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Discharge Planning in Emergency Department for Frail Older With AHF

F

F. Javier Martin Sanchez

Status

Unknown

Conditions

Acute Heart Failure
Frail Elderly Syndrome

Treatments

Other: Standard of care
Other: Multilevel Guided Discharge Planning

Study type

Interventional

Funder types

Other

Identifiers

NCT03696875
DEED FRAIL-AHF

Details and patient eligibility

About

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.

Enrollment

1,260 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,260 participants in 2 patient groups

Multilevel Guided Discharge Planning
Experimental group
Treatment:
Other: Multilevel Guided Discharge Planning
Standard of care
Active Comparator group
Treatment:
Other: Standard of care

Trial contacts and locations

1

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Central trial contact

Francisco Javier Martín-Sánchez, MD, PhD.

Data sourced from clinicaltrials.gov

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