Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/9/2018 |
| Start Date: | September 23, 2019 |
| End Date: | February 28, 2022 |
| Contact: | Alyson J Littman, PhD MPH |
| Email: | alyson.littman@va.gov |
| Phone: | (206) 277-4162 |
The proportion of US Veterans who are women is currently at its highest point in history and
is projected to continue increasing. Nonetheless, the literature regarding prosthetic and
functional outcomes in women Veterans with lower extremity amputation (LEA) is nearly
non-existent. Research in other healthcare systems indicates the presence of concerning
gender differences in both prosthetic outcomes and functional mobility, with women being less
likely to be prescribed a prosthesis, less likely to use it, and more likely to be
dissatisfied than men. This mixed-methods study will use VA administrative data, qualitative
interviews, and a patient survey to characterize women Veterans' outcomes as well as compare
them to those of male Veterans, resulting in the largest study to date on women Veterans with
LEA. Data from this rigorous evaluation will inform clinical care by identifying intervention
targets to improve prosthetic and functional outcomes for this understudied population.
is projected to continue increasing. Nonetheless, the literature regarding prosthetic and
functional outcomes in women Veterans with lower extremity amputation (LEA) is nearly
non-existent. Research in other healthcare systems indicates the presence of concerning
gender differences in both prosthetic outcomes and functional mobility, with women being less
likely to be prescribed a prosthesis, less likely to use it, and more likely to be
dissatisfied than men. This mixed-methods study will use VA administrative data, qualitative
interviews, and a patient survey to characterize women Veterans' outcomes as well as compare
them to those of male Veterans, resulting in the largest study to date on women Veterans with
LEA. Data from this rigorous evaluation will inform clinical care by identifying intervention
targets to improve prosthetic and functional outcomes for this understudied population.
Background: The VA has a long history of developing and providing state-of-the-art prosthetic
technology and rehabilitation services for Veterans with lower extremity amputations (LEA).
Despite VA's goal to provide patient-centered, gender-sensitive care to all Veterans,
prosthetics research in VA has mainly included and focused on the needs of men. Women are the
fastest growing demographic in VA, and VA currently provides care to over 1,200 women with a
major LEA. That number will likely increase as the number of women Veterans, currently at its
highest point in history, is expected to continue rising. Primary goals of rehabilitation
following a major LEA include successfully fitting a prosthesis and providing training to use
the prosthesis to achieve functional mobility. Greater prosthesis use is associated with
improved mobility, functioning, and independence as well as better quality of life. Thus,
identifying the extent to which women achieve functional mobility through prostheses that fit
them and meet their needs is critical to ensure that VA is providing excellent and equitable
care. Accordingly, the goal of this research is to provide information that will improve
clinical care for women Veterans with LEA.
Objectives: The objectives of this study are to: 1) characterize prosthetic prescription
rates, prosthetic-device types, time to prescription, and their correlates among women with
major LEA as well as evaluate gender differences in these outcomes using administrative data;
2) identify barriers and facilitators to achieving successful functional mobility, factors
impacting prosthetic use and satisfaction, and needs and preferences related to prostheses
among women with major LEA who were prescribed a prosthesis using qualitative interviews; and
3) characterize prosthetic use, prosthetic satisfaction, functional mobility, and
health-related quality of life and their correlates among women as well as evaluate gender
differences in these outcomes using survey data.
Methods: To achieve these objectives, the investigators will capitalize on VA's extensive
electronic medical record data, including the Corporate Data Warehouse and National
Prosthetics Patient Database (Aim 1), as well as conduct qualitative interviews (Aim 2) and a
quantitative survey (Aim 3) with Veterans with LEA. Both administrative data and the survey
will include women and men, to characterize women overall and in comparison to men.
Information on prescriptions for definitive prostheses will come from administrative data by
linking individuals identified in the Corporate Data Warehouse with data in the National
Prosthetics Patient Database; other outcomes will be assessed via survey. For Aim 2, the
investigators will conduct semi-structured telephone interviews with a sample of women with a
major LEA who were prescribed a prosthesis. Aim 3 will involve a self-administered mailed
survey that will permit us to characterize prosthetic use, prosthetic satisfaction,
functional mobility, and health-related quality of life and evaluate clinical,
social/environmental, and prosthetist/prostheses-related factors as potential determinants of
outcomes among women as well as potential mediators that explain observed gender differences.
Impact: For VA to realize its vision of being a world leader in providing lifelong,
gender-sensitive amputation care, assessing prosthetic and functional outcomes among women is
critical, as is understanding the factors that may negatively and positively contribute to
women's prosthetic and functional outcomes. This study would significantly expand the
evidence base for women Veterans with LEA and produce information that would inform
improvements in clinical care for this population.
technology and rehabilitation services for Veterans with lower extremity amputations (LEA).
Despite VA's goal to provide patient-centered, gender-sensitive care to all Veterans,
prosthetics research in VA has mainly included and focused on the needs of men. Women are the
fastest growing demographic in VA, and VA currently provides care to over 1,200 women with a
major LEA. That number will likely increase as the number of women Veterans, currently at its
highest point in history, is expected to continue rising. Primary goals of rehabilitation
following a major LEA include successfully fitting a prosthesis and providing training to use
the prosthesis to achieve functional mobility. Greater prosthesis use is associated with
improved mobility, functioning, and independence as well as better quality of life. Thus,
identifying the extent to which women achieve functional mobility through prostheses that fit
them and meet their needs is critical to ensure that VA is providing excellent and equitable
care. Accordingly, the goal of this research is to provide information that will improve
clinical care for women Veterans with LEA.
Objectives: The objectives of this study are to: 1) characterize prosthetic prescription
rates, prosthetic-device types, time to prescription, and their correlates among women with
major LEA as well as evaluate gender differences in these outcomes using administrative data;
2) identify barriers and facilitators to achieving successful functional mobility, factors
impacting prosthetic use and satisfaction, and needs and preferences related to prostheses
among women with major LEA who were prescribed a prosthesis using qualitative interviews; and
3) characterize prosthetic use, prosthetic satisfaction, functional mobility, and
health-related quality of life and their correlates among women as well as evaluate gender
differences in these outcomes using survey data.
Methods: To achieve these objectives, the investigators will capitalize on VA's extensive
electronic medical record data, including the Corporate Data Warehouse and National
Prosthetics Patient Database (Aim 1), as well as conduct qualitative interviews (Aim 2) and a
quantitative survey (Aim 3) with Veterans with LEA. Both administrative data and the survey
will include women and men, to characterize women overall and in comparison to men.
Information on prescriptions for definitive prostheses will come from administrative data by
linking individuals identified in the Corporate Data Warehouse with data in the National
Prosthetics Patient Database; other outcomes will be assessed via survey. For Aim 2, the
investigators will conduct semi-structured telephone interviews with a sample of women with a
major LEA who were prescribed a prosthesis. Aim 3 will involve a self-administered mailed
survey that will permit us to characterize prosthetic use, prosthetic satisfaction,
functional mobility, and health-related quality of life and evaluate clinical,
social/environmental, and prosthetist/prostheses-related factors as potential determinants of
outcomes among women as well as potential mediators that explain observed gender differences.
Impact: For VA to realize its vision of being a world leader in providing lifelong,
gender-sensitive amputation care, assessing prosthetic and functional outcomes among women is
critical, as is understanding the factors that may negatively and positively contribute to
women's prosthetic and functional outcomes. This study would significantly expand the
evidence base for women Veterans with LEA and produce information that would inform
improvements in clinical care for this population.
Inclusion Criteria:
Aim 1 (prosthetic prescription, device types, and time to prescription using administrative
data):
- Male or female Veteran with a first major lower extremity amputation performed in VA
Medical Center between FY05 and FY18, regardless of etiology.
- Amputation will be determined based on having an inpatient or outpatient procedure
code for a major LEA that is at or above the ankle (ICD-9 CM 84.13-84.19; see Appendix
4 for ICD-10 codes and CPT codes).
- Patients will need to have had at least one VHA outpatient encounter in the 24 months
prior to their amputation.
Aim 2 (qualitative interviews with women):
- Women Veteran VHA patients who have had a major lower extremity amputation, documented
prescription for a prosthesis in the VA National Prosthetics Patient Database at least
12 months prior, and be alive.
Aim 3 (prosthetic use, satisfaction, and functional mobility using survey data):
- Men and women Veteran VHA patients who have had a major lower extremity amputation,
documented prescription for a prosthesis in the VA National Prosthetics Patient
Database at least 12 months prior, and be alive.
Exclusion Criteria:
Aim 1 (prosthetic prescription, device types, and time to prescription using administrative
data):
- ankle amputations with anterior procedures (because prostheses are not indicated for
these individuals)
- prior major amputation
- unable to ambulate prior to amputation (dependent functional status, pre-operative
coma)
- hemiplegia
- quadriplegia
- ventilator dependent
- dementia
- metastatic cancer
- spinal cord injury
Aim 2 (Qualitative interviews with women):
- Specified based on eligibility criteria above.
Aim 3 (prosthetic use, satisfaction, and functional mobility using survey data):
- Specified based on eligibility criteria above.
We found this trial at
1
site
Seattle, Washington 98108
Principal Investigator: Alyson J. Littman, PhD MPH
Phone: 206-768-5357
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