Comparison of Outcomes and Access to Care for Heart Failure Trial

Overview: Randomized intervention trial to examine the impact of an acute heart failure strategy, which incorporates risk stratification and rapid outpatient care after discharge.

Study Population: Patients presenting to the emergency department with heart failure will be eligible for study inclusion.

Inclusion and Exclusion Criteria for the Study:

• Age 18 years or older
• Presents to the emergency department with acute heart failure diagnosed clinically and verified by a primary diagnosis of heart failure (ICD-10-CA code I50) on the emergency department facesheet.

Exclusion criteria

• Does not meet Framingham criteria for heart failure
• Heart failure diagnosis unlikely according to B-type natriuretic peptide values

• BNP <100 pg/mL or
• NT-proBNP <300 pg/mL
• End stage renal disease on dialysis
• Palliative patient with do not resuscitate (DNR) order present prior to emergency department arrival
• Limited mobility to attend outpatient clinic visits
• Dementia
• Nursing home resident
• No permanent home address
• Non-resident of Ontario
• Self-discharge from emergency department
• Invalid Ontario health insurance number

Inclusion and Exclusion Criteria for the RAPID-HF Clinic:

Inclusion criteria

• Patients with heart failure presenting to the emergency department meeting overall study eligibility criteria
• Discharged at any time within the first 3 days after emergency department presentation
• Using the EHMRG30-ST risk score:

• Any low-risk patient who is able to be discharged within 3 days of initial emergency department presentation
• Some intermediate-to-low risk zone EHMRG30-ST may be eligible if judged to be clinically stable
• Patient agrees to be discharged early from either the emergency department or hospital
• Able to attend outpatient clinic visits

Exclusion criteria

• High risk zone of EHMRG30-ST
• Pre-cardiac transplant
• Active cardiac ischemia without diagnostic testing done during hospital stay
• Uncontrolled arrhythmia
• Worsening renal failure compared to baseline renal function
• Significant abnormality of vital signs at the time of referral:

• Oxygen saturation on room air less than or equal to 90% which is not usual for patient
• Systolic blood pressure < 90 mmHg with symptoms of hypotension
• Heart rate in sinus rhythm greater than or equal to 100 bpm
• Respiratory rate > 20 breaths/minute
• New heart failure diagnosis (not an absolute contraindication to referral, but not recommended)

Intervention: The study involves 2 components: clinical algorithm for prognostication and post-discharge follow-up in the Rapid Ambulatory Program for Investigation and Diagnosis of Heart Failure (RAPID-HF) clinic.

The clinical decision-support algorithm intervention is a composite of 7-day and 30-day risk calculator (called EHMRG30-ST). Using the EHMRG30-ST algorithm, patients will be categorized as high, intermediate, or low risk. The decision support algorithm will recommend hospital admission or discharge/observation based on patient risk to assist clinicians making the final decision to admit or discharge. Low risk patients may be discharged early (within 3 days of initial presentation) and referred to the RAPID-HF clinic.

Patients referred to RAPID-HF will be assessed ideally within 48-72 hours of discharge. RAPID-HF provides transitional care for up to 30 days after discharge. After 30-days, care is transferred to primary care provider or specialist for ongoing care.

Study Design: Using a stepped-wedge design, participating sites will be randomized to the active intervention. At each step, hospitals that have not yet been randomized will serve as control sites.

Inclusion criteria

• Patient presenting to an emergency department with heart failure

Exclusion criteria

• Palliative or DNR
• Dialysis dependent
• Non-Ontario resident