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The purpose of this study is to find out about the risk factors for wheelchair-related falls among elderly veterans, and to find out about the costs and consequences of those falls.
Rationale and Objectives. A multitude of risk factors for falls has been reported, however many of these risk factors are not applicable to persons who use a wheelchair for mobility. Specific objectives include: (1) Describe the incidence and prevalence of wheelchair tips (near falls), falls, and fall-related injuries, (2) Describe the epidemiology of the wheelchair tip or fall event. (3) Create models for predicting wheelchair tips, falls, and fall-related injuries for elderly persons who use a wheelchair for mobility. (4) Determine healthcare utilization and direct costs associated with wheelchair-related fall injuries. (5) Describe patient perceived short- and long-term consequences of wheelchair-related falls.
Research Design. This 3-year prospective cohort study includes qualitative and quantitative data collected at baseline data and through monthly follow-up phone interviews over a 12-month period. Data Source. Baseline data on demographics, intrinsic risk factors, and extrinsic risk factors will be collected through interviews. We will assess functional status, cognition, and home management skills through standardized tools. Administrative databases will be used to gather data regarding comorbidities, Veterans Health Administration (VHA) health care utilization and direct costs. A physical therapy assistant will also conduct a wheelchair inventory and wheelchair skills test. Monthly follow-up phone interviews will include number of falls, description of the fall event/mechanism and nature of the injury, changes in modifiable risk factors, and description of injury and treatment. A separate phone interview will be conducted with a subset of subjects at 6 months post fall, using open-ended questions to gather data about patient-perceived long-term consequences of falls. At the end of the 12-month data collection, we will reassess patient's functional status and cognition. Sample. Inclusion criterion includes all veterans who (1) are aged 62 and older, (2) use a wheelchair for their primary means of mobility, (3) have used a wheelchair for at least 12 months previous to enrollment, and (4) will be using a wheelchair for at least the next 12 months. Exclusion criteria (1) no longer living in a community-based setting (e.g., admitted to nursing home), (2) do not have a telephone. We will over sample women and minorities. A total of 882 subjects are needed for a power of 0.8 and an alpha of 0.05 with an anticipated drop out rate of 30%. Analysis. Bivariate analysis will be performed to determine relationships between outcomes and risk factors. Logistic regression models for predicting wheelchair-related tips, falls and fall-related injuries will be developed based on the most important intrinsic and extrinsic risk factors, controlling for possible confounders. Falls will also be analyzed according to a survival-analysis technique. Univariate and multiple Cox regression will be used to assess the associations of different independent variables with the injurious fall. The cost analysis estimates the net or marginal costs of wheelchair users who experience a wheelchair fall accident and seek medical advice or treatment. We use a dichotomous fall (generating medical expense) variable for a "with" or "without" analysis to compare the average cost of medical care for wheelchair users without a fall involving medical observation or care to the average cost of those that did have a serious fall (including death). The difference between these two groups is a proxy of the cost of utilization due to the fall. Multivariate regression analysis will be used to gauge the net effects of a fall on costs, controlling for the wider array of factors that drive cost of treatment and thereby potentially confound univariate analysis. The control variables are demographic including co-morbid conditions and healthcare related.
Anticipated Impact. Our project is expected to identify previously unaccounted for factors that predispose persons who use a wheelchair to falls and fall-related injuries. We will create models for predicting wheelchair tips, falls, and fall-related injuries. These models will be used to develop an evidence-based, patient centered wheelchair falls prevention program targeting modifiable risk factors. Findings from this study will be so used to develop an instrument to identify fall risk in elderly wheelchair users as well as an evidenced-based prevention program. We will partner with the VA National Center for Patient Safety to disseminate these products nationally in the VHA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Older veterans who use a wheelchair for their primary means of mobility. |
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| Measure | Description | Time Frame |
|---|---|---|
| Wheelchair-related Falls | Wheelchair-related falls in 1 year follow-up period. | one year follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| Injuries From Wheelchair-related Falls | Wheelchair-related falls that resulted in an injury in the one year follow up period | one year follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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Elderly wheelchair users
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| Name | Affiliation | Role |
|---|---|---|
| Andrea M Spehar, DVM MPH JD | VA Central Office - HSR&D, Washington, DC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans Hospital | Tampa | Florida | 33637-1022 | United States | ||
| VA Medical Center, San Juan |
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Recruitment began 06/01/2007; recruitment ended 11/30/2008. Data collection ended in December 2009. Subjects were approached in a VA medical clinic and given list of qualifying criteria on our flyer. After consent, a Mini-Mental State Examination (MMSE) is administered to all potential subjects; a score of at least 24 is required to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Older veterans who use a wheelchair for their primary means of mobility. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only data for 710 participants for some of the Baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Older veterans who use a wheelchair for their primary means of mobility. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Injuries From Wheelchair-related Falls | Wheelchair-related falls that resulted in an injury in the one year follow up period | Older veterans who use a wheelchair for their primary means of mobility. Analyzed for wheelchair-related fall injury during 1-year follow-up period. | Posted | Number | participants | one year follow-up period |
|
|
The original study (PI: Dr. Nelson, Co-PI: Dr. Groer) was approved by the affiliate University of South Florida Institutional Review Board (IRB) on 06/09/2006. Subject recruitment ended November 30, 2008. Data collection ended in December 2009.
This was a non-interventional, observational study of elderly veterans who regularly used a wheelchair for mobility. Adverse events other than death were not collected. Sometimes we were told of a death by a relative when we called. Any serious adverse events were unrelated to the study, which did not involve an intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elderly Veterans Using Wheelchairs for Mobility | Older veterans who use a wheelchair for their primary means of mobility. This was an observational study. There was no intervention and thus no adverse events were collected as part of the study. Sometimes we learned of a death from a relative when we called monthly. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Subjects were elderly, used a wheelchair, and often had multiple comorbidities, so some deaths during 1-year follow-up could be expected and were unrelated to this observational study. Death note in the computerized medical record or by relative. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea M. Spehar, DVM, MPH, JD | James A. Haley Veterans' Hospital | 813-558-3947 | Andrea.Spehar@va.gov |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| San Juan |
| 00921 |
| Puerto Rico |
| Bad health |
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| Stopped using wheelchair |
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| Subject expressed security concerns |
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| Eligibility changed due to Hospice move |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The data below was subject self-report on baseline survey: "What category best represents your race/ethnicity? (check one) White, Black/African American, Hispanic, etc." Therefore, the racial and ethnic categories must be summed and the totals of racial and ethnic categories will not be equal. | Number | participants |
|
| Region of Enrollment | Number | participants |
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| Health | Participants were asked to characterize their health: Excellent, Very good, good, fair, poor. | Number | participants |
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| Pain in last 4 weeks (interference with daily activities) | Pain in last 4 weeks and its interference with daily activities | Number | participants |
|
| Pain when transfer | Number | participants |
|
| Energy levels | Scale range 4.0-20. Highest energy level = 20.0. | Mean | Standard Deviation | units on a scale |
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| Primary | Wheelchair-related Falls | Wheelchair-related falls in 1 year follow-up period. | Older veterans who use a wheelchair for their primary means of mobility. | Posted | Number | participants | one year follow-up period |
|
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|
| 40 |
| 762 |
| 0 |
| 0 |
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Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Falls vs. Wheelchair-related Falls.
| Chi-squared |
| 0.013 |
| 2-Sided |
| No |
| Superiority or Other |
| Pain when transfer. No Wheelchair-related Falls vs. Wheelchair-related Falls. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Energy level. No Wheelchair-related Falls vs. Wheelchair-related Falls. | t-test, 2 sided | 0.007 | 2-Sided | No | Superiority or Other |