Clinical trial NCT02674438: Comparison of Outcomes and Access to Care for Heart Failure Trial
Official title: Comparison of Outcomes and Access to Care for Heart Failure Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Institute for Clinical Evaluative Sciences
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 5452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Heart failure is a condition where the heart pump does not function normally causing the lungs to become congested. The primary symptom of heart failure is shortness of breath, and this often leads to patients visiting the emergency department for care. Decision-making in the emergency department is a high-stakes situation, where there is a need for decision support to guide clinicians to make better decisions about admission to hospital or discharge home. Many low-risk patients who could potentially be managed at home are admitted to hospital whereas some patients who are thought safe to discharge are actually high risk and will have adverse outcomes if they are discharged home from the emergency department.

In this trial, the investigators will study a new strategy for heart failure care, comprised of a computer algorithm to help doctors make decisions in the emergency department about the risk of their patient. For low-risk patients who are discharged home from the emergency department or after a short hospital stay, patients will be referred to a rapid follow-up clinic where the heart specialist team will rapidly assess and treat patients.

Detailed description: 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:

1. Age 18 years or older
2. 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:

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

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

Inclusion and Exclusion Criteria for the RAPID-HF Clinic:

Inclusion criteria:

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

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

Exclusion criteria:

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

   1. Oxygen saturation on room air less than or equal to 90% which is not usual for patient
   2. Systolic blood pressure \< 90 mmHg with symptoms of hypotension
   3. Heart rate in sinus rhythm greater than or equal to 100 bpm
   4. Respiratory rate \> 20 breaths/minute
7. 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.

Eligibility criteria: Inclusion Criteria:

* Patient presenting to an emergency department with heart failure

Exclusion Criteria:

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

Primary outcomes:
measure: Co-primary outcome: 30 day early events
timeFrame: 30 days
measure: Co-primary outcome: 20 month extended events
timeFrame: 20 month follow-up
Secondary outcomes:
measure: All-cause death
timeFrame: 30 days
measure: Cardiovascular hospitalization
timeFrame: 30 days
measure: Heart failure hospitalization
timeFrame: 30 days
measure: All-cause death
timeFrame: 20 months
measure: Cardiovascular hospitalization
timeFrame: 20 months
measure: Heart failure hospitalization
timeFrame: 20 months
Other outcomes:
measure: Patient-centered outcome
timeFrame: 1) 30-day and 2) 20 month
measure: Early discharge
timeFrame: 3 days
Locations:
city: Toronto
country: Canada
facility: Toronto Genera Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Douglas Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee DS, Straus SE, Farkouh ME, Austin PC, Taljaard M, Chong A, Fahim C, Poon S, Cram P, Smith S, McKelvie RS, Porepa L, Hartleib M, Mitoff P, Iwanochko RM, MacDougall A, Shadowitz S, Abrams H, Elbarasi E, Fang J, Udell JA, Schull MJ, Mak S, Ross HJ; COACH Trial Investigators. Trial of an Intervention to Improve Acute Heart Failure Outcomes. N Engl J Med. 2023 Jan 5;388(1):22-32. doi: 10.1056/NEJMoa2211680. Epub 2022 Nov 5.