Spinal Cord InjuriesNCT01236170
Understanding Quality and Equity in Wheelchairs for Veterans
An observational study of Spinal Cord Injuries and Amputees, run by VA Office of Research and Development at 5 sites in United States.
Trial summary
The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with SCI and more than 40,000 Veterans with amputated limbs (AL). Despite VA's efforts to remove financial and other barriers to the provision of wheelchairs to all Veterans who need them, preliminary evidence suggests that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Amputees
- How many people
- 497 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2011to Sep 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the following four VA Medical Centers: the Philadelphia VA Medical Center in Philadelphia, PA; the Louis Stokes VA Medical Center in Cleveland, OH; The Hunter Holmes McGuire VA Medical Center in Richmond, VA; and the James J. Peters VA Medical Center in Bronx, NY. Recruitment will occur at SCI clinics, amputee clinics, wheelchair clinics, and patient registries.
Who may be able to join
- Veterans
- age >18 years
- must have SCI with discernible neurological impairments or an amputated lower limb which results in the use of a wheelchair
- must be in power or manual wheelchair >1 year and treated at the participating VAMC
- participants must use a manual or power wheelchair as their primary means of mobility (e.g., use wheelchair > 40 hours/week
- and be non-ambulatory except for exercise purposes
Who cannot join
- In wheelchair less than 1 year
- Able to ambulate without the use of a wheelchair
- Other disorders requiring the use of a wheelchair (e.g., MS)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
Center for Health Equity Research and Promotion
Pittsburgh, Pennsylvania, 15206
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
About this study
The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with SCI and more than 40,000 Veterans with amputated limbs (AL). Despite VA's efforts to remove financial and other barriers to the provision of wheelchairs to all Veterans who need them, preliminary evidence suggests that disparities exist in the quality of wheelchairs prescribed to racial minorities and low income Veterans with SCI or AL. The proposed project will provide important information to the VA about the quality and equity of wheelchairs provided to Veterans with SCI or AL, and it will identify the patient and provider factors associated with wheelchair provision. Because Veterans with SCI and AL are considered special disability populations, identifying and understanding these factors is a critical first step to developing interventions to increase the quality and equity of wheelchairs provided to all disabled Veterans.
Read the detailed description
Wheelchairs enable Veterans to participate in home, employment, and social activities that might otherwise be inaccessible to them, thereby improving their quality of life (QOL). Despite VA's efforts to remove financial and other barriers to the provision of high quality wheelchairs to all Veterans, preliminary evidence suggests that disparities exist in the quality of wheelchairs prescribed to vulnerable (e.g., minority race/ethnicity, lower socioeconomic status) Veterans with Spinal Cord Injury (SCI) or amputated limbs (AL). This finding is concerning because patients who receive lower quality wheelchairs may be at risk for adverse physical, psychological, economic, and QOL outcomes. Mounting research demonstrates that patient psychosocial characteristics (e.g., medical mistrust, perceived discrimination, locus of control) and provider factors (e.g., demographics and training) are associated with disparities in healthcare processes and outcomes. However, for Veterans with SCI or AL, no studies to date have examined (a) what patient and provider factors are associated with the prescription of high quality wheelchairs, and (b) how these factors are associated with wheelchair quality and patient outcomes. The proposed cross-sectional, multi-site study of Veterans with SCI or AL who use a wheelchair as their primary source of mobility aims to determine whether: (1) patient demographic (e.g., race, SES) and psychosocial characteristics (e.g., medical mistrust, experience of discrimination) and provider factors (e.g., years of practice, certification, demographics) are associated with wheelchair quality; (2) wheelchair quality is associated with key patient outcomes, including satisfaction with medical care, QOL, amount of wheelchair activity, and participation in social and work-related activities; (3) patient and provider factors are independently associated with key patient outcomes including satisfaction with medical care, QOL, amount of wheelchair activity, and participation; and (4) the association of patient and provider factors with patient outcomes is explained by differences in wheelchair quality. Veterans with SCI or AL, who were prescribed their wheelchairs through the VA, will be recruited from the Philadelphia, PA, Cleveland, OH, Richmond, VA, and Bronx, NY VA Medical Centers to participate in an interview to assess their demographic characteristics, health information, psychosocial characteristics (including, experience of discrimination, perceived racism, medical mistrust, self-image, anxiety/depression, health beliefs, health literacy, and communication) and health-related outcomes (including wheelchair skills, satisfaction, QOL, participation). We will also assess amount of wheelchair activity using data logging devices, and determine wheelchair quality by its make and model. Data will also be collected from all health care providers involved in wheelchair provision for study participants.
Provider factors will include demographics (e.g., race/ethnicity, age, gender), and specialty (i.e., MD/OT/PT).
For Occupational and Physical Therapists, we will determine if they are certified by the Rehabilitation Engineering and Assistive Technology Society of North America. Years of practice since completion of medical training, number of chairs prescribed over the span of their career, what role each provider plays in the wheelchair provision process, as well as the number of continuing medical education (CME) credits and/or educational credit units (ECU) they have obtained in the past 3 years related specifically to wheelchairs, will also be assessed. Understanding the associations among the proposed patient characteristics and provider factors is an essential step toward developing tailored interventions, aimed at patients and providers, to improve the quality and equity of wheelchair service delivery for Veterans.
- Conditions
- Spinal Cord Injuries, Amputees
- Keywords
- Amputees, spinal cord injuries, quality of life, satisfaction, healthcare disparities, wheelchairs
- Medical subject headings
- Spinal Cord Injuries, Personal Satisfaction
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 |
|---|---|---|
| Group 1 | Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Assessed With the Veterans RAND 12 Item Health Survey (VR-12)
The investigators will assess QOL with the Veterans RAND 12 Item Health Survey (VR-12) and two additional physical function items designed for patients with SCI. Eight QOL domains are assessed, including physical functioning, vitality, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health, social functioning, and mental health. The VR-12 has been used extensively with Veterans in a variety of health domains and has shown to be reliable and valid in ambulatory care populations (Cronbach's alpha= .83-.85). The additional two items were added because previous research demonstrated that existing measures of physical function in the VR12 are not appropriate to patients with SCI and are not able to reveal differences in physical function among SCI patients. The investigators assessed physical QOL and mental QOL, both scales range from 0 (worst possible outcome) to 100 (best possible outcome).
Measured: Measured at baseline
Secondary outcomes (4)
Satisfaction With Wheelchair Service Delivery
The investigators assessed Satisfaction with Wheelchair Service Delivery using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily administered and scored measure of client satisfaction with services (e.g., "How would you rate the quality of service you have received?"). For the purpose of this study, the investigators asked patients to focus specifically on satisfaction with service at their SCI or AL wheelchair clinic. The scale is unidimensional, yielding a homogenous estimate of general satisfaction with services. It is scored by summing the individual items and produces a score ranging from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 has been extensively used in a variety of healthcare settings, operates similarly across ethnic groups, and demonstrates excellent psychometric properties (Cronbach's alpha = .83-.93).
Measured: one time use, at baseline
Satisfaction With Prescribed Wheelchair
We assessed Satisfaction with patients' prescribe wheelchair using the Quebec User Evaluation of Satisfaction with assistive Technology ( (QUEST). We used an 8-item subset of the QUEST to assess patients' satisfaction with their wheelchair. QUEST is the first and only standardized satisfaction assessment tool that was designed specifically for assistive technology devices. Its' development was based on major theoretical models of assistive technology. The QUEST has been widely cited and used in clinical and research settings, and demonstrates strong psychometric properties (Cronbach's alpha = .82). The 8 item subset focuses specifically on patients' satisfaction with different aspects of their wheelchair (e.g., "How satisfied are you with the dimensions (size, height, length, width) of your assistive device?"). Responses range from 1(not satisfied at all) to 5(very satisfied). Cronbach's alpha = .80 for the 8-item wheelchair subset. We chose to eliminate the other four items.
Measured: one time use, at baseline
Participation in Society
We assessed participation in society with a modified version of the Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF). The CHART was designed to provide a simple measure of involvement in life situations ("In a typical week, how many days do you get out of your house and go somewhere?") with sub-scales measuring physical independence, cognitive independence, mobility, occupation, social integration and economic self-sufficiency. The CHART-SF produces scores ranging from 0 (severe handicap) to 100 (no handicap) for each of the sub-scales and a total score ranging from 0-600. The CHART-SF is the most widely used participation measure in rehabilitation research. It has been used in various ethnic groups, and has well-established psychometric properties (test-retest reliability = .93; inter-rater reliability = .83). We dichotomized into "Disabled" and "Not Disabled" where disabled are those with a CHART score <100, and not disabled are those with a CHART score >=100
Measured: Measured at baseline
Wheelchair Activity
Measured: over a two week period following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Larissa Myaskovsky, PhD, Principal investigator, Center for Health Equity Research and Promotion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236170
- Sponsor's protocol ID
- B7148-I
- Status last verified
- Jun 2019
- First submitted
- 4 Nov 2010
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hart-Hughes S, Highsmith MJ, Phillips SL, Groer S. A review of clinical outcome assessment instruments for gait, balance, and fall rish in persons with lower level extremity amputation. Topics in Geriatric Rehabilitation. 2014 Mar 31; 30(1):70-76.
Myaskovsky L, Gao S, Hausmann LRM, Bornemann KR, Burkitt KH, Switzer GE, Fine MJ, Phillips SL, Gater D, Spungen AM, Boninger ML. How Are Race, Cultural, and Psychosocial Factors Associated With Outcomes in Veterans With Spinal Cord Injury? Arch Phys Med Rehabil. 2017 Sep;98(9):1812-1820.e3. doi: 10.1016/j.apmr.2016.12.015. Epub 2017 Jan 25.
PubMed 28130083Myaskovsky L, Gao S, Hausmann LRM, Bornemann KR, Burkitt KH, Switzer GE, Fine MJ, Phillips SL, Gater D, Spungen AM, Worobey L, Boninger ML. Quality and Equity in Wheelchairs Used by Veterans. Arch Phys Med Rehabil. 2017 Mar;98(3):442-449. doi: 10.1016/j.apmr.2016.09.116. Epub 2016 Oct 3.
PubMed 27713075
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Quality and Equity in Wheelchairs for Veterans
- ClinicalTrials.gov ID
- NCT01236170
- Acronym / sponsor ID
- B7148-I
- Conditions
- Spinal Cord Injuries, Amputees
- Keywords
- Amputees, spinal cord injuries, quality of life, satisfaction, healthcare disparities, wheelchairs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Mar 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Posted 31 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Department of Veterans Affairs (VA) provides wheelchairs to about 42,000 Veterans with SCI and more than 40,000 Veterans with amputated limbs (AL). Despite VA's efforts to remove financial and other barriers to the provision of wheelchairs to all Veterans who need them, preliminary evidence suggests that disparities exist in the quality of wheelchairs prescribed to racial minorities and low income Veterans with SCI or AL. The proposed project will provide important information to the VA about the quality and equity of wheelchairs provided to Veterans with SCI or AL, and it will identify the patient and provider factors associated with wheelchair provision. Because Veterans with SCI and AL are considered special disability populations, identifying and understanding these factors is a critical first step to developing interventions to increase the quality and equity of wheelchairs provided to all disabled Veterans.
Detailed description
Wheelchairs enable Veterans to participate in home, employment, and social activities that might otherwise be inaccessible to them, thereby improving their quality of life (QOL). Despite VA's efforts to remove financial and other barriers to the provision of high quality wheelchairs to all Veterans, preliminary evidence suggests that disparities exist in the quality of wheelchairs prescribed to vulnerable (e.g., minority race/ethnicity, lower socioeconomic status) Veterans with Spinal Cord Injury (SCI) or amputated limbs (AL). This finding is concerning because patients who receive lower quality wheelchairs may be at risk for adverse physical, psychological, economic, and QOL outcomes. Mounting research demonstrates that patient psychosocial characteristics (e.g., medical mistrust, perceived discrimination, locus of control) and provider factors (e.g., demographics and training) are associated with disparities in healthcare processes and outcomes. However, for Veterans with SCI or AL, no studies to date have examined (a) what patient and provider factors are associated with the prescription of high quality wheelchairs, and (b) how these factors are associated with wheelchair quality and patient outcomes. The proposed cross-sectional, multi-site study of Veterans with SCI or AL who use a wheelchair as their primary source of mobility aims to determine whether: (1) patient demographic (e.g., race, SES) and psychosocial characteristics (e.g., medical mistrust, experience of discrimination) and provider factors (e.g., years of practice, certification, demographics) are associated with wheelchair quality; (2) wheelchair quality is associated with key patient outcomes, including satisfaction with medical care, QOL, amount of wheelchair activity, and participation in social and work-related activities; (3) patient and provider factors are independently associated with key patient outcomes including satisfaction with medical care, QOL, amount of wheelchair activity, and participation; and (4) the association of patient and provider factors with patient outcomes is explained by differences in wheelchair quality. Veterans with SCI or AL, who were prescribed their wheelchairs through the VA, will be recruited from the Philadelphia, PA, Cleveland, OH, Richmond, VA, and Bronx, NY VA Medical Centers to participate in an interview to assess their demographic characteristics, health information, psychosocial characteristics (including, experience of discrimination, perceived racism, medical mistrust, self-image, anxiety/depression, health beliefs, health literacy, and communication) and health-related outcomes (including wheelchair skills, satisfaction, QOL, participation). We will also assess amount of wheelchair activity using data logging devices, and determine wheelchair quality by its make and model. Data will also be collected from all health care providers involved in wheelchair provision for study participants.
Provider factors will include demographics (e.g., race/ethnicity, age, gender), and specialty (i.e., MD/OT/PT).
For Occupational and Physical Therapists, we will determine if they are certified by the Rehabilitation Engineering and Assistive Technology Society of North America. Years of practice since completion of medical training, number of chairs prescribed over the span of their career, what role each provider plays in the wheelchair provision process, as well as the number of continuing medical education (CME) credits and/or educational credit units (ECU) they have obtained in the past 3 years related specifically to wheelchairs, will also be assessed. Understanding the associations among the proposed patient characteristics and provider factors is an essential step toward developing tailored interventions, aimed at patients and providers, to improve the quality and equity of wheelchair service delivery for Veterans.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the following four VA Medical Centers: the Philadelphia VA Medical Center in Philadelphia, PA; the Louis Stokes VA Medical Center in Cleveland, OH; The Hunter Holmes McGuire VA Medical Center in Richmond, VA; and the James J. Peters VA Medical Center in Bronx, NY. Recruitment will occur at SCI clinics, amputee clinics, wheelchair clinics, and patient registries.
Key inclusion criteria (6 listed)
- Veterans
- age >18 years
- must have SCI with discernible neurological impairments or an amputated lower limb which results in the use of a wheelchair
- must be in power or manual wheelchair >1 year and treated at the participating VAMC
- participants must use a manual or power wheelchair as their primary means of mobility (e.g., use wheelchair > 40 hours/week
Key exclusion criteria (3 listed)
- In wheelchair less than 1 year
- Able to ambulate without the use of a wheelchair
- Other disorders requiring the use of a wheelchair (e.g., MS)
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
Quality of Life Assessed With the Veterans RAND 12 Item Health Survey (VR-12)
Time frame: Measured at baseline
The investigators will assess QOL with the Veterans RAND 12 Item Health Survey (VR-12) and two additional physical function items designed for patients with SCI. Eight QOL domains are assessed, including physical functioning, vitality, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health, social functioning, and mental health. The VR-12 has been used extensively with Veterans in a variety of health domains and has shown to be reliable and valid in ambulatory care populations (Cronbach's alpha= .83-.85). The additional two items were added because previous research demonstrated that existing measures of physical function in the VR12 are not appropriate to patients with SCI and are not able to reveal differences in physical function among SCI patients. The investigators assessed physical QOL and mental QOL, both scales range from 0 (worst possible outcome) to 100 (best possible outcome).
4 secondary outcomes
Satisfaction With Wheelchair Service Delivery
Time frame: one time use, at baseline
Satisfaction With Prescribed Wheelchair
Time frame: one time use, at baseline
Participation in Society
Time frame: Measured at baseline
Wheelchair Activity
Time frame: over a two week period following baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationHart-Hughes S, Highsmith MJ, Phillips SL, Groer S. A review of clinical outcome assessment instruments for gait, balance, and fall rish in persons with lower level extremity amputation. Topics in Geriatric Rehabilitation. 2014 Mar 31; 30(1):70-76.
- Derived from this study: PubMed 28130083Myaskovsky L, Gao S, Hausmann LRM, Bornemann KR, Burkitt KH, Switzer GE, Fine MJ, Phillips SL, Gater D, Spungen AM, Boninger ML. How Are Race, Cultural, and Psychosocial Factors Associated With Outcomes in Veterans With Spinal Cord Injury? Arch Phys Med Rehabil. 2017 Sep;98(9):1812-1820.e3. doi: 10.1016/j.apmr.2016.12.015. Epub 2017 Jan 25.
- Derived from this study: PubMed 27713075Myaskovsky L, Gao S, Hausmann LRM, Bornemann KR, Burkitt KH, Switzer GE, Fine MJ, Phillips SL, Gater D, Spungen AM, Worobey L, Boninger ML. Quality and Equity in Wheelchairs Used by Veterans. Arch Phys Med Rehabil. 2017 Mar;98(3):442-449. doi: 10.1016/j.apmr.2016.09.116. Epub 2016 Oct 3.
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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.
Larissa Myaskovsky, PhD principal investigator
Center for Health Equity Research and Promotion
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Amputees, run by VA Office of Research and Development at 5 sites 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 6 inclusion and 3 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 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 31 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quality of Life Assessed With the Veterans RAND 12 Item Health Survey (VR-12) (time frame: Measured at baseline). 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 NCT01236170, which also lists 3 linked publications.
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 27 Jun 2019.