Discharge Planning in Emergency Department for Frail Older With AHF

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

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.

Study Overview

• Status: Unknown
• Conditions: Frail Elderly Syndrome; Acute Heart Failure
• Intervention / Treatment: Other: Standard of care; Other: Multilevel Guided Discharge Planning

• Study Type: Interventional
• Enrollment (Anticipated): 1260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
    • Contact: Martin Sanchez, MD; Phone Number: 913303750; Email: fjjms@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care	Other: Standard of care; Standard of care
Experimental: Multilevel Guided Discharge Planning	Other: Multilevel Guided Discharge Planning; Clinical recommendations and resources activations + scheduling of early visit with the specialist + communication with primary care + written instruction sheet to the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause emergency revisit rate	The proportion of patients who have ED revisit for all causes within 30 days after discharge	at 30 days post-discharge
Acute heart failure emergency revisit rate	The proportion of patients who have ED revisit for acute heart failure within 30 days after discharge	at 30 days post-discharge
Cardiovascular emergency revisit rate	The proportion of patients who have ED revisit for cardiovascular event within 30 days after discharge	at 30 days post-discharge
All-cause hospitalisation rate	The proportion of patients who have an hospitalisation for all causes within 30 days after discharge	at 30 days post-discharge
Acute heart failure hospitalisation rate	The proportion of patients who have hospitalisation for acute heart failure within 30 days after discharge	at 30 days post-discharge
Cardiovascular hospitalisation rate	The proportion of patients who have hospitalisation for cardiovascular events within 30 days after discharge	at 30 days post-discharge
All-cause mortality rate	The proportion of patients who have all-cause mortality within 30 days after discharge	at 30 days post-discharge
Cardiovascular mortality rate	The proportion of patients who have cardiovascular mortality within 30 days after discharge	at 30 days post-discharge
Free-hospitalization survival	Number of days alive out of the hospital	at 30 days post-discharge
Functional impairment (assessed by self-reported Barthel index)	Barthel index measures the subject's capacity to perform ten activities of daily living (feeding, bathing, grooming, dressing, bowel and bladder control, toileting, chair transfer, ambulation and stair climbing). The sum score ranges from 0 (totally dependent) to 100 (totally independent).	Change from baseline to 30 days post-discharge
Pharmacological adherence (assessed by Morisky Medication Adherence Scale)	The four-item MGLS measures pharmacological adherence. The score ranges from 0 (perfect adherence) to 4 (some level of non-adherence).	Within 30 days after discharge
Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire)	CTM questionnaire assesses the quality of care transitions, with lower scores indicating a poorer quality transition, and higher scores indicating a better transition.	Within 30 days after discharge
Quality of live of patients (assessed by EuroQol-5D)	EQ-5D measures of health-related quality of life. The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.	Within 30 days after discharge

Collaborators and Investigators

• Sponsor: F. Javier Martin Sanchez

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): May 15, 2022

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Heart failure; Emergency Department; Older; Frail; Discharge Planning
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Heart Failure; Emergencies
• Other Study ID Numbers: DEED FRAIL-AHF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No