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Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure

A Prospective Randomized Pilot Trial to Reduce Readmission for Frail Elderly Patients With Acute Decompensated Heart Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03246035
Acronym
HFF-ED
Enrollment
60
Registered
2017-08-11
Start date
2018-03-01
Completion date
2022-03-01
Last updated
2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Decompensated Heart Failure, Emergencies, Fragility, Heart Failure

Keywords

Acute Decompensated Heart Failure, Heart Failure, Frailty, Geriatrics, Self-care, Emergency Medicine, Cardiology, Patient Oriented Research

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.

Interventions

BEHAVIORALIntervention Group

For the intervention arm, a specialized heart failure nurse practitioner will contact the patient or their primary caregiver by telephone within 5 days post-discharge and send them an education packet by mail. During the telephone call, the nurse will (1) confirm the patient's scheduled follow-up appointment in cardiology, (2) provide recommendations for heart failure self-care behaviors that were found to be deficient at baseline. Patients will then be referred to a Geriatrics Assessment Team, who will provide individualized recommendations for frailty domains that were found to be deficient at baseline. The technique used to provide educational recommendations will be motivational interviewing.

For patients randomized to the Control Group (Standard Care), they will receive their follow-up visits, medications, diet and physical activity advice as they normally would. This is the care they would receive even if they were not enrolled in the study

Sponsors

Canadian Association of Emergency Physicians
CollaboratorINDUSTRY
Jewish General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
All-cause death, hospital readmission, or ED revisit90 days

Secondary

MeasureTime frameDescription
Rate of admission to hospital at 90 days90 daysNumber of times the patient needs to be admitted to hospital for any medical issue, over the 3 month follow-up period.
Incidence of adverse effects from medication90 daysNumber of patients who experience unexpected side effects from their heart failure medications
Self-Care Index90 daysChange in the Self-Care Heart Failure Index from enrollment to follow-up
Heart Failure Symptom Scale90 daysChange in the 12 point Heart Failure Symptom Scale from enrollment to follow-up
Rate of return visits to any ER for any medical issue30 daysNumber of times enrolled patient visits an emergency department for any medical issue, over the 90 day follow-up period.
Recruitment rate90 daysThe number of eligible of patients recruited into the study over a 3 month trial period
Attrition rate90 daysThe number of patients enrolled the study who choose to leave the study before completing the follow-up
Informed consent validation (qualitative)90 daysQualitative feedback from participants regarding the informed consent process
All-cause death, hospital readmission, or ED revisit1 year
Frailty Index90 daysChange in the Frailty Index from enrollment to follow-up

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026