- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06675071
Mortality Risk Assessment by Skilled Staff Compared to Existing Validated Tools in Skilled Nursing Departments
Mortality Risk Assessment by Skilled Caregivers Compared to Existing Validated Tools in Skilled Nursing Departments at Shmuel Harofeh Geriatric Hospital
Background The elderly population in Israel and globally is growing, increasing demand for medical services, particularly palliative care. Recommendations from 2016 emphasized the need for geriatric and skilled nursing departments to focus on end-of-life care, but implementation has been limited. High mortality and frequent readmissions are reported in long-term care, yet accurate mortality prediction tools for elderly patients remain limited. Improved mortality prediction can help identify patients who would benefit from palliative care and reduce unnecessary interventions.
Research Objectives
- Assess life expectancy of patients in skilled nursing departments.
- Compare the effectiveness of various tools in predicting six-month mortality.
Hypothesis Caregiver assessments will more accurately predict mortality than current validated tools.
Study Design Type: Prospective cohort study. Location: Shmuel Harofeh Hospital
Study Population Approximately 250 patients admitted to skilled nursing departments at Shmuel Harofeh Hospital.
Recruitment Period: Two years. Follow-up Period: Up to one year.
Methods
Epidemiological and clinical data (age, comorbidities, functional and cognitive status, lab results) will be collected. Mortality risk will be assessed using:
- Validated Tools: Including the MITCHELL scale (for patients with advanced dementia) and the POROCK scale (for institutionalized patients).
- Caregiver Assessment: Subjective life expectancy estimates by attending geriatricians and nursing staff within three days of admission and again 7-10 days later. An external geriatrician will also provide an assessment based on brief, non-invasive observation.
Data Processing Data will be coded, entered into an electronic dataset, and undergo statistical analysis after collection. No interventions beyond routine care are included.
Ethical Considerations As an observational study without intervention, a waiver for informed consent was granted.
Importance of Research Skilled nursing facilities increasingly need to provide palliative care for elderly patients. This study aims to improve mortality prediction methods, helping to identify patients for end-of-life care, ultimately enhancing care quality, and reducing costs by avoiding unnecessary hospitalizations and treatments.
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 skilled nursing departments at Shmuel Harofeh Hospital.
-
Exclusion Criteria: Patients admitted for end-of-life care
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
life expectancy of patients in skilled nursing departments
Time Frame: 3 years
|
Compare the effectiveness of various tools in predicting six-month mortality
|
3 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
Other Study ID Numbers
- SH-118-24
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.
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