Mortality PredictionNCT06675071
Mortality Risk Assessment by Skilled Staff Compared to Existing Validated Tools in Skilled Nursing Departments
An observational study of Mortality Prediction, run by Shmuel Harofeh Hospital, Geriatric Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mortality Prediction
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to 1 Jan 2028
- 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 the age of 65 years admitted to skilled nursing departments at Shmuel Harofeh Hospital.
Who may be able to join
None listed.
Who cannot join
- -
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 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.
Read more
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.
- Conditions
- Mortality Prediction
- Keywords
- older adults, long term care, Mortality Prediction, MITCHELL scale, POROCK scale
What is being measured
The primary outcome is the main question the study is designed to answer.
life expectancy of patients in skilled nursing departments
Compare the effectiveness of various tools in predicting six-month mortality
Measured: 3 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 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mortality PredictionStudies 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
- 300 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
- NCT06675071
- Sponsor's protocol ID
- SH-118-24
- 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 Risk Assessment by Skilled Staff Compared to Existing Validated Tools in Skilled Nursing Departments
- ClinicalTrials.gov ID
- NCT06675071
- Acronym / sponsor ID
- SH-118-24
- Conditions
- Mortality Prediction
- Keywords
- older adults, long term care, Mortality Prediction, MITCHELL scale, POROCK scale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shmuel Harofeh Hospital, Geriatric Medical CenterOther government
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (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 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 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 the age of 65 years admitted to skilled nursing departments at Shmuel Harofeh Hospital.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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
life expectancy of patients in skilled nursing departments
Time frame: 3 years
Compare the effectiveness of various tools in predicting six-month mortality
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 Mortality Prediction, 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?
The sponsor lists 0 inclusion and 1 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: 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?
life expectancy of patients in skilled nursing departments (time frame: 3 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.