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

NCT ID: NCT05321771

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-02

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Delirium Femoral Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm single center prospective interventional study.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Family caregiver application of HELP principles

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.

Group Type EXPERIMENTAL

Family caregiver application of HELP principles

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Family caregiver application of HELP principles

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tzvi Dwolatzky

Director Geriatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Galit Geller Bigelman, MA

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rambam Health Care Campus

Haifa, North, Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Galit Geller Bigelman, MA

Role: CONTACT

+97247771192

Orit Meshulam

Role: CONTACT

+97247772952

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tzvi Dwolatzky

Role: primary

502061183

Orit Meshulam

Role: backup

972-47772952

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 33951145 (View on PubMed)

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.

Reference Type RESULT
PMID: 10053175 (View on PubMed)

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.

Reference Type RESULT
PMID: 11129764 (View on PubMed)

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.

Reference Type RESULT
PMID: 31633738 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0508-21-RMB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Temperature Management on Postoperative Delirium
NCT06406257 NOT_YET_RECRUITING NA