Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure

NCT ID: NCT03246035

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2022-03-01

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.

Conditions

Heart Failure; Acute Decompensated Heart Failure; Fragility; Emergencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Control Group (Standard Care)

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Association of Emergency Physicians

INDUSTRY

Sponsor Role: collaborator

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Afilalo

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Afilalo, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Study Documents

Document Type: Study Protocol

Pilot study protocol

View Document

Document Type: Informed Consent Form

Patient consent Caregiver consent French and English available

View Document

Other Identifiers

ADHF-ED-JGH

Identifier Type: -

Identifier Source: org_study_id