- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02058329
A Geriatric Home Visit Program to Reduce Post-Hip Fracture Complications
February 6, 2014 updated by: Garbis Dabaghian, Northwell Health
A Geriatric Home Visit Program to Reduce Post Hip Fracture Morbidity and Mortality
The overall goal of the project is to reduce the incidence of post hip fracture morbidity and mortality by conducting geriatric fellow periodic home visits.The assessment will be multidisciplinary and will include assessments of functional status, depression, environmental risks and medical conditions.
This group will be compared against a group followed by the usual standard of care post hip fracture.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
All patients post hip fracture on the hospital's rehabilitation service that will be discharged to home will be enrolled after obtaining consent.
Patients will be randomized into the intervention group and the usual standard of care group.We will be recruiting a total of 100 patients , with equal numbers for each group.All patients will undergo an initial assessment by a Geriatric fellow prior to discharge .
The intervention group will be seen at the time of discharge in the hospital and at home at 1, 3, and 6 months post hip fracture.
The control group will be seen at the time of discharge in the hospital and then again at 6 months for follow up.
The two groups will then be compared for multiple known complications post hip fractures well as mortality.
Study Type
Interventional
Enrollment (Actual)
18
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
-
-
New York
-
Staten Island, New York, United States, 10305
- Staten Island University 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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All post hip fracture patients on the hospital's rehabilitation service being discharged to home .
Exclusion Criteria:
- Patients discharged to nursing homes or rehabilitation facilities.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No intervention
Standard of care with no home visit
|
|
Experimental: Home Visit
After the post hip-fracture patient is discharged to home, there will be home visits by a geriatric fellow assess overall function and response to treatment/s by depression screen, FIM scores, and environmental risk assessment
|
A geriatric fellow will conduct a comprehensive in hospital post discharge assessment of hip fracture patients discharged to home in the intervention group.Follow up home visits will occur at 1,3 and 6 months post discharge.Any problems will be referred to the patient's primary care physician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decreased rate of depression, falls, medication errors and post-op-complications
Time Frame: 6 months and 1 year
|
geriatric depression screen, FIM score, medication reconciliation
|
6 months and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
environmental hazards will be identified
Time Frame: 6 months and 1 year
|
safety inspection of home
|
6 months and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Jarrett, M.D., Staten Island University Hospital
- Study Director: Marianne Smith, M.D., Staten Island University Hospital
- Principal Investigator: Garbis Dabagian, M.D., Staten Island University Hospital
- Principal Investigator: Donna Seminara, M.D., Staten Island University Hospital
- Principal Investigator: Jeffery Weinberg, M.D., Staten Island University Hospital
- Principal Investigator: Mario Castellanos, M.D., Staten Island University Hospital
- Principal Investigator: Anita Szerszen, M.D., Staten Island University Hospitial
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2008
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
October 25, 2012
First Submitted That Met QC Criteria
February 6, 2014
First Posted (Estimate)
February 10, 2014
Study Record Updates
Last Update Posted (Estimate)
February 10, 2014
Last Update Submitted That Met QC Criteria
February 6, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-023
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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