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Completed

NCT Number: NCT03246035

Reducing Readmission for Frail Elderly Patients With 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.

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Key information

Conditions

Heart Failure Acute Decompensated Heart Failure Cardiovascular Diseases Disease Attributes Emergencies Fragility Frailty Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. All-cause death, hospital readmission, or ED revisit

    Time frame: 90 days

Secondary outcomes

  1. Rate of return visits to any ER for any medical issue

    Time frame: 30 days

    Number of times enrolled patient visits an emergency department for any medical issue, over the 90 day follow-up period.

  2. Rate of admission to hospital at 90 days

    Time frame: 90 days

    Number of times the patient needs to be admitted to hospital for any medical issue, over the 3 month follow-up period.

  3. Incidence of adverse effects from medication

    Time frame: 90 days

    Number of patients who experience unexpected side effects from their heart failure medications

  4. Self-Care Index

    Time frame: 90 days

    Change in the Self-Care Heart Failure Index from enrollment to follow-up

  5. Heart Failure Symptom Scale

    Time frame: 90 days

    Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up

  6. Frailty Index

    Time frame: 90 days

    Change in the Frailty Index from enrollment to follow-up

  7. Recruitment rate

    Time frame: 90 days

    The number of eligible of patients recruited into the study over a 3 month trial period

  8. Attrition rate

    Time frame: 90 days

    The number of patients enrolled the study who choose to leave the study before completing the follow-up

  9. Informed consent validation (qualitative)

    Time frame: 90 days

    Qualitative feedback from participants regarding the informed consent process

  10. All-cause death, hospital readmission, or ED revisit

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Collaborators

  • Canadian Association of Emergency Physicians

Registry information

Official study title

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

Acronym: HFF-ED

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 11, 2017
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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