Discharge Planning in Emergency Department for Frail Older With AHF
- Conditions
- Acute Heart FailureFrail Elderly Syndrome
- Interventions
- Other: Multilevel Guided Discharge PlanningOther: Standard of care
- Registration Number
- NCT03696875
- Lead Sponsor
- F. Javier Martin Sanchez
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1260
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multilevel Guided Discharge Planning Multilevel Guided Discharge Planning - Standard of care Standard of care -
- Primary Outcome Measures
Name Time Method 30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge 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 Outcome Measures
Name Time Method Acute heart failure hospitalisation rate at 30 days post-discharge The proportion of patients who have hospitalisation for acute heart failure within 30 days after discharge
All-cause mortality rate at 30 days post-discharge The proportion of patients who have all-cause mortality within 30 days after discharge
Functional impairment (assessed by self-reported Barthel index) Change from baseline to 30 days post-discharge 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).
Cardiovascular mortality rate at 30 days post-discharge The proportion of patients who have cardiovascular mortality within 30 days after discharge
Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire) Within 30 days after discharge CTM questionnaire assesses the quality of care transitions, with lower scores indicating a poorer quality transition, and higher scores indicating a better transition.
Quality of live of patients (assessed by EuroQol-5D) Within 30 days after discharge 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'.
All-cause emergency revisit rate at 30 days post-discharge The proportion of patients who have ED revisit for all causes within 30 days after discharge
Cardiovascular hospitalisation rate at 30 days post-discharge The proportion of patients who have hospitalisation for cardiovascular events within 30 days after discharge
Free-hospitalization survival at 30 days post-discharge Number of days alive out of the hospital
Acute heart failure emergency revisit rate at 30 days post-discharge The proportion of patients who have ED revisit for acute heart failure within 30 days after discharge
Cardiovascular emergency revisit rate at 30 days post-discharge The proportion of patients who have ED revisit for cardiovascular event within 30 days after discharge
All-cause hospitalisation rate at 30 days post-discharge The proportion of patients who have an hospitalisation for all causes within 30 days after discharge
Pharmacological adherence (assessed by Morisky Medication Adherence Scale) Within 30 days after discharge The four-item MGLS measures pharmacological adherence. The score ranges from 0 (perfect adherence) to 4 (some level of non-adherence).
Trial Locations
- Locations (1)
Hospital Clinico San Carlos
🇪🇸Madrid, Spain