Comfort Talk and Economic Outcomes in MRI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Amelioration of Claustrophobia and Disruptive Patient Motion in MRI Imaging (Phase 2 Randomized Training of Sites)

Conditions
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Claustrophobia, Complication of Diagnostic Procedure

Intervention / Treatment
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* Behavioral: Comfort Talk® Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must routinely perform MRI examinations Must capture data on noncompletion of MRI scans Exclusion Criteria: No dedicated MRI unit Unable to reliably capture data on noncompletion of MRI scans
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The original model was to have parallel randomized MRI sites. This was possible at one participating institution, The Ohio State Universty Medical Center (OSU). For the second institution (Duke University) staff cuts resulted in personnel cross-over between test and control sites making randomization impossible. Therefore a sequential model was used compared data from the pre- to post training period for the Duke sites. In total 12 MRI entities contributed, six at OSU, and six at Duke. Also, Duke and OSU turned out to have different modes of data collection. OSU had fully automated capture of patients scheduled, showing, and completing their examination as well as a priori numbers of available imaging slots per time unit. Duke did not collect these data electronically so that personnel could only gather the pertinent measures by daily manual diary entry. Thus the mode of result presentation is not concordant in some aspects among sites.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comfort Talk® Training<br>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. | Behavioral: Comfort Talk® Training<br>* Personnel of MRI units is trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This entails 16 hrs classroom work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.<br>* Other names: Patient sedation without medication;|
| No Intervention: Control<br>MRI sites not trained in Comfort Talk®. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equipment Utilization Q4FY15 = Baseline Quarter (OSU) | Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available | 1 quarter | 
| Equipment Utilization in Q1FY16 (OSU) | Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available | 1 quarter | 
| Equipment Utilization in Q2FY16 (OSU) | Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available | 1 quarter | 
| Equipment Utilization in Q3FY16 (OSU) | Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available | 1 quarter | 
| Equipment Utilization Over All Quarters (OSU) | Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available | 4 quarters | 
| Incompletions (Duke) | Patients who cannot complete their scan | 9 months (3 months baseline, 6 months post training) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No-shows in Q4FY15 = Baseline Quarter (OSU) | Quarterly number of scheduled patients who do not show up for their appointments | 1 quarter | 
| No-shows in Q1FY16 (OSU) | Quarterly number of scheduled patients who do not show up for their appointments | 1 quarter | 
| No-shows in Q2FY16 (OSU) | Quarterly number of scheduled patients who do not show up for their appointments | 1 quarter | 
| No-shows in Q3FY16 (OSU) | Quarterly number of scheduled patients who do not show up for their appointments | 1 quarter | 
| Trend of No-shows Over All Quarters (OSU) | Quarterly number of scheduled patients who do not show up for their appointments | 4 quarters | 
| Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU) | Quarterly percentile rankings of patients' Overall Assesment of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group. | 1 quarter | 
| Patient Satisfaction in Q1FY16 (OSU) | Quarterly percentile rankings of patients' Overall Assesment of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group. | 1 quarter | 
| Patient Satisfaction Ranking in Q2FY16 (OSU) | Quarterly percentile rankings of patients' Overall Assesment of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group. | 1 quarter | 
| Patient Satisfaction Ranking in Q3FY16 (OSU) | Quarterly percentile rankings of patients' Overall Assesment of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group. | 1 quarter | 
| Oral Sedation Rate (Duke) | Patients who receive medical sedation on site | 9 months (3 months baseline, 6 months post training) | 
| IV Sedation Rate (Duke) | Number of patients who receive intravenous (IV) sedation on site | 9 months (3 months baseline, 6 months post training) | 
| General Anesthesia Rate (Duke) | Number of patients who receive general anesthesia on site | 9 months (3 months baseline, 6 months post training) | 
| Disruptive Motion (Duke) | Patients on site who disrupt the scan by motion | 9 months (3 months baseline, 6 months post training) | 
| No-shows (Duke) | Scheduled patients who do not show for their MRI examinations. | 9 months (3 months baseline, 6 months post training) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging, Patient satisfaction, Diagnostic Imaging