Predictive Models of Readmission in Heart Failure

Heart Failure Clinical Trial

— REIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300791
• Other study ID #: PI15/01343-2015111003
• Status: Completed
• Start date: September 28, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2021
• Source: Hospital Galdakao-Usansolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: December 31, 2020
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Spain	Ainara	Bilbao	Bizkaia
Spain	Irene Rilo	Donostia San Sebastian	Gipuzkoa
Spain	Raul	Marbella	Málaga
Spain	Marisa Bare	Sabadell	Barcelona

Sponsors (6)

Lead Sponsor	Collaborator
Hospital Galdakao-Usansolo	Corporacion Parc Tauli, Hospital Costa del Sol, Hospital de Basurto, Hospital de Mendaro, Hospital Donostia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission	Up to a month after admission by heart failure	1 month
Secondary	Readmission	Up to 12 months after admission by heart failure	12 months