The CREATE Wellness Study

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 interventions…to
modify behaviors using a common approach" among patients with multiple co-morbidities, the
investigators are testing 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. The investigators
will evaluate the intervention in 3 KPNC primary care practices by enrolling 576 complex
patients who have persistently (≥ 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. The investigators will examine the
impact of the intervention on clinical outcomes (control of systolic blood pressure, HbA1c
(if with diabetes), statin treatment rates) after 12 months and patient-reported outcomes
(patient activation, medication adherence, and mental health status) after 6 months. 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.

Inclusion Criteria:

- Kaiser Permanente Northern California members enrolled in the PHASE disease management
program and not meeting all goals of care for the preceding 2 years.

Exclusion Criteria:

- Schizophrenia or personality disorder

- Unable to communicate in English

- Unwilling to participate in group-based in-person program

- Pregnant

- Terminal or debilitating illness