Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure

Heart Failure Clinical Trial

— HFF-ED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246035
• Other study ID #: ADHF-ED-JGH
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: October 2022
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Emergencies
• Fragility
• Heart Failure

Intervention

Behavioral:
• Intervention 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.

Other:
• Control Group (Standard Care)
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

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Jewish General Hospital	Canadian Association of Emergency Physicians

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death, hospital readmission, or ED revisit		90 days
Secondary	Rate of return visits to any ER for any medical issue	Number of times enrolled patient visits an emergency department for any medical issue, over the 90 day follow-up period.	30 days
Secondary	Rate of admission to hospital at 90 days	Number of times the patient needs to be admitted to hospital for any medical issue, over the 3 month follow-up period.	90 days
Secondary	Incidence of adverse effects from medication	Number of patients who experience unexpected side effects from their heart failure medications	90 days
Secondary	Self-Care Index	Change in the Self-Care Heart Failure Index from enrollment to follow-up	90 days
Secondary	Heart Failure Symptom Scale	Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up	90 days
Secondary	Frailty Index	Change in the Frailty Index from enrollment to follow-up	90 days
Secondary	Recruitment rate	The number of eligible of patients recruited into the study over a 3 month trial period	90 days
Secondary	Attrition rate	The number of patients enrolled the study who choose to leave the study before completing the follow-up	90 days
Secondary	Informed consent validation (qualitative)	Qualitative feedback from participants regarding the informed consent process	90 days
Secondary	All-cause death, hospital readmission, or ED revisit		1 year