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Discharge Planning in Emergency Department for Frail Older With AHF

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ClinicalTrials.gov Identifier: NCT03696875
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
F. Javier Martin Sanchez, Hospital San Carlos, Madrid

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.


Condition or disease Intervention/treatment Phase
Acute Heart Failure Frail Elderly Syndrome Other: Multilevel Guided Discharge Planning Other: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 1: Matched-pair cluster randomized clinical trial. Phase 2: a quasi-experimental study.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : May 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Multilevel Guided Discharge Planning 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

Active Comparator: Standard of care Other: Standard of care
Standard of care




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Cardiovascular mortality rate [ Time Frame: at 30 days post-discharge ]
    The proportion of patients who have cardiovascular mortality within 30 days after discharge

  9. Free-hospitalization survival [ Time Frame: at 30 days post-discharge ]
    Number of days alive out of the hospital

  10. 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).

  11. 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).

  12. 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.

  13. 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'.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696875


Contacts
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Contact: Francisco Javier Martín-Sánchez, MD, PhD. +34 91.330.37.50 fjjms@hotmail.com

Locations
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Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Martin Sanchez, MD    913303750    fjjms@hotmail.com   
Sponsors and Collaborators
F. Javier Martin Sanchez
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Responsible Party: F. Javier Martin Sanchez, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03696875    
Other Study ID Numbers: DEED FRAIL-AHF
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by F. Javier Martin Sanchez, Hospital San Carlos, Madrid:
Discharge Planning
Emergency Department
Heart failure
Older
Frail
Additional relevant MeSH terms:
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Heart Failure
Emergencies
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes