Discharge Planning in Emergency Department for Frail Older With AHF

Acute Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03696875
• Other study ID #: DEED FRAIL-AHF
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: May 15, 2022

Study information

• Verified date: July 2019
• Source: Hospital San Carlos, Madrid
• Contact: Francisco Javier Martín-Sánchez, MD, PhD.
• Phone: +34 91.330.37.50
• Email: fjjms[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1260
• Est. completion date: May 15, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Emergencies
• Frail Elderly Syndrome
• Heart Failure

Intervention

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
• Standard of care
Standard of care

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
F. Javier Martin Sanchez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cardiovascular hospitalisation rate	The proportion of patients who have hospitalisation for cardiovascular events within 30 days after discharge	at 30 days post-discharge
Secondary	All-cause mortality rate	The proportion of patients who have all-cause mortality within 30 days after discharge	at 30 days post-discharge
Secondary	Cardiovascular mortality rate	The proportion of patients who have cardiovascular mortality within 30 days after discharge	at 30 days post-discharge
Secondary	Free-hospitalization survival	Number of days alive out of the hospital	at 30 days post-discharge
Secondary	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
Secondary	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
Secondary	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
Secondary	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