Clinical trial NCT01236170: Understanding Quality and Equity in Wheelchairs for Veterans
Official title: Understanding Quality and Equity in Wheelchairs for Veterans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Amputees
Keywords: Amputees
spinal cord injuries
quality of life
satisfaction
healthcare disparities
wheelchairs
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-11-07
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Quality of Life Assessed With the Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: Measured at baseline
Secondary outcomes:
measure: Satisfaction With Wheelchair Service Delivery
timeFrame: one time use, at baseline
measure: Satisfaction With Prescribed Wheelchair
timeFrame: one time use, at baseline
measure: Participation in Society
timeFrame: Measured at baseline
measure: Wheelchair Activity
timeFrame: over a two week period following baseline
Other outcomes:
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital, Tampa, FL
state: Florida
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
city: Pittsburgh
country: United States
facility: Center for Health Equity Research and Promotion
state: Pennsylvania
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA
state: Virginia
Study officials:
affiliation: Center for Health Equity Research and Promotion
name: Larissa Myaskovsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Myaskovsky 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.