Clinical trial NCT03696875: Discharge Planning in Emergency Department for Frail Older With AHF
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Heart Failure
Frail Elderly Syndrome
Keywords: Discharge Planning
Emergency Department
Heart failure
Older
Frail
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 1260
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1: Matched-pair cluster randomized clinical trial. Phase 2: a quasi-experimental study.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge
timeFrame: at 30 days post-discharge
Secondary outcomes:
measure: All-cause emergency revisit rate
timeFrame: at 30 days post-discharge
measure: Acute heart failure emergency revisit rate
timeFrame: at 30 days post-discharge
measure: Cardiovascular emergency revisit rate
timeFrame: at 30 days post-discharge
measure: All-cause hospitalisation rate
timeFrame: at 30 days post-discharge
measure: Acute heart failure hospitalisation rate
timeFrame: at 30 days post-discharge
measure: Cardiovascular hospitalisation rate
timeFrame: at 30 days post-discharge
measure: All-cause mortality rate
timeFrame: at 30 days post-discharge
measure: Cardiovascular mortality rate
timeFrame: at 30 days post-discharge
measure: Free-hospitalization survival
timeFrame: at 30 days post-discharge
measure: Functional impairment (assessed by self-reported Barthel index)
timeFrame: Change from baseline to 30 days post-discharge
measure: Pharmacological adherence (assessed by Morisky Medication Adherence Scale)
timeFrame: Within 30 days after discharge
measure: Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire)
timeFrame: Within 30 days after discharge
measure: Quality of live of patients (assessed by EuroQol-5D)
timeFrame: Within 30 days after discharge
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References: