Amelioration of Claustrophobia and Disruptive Patient Motion in MRI Imaging (Phase 2 Randomized Training of Sites)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Equipment Utilization Q4FY15 = Baseline Quarter (OSU)
研究概览
简要总结
Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still. Training staffs working in MRI facilities to provide Comfort Talk® will enable patients to complete high quality imaging without medication, which will increase satisfaction and comfort while reducing sedation risks for patients, and increase efficiency and reduce loss of revenue for facilities. The effect of such training will be tested at 12 MRI sites in a randomized design. Outcome data will be collected for one year.
详细描述
Claustrophobia and disruptive patient motion are common impediments to MRI examination, but they may be prevented or ameliorated with a non-pharmacologic behavioral intervention administered by trained staff. The potential benefits of such an intervention are highly significant, considering that the alternatives are to cancel the study or administer sedation. Inability to complete their MRI scans adversely affects an estimated 700,000 patients every year in the US. These patients are either deprived of a diagnosis, subject to diagnostic delays and interpretation errors due to motion artifact, or are exposed to risks of pharmacologic sedation, including death. The imaging facilities typically cannot fill the suddenly vacated examination slots in time before the next scheduled patient and incur considerable lost revenue and efficiency. A negative patient experience further jeopardizes Value-Based reimbursement by the Centers for Medicare and Medicaid Services (CMS) towards which patient satisfaction counts 30%. The long term goal is to provide a validated, clinically feasible means for non-pharmacologic amelioration of claustrophobia and disruptive patient motion, achieved by training facility staff in Comfort Talk®.
Comfort Talk® training consists of a proprietary, standardized R3 Process of Rapport, Relaxation, and Reframing including 2 x 8-hrs class-room interaction, onsite coaching, and institution-specific web-based support to help the MRI team to further develop its own language style and skill set.
The effect of Comfort Talk® training will be quantified in a prospective randomized design at 12 MRI satellites of the Ohio State University Medical Center and Duke University Medical Center. Return of investment of training will be based on a decision-analysis model with focus on number of scans performed, cancellations from no-shows and refusals; patients unable to start or complete a scan; and sedation rates in relation to capacity, cost, and reimbursement schedule. Patient satisfaction scores will be compared using Press Ganey national benchmark percentile rankings and CMS quality standards.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must routinely perform MRI examinations
- •Must capture data on noncompletion of MRI scans
排除标准
- •No dedicated MRI unit
- •Unable to reliably capture data on noncompletion of MRI scans
研究组 & 干预措施
Comfort Talk® Training
In the experimental group, MRI personnel is trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests at the onset of the MRI scan.
干预措施: Comfort Talk® Training (Behavioral)
Control
MRI sites not trained in Comfort Talk®.
结局指标
主要结局
Equipment Utilization Q4FY15 = Baseline Quarter (OSU)
时间窗: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization in Q2FY16 (OSU)
时间窗: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization in Q1FY16 (OSU)
时间窗: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization in Q3FY16 (OSU)
时间窗: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization Over All Quarters (OSU)
时间窗: 4 quarters
Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available
Incompletions (Duke)
时间窗: 9 months (3 months baseline, 6 months post training)
Patients who cannot complete their scan
次要结局
- Disruptive Motion (Duke)(9 months (3 months baseline, 6 months post training))
- Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU)(1 quarter)
- General Anesthesia Rate (Duke)(9 months (3 months baseline, 6 months post training))
- No-shows (Duke)(9 months (3 months baseline, 6 months post training))
- Trend of No-shows Over All Quarters (OSU)(4 quarters)
- No-shows in Q4FY15 = Baseline Quarter (OSU)(1 quarter)
- No-shows in Q1FY16 (OSU)(1 quarter)
- No-shows in Q2FY16 (OSU)(1 quarter)
- Patient Satisfaction Ranking in Q2FY16 (OSU)(1 quarter)
- Patient Satisfaction Ranking in Q3FY16 (OSU)(1 quarter)
- Oral Sedation Rate (Duke)(9 months (3 months baseline, 6 months post training))
- IV Sedation Rate (Duke)(9 months (3 months baseline, 6 months post training))
- No-shows in Q3FY16 (OSU)(1 quarter)
- Patient Satisfaction in Q1FY16 (OSU)(1 quarter)
研究者
Elvira V. Lang, MD
CEO
Hypnalgesics, LLC
