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

NCT05321771 | Recruiting

• 1 other identifier: 0508-21-RMB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Femoral Fracture

Keywords

Elderly; Acute hospitalization; Family caregiver; Hospital Elder Life Program

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Family caregiver application of HELP principles

EXPERIMENTAL

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

Interventions

Family caregiver application of HELP principles OTHER

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.

Family caregiver application of HELP principles

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, North, 3109601, Israel

RECRUITING

Related Publications (4)

• Tieges Z, Maclullich AMJ, Anand A, Brookes C, Cassarino M, O'connor M, Ryan D, Saller T, Arora RC, Chang Y, Agarwal K, Taffet G, Quinn T, Shenkin SD, Galvin R. Diagnostic accuracy of the 4AT for delirium detection in older adults: systematic review and meta-analysis. Age Ageing. 2021 May 5;50(3):733-743. doi: 10.1093/ageing/afaa224.

  PMID: 33951145 RESULT

• Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.

  PMID: 10053175 RESULT

• Inouye SK, Bogardus ST Jr, Baker DI, Leo-Summers L, Cooney LM Jr. The Hospital Elder Life Program: a model of care to prevent cognitive and functional decline in older hospitalized patients. Hospital Elder Life Program. J Am Geriatr Soc. 2000 Dec;48(12):1697-706. doi: 10.1111/j.1532-5415.2000.tb03885.x.

  PMID: 11129764 RESULT

• Wang YY, Yue JR, Xie DM, Carter P, Li QL, Gartaganis SL, Chen J, Inouye SK. Effect of the Tailored, Family-Involved Hospital Elder Life Program on Postoperative Delirium and Function in Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):17-25. doi: 10.1001/jamainternmed.2019.4446.

  PMID: 31633738 RESULT

MeSH Terms

Conditions

Delirium; Femoral Fractures

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Galit Geller Bigelman, MA

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Galit Geller Bigelman, MA

CONTACT

+97247771192; GG_Bigelman@rambam.health.gov.il

Orit Meshulam

CONTACT

+97247772952; o_meshulam@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Geriatrics

Model Details: Single arm single center prospective interventional study.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 11, 2022
• Study Start: December 2, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)