Mortality and Rehospitalization Risk Assessment by Skilled Caregivers Compared to Existing Tools in Acute Geriatric Departments

November 4, 2024 updated by: Yochai Levy, Shmuel Harofeh Hospital, Geriatric Medical Center

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

  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.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients over 65 years old admitted to acute geriatric departments at Shmuel Harofe Hospital for acute conditions.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 10, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SH-120-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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