NCT Number: NCT02427737
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.
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Interventional
Not applicable
Hypnalgesics, LLC, Brookline, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Self-hypnotic relaxation, Nonpharmacologic analgesia, Nonpharmacologic anxiolysis, Patient sedation without medication
Time frame: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 4 quarters
Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 9 months (3 months baseline, 6 months post training)
Patients who cannot complete their scan
Time frame: 1 quarter
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 1 quarter
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 1 quarter
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 1 quarter
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 4 quarters
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 1 quarter
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.
Time frame: 1 quarter
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.
Time frame: 1 quarter
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.
Time frame: 1 quarter
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.
Time frame: 9 months (3 months baseline, 6 months post training)
Patients who receive medical sedation on site
Time frame: 9 months (3 months baseline, 6 months post training)
Number of patients who receive intravenous (IV) sedation on site
Time frame: 9 months (3 months baseline, 6 months post training)
Number of patients who receive general anesthesia on site
Time frame: 9 months (3 months baseline, 6 months post training)
Patients on site who disrupt the scan by motion
Time frame: 9 months (3 months baseline, 6 months post training)
Scheduled patients who do not show for their MRI examinations.
Hypnalgesics, LLC
Industry
Amelioration of Claustrophobia and Disruptive Patient Motion in MRI Imaging (Phase 2 Randomized Training of Sites)
Acronym: ComfortTalk®
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