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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05574790
Other study ID # PI18/01438
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 7, 2022
Est. completion date August 30, 2023

Study information

Verified date September 2023
Source Hospital Galdakao-Usansolo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective qualitative quantitative study was designed to create predictive models of readmission in multimorbid patients.


Description:

Social determinants have been shown to be related to the probability of readmission and death in multimorbid patients. These are increasingly older, which makes them more likely to be readmitted when their preferences are usually to be at home. Objective: To create and validate prediction models for readmission and mortality during home transitional period (1 month) and up to a year, in multimorbid patients, including variables related to the patient and their social environment. Design: Quali-quantitative. 4 hospitals from 3 regions (Andalucia, Catalonia and the Basque Country) will participate . Patients presenting at least 2 of the Ollero's categories will be included. Variables will be identified by means of nominal groups of professionals and focal groups with patients and caregivers. These variables will be included in the final models join to clinical variables, PROMS (health related quality of life, burden of the caregiver , social support). Logistic/ Cox regression models will be developed and validated internally to identify the risk of readmission and death which will be validated in an external cohort. Expected results: We hope to provide the health system with stratification tools for polypathological patients that help in identifying those patients with the greatest need for individualized interventions.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date August 30, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over 18 years of age - Patients discharged from the Internal Medicine departments of the participating centers due to acute pathology, de novo or decompensation of a chronic pathology who also present at least 2 of the cathegories of Ollero et al. Exclusion Criteria: - Patients admitted for end-of-life treatment, scheduled admissions, exacerbation of rheumatic pathology or systemic disease, study of anaemia in patients with no-known comorbidity, search for neoplasia and acute processes without associated comorbidity. - - Failure to sign the informed consent form.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
annual follow up
Collection of the following information during the year following discharge from the initial episode (initial cohort): readmissions, dates and causes of readmission, mortality

Locations

Country Name City State
Spain Hospital del Mar Barcelona
Spain Hospital Galdakao Usansolo Galdakao Bizkaia
Spain Hospital Costa del Sol Marbella Málaga
Spain Hospital Universitario Virgen del Rocío Sevilla

Sponsors (6)

Lead Sponsor Collaborator
Hospital Galdakao-Usansolo Asociacion Instituto de Investigacion en Servicios de Salud Kronikgune, Hospital Costa del Sol, Hospital del Mar, Hospitales Universitarios Virgen del Rocío, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readmission number of readmissions in the early period (transition to discharge, 1 month 1 month
Primary Readmission number of readmissions in the annual period 1 year
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