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

Sponsor

Jewish General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03246035

Collaborator

Canadian Association of Emergency Physicians (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Acute Decompensated Heart Failure Fragility Emergencies	Behavioral: Intervention Group Other: Control Group (Standard Care)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Primary Outcome - Re-admission rate to hospital for any diagnosis within 1 year of enrollment [1 year]
The incidence of patients who present to any hospital and require admission for any diagnosis over a 1 year period

Secondary Outcome Measures

Rate of return visits to any ER for any medical issue [30 days]
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 [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 [90 days]
Number of patients who experience unexpected side effects from their heart failure medications
Self-Care Index [90 days]
Change in the Self-Care Heart Failure Index from enrollment to follow-up
Heart Failure Symptom Scale [90 days]
Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up
Frailty Index [90 days]
Change in the Frailty Index from enrollment to follow-up
Recruitment rate [90 days]
The number of eligible of patients recruited into the study over a 3 month trial period
Attrition rate [90 days]
The number of patients enrolled the study who choose to leave the study before completing the follow-up
Informed consent validation (qualitative) [90 days]
Qualitative feedback from participants regarding the informed consent process

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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