Clinical trial NCT05574790: Identification of Multimorbid Patients With a Higher Probability of Readmission and Mortality
Official title: Identification of Multimorbid Patients With a Higher Probability of Readmission and Mortality: Role of Patient-related Variables
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multimorbidity
Keywords: multimorbid Patients
Readmission
Mortality
Predictive
Lead sponsor: Hospital Galdakao-Usansolo
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Costa del Sol
name: Hospital del Mar
name: Instituto de Salud Carlos III
name: Hospitales Universitarios Virgen del Rocío
name: Asociacion Instituto de Investigacion en Servicios de Salud Kronikgune
First posted: 2022-10-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multimorbid patients who are equivalently complex and with high risk for destabilization, difficult to manage and with mutual interrelationships.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Readmission
timeFrame: 1 month
measure: Readmission
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Galdakao
country: Spain
facility: Hospital Galdakao Usansolo
state: Bizkaia
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza
name: Susana García Gutiérrez, PhD
role: PRINCIPAL_INVESTIGATOR
References: