Risk stratification in acute heart failure: Rationale and design of the STRATIFY and DECIDE studies

Abstract

A critical challenge for physicians facing patients presenting with signs and symptoms of acute heart failure (AHF) is how and where to best manage them. Currently, most patients evaluated for AHF are admitted to the hospital, yet not all warrant inpatient care. Up to 50% of admissions could be potentially avoided and many admitted patients could be discharged after a short period of observation and treatment. Methods for identifying patients that can be sent home early are lacking. Improving the physician’s ability to identify and safely manage low-risk patients is essential to avoiding unnecessary use of hospital beds. Two studies (STRATIFY and DECIDE) have been funded by the National Heart Lung and Blood Institute with the goal of developing prediction rules to facilitate early decision making in AHF. Using prospectively gathered evaluation and treatment data from the acute setting (STRATIFY) and early inpatient stay (DECIDE), rules will be generated to predict risk for death and serious complications. Subsequent studies will be designed to test the external validity, utility, generalizability and cost-effectiveness of these prediction rules in different acute care environments representing racially and socioeconomically diverse patient populations. A major innovation is prediction of 5-day as well as 30-day outcomes, overcoming the limitation that 30-day outcomes are highly dependent on unpredictable, post-visit patient and provider behavior. A novel aspect of the proposed project is the use of a comprehensive cardiology review to correctly assign post-treatment outcomes to the acute presentation. Finally, a rigorous analysis plan has been developed to construct the prediction rules that will maximally extract both the statistical and clinical properties of every data element. Upon completion of this study we will subsequently externally test the prediction rules in a heterogeneous patient cohort.

Plasma bioactive adrenomedullin as a prognostic biomarker in acute heart failure

“…This study utilized a subset of patients recruited for the STRATIFY and DECIDE studies. 20 Methodological details of patient recruitment and enrollment have been reported previously. 20 The local Institutional Review Boards of the participating sites approved the study.…”

“…20 Methodological details of patient recruitment and enrollment have been reported previously. 20 The local Institutional Review Boards of the participating sites approved the study. All enrolled patients provided written informed consent for participation.…”

“…20 Enrolled patients presented to the ED with acute cardiopulmonary symptoms, met the Modified Framingham Criteria for AHF, 20 and were clinically suspected of having AHF. To ascertain if AHF was truly the cause of each patient’s acute symptoms, a panel of three cardiologists reviewed the medical record of each enrolled patient’s ED visit and subsequent hospitalization.…”

Early Management of Patients With Acute Heart Failure: State of the Art and Future Directions. A Consensus Document From the Society for Academic Emergency Medicine/Heart Failure Society of America Acute Heart Failure Working Group

“…Unfortunately, risk-prediction instruments in AHF have been largely unsuccessful when attempting to define a cohort of patients safe for early discharge and at low-risk of 30-day mortality and readmission. 92,93 More importantly, risk tools have not been implemented in the ED to determine how they augment, or detract from, clinician judgment. As a result, published tools have had little impact on ED disposition decision making.…”

Decline in Hospitalization Trend for Cardiovascular Diseases Sensitive to Primary Healthcare

“…19 In addition, difficulty in outpatient control of the disease, overestimation of its severity and premature hospitalizations become major causes for hospitalization as its main treatment; 20 thus, the lack of patient risk stratification and evidence-based clinical principles make admissions an exclusive practice. In this sense, PHC professionals play an important role for patients with this disorder, requiring individual and collective interventions for its control.…”