A Multifaceted Intervention to Reduce Low-value Care for Trauma Admissions: Evaluation of Effectiveness in a Pragmatic Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Low-value initial diagnostic imaging
研究概览
简要总结
In Canada, injury leads to more potential years of life lost and to greater costs than heart and stroke diseases combined. Furthermore, more than 50% of patients hospitalised following injury do not receive optimal care, 20% of injury deaths are estimated to be preventable, and significant variations in injury mortality and morbidity have been observed across trauma centers in Canada, the United Kingdom, Australia and the United States. Over the past decades, emphasis on adherence to evidence-based processes of care (rewards for doing more) and rapid innovation in imaging and therapeutic techniques has led to an exponential rise in unnecessary tests and procedures. Whole body computed tomography scan for single-system trauma is just one example. Low-value clinical practices, defined as "the common use of a particular intervention when the benefits don't justify the potential harm or cost" consume up to 30% of healthcare budgets. They expose patients to physical and psychological adverse events and put enormous pressure on healthcare budgets, thereby threatening accessible, universal health care. The objective of this research project is to evaluate the effectiveness of an intervention targeting reductions in low-value clinical practices for injury admissions. The results of this study should directly lead to improvements in the health systems across Canada and elsewhere. Medium and long-term advantages include an increase in healthcare efficiency and effectiveness, a reduction in costs, an increase in the availability of resources for patients who need them and a reduction in adverse events for patients hospitalized following injury.
详细描述
RATIONALE: While simple Audit & Feedback (A&F) has shown modest effectiveness for reducing low-value care, there is a knowledge gap on the effectiveness of multifaceted interventions to support de-implementation efforts. Given the need to make rapid decisions in a context of multiple diagnostic and therapeutic options, trauma is a high-risk setting for low-value care. Furthermore, trauma systems are a favorable setting for de-implementation interventions as they have quality improvement teams with medical leadership, routinely collected clinical data, and performance linked to accreditation.
OBJECTIVES: We aim to evaluate the effectiveness of a multifaceted intervention for reducing low-value clinical practices in acute adult trauma care.
METHODS: We will conduct a pragmatic cluster randomized controlled trial. Level I-III trauma centers in an inclusive Canadian trauma system (n=29) will be randomized (1:1) to receive simple A&F (control) or a multifaceted intervention (intervention). The multifaceted intervention, developed using extensive background work and United Kingdom Medical Research Council guidelines for the Development of Complex Interventions, includes an A&F report, educational materials, virtual educational meetings, and virtual facilitation visits. The primary outcome will be patient-level use of low-value initial diagnostic imaging, assessed using routinely collected trauma registry data. Secondary outcomes will be low-value specialist consultation, low-value repeat imaging for transfers, unintended consequences, and Incremental Cost-Effectiveness Ratios.
IMPACT: This innovative, timely research project will advance knowledge on the incremental effectiveness of a multifaceted intervention over simple A&F to de-implement low-value care. The intervention has a high probability of success because it targets a problem identified by stakeholders, is based on extensive background work, is low-cost, and is linked to accreditation. This intervention has the potential to reduce the adverse effects and indirect expenses of low-value trauma care for patients and families. It could also free up resources, reduce delays to care, and decrease healthcare professionals' workload, at a time of unprecedented strain on healthcare resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Local trauma committees will not be told explicitly what aspect of the intervention is randomised; they will only be aware that there are two variations of the intervention. Data extractors and analysts will be blinded to group allocation. Due to the nature of the intervention, it will not be possible to blind the investigators to allocation groups.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult level I-III trauma centers in the Trauma Care Continuum of the province of Québec -
排除标准
- •Level IV centers (patient volume too low)
结局指标
主要结局
Low-value initial diagnostic imaging
时间窗: 18-month interval (6 to 24 months) after implementation
Proportion of low-risk patients who receive head, cervical spine or whole-body computed tomography in the emergency department
次要结局
- Repeat post-transfer imaging(18-month interval (6 to 24 months) after implementation)
- Low-value specialist consultation(18-month interval (6 to 24 months) after implementation)
- Pre-transfer imaging(18-month interval (6 to 24 months) after implementation)