Identification of Multimorbid Patients With a Higher Prob... | NCT05574790

Studies
Identification of Multimorbid Patients With a Higher Probability of Readmission and Mortality

NCT05574790

Sponsor

Hospital Galdakao-Usansolo

Status

Completed

Last Update Posted

Sep 22, 2023Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Multimorbidity

Interventions

annual follow up

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 7, 2022Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Aug 30, 2023Actual

First Submitted Date

Oct 7, 2022

First Submission Date that Met QC Criteria

Oct 7, 2022

First Posted Date

Oct 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2023

Last Update Posted Date

Sep 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Susana García Gutiérrez, principal investigator, Hospital Galdakao-UsansoloPrincipal Investigator

Lead Sponsor

Hospital Galdakao-UsansoloOTHER_GOV

Collaborators

Name	Class
Hospital Costa del Sol	OTHER
Hospital del Mar	OTHER
Instituto de Salud Carlos III	OTHER_GOV
Hospitales Universitarios Virgen del Rocío

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Admitted		We will include patients who had been admitted by meeting Ollero et al categories in hospitalization ward	Other: annual follow up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
annual follow up	Other	Collection of the following information during the year following discharge from the initial episode (initial cohort): readmissions, dates and causes of readmission, mortality

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Readmission	number of readmissions in the early period (transition to discharge, 1 month	1 month
Readmission	number of readmissions in the annual period	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

multimorbid patients who are equivalently complex and with high risk for destabilization, difficult to manage and with mutual interrelationships.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susana García Gutiérrez, PhD	Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Galdakao Usansolo		Galdakao	Bizkaia	48960	Spain
Hospital Costa del Sol

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided