Watchful waiting as a strategy to reduce low-value spinal imaging: study protocol for a randomized trial.

Watchful waiting as a strategy to reduce low-value spinal imaging: study protocol for a randomized trial.
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DOI:
10.1186/s13063-021-05106-x
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发表时间:
2021-02-27
期刊:
影响因子:
2.5
通讯作者:
Tancredi DJ
Tancredi DJ
中科院分区:
医学4区
文献类型:
--
作者:
Fenton JJ;Jerant A;Franks P;Gosdin M;Fridman I;Cipri C;Weinberg G;Hudnut A;Tancredi DJ

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急性下腰痛患者经常要求诊断性成像,临床医生感到压力,默许这样的要求,以维持病人的信任和满意度。急性下腰痛患者的脊柱成像存在以下风险:假阳性结果的诊断评价、患者标签和焦虑以及不必要的治疗(包括脊柱手术)。观察等待建议是减少一些低价值治疗的有效策略,一些证据表明,观察等待方法对许多要求诊断检测的患者来说是可以接受的。我们将使用临床医生和焦点小组与初级保健患者的关键知情人访谈,以完善理论知情的标准化基于患者的干预措施,旨在教导临床医生如何在患者要求低价值脊柱成像治疗腰痛时建议观察等待。我们将在随机临床试验中测试干预的有效性。我们将在加利福尼亚州萨克拉门托招募8-10名初级保健和紧急护理诊所(约55名临床医生);临床医生将以1:1的比例随机分配至干预组和对照组。在3至6个月的时间内,干预组的临床医生将接受3次标准化患者指导员(SPI)的访问,描述急性背痛患者; SPI将指导临床医生采用三步模型,强调建立信任,移情沟通和协商观察等待方法。对照组医生将不接受任何干预。主要结局是临床医生观察到的急性背痛患者的干预后脊柱成像率,并根据基线期间的成像率进行调整。次要结果是在随访期间使用有针对性的沟通技术与SP,临床医生自我报告的使用观察等待与实际腰痛患者,其他肌肉骨骼疼痛综合征的诊断成像干预后率(以测试干预效果的泛化超过背痛),和患者的信任和满意度与医生。这项试验将确定标准化的患者指导员是否可以帮助临床医生发展与急性腰痛患者协商观察等待方法的技能,从而降低低价值脊柱成像的发生率。该试验还将研究干预效果推广到其他诊断测试的可能性。ClinicalTrials.govNCT 04255199.注册日期:2020年1月20日
Patients with acute low back pain frequently request diagnostic imaging, and 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). Watchful waiting advice has been an effective strategy to reduce some low-value treatments, and some evidence suggests a watchful waiting approach would be acceptable to many patients requesting diagnostic tests. We will use key informant interviews of clinicians and focus groups with primary care patients to refine a theory-informed standardized patient-based intervention designed to teach clinicians how to advise watchful waiting when patients request low-value spinal imaging for low back pain. We will test the effectiveness of the intervention in a randomized clinical trial. We will recruit 8–10 primary care and urgent care clinics (~ 55 clinicians) in Sacramento, CA; clinicians will be randomized 1:1 to intervention and control groups. Over a 3- to 6-month period, clinicians in the intervention group will receive 3 visits with standardized patient instructors (SPIs) portraying patients with acute back pain; SPIs will instruct clinicians in a three-step model emphasizing establishing trust, empathic communication, and negotiation of a watchful waiting approach. Control physicians will receive no intervention. The primary outcome is the post-intervention rate of spinal imaging among actual patients with acute back pain seen by the clinicians adjusted for rate of imaging during a baseline period. Secondary outcomes are use of targeted communication techniques during a follow-up visit with an SP, clinician self-reported use of watchful waiting with actual low back pain patients, post-intervention rates of diagnostic imaging for other musculoskeletal pain syndromes (to test for generalization of intervention effects beyond back pain), and patient trust and satisfaction with physicians. This trial will determine whether standardized patient instructors can help clinicians develop skill in negotiating a watchful waiting approach with patients with acute low back pain, thereby reducing rates of low-value spinal imaging. The trial will also examine the possibility that intervention effects generalize to other diagnostic tests. ClinicalTrials.govNCT 04255199. Registered on January 20, 2020
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