- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06675084
Mortality and Rehospitalization Risk Assessment by Skilled Caregivers Compared to Existing Tools in Acute Geriatric Departments
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yochai Levy
- Phone Number: 972502991516
- Email: yochai.levy@MOH.GOV.IL
Study Contact Backup
- Name: Nadya Kagansky
- Phone Number: 972506264678
- Email: batia_nadya.kagansky@moh.gov.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compare the effectiveness of skilled caregiver assessments versus validated prediction tools for mortality and rehospitalization within one year
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Identify risk factors for rehospitalization and mortality in acutely hospitalized elderly patients.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SH-120-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.