Discharge Planning in Emergency Department for Frail Older With AHF

Sponsor:

Collaborators:

Information provided by (Responsible Party):

F. Javier Martin Sanchez，Hospital San Carlos, Madrid

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

January 15, 2019

Estimated Primary Completion Date

December 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge[ Time Frame: 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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

All-cause emergency revisit rate[ Time Frame: at 30 days post-discharge ]
The proportion of patients who have ED revisit for all causes within 30 days after discharge
Acute heart failure emergency revisit rate[ Time Frame: 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[ Time Frame: 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[ Time Frame: at 30 days post-discharge ]
The proportion of patients who have an hospitalisation for all causes within 30 days after discharge
Acute heart failure hospitalisation rate[ Time Frame: at 30 days post-discharge ]
The proportion of patients who have hospitalisation for acute heart failure within 30 days after discharge
Cardiovascular hospitalisation rate[ Time Frame: at 30 days post-discharge ]
The proportion of patients who have hospitalisation for cardiovascular events within 30 days after discharge
All-cause mortality rate[ Time Frame: at 30 days post-discharge ]
The proportion of patients who have all-cause mortality within 30 days after discharge
Cardiovascular mortality rate[ Time Frame: at 30 days post-discharge ]
The proportion of patients who have cardiovascular mortality within 30 days after discharge
Free-hospitalization survival[ Time Frame: at 30 days post-discharge ]
Number of days alive out of the hospital
Functional impairment (assessed by self-reported Barthel index)[ Time Frame: 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).
Pharmacological adherence (assessed by Morisky Medication Adherence Scale)[ Time Frame: 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).
Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire)[ Time Frame: 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)[ Time Frame: 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'.

Descriptive Information

Brief Title ^ICMJE

Discharge Planning in Emergency Department for Frail Older With AHF

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 1: Matched-pair cluster randomized clinical trial. Phase 2: a quasi-experimental study.
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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
Other: Standard of care
Standard of care

Study Arms

Experimental: Multilevel Guided Discharge Planning
Active Comparator: Standard of care

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1260

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 15, 2022

Estimated Primary Completion Date

December 15, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

70 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

F. Javier Martin Sanchez，Hospital San Carlos, Madrid

Study Sponsor ^ICMJE

F. Javier Martin Sanchez

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Hospital San Carlos, Madrid

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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