Development of Clinical Prediction Rules and Health Services Research in Patients With Heart Failure

NCT03512704 | Completed

• 3 other identifiers: PI12/016712013111071PI13/02230
• Study Type: observational
• Target: 2,218
• Locations: 1 country
• Sites: 9

Brief Summary

Objectives: Objective of this project are to create several clinical prediction rules (CPR) to stratify patients into different prognostic levels: on arrival at the emergency room, at hospital discharge, in the evolution at 90 days, and up to 1 year; for clinical parameters (mortality, complications, readmissions) and the evolution of the patient health related quality of life. Additional objectives include the analysis of equity in access, continuity of care after discharge, costs, psychosocial support received, and variability in clinical decisions and in the results obtained from inclusion in the study after the visit to the emergency room until 1 year of follow-up. Methods: Prospective observational cohort study with a one year follow-up. Multicenter and coordinated study with 9 hospital in Spain. This project will include around 1000 patients diagnosed of heart failure who come to emergency services of these hospitals, whether discharge home or admitted to the hospital. Multiple parameters (about the process of care, clinical outcomes, and quality of life), will be retrieved in the emergency room visits, admission, discharge and up to one year follow up after discharge. This project bases its work in the large number of variables to be collected and would not be viable with few centers, so centers from other communities will collaborate providing more cases. Statistical analysis using multivariate logistic regression models or Cox or general linear models or multilevel analysis will derive the CPR in a subsample of the original sample which will be validated in another different subsample.

Conditions

Heart Failure

Keywords

Heart failure; clinical prediction rules; health services research

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality during hospital admission, or after discharge from the emergency room (ER), and until one year after the ER index visit

  One year

Secondary Outcomes (2)

• Readmission

  One year

• Complications

  One year

Interventions

Collection of possible predictors from patient data OTHER

Collection of sociodemographic and clinical parameters, from medical records, and health related quality of life data, that may predict the outcomes of interest (mortality, complications, readmissions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known chronic heart failure (or de novo in the emergency department visit) attended in the emergency services of the participating hospitals prospectively diagnosed with acute or decompensated heart failure and recruited during the first year of the study, including patients admitted or given discharge in the hospital emergency. The first admission of each patient during the recruitment period will be taken as a reference, and after this episode the follow-up will be carried out during a whole year, collecting all the events that happen related to their illness.

You may qualify if:

• Patients with a diagnosis of heart failure (code ICD-9-CM: 428.x, some of the 402.x) who come to hospital emergencies according to the definition, signs and symptoms used to diagnose the disease according to the clinical practice guide of the European Society of Cardiology (ESC) for the diagnosis and treatment of acute and chronic heart failure, such as, among others, lack of air or fatigue at rest or during exercise; signs of fluid retention, such as pulmonary congestion or swelling of the ankles, and objective evidence of a structural or functional cardiac disturbance at rest .
• Patients over 18 years of age and belonging to the hospital's coverage area.
• Patients who agree to participate and sign the informed consent.

You may not qualify if:

• Patients who develop episode of HF during admission, if they have been admitted for another cause.
• Patients transferred from other health centers, since study variables may be missing.
• Cerebrovascular accident in the 4 weeks before admission.
• Patients who do not wish to participate.
• Terminal status that prevents them from participating in completing the questionnaires.
• Impossibility to complete the questionnaires or with external help (reviewer, family, social) due to neurosensory, dementia or ignorance of the language.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead
• Hospital de Basurto: collaborator
• Hospital Donostia: collaborator
• Hospital Costa del Sol: collaborator
• Hospital Universitari de Bellvitge: collaborator
• Parc Taulí Hospital Universitari: collaborator
• Hospital Universitario de Canarias: collaborator
• Hospital Santa Marina: collaborator
• Hospital de Antequera: collaborator

Study Sites (9)

Hospital Comarcal de Antequera

Antequera, Spain

Location

Hospital Santa Marina

Bilbao, Spain

Location

Hospital U Basurto

Bilbao, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

Location

Hospital Galdakao-Usansolo

Galdakao, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Spain

Location

Hospital Costa del Sol

Marbella, Spain

Location

Hospital Universitari Parc Taulí

Sabadell, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jose M Quintana, MD, PhD

  Chief of Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Research Unit

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 1, 2018
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

ES (9)