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Clinical Trials/NCT05321771
NCT05321771
Recruiting
Not Applicable

The Effect of Involving a Family Caregiver in Promoting the Principles of the Hospital Elder Life Program on Decreasing Delirium Among Older Patients Hospitalized in the Orthopedic Unit Following Surgery for Post-fall Femoral Fracture.

Rambam Health Care Campus1 site in 1 country50 target enrollmentDecember 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Rambam Health Care Campus
Enrollment
50
Locations
1
Primary Endpoint
Incidence of delirium
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The Hospital Elder Life Program (HELP) has been shown to reduce delirium in hospitalized patients. In this study a family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.

Detailed Description

Approximately 30% of those aged 65 years and over will fall at least once a year. As many as 38% of all older people hospitalized following a fall are admitted with hip fractures and 93% of these will undergo surgical repair of the fracture (Ministry of Health, 2015). Fractured femur is associated with many complications. Delirium (acute confusional state) following surgery is one of the most common of these complications, it often results in adverse outcomes for both patients and caregivers (Tieges et al., 2021), and places great financial burden on the health system. It must be emphasized that delirium can be prevented, and when it occurs should be recognized and treated appropriately. The HELP (Hospital Elder Life Program) is an accepted evidence-based model that has been proven to be effective in reducing delirium at the time of acute hospitalization (Inouye et al., 1999). HELP (which has been implemented at the Rambam Healthcare Campus) is a volunteer-based program using non-pharmacological interventions that include engaging patients in conversation, particularly emphasizing orientation to time and place, encouraging eating and drinking, and assisting with early mobility (Inouye, 2000). The HELP program has been shown to reduce delirium by one-fifth in previous studies (Wang et al., 2020). In this study a family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.

Registry
clinicaltrials.gov
Start Date
December 2, 2021
End Date
June 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tzvi Dwolatzky

Director Geriatrics

Rambam Health Care Campus

Eligibility Criteria

Inclusion Criteria

  • Males and females aged 65 years and older
  • Acute hospitalization in the orthopedic unit for fractured femur post-fall
  • Expected or actual surgical intervention for treatment of fracture
  • At least one family caregiver involved in supporting the patient during hospitalization

Exclusion Criteria

  • Documented conditions that have been clinically active during the previous 6 months: including psychiatric illness; cerebrovascular disease; brain malignancy; alcohol abuse; drug abuse
  • Terminal disease
  • Inability to assess for delirium due to advanced dementia or sensory deprivation (marked impairment of vision or hearing) or any other condition that limits communication with the patient

Outcomes

Primary Outcomes

Incidence of delirium

Time Frame: From date of signing informed consent until the date of first documented diagnosis of delirium or hospital discharge, whichever came first, assessed up to a maximum of 100 days

The incidence of delirium will be determined according to the results of patient assessment by means of the CAM and 4AT instruments.

Study Sites (1)

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