The CREATE Wellness Study

Kaiser Permanente

Status: Completed

Conditions: Hypertension; Diabetes; Dyslipidemia; Heart Disease

Treatments: Behavioral: CREATE Wellness; Other: Usual Care Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02302612

R01HL117939 (U.S. NIH Grant/Contract)

CN-13-1672-H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 647 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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647 participants in 2 patient groups

CREATE Wellness

Experimental group

Description:

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 disease management program.

Treatment:

Behavioral: CREATE Wellness

Usual Care Control

Active Comparator group

Description:

Patients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program.

Treatment:

Other: Usual Care Control