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Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes (MEESSI)

Primary Purpose

Acute Heart Failure, Emergencies

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Risk stratification before decision-making about patient hospitalization or discharge
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of AHF based on Framinham criteria NT-proBNP >300 pg/mL Patient able to consent Exclusion Criteria: ST-elevation acute coronary syndrome

Sites / Locations

  • Emergency department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

INTERVENTION

USUAL CARE

Arm Description

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.

Once AHF has been diagnosed at ED, emergency physicians will decide patient disposition according to their usual strategies of care, that currently do not include risk stratification. 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.

Outcomes

Primary Outcome Measures

30-day all cause death
Death for any cause since patient randomization (day 0) to day 30
Days alive and out of hospital
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

Composite endpoint withing 30 days after discharge (ED revisit due to AHF, hospitalization due to AHF or all-cause death)
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
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.
Hospitalization due to AHF within the 30 days after discharge
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.
All-cause death within the 30 days after discharge
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.
Proportion of patients with AHF managed without hospitalization.
We will calcultate the percentage of patients with AHF that are entirely managed in the ED and sent home, without hospitalization

Full Information

First Posted
May 25, 2023
Last Updated
June 22, 2023
Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT05919225
Brief Title
Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes
Acronym
MEESSI
Official Title
Evaluation of the Impact of the MEESSI-AHF Scale on Decision Making and the Prognosis of Patients Diagnosed With Acute Heart Failure in the Emergency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure, Emergencies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-lable, multicentre, randomized, low-intervention, non-pharmacological, clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INTERVENTION
Arm Type
Experimental
Arm Description
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.
Arm Title
USUAL CARE
Arm Type
No Intervention
Arm Description
Once AHF has been diagnosed at ED, emergency physicians will decide patient disposition according to their usual strategies of care, that currently do not include risk stratification. 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.
Intervention Type
Procedure
Intervention Name(s)
Risk stratification before decision-making about patient hospitalization or discharge
Intervention Description
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.
Primary Outcome Measure Information:
Title
30-day all cause death
Description
Death for any cause since patient randomization (day 0) to day 30
Time Frame
Through study completion, an avarage of 1 year
Title
Days alive and out of hospital
Description
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.
Time Frame
Through study completion, an avarage of 1 year
Secondary Outcome Measure Information:
Title
Composite endpoint withing 30 days after discharge (ED revisit due to AHF, hospitalization due to AHF or all-cause death)
Description
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.
Time Frame
Through study completion, an avarage of 1 year
Title
ED revisit due to AHF within the 30 days after discharge
Description
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.
Time Frame
Through study completion, an avarage of 1 year
Title
Hospitalization due to AHF within the 30 days after discharge
Description
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.
Time Frame
Through study completion, an avarage of 1 year
Title
All-cause death within the 30 days after discharge
Description
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.
Time Frame
Through study completion, an avarage of 1 year
Title
Proportion of patients with AHF managed without hospitalization.
Description
We will calcultate the percentage of patients with AHF that are entirely managed in the ED and sent home, without hospitalization
Time Frame
Through study completion, an avarage of 1 year
Other Pre-specified Outcome Measures:
Title
Analysis of causes of overruling
Description
Causes of overruling will be analyzed
Time Frame
Through study completion, an avarage of 1 year
Title
Sensitivity analysis per protocol
Description
All previous analyses will be made just using patients of the intervention arm that were managed according to recommendation provided after risk stratification with MEESSI scale (i.e., disregarding patients for whom recommendation was overruled by the emergency physician)
Time Frame
Through study completion, an avarage of 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of AHF based on Framinham criteria NT-proBNP >300 pg/mL Patient able to consent Exclusion Criteria: ST-elevation acute coronary syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar Miro, PhD
Phone
(+34)638274489
Email
omiro@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Miro, PhD
Organizational Affiliation
Hospital CLinic, Barcelona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency department
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Miro, PhD
Phone
+34638274489
Email
omiro@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28973663
Citation
Miro O, Rossello X, Gil V, Martin-Sanchez FJ, Llorens P, Herrero-Puente P, Jacob J, Bueno H, Pocock SJ; ICA-SEMES Research Group. Predicting 30-Day Mortality for Patients With Acute Heart Failure in the Emergency Department: A Cohort Study. Ann Intern Med. 2017 Nov 21;167(10):698-705. doi: 10.7326/M16-2726. Epub 2017 Oct 3.
Results Reference
result
PubMed Identifier
29903688
Citation
Miro O, Rossello X, Gil V, Martin-Sanchez FJ, Llorens P, Herrero P, Jacob J, Lopez-Grima ML, Gil C, Lucas Imbernon FJ, Garrido JM, Perez-Dura MJ, Lopez-Diez MP, Richard F, Bueno H, Pocock SJ. The Usefulness of the MEESSI Score for Risk Stratification of Patients With Acute Heart Failure at the Emergency Department. Rev Esp Cardiol (Engl Ed). 2019 Mar;72(3):198-207. doi: 10.1016/j.rec.2018.05.002. Epub 2018 Jun 11. English, Spanish.
Results Reference
result
PubMed Identifier
30656867
Citation
Miro O, Gil V, Rossello X, Martin-Sanchez FJ, Llorens P, Jacob J, Herrero P, Herrera Mateo S, Richard F, Escoda R, Fuentes M, Martin Mojarro E, Llauger L, Bueno H, Pocock S. Patients with acute heart failure discharged from the emergency department and classified as low risk by the MEESSI score (multiple risk estimate based on the Spanish emergency department scale): prevalence of adverse events and predictability. Emergencias. 2019 Feb;31(1):5-14. English, Spanish.
Results Reference
result
PubMed Identifier
30690646
Citation
Wussler D, Kozhuharov N, Sabti Z, Walter J, Strebel I, Scholl L, Miro O, Rossello X, Martin-Sanchez FJ, Pocock SJ, Nowak A, Badertscher P, Twerenbold R, Wildi K, Puelacher C, du Fay de Lavallaz J, Shrestha S, Strauch O, Flores D, Nestelberger T, Boeddinghaus J, Schumacher C, Goudev A, Pfister O, Breidthardt T, Mueller C. External Validation of the MEESSI Acute Heart Failure Risk Score: A Cohort Study. Ann Intern Med. 2019 Feb 19;170(4):248-256. doi: 10.7326/M18-1967. Epub 2019 Jan 29.
Results Reference
result
PubMed Identifier
31147102
Citation
Miro O, Rossello X, Gil V, Martin-Sanchez FJ, Llorens P, Herrero-Puente P, Jacob J, Pinera P, Mojarro EM, Lucas-Imbernon FJ, Llauger L, Aguera C, Lopez-Diez MP, Valero A, Bueno H, Pocock SJ; ICA-SEMES Research Group. Analysis of How Emergency Physicians' Decisions to Hospitalize or Discharge Patients With Acute Heart Failure Match the Clinical Risk Categories of the MEESSI-AHF Scale. Ann Emerg Med. 2019 Aug;74(2):204-215. doi: 10.1016/j.annemergmed.2019.03.010. Epub 2019 May 27.
Results Reference
result
PubMed Identifier
33609116
Citation
Rossello X, Bueno H, Gil V, Jacob J, Javier Martin-Sanchez F, Llorens P, Herrero Puente P, Alquezar-Arbe A, Raposeiras-Roubin S, Lopez-Diez MP, Pocock S, Miro O. MEESSI-AHF risk score performance to predict multiple post-index event and post-discharge short-term outcomes. Eur Heart J Acute Cardiovasc Care. 2021 Apr 8;10(2):142-152. doi: 10.1177/2048872620934318.
Results Reference
result

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Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes

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