- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05574790
Identification of Multimorbid Patients With a Higher Probability of Readmission and Mortality
September 21, 2023 updated by: Susana García Gutiérrez, Hospital Galdakao-Usansolo
Identification of Multimorbid Patients With a Higher Probability of Readmission and Mortality: Role of Patient-related Variables
A prospective qualitative quantitative study was designed to create predictive models of readmission in multimorbid patients.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08003
- Hospital Del Mar
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Bizkaia
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Galdakao, Bizkaia, Spain, 48960
- Hospital Galdakao Usansolo
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Málaga
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Marbella, Málaga, Spain, 29603
- Hospital Costa del Sol
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Admitted
We will include patients who had been admitted by meeting Ollero et al categories in hospitalization ward
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Collection of the following information during the year following discharge from the initial episode (initial cohort): readmissions, dates and causes of readmission, mortality
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Readmission
Time Frame: 1 month
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number of readmissions in the early period (transition to discharge, 1 month
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1 month
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Readmission
Time Frame: 1 year
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number of readmissions in the annual period
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susana García Gutiérrez, PhD, Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
August 30, 2023
Study Registration Dates
First Submitted
October 7, 2022
First Submitted That Met QC Criteria
October 7, 2022
First Posted (Actual)
October 12, 2022
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- PI18/01438
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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