Watchful Waiting as a Strategy for Reducing Low-value Spinal Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Adjusted rate of spinal imaging during 18-month follow-up
研究概览
简要总结
The investigators will learn from the study whether actors playing the roles of patients (standardized patients) can help primary care and urgent care clinicians develop skill in offering watchful waiting to patients with acute low back pain as a means of averting low-value spinal imaging. Using patient and physician feedback, this study will refine and evaluate -- in a controlled experiment -- a simulated standardized patient intervention to enhance primary care physician use of watchful waiting when patients request low-value spinal imaging. The long-term goal of this study is to discover communication strategies primary care physicians can use to avert costly, potentially harmful testing while maintaining the patient-doctor relationship.
详细描述
Overutilization is increasingly viewed within the framework of patient safety. In primary care, patients with acute low back pain frequently request diagnostic imaging, and primary and urgent care clinicians feel pressure to acquiesce to such requests to sustain patient trust and satisfaction. Spinal imaging in patients with acute low back pain poses risks from diagnostic evaluation of false-positive findings, patient labeling and anxiety, and unnecessary treatment (including spinal surgery) with potential downstream complications.
Watchful waiting advice has been found an effective strategy to reduce low-value treatment (e.g., pediatric ear infections), and some evidence suggests a watchful waiting approach would be acceptable to many patients requesting tests. Meanwhile, psychological theory suggests that physician messages could be tailored to magnify patient acceptance of a watchful waiting strategy.
The investigators will refine and evaluate a novel simulated intervention using standardized patients (SPs) -- or actors playing the roles of patients - to teach clinicians to endorse a watchful waiting approach when patients request low-value spinal imaging for low back pain. Specific aims are:
Aim 1: To use key informant interviews of front-line clinicians and focus groups with primary care patients to refine a theory-informed standardized patient-based intervention designed to teach practicing clinicians how to advise watchful waiting when patients request low-value spinal imaging for low back pain.
Aim 2: To test the effectiveness of standardized patient instructor (SPI)-delivered clinician training in the use of watchful waiting in a randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Primary care and urgent care clinicians in the two health systems will be eligible if:
- •they intend to practice either at least 50% full-time equivalent (FTE) adult primary or urgent care in one of the target clinics for the trial duration
- •they have been in active full-time or 50% FTE practice within the health system for at least two years prior to enrollment (to enable collection of baseline testing rates).
- •Nurse practitioners and physicians assistants will be eligible if they practice in the capacity of a primary care or urgent care clinicians and meet the other requirement above.
排除标准
- 未提供
研究组 & 干预措施
Intervention
Primary care and urgent care clinicians randomized to the intervention arm will receive two to three visits with a standardized patient instructor who will physicians how to facilitate patient acceptance of a watchful waiting strategy with regard to spinal imaging in the context of acute low back pain.
干预措施: Intervention (Behavioral)
Control
Primary care and urgent care clinicians randomized to the control arm will receive a single visit with a standardized patient who simulates a visit with patient with acute low back pain but will deliver no instruction on patient communication or other content.
干预措施: Control (Behavioral)
结局指标
主要结局
Adjusted rate of spinal imaging during 18-month follow-up
时间窗: 18 months following date of first SPI visit
Rate of lumbar spinal x-ray, CT, or MRI during follow-up period, adjusted for imaging rate during 12 month pre-randomization period
次要结局
- Adjusted rate of advanced spinal imaging during 18-month follow-up(18 months following date of first SPI visit)
- Physician self-reported use of watchful waiting techniques in post-intervention questionnaires(6 months post-intervention)
- Adjusted rate of diagnostic test ordering during 18-month follow-up(18 months following date of first SPI visit)
- Adjusted rate of lumbar x-ray imaging during 18-month follow-up(18 months following date of first SPI visit)
- Patient experience ratings during 18-month follow-up(18 months following date of first SPI visit)
- Adjusted rate of neck imaging during 18-month follow-up(18 months following date of first SPI visit)
- Use of watchful waiting communication techniques based on coded transcripts(6 months post-intervention)