Clinical trial NCT03300791: Predictive Models of Readmission in Heart Failure
Official title: Predictive Models of Readmission in Heart Failure: Profile of Readmitted Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: heart failure
readmission
predictive models
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
Collaborators: name: Hospital de Basurto
name: Hospital Donostia
name: Hospital de Mendaro
name: Hospital Costa del Sol
name: Corporacion Parc Tauli
First posted: 2017-10-03
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted by the reason of heart failure

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Readmission
timeFrame: 1 month
Secondary outcomes:
measure: Readmission
timeFrame: 12 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Marisa Bare
state: Barcelona
city: Bilbao
country: Spain
facility: Ainara
state: Bizkaia
city: Donostia San Sebastian
country: Spain
facility: Irene Rilo
state: Gipuzkoa
city: Marbella
country: Spain
facility: Raul
state: Málaga
Study officials:
affiliation: Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza
name: Susana Garcia-Gutierrez, PhD
role: PRINCIPAL_INVESTIGATOR
References: