Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure (HFF-ED)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Emergencies; Acute Decompensated Heart Failure; Fragility
• Intervention / Treatment: Other: Control Group (Standard Care); Behavioral: Intervention Group

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Group (Standard Care); The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital.	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
EXPERIMENTAL: Intervention Group; The intervention will consist of contacting the patient 5 days post-discharge and arranging definitive outpatient follow-up and providing targeted medical and lifestyle advice based on deficient domains identified at baseline.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause death, hospital readmission, or ED revisit	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Incidence of adverse effects from medication	Number of patients who experience unexpected side effects from their heart failure medications	90 days
Self-Care Index	Change in the Self-Care Heart Failure Index from enrollment to follow-up	90 days
Heart Failure Symptom Scale	Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up	90 days
Frailty Index	Change in the Frailty Index from enrollment to follow-up	90 days
Recruitment rate	The number of eligible of patients recruited into the study over a 3 month trial period	90 days
Attrition rate	The number of patients enrolled the study who choose to leave the study before completing the follow-up	90 days
Informed consent validation (qualitative)	Qualitative feedback from participants regarding the informed consent process	90 days
All-cause death, hospital readmission, or ED revisit		1 year

Collaborators and Investigators

• Sponsor: Jewish General Hospital
• Collaborators: Canadian Association of Emergency Physicians
• Investigators: Principal Investigator: Jonathan Afilalo, FRCPC, Associate Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): March 1, 2021
• Study Completion (ACTUAL): March 1, 2022

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (ACTUAL): August 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Emergency Medicine; Geriatrics; Frailty; Self-care; Cardiology; Acute Decompensated Heart Failure; Patient Oriented Research
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Heart Failure; Emergencies
• Other Study ID Numbers: ADHF-ED-JGH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
   Information identifier: CODIM-MBM-17-052
   Information comments: Pilot study protocol
2. Informed Consent Form
   Information identifier: CODIM-MBM-17-052
   Information comments: Patient consent Caregiver consent French and English available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No