MultimorbidityNCT05574790
Identification of Multimorbid Patients With a Higher Probability of Readmission and Mortality
An observational study of Multimorbidity, run by Hospital Galdakao-Usansolo at 4 sites in Spain.
Trial summary
A prospective qualitative quantitative study was designed to create predictive models of readmission in multimorbid patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- annual follow up
- How many people
- 500 participants
- Where
- 4 sitesSpain
- Study dates
- 7 Feb 2022to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: multimorbid patients who are equivalently complex and with high risk for destabilization, difficult to manage and with mutual interrelationships.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital del Mar
Barcelona, 08003
Hospital Galdakao Usansolo
Galdakao, Bizkaia, 48960
Hospital Costa del Sol
Marbella, Málaga, 29603
Hospital Universitario Virgen del Rocío
Seville, 41013
About this study
Official title: 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.
Read the 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.
- Conditions
- Multimorbidity
- Being tested
- annual follow up
- Keywords
- multimorbid Patients, Readmission, Mortality, Predictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
annual follow upOther
Collection of the following information during the year following discharge from the initial episode (initial cohort): readmissions, dates and causes of readmission, mortality
| Study group | Role | What they receive |
|---|---|---|
| Admitted | We will include patients who had been admitted by meeting Ollero et al categories in hospitalization ward Receives: Other: annual follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
number of readmissions in the early period (transition to discharge, 1 month
Measured: 1 month
Readmission
number of readmissions in the annual period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start7 Feb 2022
- Primary completion30 Jun 2022
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Galdakao-Usansolo
- Sponsor type
- Other government
- Collaborators
- Hospital Costa del Sol, Hospital del Mar, Instituto de Salud Carlos III, Hospitales Universitarios Virgen del Rocío, Asociacion Instituto de Investigacion en Servicios de Salud Kronikgune
- Responsible party
- Principal investigator, Susana García Gutiérrez, Hospital Galdakao-Usansolo
- Investigators
- Susana García Gutiérrez, PhD, Principal investigator, Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574790
- Sponsor's protocol ID
- PI18/01438
- Status last verified
- Sep 2023
- First submitted
- 7 Oct 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Multimorbid Patients With a Higher Probability of Readmission and Mortality: Role of Patient-related Variables
- ClinicalTrials.gov ID
- NCT05574790
- Acronym / sponsor ID
- PI18/01438
- Conditions
- Multimorbidity
- Keywords
- multimorbid Patients, Readmission, Mortality, Predictive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hospital Galdakao-UsansoloOther government
- Collaborators
- Hospital Costa del Sol, Hospital del Mar, Instituto de Salud Carlos III, Hospitales Universitarios Virgen del Rocío, Asociacion Instituto de Investigacion en Servicios de Salud Kronikgune
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Admitted | – | Other: annual follow upWe will include patients who had been admitted by meeting Ollero et al categories in hospitalization ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- multimorbid patients who are equivalently complex and with high risk for destabilization, difficult to manage and with mutual interrelationships.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| annual follow upCollection of the following information during the year following discharge from the initial episode (initial cohort): readmissions, dates and causes of readmission, mortality | Other | Admitted |
Primary outcome
Readmission
Time frame: 1 month
number of readmissions in the early period (transition to discharge, 1 month
Readmission
Time frame: 1 year
number of readmissions in the annual period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana García Gutiérrez, PhD principal investigator
Unidad de Investigación. Hospital Galdakao-Usansolo. Osakidetza
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimorbidity, run by Hospital Galdakao-Usansolo at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.