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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multilevel Guided Discharge Planning | Experimental |
| |
| Standard of care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multilevel Guided Discharge Planning | Other | Clinical recommendations and resources activations + scheduling of early visit with the specialist + communication with primary care + written instruction sheet to the patient |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 30 days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause emergency revisit rate | The proportion of patients who have ED revisit for all causes within 30 days after discharge | at 30 days post-discharge |
| Acute heart failure emergency revisit rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Javier MartÃn-Sánchez, MD, PhD. | Contact | +34 91.330.37.50 | fjjms@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Phase 1: Matched-pair cluster randomized clinical trial. Phase 2: a quasi-experimental study.
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| Standard of care | Other | Standard of care |
|
The proportion of patients who have ED revisit for acute heart failure within 30 days after discharge
| at 30 days post-discharge |
| Cardiovascular emergency revisit rate | The proportion of patients who have ED revisit for cardiovascular event within 30 days after discharge | at 30 days post-discharge |
| All-cause hospitalisation rate | The proportion of patients who have an hospitalisation for all causes within 30 days after discharge | at 30 days post-discharge |
| Acute heart failure hospitalisation rate | The proportion of patients who have hospitalisation for acute heart failure within 30 days after discharge | at 30 days post-discharge |
| Cardiovascular hospitalisation rate | The proportion of patients who have hospitalisation for cardiovascular events within 30 days after discharge | at 30 days post-discharge |
| All-cause mortality rate | The proportion of patients who have all-cause mortality within 30 days after discharge | at 30 days post-discharge |
| Cardiovascular mortality rate | The proportion of patients who have cardiovascular mortality within 30 days after discharge | at 30 days post-discharge |
| Free-hospitalization survival | Number of days alive out of the hospital | at 30 days post-discharge |
| 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). | Change from baseline to 30 days post-discharge |
| 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). | Within 30 days after discharge |
| 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. | Within 30 days after discharge |
| 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'. | Within 30 days after discharge |
| D002318 | Cardiovascular Diseases |