Cardiovascular disease (CVD) is the leading cause of death in the U.S. Despite the availability of evidence-based guidelines and efficacious therapies, however, many patients do not achieve the full benefit of CVD risk reduction. In particular, complex patients (defined as those patients who do not respond to current disease management approaches) with multiple concurrent chronic conditions represent a key segment of the population that would benefit from new approaches to care. In response to PA-12-024: Behavioral Interventions to Address Multiple Chronic Conditions in Primary Care, which seeks "practical modify behaviors using a common approach" among patients with multiple co-morbidities, we propose to implement and rigorously evaluate an integrated behavioral intervention designed to improve a core set of chronic disease self-management skills and to overcome common barriers to care engagement encountered by this increasingly important segment of the U.S. adult primary care population. This randomized trial will be conducted within Kaiser Permanente Northern California (KPNC), an integrated care delivery system serving over 3.2 million members, including patients insured through Medicare and state Medicaid programs. We will evaluate our intervention in 3 KPNC primary care practices by enrolling 576 complex patients who have persistently (e 2 years) uncontrolled CVD risk factors (e.g. hypertension, hyperlipidemia, diabetes) despite being enrolled in a CVD disease management program. This behavioral intervention is designed to activate and engage patients, identify potentially hidden barriers to care such as alcohol misuse or sub-clinical depression, and to develop individualized care plans that are designed to catalyze more effective primary care management. Randomization will be at the patient-level, blocked by primary care provider, with the following aims: 1) To examine the impact of (intervention + usual care) vs. (usual care alone) on control of systolic blood pressure [primary outcome], LDL cholesterol, Framingham Risk Score (if no baseline CVD), and HbA1c (if with diabetes) at 12 months;2) To examine effectiveness of (intervention + usual care) vs. (usual care alone) on proximal outcomes (patient activation, medication adherence, and mental health status) after 3 and 12 months, and 3) To identify baseline patient factors associated with more vs. less successful clinical response among intervention arm patients. By focusing on core health skills and care barriers, this patient-focused intervention seeks to enable complex patients to become more effective agents of their own care and to thereby achieve similar clinical benefits as less complex patients.

Public Health Relevance

Cardiovascular disease (CVD) is the leading cause of death in the U.S. Efforts to improve CVD risk factors often fall short in complex patients with multiple co-morbid conditions, a growing, expensive, and high-risk segment of the U.S. population. We propose to implement and evaluate a multi-component behavioral intervention designed to help complex patients with CVD and other concurrent chronic conditions to become more effective agents of their own care.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project (R01)
Project #
Application #
Study Section
Special Emphasis Panel (ZRG1-HSOD-J (09))
Program Officer
Stoney, Catherine
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Kaiser Foundation Research Institute
United States
Zip Code