Secondary Outcomes Defined. Secondary outcomes include the change in systolic BP between baseline and follow-up; quality of life (depressive symptoms, physical and mental functioning); and patient and practice team satisfaction. Preliminarily, we propose a target of controlled Stage 2 hypertension to mean <140/90 mm Hg for all participants because of the very high risk African American sample and because a single BP goal is easier to implement in real-world settings. However, several evolving developments may influence this goal. First, there was considerable controversy following the 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults (JNC8) recommendation to relax the BP target for patients with hypertension aged >60 years. Second, the Systolic Blood Pressure Intervention Trial (SPRINT) was stopped earlier than its projected project period due to unexpectedly strong beneficial effects of BP control to a target of 120/80 mm Hg.42,43 In accordance with PCORI Methodology Standard 1:RQ-6, we will “provide information that supports the selection of outcomes as meeting the criteria of “patient-centered” and “relevant to decision makers,”1 such as patient and decision-maker input from meetings, surveys, or published studies.” Our discussions with patients, providers, peer coaches, practice facilitators, and the stakeholders engaged in the CABs shaped the selection of the study outcomes, which are both patient-centered and relevant to decision makers. As described in the Background and Significance (section 1), high blood pressure is a leading killer among African Americans, and leads to significant morbidity. Control of high blood pressure is a high priority in our partnering communities, confirming that this outcome is patient-centered.
