Home-visits From geRiatric tEam aFter hIp fracTure (REFIT)
Primary Purpose
Geriatric Assessment, Hip Fractures, Frailty
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Home visit and comprehensive geriatric assessment
Control group, no designated follow up
Sponsored by
About this trial
This is an interventional prevention trial for Geriatric Assessment focused on measuring Geriatric assesment, hip fracture, Home-visit, Old patients
Eligibility Criteria
Inclusion Criteria:
- Age of 70 years or older
- Hip fracture
- Ability to provide informed consent
- Residence in one of three following municipalities: Gladsaxe, Rudersdal or Lyngby-Taarbæk
Exclusion Criteria:
- No ability to provide informed consent
- Patients, who dies within 48 hours of discharge
- Terminal patients
Nursing home residents
Sites / Locations
- Herlev and Gentofte hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Geriatric home visit
Standard care
Arm Description
Home-visit where a comprehensive geriatric assessment will be performed
No follow-up.
Outcomes
Primary Outcome Measures
Time to contact to the general practitioner or hospital because of a fall
Fall-related contact for treatment or assessment
Secondary Outcome Measures
Contacts to a doctor
Number of contacts to a doctor (either hospital or the general practitioner)
Contacts to a doctor
Number of contacts to a doctor (either hospital or the general practitioner)
Falls
number of falls
Falls
number of falls
Preventable readmissions
Number of readmission deemed preventable by two blinded assessors
Number of drugs
Number of inappropriate drugs (Stop/Startt criteria)
Quality of life
Assessment of Quality of life using questionnaire (EQ VAS 0-100)
Patient satisfaction and fear of falling
Assessment patient satisfaction using questionnaire (Sat-UG-1)
Patient satisfaction and fear of faling
Assessment patient satisfaction using questionnaire (Sat-UG-1)
All cause mortaliy
Mortality
All cause mortaliy
Mortality
Muscle strength
Measured using "timed-up-and-go" test
Mobility
Assessed using the "new mobility score" (0-10, high is good)
Mobility
Assessed using the "Cumulated Ambulation Score" (0-6, high is good)
Weight
Change in weight i kilograms from discharge "Cumulated Ambulation Score", and "new mobility score"
Independence
Number of patients using walking aids
Independence
Number of patients with a new placement at a nursing homes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04777136
Brief Title
Home-visits From geRiatric tEam aFter hIp fracTure
Acronym
REFIT
Official Title
The Effect of Home-visit Follow-up With a Multidisciplinary Geriatric Team in Old Patients With a Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
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 primary objective is to examine the effect of multidisciplinary geriatric team home-visits as follow-up after a hip fracture in old patients. The hypothesis is that home-visits will reduce the number of falls, readmissions, prevent functional decline, optimize that medical treatment, and a higher degree of satisfaction and quality of life.
Detailed Description
Among older individuals, falling is a strong predictor of frailty, morbidity, and mortality and may cause a fracture. Many older patients experience recurrent falls, further functional decline, and readmission within the first three months. Hence, fall-related visits to the hospital represent a "red flag" but are also an opportunity for targeted intervention and prevention of future falls. However, many older patients are only treated for fall-related injuries and discharged without fall risk assessment or evaluation, hence there is a need for follow-up with targeted fall assessment and intervention to prevent further falls.
Thus, the present project aims to examine the effect of home-visit follow-up of older frail patients discharged from the orthopedic ward with a hip fracture. Furthermore, we will explore the effect of a cross-sectorial collaboration between hospital and municipality in the patients' homes to prevent falls, readmissions, medicine-associated adverse effects, and physical deconditioning in old frail patients.
The present study is a interventional trial. The intervention will consist of a home visit within ten weekdays of the discharge, where a comprehensive geriatric assessment (CGA) will be performed. The team performing the CGA consist of a Geriatrician and an experienced geriatric nurse. CGA is an overall assessment of the patient taking account of; the presence and severity of comorbidity, the nutritional state, cognitive and functional status, review of current medications, and social measures. The purpose is to stabilize and optimize current as well as chronic conditions, and reduce the probability of adverse events and falls, and to secure interventions or changes persist through the transition from the secondary to the primary health care system. The assessment may lead to several interventions, including; medicine review (new medicine, change in current or discontinuation), initiation of a nutritional effort or contact to a dietitian, referral to other health care services (outpatient clinics, hospitals, or general practitioner), referral to physiotherapy and/or occupational therapy or optimization of home care.
Patients randomized to the control group will receive standard care, where the subsequent need for medical service or increased home care will require contact with the general practitioner or the municipality, at the patient's initiative.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geriatric Assessment, Hip Fractures, Frailty, Old Age; Atrophy
Keywords
Geriatric assesment, hip fracture, Home-visit, Old patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Home visit from the geriatric team
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Geriatric home visit
Arm Type
Experimental
Arm Description
Home-visit where a comprehensive geriatric assessment will be performed
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
No follow-up.
Intervention Type
Other
Intervention Name(s)
Home visit and comprehensive geriatric assessment
Intervention Description
Home-visit from the geriatric team, who will do a full geriatric assessment and targeted interventions
Intervention Type
Other
Intervention Name(s)
Control group, no designated follow up
Intervention Description
Only follow-up on patients own initiative with contact to the general practitioner
Primary Outcome Measure Information:
Title
Time to contact to the general practitioner or hospital because of a fall
Description
Fall-related contact for treatment or assessment
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Contacts to a doctor
Description
Number of contacts to a doctor (either hospital or the general practitioner)
Time Frame
90 days
Title
Contacts to a doctor
Description
Number of contacts to a doctor (either hospital or the general practitioner)
Time Frame
30 days
Title
Falls
Description
number of falls
Time Frame
30 days
Title
Falls
Description
number of falls
Time Frame
90 days
Title
Preventable readmissions
Description
Number of readmission deemed preventable by two blinded assessors
Time Frame
30 days
Title
Number of drugs
Description
Number of inappropriate drugs (Stop/Startt criteria)
Time Frame
30 days
Title
Quality of life
Description
Assessment of Quality of life using questionnaire (EQ VAS 0-100)
Time Frame
90 days
Title
Patient satisfaction and fear of falling
Description
Assessment patient satisfaction using questionnaire (Sat-UG-1)
Time Frame
30 days
Title
Patient satisfaction and fear of faling
Description
Assessment patient satisfaction using questionnaire (Sat-UG-1)
Time Frame
90 days
Title
All cause mortaliy
Description
Mortality
Time Frame
30 days
Title
All cause mortaliy
Description
Mortality
Time Frame
90 days
Title
Muscle strength
Description
Measured using "timed-up-and-go" test
Time Frame
90 days
Title
Mobility
Description
Assessed using the "new mobility score" (0-10, high is good)
Time Frame
90 days
Title
Mobility
Description
Assessed using the "Cumulated Ambulation Score" (0-6, high is good)
Time Frame
90 days
Title
Weight
Description
Change in weight i kilograms from discharge "Cumulated Ambulation Score", and "new mobility score"
Time Frame
90 days
Title
Independence
Description
Number of patients using walking aids
Time Frame
90 days
Title
Independence
Description
Number of patients with a new placement at a nursing homes
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 70 years or older
Hip fracture
Ability to provide informed consent
Residence in one of three following municipalities: Gladsaxe, Rudersdal or Lyngby-Taarbæk
Exclusion Criteria:
No ability to provide informed consent
Patients, who dies within 48 hours of discharge
Terminal patients
Nursing home residents
Facility Information:
Facility Name
Herlev and Gentofte hospital
City
Herlev
State/Province
Capital Region
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home-visits From geRiatric tEam aFter hIp fracTure
We'll reach out to this number within 24 hrs