Home-visits From geRiatric tEam aFter hIp fracTure (REFIT)

May 15, 2022 updated by: Martin Schultz, Herlev Hospital

The Effect of Home-visit Follow-up With a Multidisciplinary Geriatric Team in Old Patients With a Hip Fracture

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Capital Region
      • Herlev, Capital Region, Denmark, 2730
        • Herlev and Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 120 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Geriatric home visit
Home-visit where a comprehensive geriatric assessment will be performed
Home-visit from the geriatric team, who will do a full geriatric assessment and targeted interventions
Active Comparator: Standard care
No follow-up.
Only follow-up on patients own initiative with contact to the general practitioner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to contact to the general practitioner or hospital because of a fall
Time Frame: 90 days
Fall-related contact for treatment or assessment
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contacts to a doctor
Time Frame: 90 days
Number of contacts to a doctor (either hospital or the general practitioner)
90 days
Contacts to a doctor
Time Frame: 30 days
Number of contacts to a doctor (either hospital or the general practitioner)
30 days
Falls
Time Frame: 30 days
number of falls
30 days
Falls
Time Frame: 90 days
number of falls
90 days
Preventable readmissions
Time Frame: 30 days
Number of readmission deemed preventable by two blinded assessors
30 days
Number of drugs
Time Frame: 30 days
Number of inappropriate drugs (Stop/Startt criteria)
30 days
Quality of life
Time Frame: 90 days
Assessment of Quality of life using questionnaire (EQ VAS 0-100)
90 days
Patient satisfaction and fear of falling
Time Frame: 30 days
Assessment patient satisfaction using questionnaire (Sat-UG-1)
30 days
Patient satisfaction and fear of faling
Time Frame: 90 days
Assessment patient satisfaction using questionnaire (Sat-UG-1)
90 days
All cause mortaliy
Time Frame: 30 days
Mortality
30 days
All cause mortaliy
Time Frame: 90 days
Mortality
90 days
Muscle strength
Time Frame: 90 days
Measured using "timed-up-and-go" test
90 days
Mobility
Time Frame: 90 days
Assessed using the "new mobility score" (0-10, high is good)
90 days
Mobility
Time Frame: 90 days
Assessed using the "Cumulated Ambulation Score" (0-6, high is good)
90 days
Weight
Time Frame: 90 days
Change in weight i kilograms from discharge "Cumulated Ambulation Score", and "new mobility score"
90 days
Independence
Time Frame: 90 days
Number of patients using walking aids
90 days
Independence
Time Frame: 90 days
Number of patients with a new placement at a nursing homes
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 27, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 15, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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