FractureNCT02058329
A Geriatric Home Visit Program to Reduce Post-Hip Fracture Complications
A study testing Home Visit in people with Fracture and Infection, run by Northwell Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fracture, Infection, Depression
- What is being tested?
- Home Visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All post hip fracture patients on the hospital's rehabilitation service being discharged to home .
Who cannot join
- Patients discharged to nursing homes or rehabilitation facilities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: 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.
Read the 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.
- Conditions
- Fracture, Infection, Depression, Gait Instability, Debility
- Being tested
- Home Visit
- Keywords
- Hip fracture, postoperative complications, Depression, Environmental Hazards, FIM scores, Falls
- Medical subject headings
- Fractures, Bone, Infections, Depression, Gait Disorders, Neurologic, Frailty, Hip Fractures, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home VisitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Standard of care with no home visit |
| Home Visit | Experimental | 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 Receives: Other: Home Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased rate of depression, falls, medication errors and post-op-complications
geriatric depression screen, FIM score, medication reconciliation
Measured: 6 months and 1 year
Secondary outcomes (1)
environmental hazards will be identified
safety inspection of home
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startNov 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Many patients were lost to follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital
- Responsible party
- Principal investigator, Garbis Dabaghian, Northwell Health
- Investigators
- Mark Jarrett, M.D., Principal investigator, Staten Island University HospitalMarianne Smith, M.D., Study director, Staten Island University HospitalGarbis Dabagian, M.D., Principal investigator, Staten Island University HospitalDonna Seminara, M.D., Principal investigator, Staten Island University HospitalJeffery Weinberg, M.D., Principal investigator, Staten Island University HospitalMario Castellanos, M.D., Principal investigator, Staten Island University HospitalAnita Szerszen, M.D., Principal investigator, Staten Island University Hospitial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058329
- Sponsor's protocol ID
- 08-023
- Status last verified
- Feb 2014
- First submitted
- 25 Oct 2012
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McGinn T, Conte JG, Jarrett MP, ElSayegh D. Decreasing mortality for patients undergoing hip fracture repair surgery. Jt Comm J Qual Patient Saf. 2005 Jun;31(6):304-7. doi: 10.1016/s1553-7250(05)31038-5.
PubMed 15999957
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Geriatric Home Visit Program to Reduce Post Hip Fracture Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT02058329
- Acronym / sponsor ID
- 08-023
- Conditions
- Fracture, Infection, Depression, Gait Instability, Debility
- Keywords
- Hip fracture, postoperative complications, Depression, Environmental Hazards, FIM scores, Falls
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Many patients were lost to follow-up
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Nov 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Standard of care with no home visit |
| Home Visit | Experimental | Other: Home VisitAfter 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All post hip fracture patients on the hospital's rehabilitation service being discharged to home .
Key exclusion criteria (1 listed)
- Patients discharged to nursing homes or rehabilitation facilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home VisitA 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. | Other | Home Visit |
Primary outcome
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
1 secondary outcome
environmental hazards will be identified
Time frame: 6 months and 1 year
Results and safety
The study was stopped early (reason given: Many patients were lost to follow-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Background: PubMed 15999957McGinn T, Conte JG, Jarrett MP, ElSayegh D. Decreasing mortality for patients undergoing hip fracture repair surgery. Jt Comm J Qual Patient Saf. 2005 Jun;31(6):304-7. doi: 10.1016/s1553-7250(05)31038-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Jarrett, M.D. principal investigator
Staten Island University Hospital
Marianne Smith, M.D. study director
Staten Island University Hospital
Garbis Dabagian, M.D. principal investigator
Staten Island University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Visit in people with Fracture and Infection, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Many patients were lost to follow-up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased rate of depression, falls, medication errors and post-op-complications (time frame: 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02058329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.