We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01346189
First Posted: May 2, 2011
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Aging (NIA)
Geisinger Clinic
Brigham and Women's Hospital
Harvard School of Public Health
Carnegie Mellon University
Harvard Vanguard Medical Associates
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: September 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Cardiovascular Disease
Intervention: Behavioral: Behavioral Economic Intervention

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Physician Incentives   Patient Incentives   Physician and Patient Combined Incentives   Usual Care/Control
STARTED   433   358   346   366 
COMPLETED   417 [1]   341 [2]   332 [3]   355 [4] 
NOT COMPLETED   16   17   14   11 
Withdrawal by Subject                7                5                3                5 
Physician Decision                4                0                0                0 
Moved                3                0                4                0 
Other                2                4                7                3 
Death                0                3                0                0 
Non-health system primary care physician                0                5                0                0 
Travel                0                0                0                3 
[1] 433 patients (64 primary care physicians) included in analysis
[2] 358 Patients (58 primary care physicians) included in analysis
[3] 346 patients (58 primary care physicians) included in analysis
[4] 366 patients (58 primary care physicians) included in analysis



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 No Intervention
Total Total of all reporting groups

Baseline Measures
   Physician Incentives   Patient Incentives   Physician and Patient Combined Incentives   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 433   358   346   366   1503 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.68  (8.67)   62.41  (8.63)   62.03  (8.64)   61.70  (8.89)   61.99  (8.70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female   179   164   135   161   639 
Male   254   194   211   205   864 
Race/Ethnicity 
[Units: Participants]
Count of Participants
         
White, non-Hispanic      360  83.1%      265  74.0%      285  82.4%      289  79.0%      1199  79.8% 
African American, non-Hispanic      57  13.2%      72  20.1%      42  12.1%      61  16.7%      232  15.4% 
Other non-Hispanic      8   1.8%      10   2.8%      6   1.7%      7   1.9%      31   2.1% 
Hispanic      6   1.4%      10   2.8%      7   2.0%      7   1.9%      30   2.0% 
Missing      2   0.5%      1   0.3%      6   1.7%      2   0.5%      11   0.7% 
Annual Household Income, No., $ 
[Units: Participants]
Count of Participants
         
<50,000   193   145   134   163   635 
50,000 to 100,000   144   129   126   124   523 
>100,000   85   76   68   68   297 
Education 
[Units: Participants]
Count of Participants
         
<College   148   107   102   129   486 
Some college   118   102   108   105   433 
College and postcollege graduate   165   148   133   131   577 
Marital Status 
[Units: Participants]
Count of Participants
         
Single   64   59   43   59   225 
Married   286   236   239   231   992 
Other   81   62   60   75   278 
Framingham Risk Score (FRS) [1] 
[Units: %]
Mean (Standard Deviation)
 20.1  (9.0)   19.7  (8.6)   19.1  (8.7)   20.1  (8.7)   19.8  (8.7) 
[1] The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
Pre-existing coronary artery disease (CAD) 
[Units: Participants]
Count of Participants
 143   110   115   148   516 
Taking cholesterol-reducing medications at baseline 
[Units: Participants]
Count of Participants
 166   180   200   166   712 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in LDL From Baseline to 12 Months   [ Time Frame: 12 months ]

2.  Secondary:   Change in LDL From Baseline to 15 Months   [ Time Frame: 15 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patients in the control group received electronic pill bottles and may have been more adherent than is typical; Mean of about 6 patients per physician enrolled, limiting total size of potential reward; Adherence info came from pill bottle opening


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kevin G. Volpp
Organization: University of Pennsylvania and Department of Veteran Affairs
e-mail: volpp70@wharton.upenn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01346189     History of Changes
Other Study ID Numbers: 812701
RC4AG039114 ( U.S. NIH Grant/Contract )
First Submitted: April 26, 2011
First Posted: May 2, 2011
Results First Submitted: September 21, 2017
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017