Clinical trial NCT03246035: Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure
Official title: A Prospective Randomized Pilot Trial to Reduce Readmission for Frail Elderly Patients With Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Acute Decompensated Heart Failure
Fragility
Emergencies
Keywords: Acute Decompensated Heart Failure
Heart Failure
Frailty
Geriatrics
Self-care
Emergency Medicine
Cardiology
Patient Oriented Research
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Association of Emergency Physicians
First posted: 2017-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized study designed to determine whether telephone based interventions can prevent return hospital visits for elderly and frail patients with acute symptoms of heart failure. Specifically, the intervention will improve patients ability to monitor and address self care of heart failure at home.

Detailed description: Acute decompensated heart failure (ADHF) is a common illness in Canadian emergency departments (ED). The frail subset of elderly patients with ADHF is challenging to treat, use a large proportion of available resources, and are at higher risk for complications, including readmission to hospital after discharge. The investigators believe that by improving access to follow-up, optimizing self-care, and addressing the various cognitive and physical limitations of frailty, it will be possible to improve quality of life and reduce readmission rates for frail patients with ADHF.

Eligibility criteria: Inclusion Criteria:

* Patients who presented to the ED and who are being discharged with a primary or secondary diagnosis of ADHF
* Age ≥ 65
* Frailty, defined as a FRAIL score \>=3/5 or Clinical Frailty Scale (CFS) score \>=5/9
* Informed consent provided by the patient or proxy

Exclusion Criteria:

* Significant dementia or active delirium
* Severe frailty, defined as a CFS score \>=8/9
* Prohibitive language barrier
* Primary address outside of Quebec
* Patient deemed to be palliative or moribund by treating team

Primary outcomes:
measure: All-cause death, hospital readmission, or ED revisit
timeFrame: 90 days
Secondary outcomes:
measure: Rate of return visits to any ER for any medical issue
timeFrame: 30 days
measure: Rate of admission to hospital at 90 days
timeFrame: 90 days
measure: Incidence of adverse effects from medication
timeFrame: 90 days
measure: Self-Care Index
timeFrame: 90 days
measure: Heart Failure Symptom Scale
timeFrame: 90 days
measure: Frailty Index
timeFrame: 90 days
measure: Recruitment rate
timeFrame: 90 days
measure: Attrition rate
timeFrame: 90 days
measure: Informed consent validation (qualitative)
timeFrame: 90 days
measure: All-cause death, hospital readmission, or ED revisit
timeFrame: 1 year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Associate Professor
name: Jonathan Afilalo, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: