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

Abstract

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.