Discharge Planning in Emergency Department for Frail Older With AHF

NCT ID: NCT03696875

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-20
• Study Completion Date: 2022-05-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multilevel Guided Discharge Planning

Group Type: EXPERIMENTAL

Multilevel Guided Discharge Planning

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

Standard of care

Interventions

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

Intervention Type: OTHER

Standard of care

Standard of care

Intervention Type: OTHER

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.
• 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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

F. Javier Martin Sanchez

OTHER

Sponsor Role: lead

Responsible Party

F. Javier Martin Sanchez

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Clinico San Carlos

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Francisco Javier Martín-Sánchez, MD, PhD.

Role: CONTACT

fjjms@hotmail.com

+34 91.330.37.50

Facility Contacts

Martin Sanchez, MD

Role: primary

fjjms@hotmail.com

913303750

Other Identifiers

DEED FRAIL-AHF

Identifier Type: -

Identifier Source: org_study_id