Predictive Models of Readmission in Heart Failure (REIC)

Predictive Models of Readmission in Heart Failure: Profile of Readmitted Patients

This is a prospective nested case-control study.

Our goals are to create predictive models to readmissions for heart failure and also to define profiles for patients who are readmitted during the first month after the index episode.

Patients who will be admitted in five hospitals in spain by the reason of a heart failure will be recruited during 18 months. Those who will be readmitted in a hospital up to a month after the index episode will be considered cases. Controls will be selected from the initial cohort of hospitalized patients.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Admitted

Detailed Description

Objective: To create models for predicting the risk of readmission short term (30-90 days) and medium term (one year).To identify differences between patients readmitted and not readmitted, and profiles of frequently preventable readmissions in our setting.

Methodology: Observational prospective cohort of patients who are discharged with a diagnosis of heart failure in 5 participating centers. further, a nested case-control will be developed in the previous cohort, being cases those readmitted and controls will be chosen according to age, sex, etiology of heart failure, comorbidities and functional status. Sociodemographic, clinical and health related quality of life, empowerment and baseline self-efficacy as predictors of readmission were collected.

Regarding the cases and controls, the quality of life in post-discharge transitional period, empowerment and self-efficacy, caregiver burden, social support, discharge care model, use of health services and adequation, conciliation and adherence to treatment will be assessed . Cox proportional hazards models will be created, and conditional logistic regression models to identify differences between cases and controls.

Expected Results: National Health System will be provided with tools for predicting the risk of readmission useful to clinicians and managers to offer discharge individualized care. The most common characteristics of readmissions and preventable readmissions will be identified, which will be helpful to create specific actions in the future.

• Study Type: Observational
• Enrollment (Actual): 1250

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Marisa Bare
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48013
      • Ainara
  • Gipuzkoa
    • Donostia San Sebastian, Gipuzkoa, Spain, 20014
      • Irene Rilo
  • Málaga
    • Marbella, Málaga, Spain, 29600
      • Raul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted by the reason of heart failure

Description

Inclusion Criteria:

• Patients admitted by acute heart failure (de novo and acute decompensated) (International Classification of Diseases, Ninth Revision, Clinical Modification: 428.x; some of the 402.x group), older tan 18 who will accept to participate.

Exclusion Criteria:

• patients who develop HF episodes during admission, if have been admitted for another reason,
• patients transferred from other health centers,
• myocardial infarction or stroke in the 4 weeks prior to admission,
• life expectancy less than one year, for HF at the terminal or cause different from the CI according to the assessment of the study subjects,
• inability to complete the questionnaires or with assistance external (reviewer, family, social) because of sensorineural reason, dementia or ignorance of the language.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Admitted; We will include patients who had beeb admitted by an acute heart failure in hospitalization ward	Other: Admitted; Readmitted patients in the next months after an episode of aute heart failure will be recruited. Controls will be selected between those who were admitted in the baseline but not readmitted in this month.; Other Names: Not readmitted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission	Up to a month after admission by heart failure	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission	Up to 12 months after admission by heart failure	12 months

Collaborators and Investigators

• Sponsor: Hospital Galdakao-Usansolo
• Collaborators: Hospital Donostia; Hospital de Basurto; Corporacion Parc Tauli; Hospital de Mendaro; Hospital Costa del Sol
• Investigators: Principal Investigator: Susana Garcia-Gutierrez, PhD, Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: heart failure; readmission; predictive models
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PI15/01343-2015111003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No