Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure (HFF-ED)
Primary Purpose
Heart Failure, Acute Decompensated Heart Failure, Fragility
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intervention Group
Control Group (Standard Care)
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Acute Decompensated Heart Failure, Heart Failure, Frailty, Geriatrics, Self-care, Emergency Medicine, Cardiology, Patient Oriented Research
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
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group (Standard Care)
Intervention Group
Arm Description
The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital.
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.
Outcomes
Primary Outcome Measures
All-cause death, hospital readmission, or ED revisit
Secondary Outcome Measures
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.
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.
Incidence of adverse effects from medication
Number of patients who experience unexpected side effects from their heart failure medications
Self-Care Index
Change in the Self-Care Heart Failure Index from enrollment to follow-up
Heart Failure Symptom Scale
Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up
Frailty Index
Change in the Frailty Index from enrollment to follow-up
Recruitment rate
The number of eligible of patients recruited into the study over a 3 month trial period
Attrition rate
The number of patients enrolled the study who choose to leave the study before completing the follow-up
Informed consent validation (qualitative)
Qualitative feedback from participants regarding the informed consent process
All-cause death, hospital readmission, or ED revisit
Full Information
NCT ID
NCT03246035
First Posted
June 28, 2017
Last Updated
October 12, 2022
Sponsor
Jewish General Hospital
Collaborators
Canadian Association of Emergency Physicians
1. Study Identification
Unique Protocol Identification Number
NCT03246035
Brief Title
Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure
Acronym
HFF-ED
Official Title
A Prospective Randomized Pilot Trial to Reduce Readmission for Frail Elderly Patients With Acute Decompensated Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
Collaborators
Canadian Association of Emergency Physicians
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group (Standard Care)
Arm Type
Active Comparator
Arm Description
The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group (Standard Care)
Intervention Description
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
Primary Outcome Measure Information:
Title
All-cause death, hospital readmission, or ED revisit
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Rate of return visits to any ER for any medical issue
Description
Number of times enrolled patient visits an emergency department for any medical issue, over the 90 day follow-up period.
Time Frame
30 days
Title
Rate of admission to hospital at 90 days
Description
Number of times the patient needs to be admitted to hospital for any medical issue, over the 3 month follow-up period.
Time Frame
90 days
Title
Incidence of adverse effects from medication
Description
Number of patients who experience unexpected side effects from their heart failure medications
Time Frame
90 days
Title
Self-Care Index
Description
Change in the Self-Care Heart Failure Index from enrollment to follow-up
Time Frame
90 days
Title
Heart Failure Symptom Scale
Description
Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up
Time Frame
90 days
Title
Frailty Index
Description
Change in the Frailty Index from enrollment to follow-up
Time Frame
90 days
Title
Recruitment rate
Description
The number of eligible of patients recruited into the study over a 3 month trial period
Time Frame
90 days
Title
Attrition rate
Description
The number of patients enrolled the study who choose to leave the study before completing the follow-up
Time Frame
90 days
Title
Informed consent validation (qualitative)
Description
Qualitative feedback from participants regarding the informed consent process
Time Frame
90 days
Title
All-cause death, hospital readmission, or ED revisit
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Afilalo, FRCPC
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.ladydavis.ca/en/jonathanafilalo
Available IPD/Information Identifier
CODIM-MBM-17-052
Available IPD/Information Comments
Pilot study protocol
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
http://www.ladydavis.ca/en/jonathanafilalo
Available IPD/Information Identifier
CODIM-MBM-17-052
Available IPD/Information Comments
Patient consent Caregiver consent French and English available
Learn more about this trial
Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure
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