Family Caregiver Role in Decreasing Delirium in Older Patients With Fractured Femur Using HELP Principles.

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Delirium, Femoral Fracture

Intervention / Treatment
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* Other: Family caregiver application of HELP principles


Participation Criteria
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Eligibility Criteria
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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 Delirium 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm single center prospective interventional study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family caregiver application of HELP principles<br>The family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. The patient will be assessed daily by means of the Confusion Assessment Method (CAM) and the 4 'A's test (Arousal, Attention, Abbreviated Mental Test - 4, Acute change) (4AT) to determine delirium incidence. | Other: Family caregiver application of HELP principles<br>* The family caregiver will apply the principles of the HELP program in a structured manner following training by a nurse clinical specialist in geriatrics. These principles include engaging patients in conversation, particularly emphasizing orientation to time and place, encouraging eating and drinking, and assisting with early mobility.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium | The incidence of delirium will be determined according to the results of patient assessment by means of the CAM and 4AT instruments. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Acute hospitalization, Family caregiver, Hospital Elder Life Program