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

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

Interventions

OTHER

Collection of possible predictors from patient data

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)

Sponsors & Collaborators

• Hospital de Basurto

  collaborator OTHER

• Hospital Donostia

  collaborator OTHER

• Hospital Costa del Sol

  collaborator OTHER

• Hospital Universitari de Bellvitge

  collaborator OTHER

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Hospital Universitario de Canarias

  collaborator OTHER

• Hospital Santa Marina

  collaborator UNKNOWN

• Hospital de Antequera

  collaborator UNKNOWN

• Hospital Galdakao-Usansolo

  lead OTHER_GOV

Principal Investigators

• Jose M Quintana, MD, PhD · Chief of Research Unit

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2017-12-31

Completion

2018-12-31

Countries

• Spain

Study Locations