Comfort Talk and Economic Outcomes in MRI

Not Applicable

Completed

Conditions: Claustrophobia
Complication of Diagnostic Procedure

Registration Number: NCT02427737

Lead Sponsor: Hypnalgesics, LLC

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Equipment Utilization Q4FY15 = Baseline Quarter (OSU)	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)	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)	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)	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)	4 quarters	Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available
Incompletions (Duke)	9 months (3 months baseline, 6 months post training)	Patients who cannot complete their scan

Secondary Outcome Measures

Name	Time	Method
Disruptive Motion (Duke)	9 months (3 months baseline, 6 months post training)	Patients on site who disrupt the scan by motion
Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU)	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.
General Anesthesia Rate (Duke)	9 months (3 months baseline, 6 months post training)	Number of patients who receive general anesthesia on site
No-shows (Duke)	9 months (3 months baseline, 6 months post training)	Scheduled patients who do not show for their MRI examinations.
Trend of No-shows Over All Quarters (OSU)	4 quarters	Quarterly number of scheduled patients who do not show up for their appointments
No-shows in Q4FY15 = Baseline Quarter (OSU)	1 quarter	Quarterly number of scheduled patients who do not show up for their appointments
No-shows in Q1FY16 (OSU)	1 quarter	Quarterly number of scheduled patients who do not show up for their appointments
No-shows in Q2FY16 (OSU)	1 quarter	Quarterly number of scheduled patients who do not show up for their appointments
Patient Satisfaction Ranking in Q2FY16 (OSU)	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.
Patient Satisfaction Ranking in Q3FY16 (OSU)	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.
Oral Sedation Rate (Duke)	9 months (3 months baseline, 6 months post training)	Patients who receive medical sedation on site
IV Sedation Rate (Duke)	9 months (3 months baseline, 6 months post training)	Number of patients who receive intravenous (IV) sedation on site
No-shows in Q3FY16 (OSU)	1 quarter	Quarterly number of scheduled patients who do not show up for their appointments
Patient Satisfaction in Q1FY16 (OSU)	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.

Trial Locations

Locations (3): Hypnalgesics, LLC
🇺🇸
Brookline, Massachusetts, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Hypnalgesics, LLC
🇺🇸Brookline, Massachusetts, United States