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A Geriatric Home Visit Program to Reduce Post-Hip Fracture Complications

Primary Purpose

Fracture, Infection, Depression

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Home Visit

About this trial

This is an interventional prevention trial for Fracture focused on measuring Hip fracture, postoperative complications, Depression, Environmental Hazards, FIM scores, Falls

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Staten Island University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No intervention

Home Visit

Arm Description

Standard of care with no 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

Outcomes

Primary Outcome Measures

Decreased rate of depression, falls, medication errors and post-op-complications

geriatric depression screen, FIM score, medication reconciliation

Secondary Outcome Measures

environmental hazards will be identified

safety inspection of home

Full Information

NCT ID

NCT02058329

First Posted

October 25, 2012

Last Updated

February 6, 2014

Sponsor

Northwell Health

Collaborators

Staten Island University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02058329

Brief Title

A Geriatric Home Visit Program to Reduce Post-Hip Fracture Complications

Official Title

A Geriatric Home Visit Program to Reduce Post Hip Fracture Morbidity and Mortality

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Terminated

Why Stopped

Many patients were lost to follow-up

Study Start Date

November 2008 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

Collaborators

Staten Island University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fracture, Infection, Depression, Gait Instability, Debility

Keywords

Hip fracture, postoperative complications, Depression, Environmental Hazards, FIM scores, Falls

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No intervention

Arm Type

No Intervention

Arm Description

Standard of care with no home visit

Arm Title

Home Visit

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Home Visit

Intervention Description

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.

Primary Outcome Measure Information:

Title

Decreased rate of depression, falls, medication errors and post-op-complications

Description

geriatric depression screen, FIM score, medication reconciliation

Time Frame

6 months and 1 year

Secondary Outcome Measure Information:

Title

environmental hazards will be identified

Description

safety inspection of home

Time Frame

6 months and 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Jarrett, M.D.

Organizational Affiliation

Staten Island University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marianne Smith, M.D.

Organizational Affiliation

Staten Island University Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Garbis Dabagian, M.D.

Organizational Affiliation

Staten Island University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Donna Seminara, M.D.

Organizational Affiliation

Staten Island University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffery Weinberg, M.D.

Organizational Affiliation

Staten Island University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mario Castellanos, M.D.

Organizational Affiliation

Staten Island University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anita Szerszen, M.D.

Organizational Affiliation

Staten Island University Hospitial

Official's Role

Principal Investigator

Facility Information:

Facility Name

Staten Island University Hospital

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

15999957

Citation

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.

Results Reference

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A Geriatric Home Visit Program to Reduce Post-Hip Fracture Complications

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