Family Caregiver Role in Decreasing Delirium in Older Patients With Fractured Femur Using HELP Principles. (FamHelp)
Primary Purpose
Delirium, Femoral Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Family caregiver application of HELP principles
Sponsored by
About this trial
This is an interventional diagnostic trial for Delirium focused on measuring Elderly, Acute hospitalization, Family caregiver, Hospital Elder Life Program
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
- 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
Sites / Locations
- Rambam Health Care CampusRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Family caregiver application of HELP principles
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05321771
First Posted
March 14, 2022
Last Updated
March 28, 2023
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT05321771
Brief Title
Family Caregiver Role in Decreasing Delirium in Older Patients With Fractured Femur Using HELP Principles.
Acronym
FamHelp
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Femoral Fracture
Keywords
Elderly, Acute hospitalization, Family caregiver, Hospital Elder Life Program
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm single center prospective interventional study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Family caregiver application of HELP principles
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Family caregiver application of HELP principles
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of delirium
Description
The incidence of delirium will be determined according to the results of patient assessment by means of the CAM and 4AT instruments.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Galit Geller Bigelman, MA
Phone
+97247771192
Email
GG_Bigelman@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Orit Meshulam
Phone
+97247772952
Email
o_meshulam@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galit Geller Bigelman, MA
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
State/Province
North
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzvi Dwolatzky
Phone
502061183
Email
t_dwolatzky@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Orit Meshulam
Phone
972-47772952
Email
o_meshulam@rambam.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available to other researchers on request
Citations:
PubMed Identifier
33951145
Citation
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.
Results Reference
result
PubMed Identifier
10053175
Citation
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.
Results Reference
result
PubMed Identifier
11129764
Citation
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.
Results Reference
result
PubMed Identifier
31633738
Citation
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.
Results Reference
result
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Family Caregiver Role in Decreasing Delirium in Older Patients With Fractured Femur Using HELP Principles.
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