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.

Public Health Relevance

Adult Americans do not know their chances of having a heart attack or stroke or the ways available to reduce this risk, and they end up with prevention regimens that are inconsistent with the threat they face or with their preferences. Experts have recommended that, to reduce the large cost in dollars and human suffering of preventable cardiovascular disease, clinicians and patients should work together to review each person?s risk and the effective options available to reduce it, and to craft a preventive plan; this so-called shared decision making, however, seldom takes place. We propose to study and identify the most effective ways by which primary care practices can make shared decision making a routine part of their usual care, such that people at risk can end up with effective prevention plans that are feasible and consistent with their risk and preferences.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
1R01HL151662-01
Application #
9940198
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Shero, Susan
Project Start
2020-05-01
Project End
2024-04-30
Budget Start
2020-05-01
Budget End
2021-04-30
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905