Comfort Talk and Economic Outcomes in MRI

Claustrophobia Clinical Trial

— ComfortTalk®  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427737
• Other study ID #: 2CTOSUD2015
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2019
• Source: Hypnalgesics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Claustrophobia
• Complication of Diagnostic Procedure
• Phobic Disorders

Intervention

Behavioral:
• Comfort Talk® Training
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.

Locations

Country	Name	City	State
United States	Hypnalgesics, LLC	Brookline	Massachusetts
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Hypnalgesics, LLC	Duke University, Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. Epub 2005 Jan 26. — View Citation

Lang EV, Rosen MP. Cost analysis of adjunct hypnosis with sedation during outpatient interventional radiologic procedures. Radiology. 2002 Feb;222(2):375-82. — View 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. — View 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. Review. — View Citation

Lang EV. A Better Patient Experience Through Better Communication. J Radiol Nurs. 2012 Dec 1;31(4):114-119. — View 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. — View Citation

Outcome

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