Incentives,; Diabetes,; Medicaid,; Health behavior,; Cost effectiveness

Outcome Measures

Primary Outcomes (7)

• Changes in HbA1c From Baseline to the End of Intervention (December 2015)

  Changes in Hemoglobin A1c from baseline to end of study. Change = (End of Intervention score - Baseline score)

  Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment

• Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015)

  Changes in systolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)

  Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment

• Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015)

  Changes in diastolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)

  Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment

• Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015)

  Changes in total cholesterol from baseline to end of study. Change = (End of Intervention score - Baseline score)

  Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment

• Changes in Triglycerides From Baseline to the End of Intervention (December 2015)

  Changes in triglycerides from baseline to end of study. Change = (End of Intervention score - Baseline score)

  Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment

• Changes in LDL From Baseline to the End of Intervention (December 2015)

  Changes in LDL from baseline to end of study. Change = (End of Intervention score - Baseline score)

  Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment

• Changes in HDL From Baseline to the End of Intervention (December 2015)

  Changes in HDL from baseline to end of study. Change = (End of Intervention score - Baseline score)

  Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment

Secondary Outcomes (3)

• 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 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

• 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

Study Arms (2)

Financial Incentives Group

EXPERIMENTAL

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.

Behavioral: Financial Incentives

Control Group

NO INTERVENTION

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.

Interventions

Financial Incentives 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

Financial Incentives Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed with diabetes mellitus
• 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

You may not qualify if:

• Current pregnancy - gestational diabetes
• End-stage Renal Disease
• Does not speak English

Sponsors & Collaborators

• University of Hawaii: lead
• Centers for Medicare and Medicaid Services: collaborator
• Hawaii Department of Human Services (DHS): collaborator
• Kaiser Permanente: collaborator
• RTI International: collaborator
• IMPAQ International, LLC.: collaborator
• Econometrica, Inc.: collaborator

Study Sites (1)

Kaiser Permanente Hawaii

Honolulu, Hawaii, 96813, United States

Location

Related Publications (5)

• 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.

  BACKGROUND

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

  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.

  PMID: 19102784 BACKGROUND

• 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.

  PMID: 24139781 BACKGROUND

• 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.

  PMID: 18646105 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Health Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Limitations and Caveats

Loss of Medicaid status led to reduced # of data points analyzed. Unequally spaced intervention period across subjects increased the variability of outcomes. Usual care setting with providers ordering lab tests led to high # of missing test results.

Results Point of Contact

• Title: Dr. Chuan Chinn
• Organization: University of Hawaii, Center on Disability Studies

chuanc@hawaii.edu

8089565379

Study Officials

• Ritabelle Fernandes, MD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

• Rebecca R. Ozaki, PhD

  Unversity of Hawaii - Center on Disability Studies

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 25, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2016
• Last Updated: March 15, 2019
• Results First Posted: January 30, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)