Clinical trial NCT02302612: The CREATE Wellness Study
Official title: Multi-Component Behavioral Intervention for Complex Patients With CVD Risk. The Changing Results: Engage and Activate to Enhance Wellness (CREATE Wellness) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Heart Disease
Hypertension
Dyslipidemia
Keywords: chronic conditions
complex patients
engagement
activation
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-11-27
Enrollment: 647
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite CVD Goal
timeFrame: 12-months
Secondary outcomes:
measure: Perceived efficacy in patient-physician interactions (PEPPI) - 10 items
timeFrame: 6 months
measure: Effective Consumer Scale (EC-17)
timeFrame: 6 months
measure: Patient Activation Measure (PAM) - 13 items
timeFrame: 6 months
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Kaiser Permanente San Jose Sabrina Wood, BA (510) 891-3551 Sabrina.B.Wood@kp.org
state: California
Study officials:
affiliation: Division of Research, KPNC
name: Richard W Grant, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iturralde E, Sterling SA, Uratsu CS, Mishra P, Ross TB, Grant RW. Changing Results-Engage and Activate to Enhance Wellness: A Randomized Clinical Trial to Improve Cardiovascular Risk Management. J Am Heart Assoc. 2019 Dec 3;8(23):e014021. doi: 10.1161/JAHA.119.014021. Epub 2019 Nov 30.
citation: Torres DX, Lu WY, Uratsu CS, Sterling SA, Grant RW. Knowing How to Ask Good Questions: Comparing Latinos and Non-Latino Whites Enrolled in a Cardiovascular Disease Prevention Study. Perm J. 2019;23:18-258. doi: 10.7812/TPP/18-258.
citation: Miller-Rosales C, Sterling SA, Wood SB, Ross T, Makki M, Zamudio C, Kane IM, Richardson MC, Samayoa C, Charvat-Aguilar N, Lu WY, Vo M, Whelan K, Uratsu CS, Grant RW. CREATE Wellness: A multi-component behavioral intervention for patients not responding to traditional Cardiovascular disease management. Contemp Clin Trials Commun. 2017 Oct 4;8:140-146. doi: 10.1016/j.conctc.2017.10.001. eCollection 2017 Dec.