Social Worker Presence in Outpatient Fracture Clinics: A Batched Stepped-Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Number of visits to emergency room or urgent care
研究概览
简要总结
Every year, many Canadians sustain a fracture that requires surgical treatment and results in a long recovery period. During this recovery period, patients may experience new or worsening mental health issues including depression, anxiety, or post-traumatic stress disorder. Additionally, patients may experience new or worsening social and financial problems, such as food and housing insecurity, due to being unable to work or take care of other daily responsibilities. Current care for fracture patients is focused on treating their physical injuries and overlooks these other challenges. To address this gap in care, the investigators propose having a social worker available in the fracture clinic to provide patients with support beyond the care of their physical injury.
The investigators propose a trial of 2,000 patients to determine if social worker support improves recovery for patients after a serious fracture by reducing the number of times they return to the emergency room or urgent care centre. This trial will also determine if social work support improves patients' mental health, financial security, ability to work, and level of satisfaction with the care they receive, and whether it reduces the amount of opioid medication they use and number of missed visits during their recovery. Patients will be randomly assigned to receive either support from a social worker or usual care. For patients assigned to receive social worker support, the social worker will assess their individual needs and provide support, information, and referrals to social support services. The social worker will continue to support patients for up to one year after they join the trial. Patients will complete questionnaires at enrollment and at 6 weeks and 3, 6, 9, and 12 months after enrollment.
If this trial shows that support from a social worker in the fracture clinic during their recovery period is beneficial to patients who have experienced a serious fracture requiring surgery, it has the potential to change care for patients who experience these potentially life-changing injuries.
详细描述
Each year, approximately 15% of Canadians experience an orthopaedic injury serious enough to affect their ability to engage in everyday activities. These injuries include fractures and dislocations that are typically managed operatively by an orthopaedic trauma surgeon and frequently result in prolonged recovery periods. Despite a comprehensive and well-researched approach to medical aspects of recovery, this patient population seldom receives adequate social support for the non-physical consequences of their injuries.
Following a serious orthopaedic injury, patients may face numerous life changes including negative impacts on relationships, independence, emotional well-being, financial stability, and ability to work or participate fully in daily activities. Patients may also experience new or worsening mental health problems. Studies have found orthopaedic trauma patients to have higher-than-average rates of many types of mental health disorders, including depression and anxiety. A 2017 systematic review found that, post-injury, the weighted pooled prevalence of depression and post-traumatic stress disorder in orthopaedic trauma patients was 33% and 27%, respectively. Post-injury, there is a correlation between symptoms of depression and reduced physical function and magnitude of disability.
As they often necessitate prolonged periods away from work, traumatic orthopaedic injuries significantly affect employment and income. For many, financial repercussions are immediate, leading to income loss even with minor injuries. It is not uncommon for physical impairment from orthopaedic injuries to keep patients from returning to work for 6 months or more, with compounding detrimental effects on relationships, self-worth, and future job prospects. Research on the financial toll of orthopaedic injuries found that fractures were associated with substantial individual and household income loss up to 5 years after injury, and 1 in 5 patients sustained catastrophic income loss in the 2 years after their injury. Navigating the bureaucratic and logistical challenges of securing employment insurance or Workplace Safety and Insurance Board benefits post-injury can be overwhelming, adding to the burden faced by the injured person or their caregivers.
The stress of a serious orthopaedic injury may also lead to or exacerbate substance abuse problems, which may include increased alcohol intake and drug use. In addition, opioids are a ubiquitous part of perioperative pain management following an orthopaedic injury. Despite increasing regulations, more than 80% of orthopaedic trauma patients are prescribed opioids in the post-surgical period. Patients may have low levels of information about safe opioid use, alternative methods of pain management, and what to expect during recovery. When coupled with other post-injury challenges, including mental health issues, job loss, and income reduction, these factors may lead to opioid addiction, potentially resulting in permanent job loss, being without a home, and even death.
The combined stress of physical recovery, financial strain, risk of addiction, changes in relationship dynamics, and the intricacies of obtaining aid or services can be emotionally and mentally taxing for orthopaedic patients and their support networks. Orthopaedic trauma patients urgently need outpatient support for their recovery from injury. The orthopaedic fracture clinic is the only outpatient care that these patients receive. Supplementing medical treatment with a comprehensive support system and strategies to mitigate the non-physical impacts of orthopaedic injury has the potential to significantly reduce the negative impact of these traumatic injuries. To address this urgent social need, the investigators propose the integration of a dedicated social worker within the fracture clinic setting to provide support to patients with serious orthopaedic injuries. A clinical trial is needed to evaluate the efficacy of having a social worker in the fracture clinic before widespread hospital policy changes can be implemented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are:
- •Aged 18 or older.
- •Has fracture of the appendicular skeleton
- •Fracture required surgical management.
- •Fracture occurred within the past 12 weeks.
- •3. Willing to comply with the protocol.
- •Willing to provide informed consent.
排除标准
- •Incarceration.
- •Expected injury survival of less than 6 months.
- •Terminal illness with expected survival of less than 6 months.
- •Currently enrolled in a trial that does not permit co-enrollment.
- •Unable to engage in protocol in the languages available in the local cluster.
- •Prior enrollment in the trial.
- •Declined to provide informed consent.
- •Not approached at (or prior to) the first post-surgery fracture clinic visit (missed participant).
- •Other reason to exclude the patient, as approved by the Methods Centre.
研究组 & 干预措施
Usual Care Arm
Participants enrolled during the usual care phase will receive the current standard treatment for their fracture. The current standard of care post-surgery for fractures, in the fracture clinic, is to provide medical treatment for injuries including casts, monitoring for infection, x-rays, etc. This is provided by surgeons, nurses and technicians. Any psychosocial needs are managed at patient request either by the surgeon or another clinic health care professional (in the case of simple forms) or by a hospital social worker, who usually has a full-time workload outside of the fracture clinic.
Social Work Intervention Group
Participants enrolled during the treatment phase at their clinic will receive social work support for 6 months from the time of enrollment. They will have an intake appointment with the social worker before or during their initial fracture clinic visit to assess their needs, identify goals that they can address with the support of the social worker, and collaboratively formulate a personalized care plan tailored to their specific circumstances. The social worker will then implement the plan, which may involve educating participants and their support network, coordinating delivery of care and benefits, making referrals to community services, advocating for the participant, and providing emotional support and brief counselling. The social worker will be accessible to participants for 6 months post-enrollment, following up via telephone, telemedicine or in-person to evaluate the effectiveness of the care plan and offer sustained ongoing support.
干预措施: Social Work support (Other)
结局指标
主要结局
Number of visits to emergency room or urgent care
时间窗: For 6 months from the date of enrollment
Research personnel will ask participants if they went to the emergency room or to an urgent care facility at each of the follow-up visits 6 weeks, 3 months, and 6 months after consent. Research personnel will review the participant's medical records for emergency room and urgent care visits . We will document the date of the visit and the reason for the visit. We will also document whether the visit occurred at the same or different hospital and hospital system where the participant is receiving care for the fracture.
次要结局
- LIMB-Q Questionnaire(For 6 months from the date of enrollment)
- Opioid Use(For 6 months from the date of enrollment)
- Number of Missed Clinic Visits(For 6 months from the date of enrollment)
- Number and characteristics of interactions with social worker(For 6 months from the date of enrollment)
研究者
Sheila Sprague
Research Director / Associate Professor
McMaster University