PROJECT SUMMARY/ABSTRACT
The primary prevention of cardiovascular (CV) events is often more intense in individuals at
lower risk and vice versa (risk-treatment paradox) in part due to unawareness of each person’s
CV risk, of their preferences for prevention interventions, and of their feasibility in each person’s
daily life. Extant practice guidelines recommend that clinicians and patients work together to
arrive at an effective and feasible prevention plan that is congruent with each person’s CV risk
and informed preferences, a process called shared decision making (SDM). An effective and
innovative tool that estimates CV risk and shows the impact and features of available lifestyle
and pharmacological preventive interventions for use during the clinical encounter to enable
SDM, the CV Prevention Choice tool, is available yet remains rarely used in practice.
Our broad goal is to promote patient-centered care that effectively reduces the substantial
burden of CV disease among Americans. This study, directly responsive to PA-19-166, seeks to
identify implementation approaches that foster routine SDM about primary CV prevention in a
diverse set of primary care practices across the U.S. This 5-year study – proposed by a
multidisciplinary team with expertise in preventive cardiology, SDM, and implementation science
– will draw on an implementation framework (Consolidated Framework for Implementation
Research), an implementation theory (Normalization Process Theory), and an evaluation
framework (RE-AIM) to design, conduct, and report a mixed method, hybrid implementation-
effectiveness (Type III), stepped-wedge clustered randomized trial to determine:
- Implementation effectiveness (Aim 1) by evaluating practice contexts and engagement of
users in implementation strategies, implementation outcomes (e.g., reach, adoption) associated
with these strategies, and how implementation fosters routine adoption of SDM and the CV
Prevention Choice tool in primary care practices, and
- SDM effectiveness (Aim 2) estimated by the extent to which individual CV prevention plans
are feasible and congruent with each person’s estimated CV risk and preferences.
By the project’s end, we expect to have (a) identified the most effective implementation
strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to
achieve feasible and risk-concordant CV prevention in primary care.