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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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

  1. Assess life expectancy of patients in skilled nursing departments.
  2. 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:

  1. Validated Tools: Including the MITCHELL scale (for patients with advanced dementia) and the POROCK scale (for institutionalized patients).
  2. 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.

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.

  1. 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.

  1. First posted5 Nov 2024
  2. Study start10 Nov 2024 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

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
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

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.

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