PCORI Funded Guided Heart Failure Study
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.
Incorporating Patient and Caregiver Experiences Into Cardiovascular Clinical Trial Design(link opens in new window) - JAMA Cardiology
Design and Rationale of a Randomized Trial of a Care Transition Strategy in Patients With Acute Heart Failure Discharged From the Emergency Department: GUIDED-HF (Get With the Guidelines in Emergency Department Patients With Heart Failure).(link opens in new window) - Circulation Heart Failure
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. Get With The Guidelines®- Heart Failure (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.KNOWLEDGE GAP
- 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.
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.ANTICIPATED IMPACT
If GUIDED HF successfully improves outcomes and mitigates disparities in patients with AHF discharged from the ED it would have a tremendous impact on current practice. This would result in a change in current HF guidelines, increasing the level of evidence regarding ED discharge practices, and informing practitioners about the impact of GUIDED HF on disparities in vulnerable ED patients. Importantly, the AHA would assist with implementing the GUIDED HF strategy at all of the GWTG:HF hospitals. This would ensure all ED patients with AHF, regardless of whether they were admitted or discharged from the ED, would be eligible for GWTG:HF transition interventions. Importantly, from a patient perspective, improvements in HF quality of life, knowledge and patient satisfaction would facilitate the uptake of this initiative.