Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes
- Conditions
- Acute Heart FailureEmergencies
- Interventions
- Procedure: Risk stratification before decision-making about patient hospitalization or discharge
- Registration Number
- NCT05919225
- Lead Sponsor
- Hospital Clinic of Barcelona
- Brief Summary
Evaluate the impact the application of the MESSI-AHF scale (a risk stratification scale specifically derived and validated in patients diagnosed with acute heart failure, AHF) in decision making (admission vs. discharge) by emergency physicians in emergency departments (ED) and its potential impact on on the short-term prognosis of patients with AHF.
- Detailed Description
Study 1: A non-intervention study involving the consecutive inclusion of 3,200 patients with AHF in 16 Spanish EDs managed according to the usual practice. Individual risk will be retrospectively stratified according to the MEESSI-AHF scale, and we will analyze the distribution of the categories of risk in patients admitted and discharged and the prognosis of patients with low risk discharged from the ED and compare the events observed in this subgroup of patients with the recommended international standards. Study 2: This is a cuasiexperimental study in 8 EDs with consecutive inclusion of 1,600 patients with AHF managed according to the usual practice (without stratification of risk, pre-phase) and 1,600 patients managed after the implementation of the MEESSI-AHF scales for risk stratification before the final decision making in the ED (post-phase). If the patient has low risk the calculator will propose discharge; for the remaining categories of risk the calculator will propose patient admission. The final decision corresponds to the attending physician and if this decision differs from what was proposed, a reason will be given. Study 3: Open multicentre (8 EDs) randomized clinical trial (1:1) comparing the results obtained in the patients randomized to usual clinical practice (1,600 patients) with those obtained in the patients randomized to the use of the MEESSI-AHF scale for risk stratification (1,600 patients) prior to decision making. The dynamics of the decision proposed by the scale will be the same as that in Study 2. Main outcomes (Studies 1, 2, 3): Death (by any cause and cardiovascular cause) at 30 days and at 1 year; combined event (revisit to the ED or hospitalization for AHF or death) at 30 days post-discharge (global analysis of all the patients with AHF stratified by categories of risk); days alive and outside the hospital at 30 days after the index event (consultation to the ED); and proportion of patients managed without hospitalization.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3200
- Clinical diagnosis of AHF based on Framinham criteria
- NT-proBNP >300 pg/mL
- Patient able to consent
- ST-elevation acute coronary syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INTERVENTION Risk stratification before decision-making about patient hospitalization or discharge Once AHF has been diagnosed at ED, and before decision-making about hospitalize/discharge home is taken, physicians will objectively measure the severity of decompensation, based on risk of 30-day death using MEESSI scale. As result, patient can be allocated to low, intermediate, high or very-high risk. For patients classified as low-risk, the propocol recommendation will be discharge patient to home. For patients classified as increased risk (i.e., intermediate, high or very-high risk categories), the protocol recommendation will be to hospitalize patient. Nonetheless, final decission will be left to emergency physician, and overruling (disposition against recommendation) will be allowed. For discharged patients, there is no follow up intervention planned, and it will be based on current centre protocols.For hospitalized patients, department of admission will be based on current centre protocols, with no intervention at this level.
- Primary Outcome Measures
Name Time Method 30-day all cause death Through study completion, an avarage of 1 year Death for any cause since patient randomization (day 0) to day 30
Days alive and out of hospital Through study completion, an avarage of 1 year Number of days with patient staying out of hospital (it can be at home, et residencial nursing house, etc., but not at hospital) from randomization (day 0) to day 30.
- Secondary Outcome Measures
Name Time Method Composite endpoint withing 30 days after discharge (ED revisit due to AHF, hospitalization due to AHF or all-cause death) Through study completion, an avarage of 1 year Event will be considered if patient present ED revisit due to AHF, hospitalization due to AHF or all-cause death from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.
ED revisit due to AHF within the 30 days after discharge Through study completion, an avarage of 1 year Event will be considered if patient present ED revisit due to AHF from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.
All-cause death within the 30 days after discharge Through study completion, an avarage of 1 year Event will be considered if patient dies from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.
Hospitalization due to AHF within the 30 days after discharge Through study completion, an avarage of 1 year Event will be considered if patient is hospitalized due to AHF from the time of discharge (from ED or after hospitalization, day 0) to day 30. Accordingly, patients dying during index event (in-hospital mortality) did not account for this outcome.
Proportion of patients with AHF managed without hospitalization. Through study completion, an avarage of 1 year We will calcultate the percentage of patients with AHF that are entirely managed in the ED and sent home, without hospitalization
Trial Locations
- Locations (19)
Emergency Department, Hospital Sant Pau i Santa Tecla
🇪🇸Tarragona, Spain
Emergency Department, Hospital Dr. Peset
🇪🇸Valencia, Spain
Emergency Department, Hospital La Fe
🇪🇸Valencia, Spain
Emergency Department, Hospital Infanta Leonor
🇪🇸Madrid, Spain
Emergency Department, Hospital Marques de Valdecilla
🇪🇸Santander, Spain
Emergency Department, Hospital de Salamanca
🇪🇸Salamanca, Spain
Emergency Department, Hospital de Móstoles
🇪🇸Móstoles, Madrid, Spain
Emergency department
🇪🇸Barcelona, Catalonia, Spain
Emergency Department, Hospital de Getafe
🇪🇸Getafe, Madrid, Spain
Emergency Department, Hospital de Albacete
🇪🇸Albacete, Spain
Emergency Department, Hospital Dr. Balmis
🇪🇸Alicante, Spain
Emergency Department, Hospital de Sant Pau
🇪🇸Barcelona, Spain
Emergency Department, Hospital del Mar
🇪🇸Barcelona, Spain
Emergency Department, Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Emergency Department, Hospital Dr. Gregorio Marañón
🇪🇸Madrid, Spain
Emergency Department, Hospital La Mancha
🇪🇸Ciudad Real, Spain
Emergency Department, Hospital de Gandia
🇪🇸Gandia, Valencia, Spain
Emergency Department, Hospital de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain