American Heart Association is pleased to the opportunity to be included in two new research studies, MaRISS and PROSPER.
Have you heard of the MaRISS, PROSPER, and ARAMIS clinical research studies?
- Mild and Rapidly Improving Stroke Study (MaRISS) a multi-center study trial designed to evaluate the long-term outcomes of patients with a diagnosis of mild stroke? Want more information? Contact Edna Kavuma, Program Manager at 214-706-1994 or firstname.lastname@example.org
- Patient-centered Research into Outcomes Stroke Patients prefer and Effectiveness Research (PROSPER) is a multi-center study that will evaluate post-discharge functional status, disability, depression and quality of life in stroke survivors. For more information contact Laura Drew, Coordinator, at 919-668-8892 or PROSPER@dm.duke.edu.
- ARAMIS (Addressing Real-world Anticoagulant Management Issues in Stroke) is a multi-center study that will provide important and timely insight into the management of acute stroke patients who are taking novel oral anticoagulant (NOA) prior to stroke. Want more information? Please contact DCRI at ARAMIS@dm.duke.edu.
Have your heard about the PCORI Funded Guided Heart Failure Study?
GWTG Interventions to Reduce Disparities in AHF Patients Discharged from the ED (GUIDED HF)
With support from a three-year, $2 million research grant from Patient-Centered Outcomes Research Institute (PCORI), Vanderbilt University Medical Center and the American Heart Association are teaming up to study heart failure care in the Emergency Department.
About The Study:
BACKGROUND AND SIGNIFICANCE
Heart failure affects nearly 6 million Americans and results in over one million annual hospital discharges as the primary discharge diagnosis and an additional two million hospitalizations where HF is a secondary contributing diagnosis. Further, nearly one million ED visits for AHF occur annually in the United States and over 80% result in a hospital admission. Most importantly, vulnerable patients are discharged from the ED more often than non-vulnerable patients and experience a disproportionate increase in subsequent ED visits and hospital admissions. GWTG:HF has been successfully implemented in the inpatient setting and has improved processes of care and mitigated disparities in HF outcomes. However, patients discharged from the ED do not currently receive this benefit. GWTG:HF implementation in patients discharged from the ED with AHF has the potential to significantly impact clinical and patient-centric outcomes. Determining whether this approach is effective at improving outcomes and reducing disparities would fill in a critical evidence gap and facilitate guideline adaptation.
- For patients discharged from the emergency department (ED) with acute heart failure (AHF):
Does our transition nurse coordinator (TNC) and our GWTG:HF interventions reduce HF disparities in time to ED revisit, hospital admission and cardiovascular death between vulnerable and non-vulnerable patients?
- Does our TNC and our GWTG:HF interventions improve patient centered outcomes such as HF related quality of life (QOL), HF knowledge and patient satisfaction?
- To estimate the reduction in disparities in time to first 1) ED/clinic revisit or hospital admission due to AHF or 2) cardiovascular death in vulnerable patients as a result of our transition nurse coordinator (TNC) strategy.
- To compare patient satisfaction, HF knowledge and QOL between usual care and our TNC strategy 1) between those with and without vulnerable characteristics and 2) in all AHF patients discharged from the ED.
- Overall Design and Intervention: GUIDED HF is a multicenter, randomized, 1:1 trial comparing 1) standardized ED discharge vs. 2) a tailored discharge plan implementing GWTG:HF via a TNC in patients with AHF discharged from the ED. We will stratify by site and vulnerable and non-vulnerable characteristics.
- Study Population: The trial will enroll patients discharged from the ED with AHF, as diagnosed by the treating physician. Entry criteria will permit enrollment of ED patients: 1) in whom AHF is diagnosed, 2) for whom ED physicians intend to discharge, 3) who are low-risk and will not have difficulties complying with the protocol due to psychiatric disease, dementia, or proximity to the enrolling institution, making the TNC home visit problematic.
- Primary/secondary outcomes: Outcomes were selected on the basis of importance to patients and their families: primary, time to 90-day ED revisit, hospital admission or CV death, and secondary, HF quality of life, HF knowledge and patient satisfaction.
Pre-specified Subgroup Analyses. Subgroups of interest are African Americans, those with low socioeconomic status, low health literacy, and uninsured.
Analytic Methods. The planned sample size of 700 subjects, equally distributed across the two intervention arms, will provide excellent precision to address Aim 1 and Aim 2 using a Type I Error rate of 5% in a two-sided test. The power calculation is based on standard methods for a proportional hazards model. Importantly, this sample size will also provide adequate power to determine the impact of our treatment effects in African Americans, those with low health literacy/numeracy and those with low socioeconomic status.
PATIENT AND STAKEHOLDER ENGAGEMENT
In strategic alliance with the American Heart Association (AHA), we have constructed three tiers of stakeholder engagement: 1) a virtual online community of patients reached via social media, 2) yearly community engagement studios to inform study process improvements, and 3) semiannual Patient Engagement Steering Committee meetings. All stakeholders (patients, caretakers, nurses, advocacy organization stakeholders, payers, etc.) will actively share their expertise in every element of the study, from design and conduct to the ultimate dissemination of GUIDED HFs findings. The AHA will play a key role in dissemination, ensuring ongoing patient inclusion efforts are successful, and any national practice guideline revisions deemed necessary based on study results.