Trial Outcomes & Findings for Hawaii Patient Reward And Incentives to Support Empowerment (NCT NCT02123251)
NCT ID: NCT02123251
Last Updated: 2019-03-15
Results Overview
Changes in Hemoglobin A1c from baseline to end of study. Change = (End of Intervention score - Baseline score)
COMPLETED
NA
320 participants
Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
2019-03-15
Participant Flow
The study recruited 320 eligible patients from Kaiser Permanente Hawaii. Participants were randomly assigned into the intervention or control group with 159 and 161 in each group respectively. The randomized control trial (RCT) was conducted from May 2014 to December 31, 2015 with rolling enrollment from May 2014 to January 2015.
Participant milestones
| Measure |
Financial Incentives
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 American Diabetes Association (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.
|
Control
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.
|
|---|---|---|
|
Overall Study
STARTED
|
159
|
161
|
|
Overall Study
COMPLETED
|
125
|
131
|
|
Overall Study
NOT COMPLETED
|
34
|
30
|
Reasons for withdrawal
| Measure |
Financial Incentives
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 American Diabetes Association (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.
|
Control
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Lost Medicaid eligibility
|
29
|
22
|
|
Overall Study
Switched Managed Care Organization (MCO)
|
4
|
4
|
Baseline Characteristics
Hawaii Patient Reward And Incentives to Support Empowerment
Baseline characteristics by cohort
| Measure |
Financial Incentives
n=159 Participants
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.
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.
|
Control
n=161 Participants
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.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
145 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
54 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
40 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
159 participants
n=5 Participants
|
161 participants
n=7 Participants
|
320 participants
n=5 Participants
|
|
History of Hypertension
|
115 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
History of Heart Disease
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
History of Smoking or Tobacco Dependence
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollmentPopulation: Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.
Changes in Hemoglobin A1c from baseline to end of study. Change = (End of Intervention score - Baseline score)
Outcome measures
| Measure |
Financial Incentives
n=159 Participants
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.
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.
|
Control
n=161 Participants
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.
|
|---|---|---|
|
Changes in HbA1c From Baseline to the End of Intervention (December 2015)
|
0.0660 percentage of glycosylated hemoglobin
Interval -0.2158 to 0.3478
|
-0.3440 percentage of glycosylated hemoglobin
Interval -0.6546 to -0.0334
|
PRIMARY outcome
Timeframe: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollmentPopulation: Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.
Changes in systolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)
Outcome measures
| Measure |
Financial Incentives
n=159 Participants
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.
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.
|
Control
n=161 Participants
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.
|
|---|---|---|
|
Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015)
|
-1.3579 mmHg
Interval -3.8541 to 1.1383
|
0.9337 mmHg
Interval -1.9684 to 3.8358
|
PRIMARY outcome
Timeframe: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollmentPopulation: Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.
Changes in diastolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)
Outcome measures
| Measure |
Financial Incentives
n=159 Participants
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.
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.
|
Control
n=161 Participants
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.
|
|---|---|---|
|
Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015)
|
-2.1895 mmHg
Interval -3.9359 to -0.4432
|
-1.1002 mmHg
Interval -2.8352 to 0.6347
|
PRIMARY outcome
Timeframe: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollmentPopulation: Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.
Changes in total cholesterol from baseline to end of study. Change = (End of Intervention score - Baseline score)
Outcome measures
| Measure |
Financial Incentives
n=159 Participants
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.
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.
|
Control
n=161 Participants
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.
|
|---|---|---|
|
Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015)
|
-3.9141 mg/dL
Interval -14.6584 to 6.8303
|
2.5709 mg/dL
Interval -13.1754 to 8.0336
|
PRIMARY outcome
Timeframe: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollmentPopulation: Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.
Changes in triglycerides from baseline to end of study. Change = (End of Intervention score - Baseline score)
Outcome measures
| Measure |
Financial Incentives
n=159 Participants
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.
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.
|
Control
n=161 Participants
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.
|
|---|---|---|
|
Changes in Triglycerides From Baseline to the End of Intervention (December 2015)
|
0.4843 mg/dL
Interval -48.524 to 49.4935
|
18.2713 mg/dL
Interval -8.7418 to 45.2845
|
PRIMARY outcome
Timeframe: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollmentPopulation: Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.
Changes in LDL from baseline to end of study. Change = (End of Intervention score - Baseline score)
Outcome measures
| Measure |
Financial Incentives
n=159 Participants
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.
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.
|
Control
n=161 Participants
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.
|
|---|---|---|
|
Changes in LDL From Baseline to the End of Intervention (December 2015)
|
0.4523 mg/dL
Interval -7.3542 to 6.4495
|
1.3620 mg/dL
Interval -8.9651 to 6.241
|
PRIMARY outcome
Timeframe: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollmentPopulation: Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.
Changes in HDL from baseline to end of study. Change = (End of Intervention score - Baseline score)
Outcome measures
| Measure |
Financial Incentives
n=159 Participants
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.
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.
|
Control
n=161 Participants
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.
|
|---|---|---|
|
Changes in HDL From Baseline to the End of Intervention (December 2015)
|
0.6705 mg/dL
Interval -0.7934 to 2.1344
|
-0.0472 mg/dL
Interval -1.4807 to 1.3863
|
SECONDARY outcome
Timeframe: Before intervention (3 years prior to baseline) and during intervention (2 years from baseline to end of intervention)Changes of total cost expenditures including emergency room use and hospitalizations in the intervention and control groups before and during intervention.
Outcome measures
| Measure |
Financial Incentives
n=159 Participants
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.
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.
|
Control
n=161 Participants
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.
|
|---|---|---|
|
Changes in Health Utilization Cost Before and During Intervention - Amount Paid by Service Providers
|
-0.185 dollars/day
Standard Error 0.674
|
-0.203 dollars/day
Standard Error 0.484
|
SECONDARY outcome
Timeframe: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollmentPopulation: Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model; this provides unbiased results when missing data is random. Not all participants submitted surveys at each data point.
SDSCA is a validated, self-reported measure assessing the average # of days the recommended diabetes self-care activities are performed over the past 7 days in the areas of general diet, specific diet, exercise, blood-glucose testing, and foot care at baseline, mid, and end of intervention. Possible scores range from 0 to 7 days. Change = (End of Intervention Score - Baseline Score)
Outcome measures
| Measure |
Financial Incentives
n=147 Participants
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.
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.
|
Control
n=131 Participants
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.
|
|---|---|---|
|
Change From Baseline to End of Intervention (December 2015) in General Diet Subscale of The Summary of Diabetes Self-Care Activities (SDSCA) Measure
|
0.7796 units on a scale
Interval 0.3492 to 1.2099
|
0.1393 units on a scale
Interval -0.3028 to 0.5814
|
SECONDARY outcome
Timeframe: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollmentPopulation: Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model; this provides unbiased results when the type of missing data is random. Not all participants submitted surveys at each data point.
The SF-36v2 is validated, self reported short-form health survey used to assess changes over time in the well-being of participants. It consists of 2 component summary measures that further summarize 8 health domain scales. The Physical Component Summary (PCS) measure is derived from domain scales of Physical Functioning (10 items), Role-Physical (4 items), Bodily Pain (2 items), and General Health (5 items). Scores of component summary measures and health domain scales range from 0 to 100 with higher scores indicating better outcomes. Norm-based scoring was used so that scores for each health domain scale and component summary measure have a mean of 50 and standard deviation of 10 based on the 2009 U.S. general population. The SF-36v2 was used to assess participants' health and wellbeing at baseline, mid, and endpoint of intervention. Change = (Midpoint Score - Baseline Score)
Outcome measures
| Measure |
Financial Incentives
n=145 Participants
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.
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.
|
Control
n=132 Participants
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.
|
|---|---|---|
|
Change From Baseline to End of Intervention (December 2015) in Physical Component Summary Measure of the Short Form (SF-36v2) Health Survey
|
0.5162 units on a scale
Interval -0.8996 to 1.9319
|
-1.6027 units on a scale
Interval -3.0495 to -0.1558
|
Adverse Events
Financial Incentives
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Chuan Chinn
University of Hawaii, Center on Disability Studies
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60