The CREATE Wellness Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

647 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Heart Disease Hypertension Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CREATE Wellness

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.

Group Type EXPERIMENTAL

CREATE Wellness

Intervention Type BEHAVIORAL

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

Usual Care Control

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

Group Type ACTIVE_COMPARATOR

Usual Care Control

Intervention Type OTHER

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

Interventions

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CREATE Wellness

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

Intervention Type BEHAVIORAL

Usual Care Control

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No