Trial Outcomes & Findings for A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk (NCT NCT01346189)
NCT ID: NCT01346189
Last Updated: 2017-12-06
Results Overview
Change in LDL-C levels (mg/dL)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1503 participants
Primary outcome timeframe
12 months
Results posted on
2017-12-06
Participant Flow
Participant milestones
| Measure |
Physician Incentives
(with adherence feedback)
Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Patient Incentives
(with adherence feedback)
Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Physician and Patient Combined Incentives
(with adherence feedback)
Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Usual Care/Control
No Intervention
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
433
|
358
|
346
|
366
|
|
Overall Study
COMPLETED
|
417
|
341
|
332
|
355
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
14
|
11
|
Reasons for withdrawal
| Measure |
Physician Incentives
(with adherence feedback)
Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Patient Incentives
(with adherence feedback)
Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Physician and Patient Combined Incentives
(with adherence feedback)
Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Usual Care/Control
No Intervention
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
3
|
5
|
|
Overall Study
Physician Decision
|
4
|
0
|
0
|
0
|
|
Overall Study
Moved
|
3
|
0
|
4
|
0
|
|
Overall Study
Other
|
2
|
4
|
7
|
3
|
|
Overall Study
Death
|
0
|
3
|
0
|
0
|
|
Overall Study
Non-health system primary care physician
|
0
|
5
|
0
|
0
|
|
Overall Study
Travel
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk
Baseline characteristics by cohort
| Measure |
Physician Incentives
n=433 Participants
(with adherence feedback)
Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Patient Incentives
n=358 Participants
(with adherence feedback)
Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Physician and Patient Combined Incentives
n=346 Participants
(with adherence feedback)
Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Usual Care
n=366 Participants
No Intervention
|
Total
n=1503 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.68 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
62.41 years
STANDARD_DEVIATION 8.63 • n=7 Participants
|
62.03 years
STANDARD_DEVIATION 8.64 • n=5 Participants
|
61.70 years
STANDARD_DEVIATION 8.89 • n=4 Participants
|
61.99 years
STANDARD_DEVIATION 8.70 • n=21 Participants
|
|
Sex: Female, Male
Female
|
179 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
639 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
254 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
205 Participants
n=4 Participants
|
864 Participants
n=21 Participants
|
|
Race/Ethnicity
White, non-Hispanic
|
360 Participants
n=5 Participants
|
265 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
289 Participants
n=4 Participants
|
1199 Participants
n=21 Participants
|
|
Race/Ethnicity
African American, non-Hispanic
|
57 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
|
Race/Ethnicity
Other non-Hispanic
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race/Ethnicity
Hispanic
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race/Ethnicity
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Annual Household Income, No., $
<50,000
|
193 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
635 Participants
n=21 Participants
|
|
Annual Household Income, No., $
50,000 to 100,000
|
144 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
523 Participants
n=21 Participants
|
|
Annual Household Income, No., $
>100,000
|
85 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
297 Participants
n=21 Participants
|
|
Education
<College
|
148 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
486 Participants
n=21 Participants
|
|
Education
Some college
|
118 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
433 Participants
n=21 Participants
|
|
Education
College and postcollege graduate
|
165 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
577 Participants
n=21 Participants
|
|
Marital Status
Single
|
64 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
225 Participants
n=21 Participants
|
|
Marital Status
Married
|
286 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
992 Participants
n=21 Participants
|
|
Marital Status
Other
|
81 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
278 Participants
n=21 Participants
|
|
Framingham Risk Score (FRS)
|
20.1 %
STANDARD_DEVIATION 9.0 • n=5 Participants
|
19.7 %
STANDARD_DEVIATION 8.6 • n=7 Participants
|
19.1 %
STANDARD_DEVIATION 8.7 • n=5 Participants
|
20.1 %
STANDARD_DEVIATION 8.7 • n=4 Participants
|
19.8 %
STANDARD_DEVIATION 8.7 • n=21 Participants
|
|
Pre-existing coronary artery disease (CAD)
|
143 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
516 Participants
n=21 Participants
|
|
Taking cholesterol-reducing medications at baseline
|
166 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
712 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Subjects were lost to follow-up, or withdrawn for other reasons. Thus the number analyzed at the 12 month time point does not equal the number analyzed during baseline.
Change in LDL-C levels (mg/dL)
Outcome measures
| Measure |
Physician Incentives
n=433 Participants
(with adherence feedback)
Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Patient Incentives
n=358 Participants
(with adherence feedback)
Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Physician and Patient Combined Incentives
n=346 Participants
(with adherence feedback)
Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Usual Care
n=366 Participants
|
|---|---|---|---|---|
|
Change in LDL From Baseline to 12 Months
Mean Reduction
|
27.9 mg/dL
Interval 24.9 to 31.0
|
25.1 mg/dL
Interval 21.6 to 28.5
|
33.6 mg/dL
Interval 30.1 to 37.1
|
25.1 mg/dL
Interval 21.7 to 28.5
|
|
Change in LDL From Baseline to 12 Months
Baseline
|
159.9 mg/dL
Interval 157.4 to 162.5
|
160.6 mg/dL
Interval 157.6 to 163.0
|
160.1 mg/dL
Interval 157.3 to 163.3
|
161.5 mg/dL
Interval 159.0 to 164.7
|
|
Change in LDL From Baseline to 12 Months
12 Months
|
132 mg/dL
Interval 127.8 to 135.3
|
135.5 mg/dL
Interval 130.8 to 138.9
|
126.4 mg/dL
Interval 123.1 to 130.1
|
136.4 mg/dL
Interval 132.5 to 140.7
|
SECONDARY outcome
Timeframe: 15 monthsChange in LDL-C levels (mg/dL) from baseline to 15 months
Outcome measures
| Measure |
Physician Incentives
n=433 Participants
(with adherence feedback)
Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Patient Incentives
n=358 Participants
(with adherence feedback)
Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Physician and Patient Combined Incentives
n=346 Participants
(with adherence feedback)
Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Usual Care
n=366 Participants
|
|---|---|---|---|---|
|
Change in LDL From Baseline to 15 Months
|
29.1 mg/dL
Interval 25.3 to 32.9
|
23.9 mg/dL
Interval 19.8 to 27.9
|
32.8 mg/dL
Interval 28.7 to 36.8
|
25.8 mg/dL
Interval 21.5 to 30.2
|
Adverse Events
Physician Incentives
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Patient Incentives
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Physician and Patient Combined Incentives
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care/Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Physician Incentives
n=433 participants at risk
(with adherence feedback)
Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Patient Incentives
n=358 participants at risk
(with adherence feedback)
Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Physician and Patient Combined Incentives
n=346 participants at risk
(with adherence feedback)
Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Usual Care/Control
n=366 participants at risk
|
|---|---|---|---|---|
|
Surgical and medical procedures
Pancreatic mass
|
0.00%
0/433 • Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Defining Adverse Events: In this study, ALT greater than or equal to three times the upper limit of normal was considered an adverse event. Defining Serious Adverse Events: A definition for an SAE was assigned as ALT greater than or equal to 400 U/L, or hospitalizations or deaths caused by Myalgia or Rhabdomyolysis or liver toxicity.
|
0.00%
0/358 • Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Defining Adverse Events: In this study, ALT greater than or equal to three times the upper limit of normal was considered an adverse event. Defining Serious Adverse Events: A definition for an SAE was assigned as ALT greater than or equal to 400 U/L, or hospitalizations or deaths caused by Myalgia or Rhabdomyolysis or liver toxicity.
|
0.29%
1/346 • Number of events 1 • Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Defining Adverse Events: In this study, ALT greater than or equal to three times the upper limit of normal was considered an adverse event. Defining Serious Adverse Events: A definition for an SAE was assigned as ALT greater than or equal to 400 U/L, or hospitalizations or deaths caused by Myalgia or Rhabdomyolysis or liver toxicity.
|
0.00%
0/366 • Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Defining Adverse Events: In this study, ALT greater than or equal to three times the upper limit of normal was considered an adverse event. Defining Serious Adverse Events: A definition for an SAE was assigned as ALT greater than or equal to 400 U/L, or hospitalizations or deaths caused by Myalgia or Rhabdomyolysis or liver toxicity.
|
Other adverse events
| Measure |
Physician Incentives
n=433 participants at risk
(with adherence feedback)
Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Patient Incentives
n=358 participants at risk
(with adherence feedback)
Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Physician and Patient Combined Incentives
n=346 participants at risk
(with adherence feedback)
Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.
Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers.
|
Usual Care/Control
n=366 participants at risk
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Elevated Alanine Aminotransferase (ALT)
|
0.00%
0/433 • Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Defining Adverse Events: In this study, ALT greater than or equal to three times the upper limit of normal was considered an adverse event. Defining Serious Adverse Events: A definition for an SAE was assigned as ALT greater than or equal to 400 U/L, or hospitalizations or deaths caused by Myalgia or Rhabdomyolysis or liver toxicity.
|
0.00%
0/358 • Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Defining Adverse Events: In this study, ALT greater than or equal to three times the upper limit of normal was considered an adverse event. Defining Serious Adverse Events: A definition for an SAE was assigned as ALT greater than or equal to 400 U/L, or hospitalizations or deaths caused by Myalgia or Rhabdomyolysis or liver toxicity.
|
0.00%
0/346 • Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Defining Adverse Events: In this study, ALT greater than or equal to three times the upper limit of normal was considered an adverse event. Defining Serious Adverse Events: A definition for an SAE was assigned as ALT greater than or equal to 400 U/L, or hospitalizations or deaths caused by Myalgia or Rhabdomyolysis or liver toxicity.
|
0.27%
1/366 • Number of events 1 • Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Defining Adverse Events: In this study, ALT greater than or equal to three times the upper limit of normal was considered an adverse event. Defining Serious Adverse Events: A definition for an SAE was assigned as ALT greater than or equal to 400 U/L, or hospitalizations or deaths caused by Myalgia or Rhabdomyolysis or liver toxicity.
|
Additional Information
Dr. Kevin G. Volpp
University of Pennsylvania and Department of Veteran Affairs
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place