Discharge Planning in Emergency Department to Reduce 30-day Adverse Outcomes for Frail Older Patients With Acute Heart Failure: Design and Rationale of DEED FRAIL-AHF Clinical Trial Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Heart Failure
- Sponsor
- F. Javier Martin Sanchez
- Enrollment
- 1260
- Locations
- 1
- Primary Endpoint
- 30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge
- Last Updated
- 6 years ago
Overview
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.
Investigators
F. Javier Martin Sanchez
Principal Investigator
Hospital San Carlos, Madrid
Eligibility Criteria
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.
Outcomes
Primary Outcomes
30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge
Time Frame: at 30 days post-discharge
The proportion of patients who have emergency revisit or hospital admission for acute heart failure or cardiovascular mortality within 30 days after discharge
Secondary Outcomes
- Acute heart failure hospitalisation rate(at 30 days post-discharge)
- All-cause mortality rate(at 30 days post-discharge)
- Functional impairment (assessed by self-reported Barthel index)(Change from baseline to 30 days post-discharge)
- Cardiovascular mortality rate(at 30 days post-discharge)
- Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire)(Within 30 days after discharge)
- Quality of live of patients (assessed by EuroQol-5D)(Within 30 days after discharge)
- All-cause emergency revisit rate(at 30 days post-discharge)
- Cardiovascular hospitalisation rate(at 30 days post-discharge)
- Free-hospitalization survival(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)
- Pharmacological adherence (assessed by Morisky Medication Adherence Scale)(Within 30 days after discharge)