Discharge Planning in Emergency Department for Frail Older With AHF

NCT03696875 | Unknown

• 1 other identifier: DEED FRAIL-AHF
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To demonstrate the efficacy of care transition holistic intervention (Multilevel Guided Discharge Planning, MGDP) in reducing 30-day adverse outcomes among frail older patients with acute heart failure (AHF) discharged from Emergency Departments (EDs) and to validate the results of MGDP in real life. Method: Investigators will select frail patients ≥70 years with primary diagnosis of AHF discharged from EDs. The intervention will consist of MGDP implementation: 1) checklist that includes clinical recommendations and resources activations; 2) scheduling of early visit with the specialist; 3) communication with primary care; 4) providing a written instruction sheet to patient or caregiver. Phase 1: matched-pair cluster randomized clinical trial. EDs were randomly allocated to intervention (n = 10) or control (n = 10) group. Investigators will compare the outcomes between intervention and control groups. Phase 2: a quasi-experimental study. The 20 EDs will carry out the intervention. Investigators will compare the outcomes between phase 1 and phase 2 of intervention group and between phase 1 and phase 2 of control group. The main outcome is a 30-day composite endpoint (ED revisit or hospital admission for AHF and cardiovascular death) after being discharged.

Conditions

Acute Heart Failure; Frail Elderly Syndrome

Keywords

Discharge Planning; Emergency Department; Heart failure; Older; Frail

Outcome Measures

Primary Outcomes (1)

• 30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge

  The proportion of patients who have emergency revisit or hospital admission for acute heart failure or cardiovascular mortality within 30 days after discharge

  at 30 days post-discharge

Secondary Outcomes (13)

• All-cause emergency revisit rate

  at 30 days post-discharge

• Acute heart failure emergency revisit rate

  at 30 days post-discharge

• Cardiovascular emergency revisit rate

  at 30 days post-discharge

• All-cause hospitalisation rate

  at 30 days post-discharge

• Acute heart failure hospitalisation rate

  at 30 days post-discharge

Study Arms (2)

Multilevel Guided Discharge Planning

EXPERIMENTAL

Other: Multilevel Guided Discharge Planning

Standard of care

ACTIVE COMPARATOR

Other: Standard of care

Interventions

Multilevel Guided Discharge Planning OTHER

Clinical recommendations and resources activations + scheduling of early visit with the specialist + communication with primary care + written instruction sheet to the patient

Multilevel Guided Discharge Planning

Standard of care OTHER

Standard of care

Standard of care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥70 years.
• Diagnosis of descompensated chronic heart failure.
• Screening for frailty positive (ISAR ≥ 2).
• Planned discharge home from Emergency Department (included observation and short stay unit).
• Written informed consent provided by the patient or proxy.

You may not qualify if:

• De novo (new onset) acute heart failure (AHF).
• Severe episode of acute heart failure (≥9th decile of MEESSI-AHF Score).
• Uncorrected clinically significant primary valvular disease.
• Acute coronary syndrome currently or within 30 days prior to enrolment.
• Surgery or implanted device within 30 days prior to enrolment.
• Significant arrhythmias.
• Uncorrected systolic blood pressure \< 100 mmHg, O2 saturation baseline \< 92%, heart rate \< 60 or \>110 bpm, serum sodium \< 130 mmol/l, serum potassium \>5,5 mmol/l or hemoglobin \<9 g/dL prior to enrolment.
• Planned treatment with vasoactive therapies, ventricular assist device, heart surgery or transplant within 6 months.
• End stage renal disease.
• Severe disability.
• Difficulty intervention due to significant dementia, active delirium or psychiatric disorder.
• Condition with a life expectancy \<1 year.
• Length of stay in Emergency Department ≥96 hours.
• Discharged to facility care.
• Inability of outpatient follow-up.

Sponsors & Collaborators

• F. Javier Martin Sanchez: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Emergencies; Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Francisco Javier Martín-Sánchez, MD, PhD.

CONTACT

+34 91.330.37.50; fjjms@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Phase 1: Matched-pair cluster randomized clinical trial. Phase 2: a quasi-experimental study.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 5, 2018
• Study Start: May 20, 2019
• Primary Completion: December 20, 2021
• Study Completion: May 15, 2022
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

ES (1)