Clinical trial NCT02427737: Comfort Talk and Economic Outcomes in MRI
Official title: Amelioration of Claustrophobia and Disruptive Patient Motion in MRI Imaging (Phase 2 Randomized Training of Sites)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Claustrophobia
Complication of Diagnostic Procedure
Keywords: Magnetic Resonance Imaging
Patient satisfaction
Diagnostic Imaging
Lead sponsor: Hypnalgesics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
name: Duke University
First posted: 2015-04-28
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Equipment Utilization Q4FY15 = Baseline Quarter (OSU)
timeFrame: 1 quarter
measure: Equipment Utilization in Q1FY16 (OSU)
timeFrame: 1 quarter
measure: Equipment Utilization in Q2FY16 (OSU)
timeFrame: 1 quarter
measure: Equipment Utilization in Q3FY16 (OSU)
timeFrame: 1 quarter
measure: Equipment Utilization Over All Quarters (OSU)
timeFrame: 4 quarters
measure: Incompletions (Duke)
timeFrame: 9 months (3 months baseline, 6 months post training)
Secondary outcomes:
measure: No-shows in Q4FY15 = Baseline Quarter (OSU)
timeFrame: 1 quarter
measure: No-shows in Q1FY16 (OSU)
timeFrame: 1 quarter
measure: No-shows in Q2FY16 (OSU)
timeFrame: 1 quarter
measure: No-shows in Q3FY16 (OSU)
timeFrame: 1 quarter
measure: Trend of No-shows Over All Quarters (OSU)
timeFrame: 4 quarters
measure: Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU)
timeFrame: 1 quarter
measure: Patient Satisfaction in Q1FY16 (OSU)
timeFrame: 1 quarter
measure: Patient Satisfaction Ranking in Q2FY16 (OSU)
timeFrame: 1 quarter
measure: Patient Satisfaction Ranking in Q3FY16 (OSU)
timeFrame: 1 quarter
measure: Oral Sedation Rate (Duke)
timeFrame: 9 months (3 months baseline, 6 months post training)
measure: IV Sedation Rate (Duke)
timeFrame: 9 months (3 months baseline, 6 months post training)
measure: General Anesthesia Rate (Duke)
timeFrame: 9 months (3 months baseline, 6 months post training)
measure: Disruptive Motion (Duke)
timeFrame: 9 months (3 months baseline, 6 months post training)
measure: No-shows (Duke)
timeFrame: 9 months (3 months baseline, 6 months post training)
Other outcomes:
Locations:
city: Brookline
country: United States
facility: Hypnalgesics, LLC
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Hypnalgesics, LLC
name: Elvira V Lang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang EV, Ward C, Laser E. Effect of team training on patients' ability to complete MRI examinations. Acad Radiol. 2010 Jan;17(1):18-23. doi: 10.1016/j.acra.2009.07.002. Epub 2009 Sep 5.
citation: Lang EV, Yuh WT, Ajam A, Kelly R, Macadam L, Potts R, Mayr NA. Understanding patient satisfaction ratings for radiology services. AJR Am J Roentgenol. 2013 Dec;201(6):1190-5; quiz 1196. doi: 10.2214/AJR.13.11281.
citation: Lang EV. A Better Patient Experience Through Better Communication. J Radiol Nurs. 2012 Dec 1;31(4):114-119. doi: 10.1016/j.jradnu.2012.08.001.
citation: Flory N, Lang EV. Distress in the radiology waiting room. Radiology. 2011 Jul;260(1):166-73. doi: 10.1148/radiol.11102211. Epub 2011 Apr 7.
citation: Lang EV, Hatsiopoulou O, Koch T, Berbaum K, Lutgendorf S, Kettenmann E, Logan H, Kaptchuk TJ. Can words hurt? Patient-provider interactions during invasive procedures. Pain. 2005 Mar;114(1-2):303-9. doi: 10.1016/j.pain.2004.12.028. Epub 2005 Jan 26.
citation: Lang EV, Rosen MP. Cost analysis of adjunct hypnosis with sedation during outpatient interventional radiologic procedures. Radiology. 2002 Feb;222(2):375-82. doi: 10.1148/radiol.2222010528.
citation: Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.
citation: Norbash A, Yucel K, Yuh W, Doros G, Ajam A, Lang E, Pauker S, Mayr N. Effect of team training on improving MRI study completion rates and no-show rates. J Magn Reson Imaging. 2016 Oct;44(4):1040-7. doi: 10.1002/jmri.25219. Epub 2016 Apr 6.
citation: Ajam AA, Nguyen XV, Kelly RA, Ladapo JA, Lang EV. Effects of Interpersonal Skills Training on MRI Operations in a Saturated Market: A Randomized Trial. J Am Coll Radiol. 2017 Jul;14(7):963-970. doi: 10.1016/j.jacr.2017.03.015. Epub 2017 Apr 28.
citation: Ladapo JA, Spritzer CE, Nguyen XV, Pool J, Lang E. Economics of MRI Operations After Implementation of Interpersonal Skills Training. J Am Coll Radiol. 2018 Dec;15(12):1775-1783. doi: 10.1016/j.jacr.2018.01.017. Epub 2018 Mar 9.