Shared Decision-Making for the Promotion of Patient-Centered Imaging in the Emergency Department: Suspected Kidney Stones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Feasibility of study
研究概览
简要总结
Although a CT scan is required for some Emergency Department patients with signs and symptoms of a kidney stone, recent evidence has shown that routine scanning is unnecessary and may expose young patients to significant cumulative radiation, increasing their risk of future cancers. Shared Decision-Making may facilitate diagnostic imaging decisions that are more inline with patients' values and preferences. By comparing a shared approach to diagnostic decision-making to a traditional, physician-directed approach, this study lays the foundation for a future randomized trial that will reduce radiation exposure, improve engagement, and improve the quality and patient-centeredness of Emergency Department care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with acute flank pain - for whom clinician believes acute flank pain may be from renal colic
- •who are deemed by the treating clinician to be at low risk for dangerous alternative diagnoses.
- •Clinician is considering imaging patient for kidney stones (any imaging)
排除标准
- •Recent trauma related to pain (including minor such as lifting/turning)
- •Pregnancy (previous or discovered during ED visit)
- •Recent surgical procedure on abdomen or pelvis (30d)
- •Recent urologic procedure (30d)
- •Recent childbirth (30d)
- •Signs of Systemic Infection: Fever >100.9 (101 and up), SBP <90, HR>120
- •Moderate or severe abdominal tenderness or rebound/guarding, consistently present (present for more than one exam, or present after patient treated with pain medication)
- •Second doctor's visit (ED, PCP, urgent care) for THIS episode of pain (previous similar visits ok if pain gone for >30d in between episodes) (if seen at PCP or urgent care in same day or 24 hour period, this is not an exclusion, but if seen at PCP/urgent care or ED 1-30 days prior to index visit, with same pain, excluded)
- •Known history of one kidney or other urological/renal abnormality (including neurogenic bladder, ESRD and paraplegia; or if solitary kidney discovered on US)
- •Known malignancy (any) within past year (or received treatment in the past 12 months)
- •Immunocompromised (chronic steroids, HIV, crohns, immunomodulators or severely ill chronically)
- •On anticoagulation
- •Crisis patient (behavioral health)/belligerent
- •Lacks capacity for medical decision-making
- •Unlikely to respond to follow-up calls (IVDA, homeless, no phone)
- •Clinician is concerned for alternative diagnosis requiring CT scan (appendicitis) (>5% likelihood by clinician gestalt)
- •Patient is not improving clinically and clinician is considering admission
结局指标
主要结局
Feasibility of study
时间窗: Up to 12 months
Is this study feasible? Investigators will record number of patients enrolled. An enrollment of at least three patients per month will indicate feasibility.
CT scan rate
时间窗: Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
We hypothesize that SDM will lead to a change in CT scans performed at the index visits and in the first 60 days
Radiation exposure
时间窗: Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
We hypothesize that SDM will lead to a change in exposure to radiation. We will record radiation exposure for each CT done between day 0 and day 60, as indicated by DLP on CT reports.
Fidelity
时间窗: Up to 12 months
Does the DA do what we think it is doing? Fidelity will be examined after 50 patients are enrolled: conversations between patients and clinicians will be scored for whether shared decision-making occurred. If SDM is NOT occurring in the intervention group (\>75% of interactions) or IS occurring in the usual care group (\>50% of interactions), fidelity will not be considered met.
Patient Knowledge
时间窗: Measured at the end of the index visit. (Day 0)
We hypothesize that the intervention group will have increased knowledge regarding radiation exposure and diagnostic options. This will be tested with a 10 question Knowledge Test developed by stakeholders for this study and delivered at the end of the index visit. The scores for this test range from 0-10 with 10 indicating higher knowledge (more correct answers)
次要结局
- Implementation Outcomes(Day 0, end of visit)
- Occurrence of SDM(Day 0, end of visit)
- ED revisits(60 days)
- Patient Satisfaction(Day 0, end of visit)
- Overall Radiation Burden(within 60 days from index ED visit)
- Safety: missed diagnosis(60 days from index ED visit)
- Trust in physician(Day 0, end of visit)
- ED Length of Stay(Day 0, end of visit)
- Qualitative evaluation(Day 0, end of visit)
- Patient engagement(Day 0, end of visit)
研究者
Elizabeth Schoenfeld, MD
Assistant Professor
Baystate Medical Center