Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure

NCT03246035 | Completed

• 1 other identifier: ADHF-ED-JGH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• All-cause death, hospital readmission, or ED revisit

  90 days

Secondary Outcomes (10)

• Rate of return visits to any ER for any medical issue

  30 days

• Rate of admission to hospital at 90 days

  90 days

• Incidence of adverse effects from medication

  90 days

• Self-Care Index

  90 days

• Heart Failure Symptom Scale

  90 days

Study Arms (2)

Control Group (Standard Care)

ACTIVE COMPARATOR

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)

Intervention Group

EXPERIMENTAL

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

Interventions

Intervention Group 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.

Intervention Group

Control Group (Standard Care) 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

Control Group (Standard Care)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jewish General Hospital: lead
• Canadian Association of Emergency Physicians: collaborator

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Heart Failure; Emergencies; Frailty

Interventions

Control Groups; Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jonathan Afilalo, FRCPC

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: August 11, 2017
• Study Start: March 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)