The CREATE Wellness Study
Condition: Diabetes; Heart Disease; Hypertension; Dyslipidemia
MeSH terms: Heart Diseases; Dyslipidemias
Study type: Interventional

Summary: 
      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. The investigators are
      testing 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.
    

Detailed description: 
      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.
    

Intervention name(s): CREATE Wellness; Usual Care Control
Intervention type(s): Behavioral; Other
Intervention description(s): Patients allocated to the intervention arm will receive three group sessions with between visit contacts designed to increase activation and engagement with their care plans. They will also continue to be enrolled in the KP PHASE program; Patients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: chronic conditions; complex patients; engagement; activation