AmputationNCT03733054
Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
An observational study of Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amputation
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 1 Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: VHA patients - national sample
Who may be able to join
- 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 lower extremity amputation (ICD-9 CM 84.13-84.19; ICD-10 codes and CPT codes also assessed but not detailed here because of space limitations).
- 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, self-reported receiving a prescription for a prosthesis at least 12 months prior, and 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, self-reported prescription for a prosthesis at least 12 months prior, and be alive.
Who cannot join
- Aim 1 (prosthetic prescription, device types, and time to prescription using administrative data):
- prior major amputation
- unable to ambulate prior to amputation , including spinal cord injury, paraplegia, hemiplegia, or quadriplegia
- dementia
- hemipelvectomy or hip disarticulation
- ankle disarticulation
Show all 12Show fewer
- bilateral amputation or not definitive
- death in the 3 weeks after index amputation
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
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.
Read the detailed description
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 (Aim 1), 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. The investigators will determine which patients have received prescriptions for definitive prostheses by linking procedure data related to amputations and prosthetics data (which are all available within the Corporate Data Warehouse); 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.
- Conditions
- Amputation
- Keywords
- female, Veterans, Quality of life, Prostheses, Lower extremity amputation, Surveys and questionnaires, electronic health records
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Men | Men with lower limb amputation | |
| Women | Women with lower limb amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic prescription rate
Prosthetic prescription determined based on data in VA electronic medical records Sample will include those with an amputation between October 2004 (start of FY2005) and September 2018 (end of FY2018)
Measured: 12-months post first major amputation
Use of prosthesis
Orthotics and Prosthetics Users' Survey (OPUS) - 2 items Item 1: Hours per day of wear time for prosthesis Item 2: Hours per day of walking on prosthesis
Measured: July 2020-December 2021
Secondary outcomes (5)
Functional satisfaction with prosthesis
Trinity Amputation and Prosthesis Experiences Scales (TAPES) Satisfaction subscale Functional satisfaction (5 items) - score range: 5-15 (higher score = more satisfied)
Measured: July 2020-December 2021
Overall satisfaction with prosthesis
Trinity Amputation and Prosthesis Experiences Scales (TAPES) Satisfaction subscale Overall satisfaction (1 item) - score range: 0 (not at all satisfied) to 10 (very satisfied)
Measured: July 2020-December 2021
Aesthetic satisfaction with prosthesis
Trinity Amputation and Prosthesis Experiences Scales (TAPES) Satisfaction subscale Aesthetic satisfaction (3 items) - score range: 3-9 (higher score = more satisfied)
Measured: July 2020-December 2021
Functional mobility
Prosthetic Limb Users Survey (PLUS-M)
Measured: July 2020-December 2021
Health-related quality of life
PROMIS Scale V1.2 - Global Health which has two subscales - Global Physical Health (range 16.2-67.7) and Global Mental Health (21.2-67.6) Higher scores indicate better health Mean=50, Standard Deviation=10
Measured: July 2020-December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start24 Sep 2019
- Primary completion31 Mar 2022
- Study completion1 Dec 2022
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 AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alyson J. Littman, PhD MPH, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733054
- Sponsor's protocol ID
- A2797-R
- Status last verified
- Feb 2023
- First submitted
- 5 Nov 2018
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created and shared.
Publications
Lehavot K, Young JP, Thomas RM, Williams RM, Turner AP, Norvell DC, Czerniecki JM, Korpak A, Littman AJ. Voices of Women Veterans with Lower Limb Prostheses: a Qualitative Study. J Gen Intern Med. 2022 Sep;37(Suppl 3):799-805. doi: 10.1007/s11606-022-07572-8. Epub 2022 Sep 1.
PubMed 36050521
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
- ClinicalTrials.gov ID
- NCT03733054
- Acronym / sponsor ID
- A2797-R
- Conditions
- Amputation
- Keywords
- female, Veterans, Quality of life, Prostheses, Lower extremity amputation, Surveys and questionnaires, electronic health records
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 7 Nov 2018 (actual)
- 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 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.
Detailed description
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 (Aim 1), 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. The investigators will determine which patients have received prescriptions for definitive prostheses by linking procedure data related to amputations and prosthetics data (which are all available within the Corporate Data Warehouse); 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men | – | –Men with lower limb amputation |
| Women | – | –Women with lower limb amputation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- VHA patients - national sample
Key inclusion criteria (8 listed)
- 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 lower extremity amputation (ICD-9 CM 84.13-84.19; ICD-10 codes and CPT codes also assessed but not detailed here because of space limitations).
- Patients will need to have had at least one VHA outpatient encounter in the 24 months prior to their amputation.
- Women Veteran VHA patients who have had a major lower extremity amputation, self-reported receiving a prescription for a prosthesis at least 12 months prior, and alive.
Key exclusion criteria (12 listed)
- Aim 1 (prosthetic prescription, device types, and time to prescription using administrative data):
- prior major amputation
- unable to ambulate prior to amputation , including spinal cord injury, paraplegia, hemiplegia, or quadriplegia
- dementia
- hemipelvectomy or hip disarticulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prosthetic prescription rate
Time frame: 12-months post first major amputation
Prosthetic prescription determined based on data in VA electronic medical records Sample will include those with an amputation between October 2004 (start of FY2005) and September 2018 (end of FY2018)
Use of prosthesis
Time frame: July 2020-December 2021
Orthotics and Prosthetics Users' Survey (OPUS) - 2 items Item 1: Hours per day of wear time for prosthesis Item 2: Hours per day of walking on prosthesis
5 secondary outcomes
Functional satisfaction with prosthesis
Time frame: July 2020-December 2021
Overall satisfaction with prosthesis
Time frame: July 2020-December 2021
Aesthetic satisfaction with prosthesis
Time frame: July 2020-December 2021
Functional mobility
Time frame: July 2020-December 2021
Health-related quality of life
Time frame: July 2020-December 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Results publication: PubMed 36050521Lehavot K, Young JP, Thomas RM, Williams RM, Turner AP, Norvell DC, Czerniecki JM, Korpak A, Littman AJ. Voices of Women Veterans with Lower Limb Prostheses: a Qualitative Study. J Gen Intern Med. 2022 Sep;37(Suppl 3):799-805. doi: 10.1007/s11606-022-07572-8. Epub 2022 Sep 1.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created and shared.
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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.
Alyson J. Littman, PhD MPH principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, run by VA Office of Research and Development 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 16 Feb 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prosthetic prescription rate (time frame: 12-months post first major amputation). The study lists 2 primary outcomes in all. 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 NCT03733054, 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 16 Feb 2023.