Changing Results—Engage and Activate to Enhance Wellness: A Randomized Clinical Trial to Improve Cardiovascular Risk Management

BACKGROUND: Despite the success of current cardiovascular disease (CVD) management programs, many patients do not achieve optimal control of CVD‐related risk factors. New strategies are needed to better activate and engage these patients. METHODS AND RESULTS: We conducted a parallel, 2‐arm, randomized controlled trial, CREATE Wellness (Changing Results—Engage and Activate to Enhance Wellness) from February 2015 to September 2017 with 12‐month follow‐up to September 2018. Eligible participants had ≥1 uncontrolled CVD risk factors (hyperlipidemia, hypertension, or diabetes mellitus) for at least 2 years before study enrollment. The control group (n=315) received usual care within an existing CVD population‐based disease management program. The intervention group (n=332) received usual care plus a group‐based behavioral intervention focused on patient activation and engagement. Study outcomes included patient activation and patient‐centered care processes (6 months) and healthcare system engagement, medication adherence, and control of CVD risk factors (12 months). Compared with the control group at follow‐up, the intervention group had greater improvement in patient activation (adjusted mean difference=2.8, P=0.01), patient‐centered care (adjusted mean difference=0.19, P=0.003), and 2 out of 3 measures of healthcare system engagement (eg, secure messages exchanged with a population health manager; adjusted incidence rate ratio=1.7, P=0.01). Intervention and control arms did not differ on improvement in 1‐year CVD risk factor control. CONCLUSIONS: Further work is needed to more effectively connect increased patient activation and engagement to downstream changes in risk factor control. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02302612.