Back to resultsDischarge Planning in Emergency Department for Frail Older With AHF
Primary Purpose
Acute Heart Failure, Frail Elderly Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multilevel Guided Discharge Planning
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Acute Heart Failure focused on measuring Discharge Planning, Emergency Department, Heart failure, Older, Frail
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.
Sites / Locations
- Hospital Clinico San CarlosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multilevel Guided Discharge Planning
Standard of care
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
All-cause emergency revisit rate
The proportion of patients who have ED revisit for all causes within 30 days after discharge
Acute heart failure emergency revisit rate
The proportion of patients who have ED revisit for acute heart failure within 30 days after discharge
Cardiovascular emergency revisit rate
The proportion of patients who have ED revisit for cardiovascular event within 30 days after discharge
All-cause hospitalisation rate
The proportion of patients who have an hospitalisation for all causes within 30 days after discharge
Acute heart failure hospitalisation rate
The proportion of patients who have hospitalisation for acute heart failure within 30 days after discharge
Cardiovascular hospitalisation rate
The proportion of patients who have hospitalisation for cardiovascular events within 30 days after discharge
All-cause mortality rate
The proportion of patients who have all-cause mortality within 30 days after discharge
Cardiovascular mortality rate
The proportion of patients who have cardiovascular mortality within 30 days after discharge
Free-hospitalization survival
Number of days alive out of the hospital
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).
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).
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.
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'.
Full Information
NCT ID
NCT03696875
First Posted
September 28, 2018
Last Updated
July 3, 2019
Sponsor
F. Javier Martin Sanchez
1. Study Identification
Unique Protocol Identification Number
NCT03696875
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
May 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
F. Javier Martin Sanchez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure, Frail Elderly Syndrome
Keywords
Discharge Planning, Emergency Department, Heart failure, Older, Frail
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Phase 1: Matched-pair cluster randomized clinical trial. Phase 2: a quasi-experimental study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multilevel Guided Discharge Planning
Arm Type
Experimental
Arm Title
Standard of care
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Multilevel Guided Discharge Planning
Intervention Description
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
Intervention Name(s)
Standard of care
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
30-day emergency revisit or hospital admission for acute heart failure or cardiovascular mortality rate after discharge
Description
The proportion of patients who have emergency revisit or hospital admission for acute heart failure or cardiovascular mortality within 30 days after discharge
Time Frame
at 30 days post-discharge
Secondary Outcome Measure Information:
Title
All-cause emergency revisit rate
Description
The proportion of patients who have ED revisit for all causes within 30 days after discharge
Time Frame
at 30 days post-discharge
Title
Acute heart failure emergency revisit rate
Description
The proportion of patients who have ED revisit for acute heart failure within 30 days after discharge
Time Frame
at 30 days post-discharge
Title
Cardiovascular emergency revisit rate
Description
The proportion of patients who have ED revisit for cardiovascular event within 30 days after discharge
Time Frame
at 30 days post-discharge
Title
All-cause hospitalisation rate
Description
The proportion of patients who have an hospitalisation for all causes within 30 days after discharge
Time Frame
at 30 days post-discharge
Title
Acute heart failure hospitalisation rate
Description
The proportion of patients who have hospitalisation for acute heart failure within 30 days after discharge
Time Frame
at 30 days post-discharge
Title
Cardiovascular hospitalisation rate
Description
The proportion of patients who have hospitalisation for cardiovascular events within 30 days after discharge
Time Frame
at 30 days post-discharge
Title
All-cause mortality rate
Description
The proportion of patients who have all-cause mortality within 30 days after discharge
Time Frame
at 30 days post-discharge
Title
Cardiovascular mortality rate
Description
The proportion of patients who have cardiovascular mortality within 30 days after discharge
Time Frame
at 30 days post-discharge
Title
Free-hospitalization survival
Description
Number of days alive out of the hospital
Time Frame
at 30 days post-discharge
Title
Functional impairment (assessed by self-reported Barthel index)
Description
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).
Time Frame
Change from baseline to 30 days post-discharge
Title
Pharmacological adherence (assessed by Morisky Medication Adherence Scale)
Description
The four-item MGLS measures pharmacological adherence. The score ranges from 0 (perfect adherence) to 4 (some level of non-adherence).
Time Frame
Within 30 days after discharge
Title
Satisfaction of patient or caregiver about transition of care (assessed by Care Transitions Measure questionnaire)
Description
CTM questionnaire assesses the quality of care transitions, with lower scores indicating a poorer quality transition, and higher scores indicating a better transition.
Time Frame
Within 30 days after discharge
Title
Quality of live of patients (assessed by EuroQol-5D)
Description
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'.
Time Frame
Within 30 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco Javier Martín-Sánchez, MD, PhD.
Phone
+34 91.330.37.50
Email
fjjms@hotmail.com
Facility Information:
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Sanchez, MD
Phone
913303750
Email
fjjms@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Discharge Planning in Emergency Department for Frail Older With AHF
We'll reach out to this number within 24 hrs