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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01346189
• Collaborator: National Institute on Aging (NIA) (NIH), Geisinger Clinic (Other), Brigham and Women's Hospital (Other), Harvard School of Public Health (HSPH) (Other), Carnegie Mellon University (Other), Harvard Vanguard Medical Associates (Other)
• Enrollment: 1,503
• Locations: 3
• Arms: 4
• Duration (Months): 35
• Patients Per Site: 501
• Patients Per Site Per Month: 14.3

Study Details

Study Description

Brief Summary

Using a 4-arm, cluster-randomized controlled trial, the investigators will test the effectiveness of different behavioral economic interventions in increasing statin use and reducing LDL cholesterol among patients with poor cholesterol control who are at very high risk for CVD. The investigators will test these approaches among primary care physicians and their patients at very high risk of CVD at Geisinger Health System and University of Pennsylvania outpatient clinics.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Behavioral: Behavioral Economic Intervention	N/A

Detailed Description

Cardiovascular disease (CVD) is the leading cause of death in the United States. Despite strong evidence that reducing low-density lipoproteins (LDL) with statins successfully lowers CVD risk, physicians under-prescribe statins, physicians fail to intensify treatment when indicated, and more than 50% of patients stop taking statins within one year of first prescription, though such therapy typically should be life-long. In this study, we will test the effectiveness of different behavioral economic interventions in increasing statin use and reducing LDL cholesterol among patients with poor cholesterol control who are at very high risk for CVD. The application of conceptual approaches from behavioral economics offers considerable promise in advancing health and health care. Pay for performance initiatives represent one such potential application, but one in which incorporating the underlying psychology of decision makers has not generally been done, and experimental tests have not been conducted. We will test these approaches among primary care physicians and their patients at very high risk of CVD at Geisinger Health System and University of Pennsylvania outpatient clinics. Using a 4-arm, cluster-randomized controlled trial, we aim to answer these questions: [1] How does the provision of provider incentives compare to the provision of patient incentives, to a combination of patient and provider incentives, or to no incentives at all? [2] Are results sustained after incentives and other interventions are withdrawn? [3] How do these approaches compare in implementation, acceptability, cost, and cost-effectiveness?

Study Design

• Study Type: Interventional
• Actual Enrollment: 1503 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Trial of Behavioral Economic Interventions to Reduce CVD Risk
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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: Behavioral Economic Intervention; Various combinations of financial incentives to patients and providers.
Active Comparator: 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: Behavioral Economic Intervention; Various combinations of financial incentives to patients and providers.
Active Comparator: 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: Behavioral Economic Intervention; Various combinations of financial incentives to patients and providers.
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

1. Change in LDL From Baseline to 12 Months [12 months]

   Change in LDL-C levels (mg/dL)

Secondary Outcome Measures

1. Change in LDL From Baseline to 15 Months [15 months]

   Change in LDL-C levels (mg/dL) from baseline to 15 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Physicians: All primary care providers who have at least 5 patients who meet eligibility criteria will be eligible.

• Patients: 10-year CVD risk of between 10-20% who do not have an LDL below 140 mg/dl or 10-year CVD risk of at least 20% (including those with preexisting CHD) who do not have an LDL below 120 mg/dl will be the primary inclusion criteria. We have chosen to include all patients meeting these inclusion criteria regardless of their reported adherence to statins, as there clearly is room for improvement in the LDL through a combination of physician and patient actions.

Exclusion Criteria:

• Patients will be excluded if they have a known allergy or history of side effects to statins, will not or cannot give consent, or have a markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or dementia).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harvard Vanguard Medical Associates	Boston	Massachusetts	United States	02120
2	Geisinger Health System	Danville	Pennsylvania	United States	17822
3	Unversity of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• National Institute on Aging (NIA)
• Geisinger Clinic
• Brigham and Women's Hospital
• Harvard School of Public Health (HSPH)
• Carnegie Mellon University
• Harvard Vanguard Medical Associates

Investigators

• Principal Investigator: Kevin Volpp, MD, PhD, University of Pennsylvania
• Principal Investigator: David Asch, MD, MBA, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01346189
• Other Study ID Numbers: 812701; RC4AG039114
• First Posted: May 2, 2011
• Last Update Posted: Dec 6, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by University of Pennsylvania: Cardiovascular Disease
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

Participant Flow

Arm/Group Title	Physician Incentives	Patient Incentives	Physician and Patient Combined Incentives	Usual Care/Control
Arm/Group Description	(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.	(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.	(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.	No Intervention
Period Title: Overall Study
STARTED	433	358	346	366
COMPLETED	417	341	332	355
NOT COMPLETED	16	17	14	11

Baseline Characteristics

Arm/Group Title	Physician Incentives	Patient Incentives	Physician and Patient Combined Incentives	Usual Care	Total
Arm/Group Description	(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.	(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.	(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.	No Intervention	Total of all reporting groups
Overall Participants	433	358	346	366	1503
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.68 (8.67)	62.41 (8.63)	62.03 (8.64)	61.70 (8.89)	61.99 (8.70)
Sex: Female, Male (Count of Participants)
Female	179 41.3%	164 45.8%	135 39%	161 44%	639 42.5%
Male	254 58.7%	194 54.2%	211 61%	205 56%	864 57.5%
Race/Ethnicity (Count of Participants)
White, non-Hispanic	360 83.1%	265 74%	285 82.4%	289 79%	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%	7 1.9%	30 2%
Missing	2 0.5%	1 0.3%	6 1.7%	2 0.5%	11 0.7%
Annual Household Income, No., $ (Count of Participants)
<50,000	193 44.6%	145 40.5%	134 38.7%	163 44.5%	635 42.2%
50,000 to 100,000	144 33.3%	129 36%	126 36.4%	124 33.9%	523 34.8%
>100,000	85 19.6%	76 21.2%	68 19.7%	68 18.6%	297 19.8%
Education (Count of Participants)
<College	148 34.2%	107 29.9%	102 29.5%	129 35.2%	486 32.3%
Some college	118 27.3%	102 28.5%	108 31.2%	105 28.7%	433 28.8%
College and postcollege graduate	165 38.1%	148 41.3%	133 38.4%	131 35.8%	577 38.4%
Marital Status (Count of Participants)
Single	64 14.8%	59 16.5%	43 12.4%	59 16.1%	225 15%
Married	286 66.1%	236 65.9%	239 69.1%	231 63.1%	992 66%
Other	81 18.7%	62 17.3%	60 17.3%	75 20.5%	278 18.5%
Framingham Risk Score (FRS) (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	20.1 (9.0)	19.7 (8.6)	19.1 (8.7)	20.1 (8.7)	19.8 (8.7)
Pre-existing coronary artery disease (CAD) (Count of Participants)
Count of Participants [Participants]	143 33%	110 30.7%	115 33.2%	148 40.4%	516 34.3%
Taking cholesterol-reducing medications at baseline (Count of Participants)
Count of Participants [Participants]	166 38.3%	180 50.3%	200 57.8%	166 45.4%	712 47.4%

Outcome Measures

1. Primary Outcome

Title	Change in LDL From Baseline to 12 Months
Description	Change in LDL-C levels (mg/dL)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Physician Incentives	Patient Incentives	Physician and Patient Combined Incentives	Usual Care
Arm/Group Description	(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.	(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.	(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.
Measure Participants	433	358	346	366
Mean Reduction	27.9	25.1	33.6	25.1
Baseline	159.9	160.6	160.1	161.5
12 Months	132	135.5	126.4	136.4

2. Secondary Outcome

Title	Change in LDL From Baseline to 15 Months
Description	Change in LDL-C levels (mg/dL) from baseline to 15 months
Time Frame	15 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physician Incentives	Patient Incentives	Physician and Patient Combined Incentives	Usual Care
Arm/Group Description	(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.	(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.	(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.
Measure Participants	433	358	346	366
Mean (95% Confidence Interval) [mg/dL]	29.1	23.9	32.8	25.8

Adverse Events

Time Frame	Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Adverse Event Reporting Description	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.
Arm/Group Title	Physician Incentives		Patient Incentives		Physician and Patient Combined Incentives		Usual Care/Control
Arm/Group Description	(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.		(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.		(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.
All Cause Mortality
	Physician Incentives		Patient Incentives		Physician and Patient Combined Incentives		Usual Care/Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/433 (0.5%)		3/358 (0.8%)		0/346 (0%)		1/366 (0.3%)
Serious Adverse Events
	Physician Incentives		Patient Incentives		Physician and Patient Combined Incentives		Usual Care/Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/433 (0%)		0/358 (0%)		1/346 (0.3%)		0/366 (0%)
Surgical and medical procedures
Pancreatic mass	0/433 (0%)	0	0/358 (0%)	0	1/346 (0.3%)	1	0/366 (0%)	0
Other (Not Including Serious) Adverse Events
	Physician Incentives		Patient Incentives		Physician and Patient Combined Incentives		Usual Care/Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/433 (0%)		0/358 (0%)		0/346 (0%)		1/366 (0.3%)
Blood and lymphatic system disorders
Elevated Alanine Aminotransferase (ALT)	0/433 (0%)	0	0/358 (0%)	0	0/346 (0%)	0	1/366 (0.3%)	1

Limitations/Caveats

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

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.