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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.

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 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.

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Exclusion Criteria: 1. Admission for social reasons. 2. Patients under palliative end of life care.

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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

  1. Evaluate mortality and rehospitalization rates in acute geriatric departments.
  2. Identify risk factors for rehospitalization and mortality in acutely hospitalized elderly patients.
  3. Compare the effectiveness of skilled caregiver assessments versus validated prediction tools for mortality and rehospitalization within one year.

Hypotheses

  1. Mortality and rehospitalization rates in acute geriatric departments are comparable to those in internal medicine.
  2. Multiple factors-such as age, family support, comorbidities, functional and cognitive status-correlate with mortality risk.
  3. 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:

  1. Mortality Prediction using the WALTER Index for the elderly.
  2. Rehospitalization Risk using the LACE Index, validated for 30-day readmission risk.
  3. 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.

Keywords
Geriatric, acute care, older adults

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the effectiveness of skilled caregiver assessments versus validated prediction tools for mortality and rehospitalization within one year

    Measured: 2 years

Secondary outcomes (1)
  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.

  1. First posted5 Nov 2024
  2. Study start10 Nov 2024 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 May 2027 (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
600 participants (estimated)
Target duration
1 Year
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

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.

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