Clinical Decision SupportNCT06675084
Mortality and Rehospitalization Risk Assessment by Skilled Caregivers Compared to Existing Tools in Acute Geriatric Departments
An observational study of Clinical Decision Support, run by Shmuel Harofeh Hospital, Geriatric Medical Center.
Trial summary
Mortality and Rehospitalization Risk Assessment by Skilled Caregivers Compared to Existing Tools in Acute Geriatric Departments Background The elderly population in Israel and worldwide is steadily increasing, leading to greater demand for medical services, including palliative care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Clinical Decision Support
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to 1 May 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 65 years old admitted to acute geriatric departments at Shmuel Harofe Hospital for acute conditions.
Inclusion Criteria: Patients admitted to acute geriatric departments at Shmuel Harofe Hospital for acute conditions.
-
Exclusion Criteria: 1. Admission for social reasons. 2. Patients under palliative end of life care.
-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Mortality and Rehospitalization Risk Assessment by Skilled Caregivers Compared to Existing Tools in Acute Geriatric Departments
Background The elderly population in Israel and worldwide is steadily increasing, leading to greater demand for medical services, including palliative care. In 2019, individuals aged 65+ accounted for 64% of hospital admissions and 70% of hospital days in Israel. Approximately 19% of these were readmissions, a rate that increases with age. Effective tools for identifying patients at high risk of rehospitalization and mortality are lacking, which, if improved, could benefit patients through targeted palliative and end-of-life care. Enhanced tools could reduce unnecessary interventions, improve patient well-being, and alleviate economic burdens on healthcare.
Read more
Research Objectives
- Evaluate mortality and rehospitalization rates in acute geriatric departments.
- Identify risk factors for rehospitalization and mortality in acutely hospitalized elderly patients.
- Compare the effectiveness of skilled caregiver assessments versus validated prediction tools for mortality and rehospitalization within one year.
Hypotheses
- Mortality and rehospitalization rates in acute geriatric departments are comparable to those in internal medicine.
- Multiple factors-such as age, family support, comorbidities, functional and cognitive status-correlate with mortality risk.
- Skilled caregiver assessments predict mortality and rehospitalization more accurately than existing validated tools.
Study Design Type: Prospective cohort observational study. Location: Shmuel Harofe Hospital.
Study Population Participants are elderly patients admitted to acute geriatric departments at Shmuel Harofe Hospital for acute conditions. Approximately 600 participants will be recruited, with an additional 200-300 if statistical analysis reveals trends.
Recruitment Period: Two years. Follow-up Period: Up to one year post-admission.
Methods and Materials
Data will be collected on demographic, functional, cognitive, and emotional factors, as well as clinical history, hospital admissions, comorbidities, and lab results. Predictive assessments will include:
- Mortality Prediction using the WALTER Index for the elderly.
- Rehospitalization Risk using the LACE Index, validated for 30-day readmission risk.
- Subjective Caregiver Assessments from geriatric specialists and nursing supervisors, estimating life expectancy and 30-day, 3-month, and 1-year rehospitalization risk.
Data Analysis Data will be coded and statistically analyzed without interventions outside of standard care. The WALTER and LACE indices will utilize existing clinical data.
Ethical Considerations As this is an observational study without intervention, a waiver for informed consent was granted.
Importance of Research Early identification of high-risk patients will enable preventive interventions, support transitions to palliative care where appropriate, and promote advance directives, ultimately improving patient care and reducing healthcare costs by preventing costly, unnecessary readmissions and interventions.
- Conditions
- Clinical Decision Support
- Keywords
- Geriatric, acute care, older adults
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effectiveness of skilled caregiver assessments versus validated prediction tools for mortality and rehospitalization within one year
Measured: 2 years
Secondary outcomes (1)
Identify risk factors for rehospitalization and mortality in acutely hospitalized elderly patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Decision SupportStudies 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
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shmuel Harofeh Hospital, Geriatric Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yochai Levy, Shmuel Harofeh Hospital, Geriatric Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675084
- Sponsor's protocol ID
- SH-120-24
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Rehospitalization Risk Assessment by Skilled Caregivers Compared to Existing Tools in Acute Geriatric Departments
- ClinicalTrials.gov ID
- NCT06675084
- Acronym / sponsor ID
- SH-120-24
- Conditions
- Clinical Decision Support
- Keywords
- Geriatric, acute care, older adults
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shmuel Harofeh Hospital, Geriatric Medical CenterOther government
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 5 Nov 2024 (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.
Mortality and Rehospitalization Risk Assessment by Skilled Caregivers Compared to Existing Tools in Acute Geriatric Departments
Background The elderly population in Israel and worldwide is steadily increasing, leading to greater demand for medical services, including palliative care. In 2019, individuals aged 65+ accounted for 64% of hospital admissions and 70% of hospital days in Israel. Approximately 19% of these were readmissions, a rate that increases with age. Effective tools for identifying patients at high risk of rehospitalization and mortality are lacking, which, if improved, could benefit patients through targeted palliative and end-of-life care. Enhanced tools could reduce unnecessary interventions, improve patient well-being, and alleviate economic burdens on healthcare.
Research Objectives
- Evaluate mortality and rehospitalization rates in acute geriatric departments.
- Identify risk factors for rehospitalization and mortality in acutely hospitalized elderly patients.
- Compare the effectiveness of skilled caregiver assessments versus validated prediction tools for mortality and rehospitalization within one year.
Hypotheses
- Mortality and rehospitalization rates in acute geriatric departments are comparable to those in internal medicine.
- Multiple factors-such as age, family support, comorbidities, functional and cognitive status-correlate with mortality risk.
- Skilled caregiver assessments predict mortality and rehospitalization more accurately than existing validated tools.
Study Design Type: Prospective cohort observational study. Location: Shmuel Harofe Hospital.
Study Population Participants are elderly patients admitted to acute geriatric departments at Shmuel Harofe Hospital for acute conditions. Approximately 600 participants will be recruited, with an additional 200-300 if statistical analysis reveals trends.
Recruitment Period: Two years. Follow-up Period: Up to one year post-admission.
Methods and Materials
Data will be collected on demographic, functional, cognitive, and emotional factors, as well as clinical history, hospital admissions, comorbidities, and lab results. Predictive assessments will include:
- Mortality Prediction using the WALTER Index for the elderly.
- Rehospitalization Risk using the LACE Index, validated for 30-day readmission risk.
- Subjective Caregiver Assessments from geriatric specialists and nursing supervisors, estimating life expectancy and 30-day, 3-month, and 1-year rehospitalization risk.
Data Analysis Data will be coded and statistically analyzed without interventions outside of standard care. The WALTER and LACE indices will utilize existing clinical data.
Ethical Considerations As this is an observational study without intervention, a waiver for informed consent was granted.
Importance of Research Early identification of high-risk patients will enable preventive interventions, support transitions to palliative care where appropriate, and promote advance directives, ultimately improving patient care and reducing healthcare costs by preventing costly, unnecessary readmissions and interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 65 years old admitted to acute geriatric departments at Shmuel Harofe Hospital for acute conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the effectiveness of skilled caregiver assessments versus validated prediction tools for mortality and rehospitalization within one year
Time frame: 2 years
1 secondary outcome
Identify risk factors for rehospitalization and mortality in acutely hospitalized elderly patients.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Decision Support, run by Shmuel Harofeh Hospital, Geriatric Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yochai Levy (972502991516, yochai.levy@MOH.GOV.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the effectiveness of skilled caregiver assessments versus validated prediction tools for mortality and rehospitalization within one year (time frame: 2 years). 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 5 Nov 2024.