REIC: Predictive Models of Readmission in Heart Failure

• Sponsor: Hospital Galdakao-Usansolo (Other)
• Overall Status: Completed
• CT.gov ID: NCT03300791
• Collaborator: Hospital de Basurto (Other), Hospital Donostia (Other), Hospital de Mendaro (Other), Hospital Costa del Sol (Other), Corporacion Parc Tauli (Other)
• Enrollment: 1,250
• Locations: 4
• Actual Duration (Months): 39.1
• Patients Per Site: 312.5
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	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 Design

• Study Type: Observational
• Actual Enrollment: 1250 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Predictive Models of Readmission in Heart Failure: Profile of Readmitted Patients
• Actual Study Start Date: Sep 28, 2017
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Readmission [1 month]

   Up to a month after admission by heart failure

Secondary Outcome Measures

1. Readmission [12 months]

   Up to 12 months after admission by heart failure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marisa Bare	Sabadell	Barcelona	Spain	08208
2	Ainara	Bilbao	Bizkaia	Spain	48013
3	Irene Rilo	Donostia San Sebastian	Gipuzkoa	Spain	20014
4	Raul	Marbella	Málaga	Spain	29600

Sponsors and Collaborators

• Hospital Galdakao-Usansolo
• Hospital de Basurto
• Hospital Donostia
• Hospital de Mendaro
• Hospital Costa del Sol
• Corporacion Parc Tauli

Investigators

• Principal Investigator: Susana Garcia-Gutierrez, PhD, Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Susana García Gutiérrez, PhD, Hospital Galdakao-Usansolo
• ClinicalTrials.gov Identifier: NCT03300791
• Other Study ID Numbers: PI15/01343-2015111003
• First Posted: Oct 3, 2017
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Susana García Gutiérrez, PhD, Hospital Galdakao-Usansolo: heart failure; readmission; predictive models
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Sep 29, 2021