Prospective Randomized Trial to Determine the Safety of Reusing Walking Boot Components for Patients Recovering From Acute Foot and Ankle Injuries
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of skin based complications (%)
研究概览
简要总结
The investigators primary purposes is to determine the safety of reusing a specific durable medical equipment (DME) item (walking boots) components for patients recovering from acute foot and ankle injuries.
The investigators secondary purpose is to determine the number of reuse episodes specific walking boot components can endure without increased failure rates.
To support further study of DME reuse, product design, and advocate for evolving regulations that promote waste reduction via development of reusable DME products in the US.
详细描述
The designation of an item as "durable medical equipment" (DME) implies the item is designed to be long-lasting and hold up to prolonged use. In practice, however, many DME items are utilized for a single patient after a single injury or procedure. This is particularly true in pediatric care, where patients are growing, and saving the item for later use is unlikely to maintain appropriate fit for the older child.
Walking boots, also termed CAM boots, are prescribed frequently in pediatric orthopaedic clinics across the country. These boots provide support, comfort, and immobilization while also allowing for removal to allow patients to begin wound care, range of motion exercises, and bathing. They provide a valuable transitional stage between casting and splinting and resumption of typical, unsupported ambulation and other activities. While differences in design exist between vendors, the vast majority of walking boots have a modular design including a base/sole attached to rigid medial and lateral posts, soft fabric/Velcro straps, and a soft cushioned liner. This modular design lends itself to opportunities for reuse and refurbishment, yet this is rarely considered.
Boots and other DME contribute considerable costs to patients and family. The costs of DME items vary widely, with simple items like canes costing less than $100 and custom items like power wheelchairs costing more than $5,000. In total, US spending on mobility-related DME items reached $1.5 billion in 2001, a figure that has likely grown exponentially over the past 2 decades due to inflation and supply chain shortages. Patients and health systems both encounter DME related charges, and health insurance payments for DME vary widely across payors. Provision of DME is a frequent cause of hospital discharge delays, contributing to lengthier hospital stays, prolonged immobilization, and greater cost of care. This is particularly true for low-income and uninsured families, perpetuating discrepancies in health equity and access to care. Charity care programs facilitate access to DME in some states, however Anti-Kickback statutes and other policies obstruct provision of free equipment in many systems.
Studies have shown that patients get little to no information related to appropriate reuse, recycling and other disposal programs for walking boots and other DME. Interview based studies suggest that equipment disposal options are simply not a part of discussions with patients-time with patients can be limited, time spent obtaining and fitting the DME item can be prolonged leaving little time to discuss other topics, and discussing disposal methods has been cited as sending a potential "mixed message" regarding the importance of the DME item itself.
Larger, more costly DME items owned by health systems including hospital beds and wheelchairs tend to be maintained by hospitals and care facilities so long as they can function without posing a threat to patient or staff safety. This is typically done through informal policies and guidance, borrowing from existing environmental service practices within a given facility for equipment cleaning and maintenance. Rental programs are available in many health systems for such items, with infrastructure to support their inspection, cleaning, and refurbishment as well as delivery and pick-up for some.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is of ambulatory age
- •Patient is ambulatory at baseline (i.e. prior to injury or intervention)
- •Patient is recovering from an acute foot or ankle injury (bony or soft tissue)
- •Patients expected to utilize the boot for <12 weeks total
- •Prescribed in the outpatient clinic setting only
排除标准
- •Patients with ongoing infection, skin lesions, or wounds
- •Immunosuppressed patients
- •Patients with autism or behavioral concerns
- •Non ambulatory patients
- •Fitted and provided in the operating room or inpatient settings
研究组 & 干预措施
New durable medical equipment (DME) walking boot
A patient will be randomized to the "new" boot arm of the study.
干预措施: New durable medical equipment (DME) walking boot (Device)
Re-used durable medical equipment (DME) walking boot
A patient will be randomized to the "reuse" boot arm of the study.
干预措施: Re-used durable medical equipment (DME) walking boot (Device)
结局指标
主要结局
Rate of skin based complications (%)
时间窗: 1-2 weeks after boot receipt
blisters, sores, erythema, rashes
Rate of skin based complications (%)
时间窗: 4-weeks after boot receipt
blisters, sores, erythema, rashes
Rate of skin based complications (%)
时间窗: 3 months after boot receipt
blisters, sores, erythema, rashes
次要结局
未报告次要终点
研究者
Laura Bellaire
Principle Investigator
University of Utah
