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NCT Number: NCT01346189

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard Vanguard Medical Associates, Boston, Massachusetts, United States

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About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Behavioral Economic Intervention

Behavioral

Various combinations of financial incentives to patients and providers.

Primary outcomes

  1. Change in LDL From Baseline to 12 Months

    Time frame: 12 months

    Change in LDL-C levels (mg/dL)

Secondary outcomes

  1. Change in LDL From Baseline to 15 Months

    Time frame: 15 months

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Official study title

A Randomized Trial of Behavioral Economic Interventions to Reduce CVD Risk

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 2, 2011
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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