Pressure Ulcer
Conditions
Keywords
pressure ulcer
Brief summary
The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of the proposed trial will provide the level of evidence needed to change the standard of care to include the routine evaluation of at-risk residents for seating and positioning needs and the provision of pressure-reducing cushions as a preventive measure against sitting-acquired pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs, and improved quality of life.
Detailed description
Pressure ulcers (aka pressure sores, bed sores and decubitus ulcers) are a significant healthcare problem for the growing number of United States elderly long-term care (LTC) residents. Pressure ulcers (PU) diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs. Despite Federal preventive mandates for the long-term care (LTC) setting, widespread non-compliance occurs. The last three Centers for Medicare and Medicaid Services (CMS) LTC surveys showed a cumulative increase of 21% in the number of citations issued for failure to provide proper intervention to prevent or treat pressure ulcers. Costs for the management of PU in the US likely exceed $6.4 billion annually with a prevalence of approximately 28% in the LTC population. Estimates of the number of sitting-acquired PU in the elderly, at-risk population range from 36-50%. Several studies, including our own pilot investigation, support these estimates and have suggested that the use of wheelchair cushions designed to reduce interface pressure will reduce the incidence of sitting-acquired PU. Despite this evidence, elderly wheelchair users are not routinely evaluated for seating and positioning needs as definitive studies have not been completed to justify funding for such seating interventions. Consequently, elderly Medicare beneficiaries are being denied access to medically necessary and clinically appropriate interventions and instead are most frequently provided with convoluted or segmented-foam cushions that are not designed for pressure ulcer prevention. The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of the proposed trial will provide the level of evidence needed to change the standard of care to include the routine evaluation of at-risk residents for seating and positioning needs and the provision of pressure-reducing cushions as a preventive measure against sitting-acquired pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs, and improved quality of life.
Interventions
DEVICESkin Protection Wheelchair Seat Cushion
Cushion receiving CMS code for Skin Protection Wheelchair Cushion
DEVICESegmented Foam Wheelchair Seat Cushion
General use class wheelchair seat cushion
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 and older * use wheelchair \> 6 hours per day * no pressure ulcer on sitting surface * Braden score of 18 or less * combined activity and mobility Braden sub-score of 5 or less
Exclusion criteria
* Body Weight exceeds 250 lbs. * Hip Width exceeds 20 inches * does not meet all criteria of seating needs assessment * current use of cushioning material or wheelchair better than study devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sitting-induced Pressure Ulcers | 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Segmented Foam Cushion Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes
Segmented Foam Wheelchair Seat Cushion: General use class wheelchair seat cushion | 119 |
| Skin Protection Cushion Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion
Skin Protection Wheelchair Seat Cushion: Cushion receiving CMS code for Skin Protection Wheelchair Cushion | 113 |
| Total | 232 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not receive intervention | 4 | 6 |
| Overall Study | Lost to Follow-up | 21 | 21 |
Baseline characteristics
| Characteristic | Segmented Foam Cushion | Skin Protection Cushion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 119 Participants | 113 Participants | 232 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 86.5 years STANDARD_DEVIATION 7.7 | 86.7 years STANDARD_DEVIATION 7.4 | 86.6 years STANDARD_DEVIATION 7.6 |
| Body Mass Index | 25.0 kg/m^2 STANDARD_DEVIATION 5.2 | 24.6 kg/m^2 STANDARD_DEVIATION 4.4 | 24.8 kg/m^2 STANDARD_DEVIATION 4.8 |
| Incontinence | 97 participants | 97 participants | 194 participants |
| Sex: Female, Male Female | 106 Participants | 91 Participants | 197 Participants |
| Sex: Female, Male Male | 13 Participants | 22 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 119 | 0 / 113 |
| serious Total, serious adverse events | 0 / 119 | 0 / 113 |
Outcome results
Primary
Sitting-induced Pressure Ulcers
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Segmented Foam Cushion | Sitting-induced Pressure Ulcers | 8 participants |
| Skin Protection Cushion | Sitting-induced Pressure Ulcers | 1 participants |
p-value: 0.04Fisher Exact