ComfortTalk®: Comfort Talk and Economic Outcomes in MRI

• Sponsor: Hypnalgesics, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02427737
• Collaborator: Ohio State University (Other), Duke University (Other)
• Enrollment: 12
• Locations: 3
• Arms: 2
• Duration (Months): 28
• Patients Per Site: 4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Claustrophobia; Complication of Diagnostic Procedure	Behavioral: Comfort Talk® Training	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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)
• Primary Purpose: Health Services Research
• Official Title: Amelioration of Claustrophobia and Disruptive Patient Motion in MRI Imaging (Phase 2 Randomized Training of Sites)
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jul 31, 2017
• Actual Study Completion Date: Jul 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Comfort Talk® Training 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; 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
No Intervention: Control MRI sites not trained in Comfort Talk®.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. Incompletions (Duke) [9 months (3 months baseline, 6 months post training)]

   Patients who cannot complete their scan

Secondary Outcome Measures

1. No-shows in Q4FY15 = Baseline Quarter (OSU) [1 quarter]

   Quarterly number of scheduled patients who do not show up for their appointments

2. No-shows in Q1FY16 (OSU) [1 quarter]

   Quarterly number of scheduled patients who do not show up for their appointments

3. No-shows in Q2FY16 (OSU) [1 quarter]

   Quarterly number of scheduled patients who do not show up for their appointments

4. No-shows in Q3FY16 (OSU) [1 quarter]

   Quarterly number of scheduled patients who do not show up for their appointments

5. Trend of No-shows Over All Quarters (OSU) [4 quarters]

   Quarterly number of scheduled patients who do not show up for their appointments

6. 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.

7. 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.

8. 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.

9. 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.

10. Oral Sedation Rate (Duke) [9 months (3 months baseline, 6 months post training)]

    Patients who receive medical sedation on site

11. IV Sedation Rate (Duke) [9 months (3 months baseline, 6 months post training)]

    Number of patients who receive intravenous (IV) sedation on site

12. General Anesthesia Rate (Duke) [9 months (3 months baseline, 6 months post training)]

    Number of patients who receive general anesthesia on site

13. Disruptive Motion (Duke) [9 months (3 months baseline, 6 months post training)]

    Patients on site who disrupt the scan by motion

14. No-shows (Duke) [9 months (3 months baseline, 6 months post training)]

    Scheduled patients who do not show for their MRI examinations.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hypnalgesics, LLC	Brookline	Massachusetts	United States	02446
2	Duke University Medical Center	Durham	North Carolina	United States	27710
3	Ohio State University Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Hypnalgesics, LLC
• Ohio State University
• Duke University

Investigators

• Principal Investigator: Elvira V Lang, MD, Hypnalgesics, LLC

Study Documents (Full-Text)

• Study Protocol - Aug 13, 2015

More Information

Publications

• 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.
• 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.
• 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.
• Lang EV, Rosen MP. Cost analysis of adjunct hypnosis with sedation during outpatient interventional radiologic procedures. Radiology. 2002 Feb;222(2):375-82.
• 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.
• 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.
• Lang EV. A Better Patient Experience Through Better Communication. J Radiol Nurs. 2012 Dec 1;31(4):114-119.
• 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.

• Responsible Party: Elvira V. Lang, MD, CEO, Hypnalgesics, LLC
• ClinicalTrials.gov Identifier: NCT02427737
• Other Study ID Numbers: 2CTOSUD2015
• First Posted: Apr 28, 2015
• Last Update Posted: Sep 12, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Elvira V. Lang, MD, CEO, Hypnalgesics, LLC: Magnetic Resonance Imaging; Patient satisfaction; Diagnostic Imaging
• Additional relevant MeSH terms: Phobic Disorders; Hypnotics and Sedatives

Study Results

Participant Flow

Recruitment Details	At OSUMC randomization was maintained (3 trained, 3 control sites). At Duke University considerable staff cuts at the onset of the trial resulted in extensive staff rotations making maintenance of randomization impossible. Thus a pre-post training comparison for the 6 sites was done (pre-training baseline = control, post-training = training arm)
Pre-assignment Detail	Different participants were assessed at baseline and at each period after training. Clinical sites, not participants, were enrolled in the study. Note that "participants" refers to all patients scheduled to be examined on the available imaging slots, including patients who showed ("completed") and those who were no-shows ("not completed").

Arm/Group Title	Comfort Talk® Training	Control
Arm/Group Description	MRI clinical sites form the experimental group. Their 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 study. 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 will entail 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.	MRI sites are not be trained in Comfort Talk®. Please note that at OSU both trained and control sites had a baseline and three post-training periods. At Duke, the data in the initial baseline period became the control data in a pre to post comparison for reasons explained above. Therefore Duke has only 2 time periods with the initial "Baseline" entered as "Control."
Period Title: OSU Baseline Q4FY15
STARTED	4158	3446
COMPLETED	3940	3230
NOT COMPLETED	218	216
Period Title: OSU Baseline Q4FY15
STARTED	4030	3246
COMPLETED	3815	3032
NOT COMPLETED	215	214
Period Title: OSU Baseline Q4FY15
STARTED	4121	3070
COMPLETED	3907	2857
NOT COMPLETED	214	213
Period Title: OSU Baseline Q4FY15
STARTED	4148	2931
COMPLETED	3928	2716
NOT COMPLETED	220	215
Period Title: OSU Baseline Q4FY15
STARTED	9658	4446
COMPLETED	8879	4051
NOT COMPLETED	779	395

Baseline Characteristics

Arm/Group Title	Comfort Talk® Training OSU	Control OSU	Total
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.	Total of all reporting groups
Overall Participants	0	0	0
Overall Imaging Slots	0	0	0
Age, Customized () []
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []

Outcome Measures

1. Primary Outcome

Title	Equipment Utilization Q4FY15 = Baseline Quarter (OSU)
Description	Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time Frame	1 quarter

Outcome Measure Data

Analysis Population Description

Imaging slots available in the quarter

Arm/Group Title	Comfort Talk® Training	Control
Arm/Group Description	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. 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 will entail 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.	MRI sites not trained in Comfort Talk®.
Measure Participants	3940	3230
Measure Imaging slots	4754	4219
Number [Proportion of completed scans per slots]	0.83	0.77

2. Primary Outcome

Title	Equipment Utilization in Q1FY16 (OSU)
Description	Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time Frame	1 quarter

Outcome Measure Data

Analysis Population Description

Participants completing their scans

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	3815	3032
Measure Imaging slots	4583	4144
Number [Proportion of completed scans per slots]	0.832	0.732

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments	Comparison among trained and untrained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training
	Comments	Change in the average quarterly completion rate as compared to the baseline quarter
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3037
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments	Change in the average quarterly completion rate as compared to the baseline quarter
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments

3. Primary Outcome

Title	Equipment Utilization in Q2FY16 (OSU)
Description	Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time Frame	1 quarter

Outcome Measure Data

Analysis Population Description

Imaging slots available in the quarter

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	3907	2857
Measure Imaging Slots	4659	4204
Number [Proportion of completed scans per slots]	0.839	0.680

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments	Comparison among trained and untrained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training
	Comments	Change in the average quarterly completion rate as compared to the baseline quarter
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2010
	Comments	Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments	Change in the average quarterly completion rate as compared to the baseline quarter
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared
	Comments

4. Primary Outcome

Title	Equipment Utilization in Q3FY16 (OSU)
Description	Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time Frame	1 quarter

Outcome Measure Data

Analysis Population Description

Imaging slots available in the quarter

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	3928	2716
Measure Imaging slots	4647	4199
Number [Proportion of completed scans per slots]	0.845	0.647

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments	Comparison among trained and untrained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments	Change in the quarterly equipment utilization rate as compared to the baseline quarter Q4FY15 over time and at sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.303
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10. Chi-square analysis was used to assess equipment utilization at trained sites compared with untrained sites when stratifying by time (chi-square MH = 858.2).
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments	Change in the average quarterly completion rate as compared to the baseline quarter
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments

5. Primary Outcome

Title	Equipment Utilization Over All Quarters (OSU)
Description	Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available
Time Frame	4 quarters

Outcome Measure Data

Analysis Population Description

Imaging slots available

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	15590	11835
Measure Imaging slots	18643	16766
Number [Proportion of completed scans per slots]	0.836	0.705

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	CMH test was used with time as a strata variable (rather than pooling all data together as in the regular chi-squared test). The CMH chi-squared value was 858.2, and the regular chi-squared value was 858.8.
	Method	Chi-squared, Corrected
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.

6. Primary Outcome

Title	Incompletions (Duke)
Description	Patients who cannot complete their scan
Time Frame	9 months (3 months baseline, 6 months post training)

Outcome Measure Data

Analysis Population Description

Patients showing for their MRI scans

Arm/Group Title	Baseline (Duke)	Post Comfort Talk® Training
Arm/Group Description	Patients who show for their MRI scans prior to team Training in Comfort Talk®	Patient who show for their MRI scans after team training in Comfort Talk®
Measure Participants	4051	8879
Count of Participants [Participants]	52 Infinity	27 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	No-shows in Q4FY15 = Baseline Quarter (OSU)
Description	Quarterly number of scheduled patients who do not show up for their appointments
Time Frame	1 quarter

Outcome Measure Data

Analysis Population Description

Scheduled patients

Arm/Group Title	Comfort Talk® Training	Control
Arm/Group Description	MRI clinical sites form the experimental group. Their 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 study. 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 will entail 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.	MRI sites are not be trained in Comfort Talk®. Please note that at OSU both trained and control sites had a baseline and three post-training periods. At Duke, the data in the initial baseline period became the control data in a pre to post comparison for reasons explained above. Therefore Duke has only 2 time period with the initial "Baseline" entered as "Control."
Measure Participants	4158	3446
Count of Participants [Participants]	218 Infinity	216 Infinity

8. Secondary Outcome

Title	No-shows in Q1FY16 (OSU)
Description	Quarterly number of scheduled patients who do not show up for their appointments
Time Frame	1 quarter

Outcome Measure Data

Analysis Population Description

Patients scheduled for MRI

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	4030	3246
Count of Participants [Participants]	215 Infinity	214 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments	Comparison among trained and untrained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2357
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training
	Comments	Change in the quarterly no-shows as compared to the baseline quarter
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8523
	Comments	No Bonferroni-correction
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments	Change in the quarterly average no-show rate as compared to the baseline quarter at untrained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5883
	Comments	Bonferroni-correction was not done for this nonsignificant result since the corrected p-value would be have been greater than 1, which is not possible.
	Method	Chi-squared
	Comments

9. Secondary Outcome

Title	No-shows in Q2FY16 (OSU)
Description	Quarterly number of scheduled patients who do not show up for their appointments
Time Frame	1 quarter

Outcome Measure Data

Analysis Population Description

Patients scheduled for MRI

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	4121	3070
Count of Participants [Participants]	214 Infinity	213 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments	Comparison among trained and untrained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0195
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training
	Comments	Change in the quarterly no-shows compared to the baseline quarter
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.276
	Comments	No Bonferroni-correction
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments	Change in the quarterly no-shows as compared to the baseline quarter at untrained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2764
	Comments	No Bonferroni-correction
	Method	Chi-squared
	Comments

10. Secondary Outcome

Title	No-shows in Q3FY16 (OSU)
Description	Quarterly number of scheduled patients who do not show up for their appointments
Time Frame	1 quarter

Outcome Measure Data

Analysis Population Description

Patients scheduled for MRI

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	4148	2931
Count of Participants [Participants]	220 Infinity	215 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments	Comparison among trained and untrained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training
	Comments	Change in the quarterly average no show rate as compared to the baseline quarter for trained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.9012
	Comments	Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Control
	Comments	Change in the quarterly average no-show rate as compared to the baseline quarter for untrained sites
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.9065
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments

11. Secondary Outcome

Title	Trend of No-shows Over All Quarters (OSU)
Description	Quarterly number of scheduled patients who do not show up for their appointments
Time Frame	4 quarters

Outcome Measure Data

Analysis Population Description

Patients scheduled for MRI

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	16457	12693
Count of Participants [Participants]	867 Infinity	858 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments	Comparison among trained and untrained sites over time
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.
	Method	Chi-squared, Corrected
	Comments	CMH test with time as a strata variable was 28.7; chi-square value with pooling all data together was 28.6

12. Secondary Outcome

Title	Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU)
Description	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

Outcome Measure Data

Analysis Population Description

Number of participants who returned surveys during that quarter.

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	116	71
Mean (Standard Deviation) [National Satisfaction Ranking]	42.3 (35.2)	65.0 (36.7)

13. Secondary Outcome

Title	Patient Satisfaction in Q1FY16 (OSU)
Description	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

Outcome Measure Data

Analysis Population Description

Number of participants who returned surveys during that quarter.

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	135	110
Mean (Standard Deviation) [National Percentile Satisfaction Ranking]	71.0 (21.2)	60.1 (41.7)

14. Secondary Outcome

Title	Patient Satisfaction Ranking in Q2FY16 (OSU)
Description	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

Outcome Measure Data

Analysis Population Description

Number of participants who returned surveys during that quarter.

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	138	106
Mean (Standard Deviation) [National Percentile Satisfaction Ranking]	75.3 (16.8)	42.3 (40.1)

15. Secondary Outcome

Title	Patient Satisfaction Ranking in Q3FY16 (OSU)
Description	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

Outcome Measure Data

Analysis Population Description

Number of participants who returned surveys during that quarter.

Arm/Group Title	Comfort Talk® Training OSU	Control OSU
Arm/Group Description	Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.	Three MRI sites at OSU were not trained in Comfort Talk®.
Measure Participants	158	87
Mean (Standard Deviation) [National Percentile Satisfaction Ranking]	76.7 (16.9)	36 (41.7)

16. Secondary Outcome

Title	Oral Sedation Rate (Duke)
Description	Patients who receive medical sedation on site
Time Frame	9 months (3 months baseline, 6 months post training)

Outcome Measure Data

Analysis Population Description

Patients showing for their MRI scans

Arm/Group Title	Baseline (Duke)	Post Comfort Talk® Training
Arm/Group Description	Patients who show for their MRI scans prior to team Training in Comfort Talk®	Patient who show for their MRI scans after team training in Comfort Talk®
Measure Participants	4051	8879
Count of Participants [Participants]	100 Infinity	128 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

17. Secondary Outcome

Title	IV Sedation Rate (Duke)
Description	Number of patients who receive intravenous (IV) sedation on site
Time Frame	9 months (3 months baseline, 6 months post training)

Outcome Measure Data

Analysis Population Description

Patients showing for their MRI scans

Arm/Group Title	Baseline (Duke)	Post Comfort Talk® Training
Arm/Group Description	Patients who show for their MRI scans prior to team Training in Comfort Talk®	Patient who show for their MRI scans after team training in Comfort Talk®
Measure Participants	4051	8879
Count of Participants [Participants]	103 Infinity	196 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2396
	Comments
	Method	Chi-squared
	Comments

18. Secondary Outcome

Title	General Anesthesia Rate (Duke)
Description	Number of patients who receive general anesthesia on site
Time Frame	9 months (3 months baseline, 6 months post training)

Outcome Measure Data

Analysis Population Description

Patients showing for their MRI scans

Arm/Group Title	Baseline (Duke)	Post Comfort Talk® Training
Arm/Group Description	Patients who show for their MRI scans prior to team Training in Comfort Talk®	Patient who show for their MRI scans after team training in Comfort Talk®
Measure Participants	4051	8879
Count of Participants [Participants]	29 Infinity	55 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5267
	Comments
	Method	Chi-squared
	Comments

19. Secondary Outcome

Title	Disruptive Motion (Duke)
Description	Patients on site who disrupt the scan by motion
Time Frame	9 months (3 months baseline, 6 months post training)

Outcome Measure Data

Analysis Population Description

Patients showing for their MRI scans

Arm/Group Title	Baseline (Duke)	Post Comfort Talk® Training
Arm/Group Description	Patients who show for their MRI scans prior to team Training in Comfort Talk®	Patient who show for their MRI scans after team training in Comfort Talk®
Measure Participants	4051	8879
Count of Participants [Participants]	42 Infinity	11 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

20. Secondary Outcome

Title	No-shows (Duke)
Description	Scheduled patients who do not show for their MRI examinations.
Time Frame	9 months (3 months baseline, 6 months post training)

Outcome Measure Data

Analysis Population Description

Patients scheduled for MRI scans

Arm/Group Title	Baseline (Duke)	Post Comfort Talk® Training
Arm/Group Description	Patients who show for their MRI scans prior to team Training in Comfort Talk®	Patient who show for their MRI scans after team training in Comfort Talk®
Measure Participants	4446	9658
Count of Participants [Participants]	395 Infinity	779 Infinity

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Comfort Talk® Training, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	One year starting with the training
Adverse Event Reporting Description	Adverse events were monitored during the training days of the MRI teams. Then assessment was non-systematic in that we would have reported adverse events if they had become known or being collected after training. Patients at risk were only those in the post-training period who showed up at the facility including those who completed their scans and also those who did not. Number of deaths was not specifically monitored.
Arm/Group Title	Comfort Talk® Training (OSU)		Control (OSU)		Baseline = Control (Duke)		Comfort Talk® Training (Duke)
Arm/Group Description	Three MRI clinical sites form the experimental group. Their personnel was 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 study. Comfort Talk® Training: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 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.		Three MRI sites were not trained in Comfort Talk®.		Data from 6 Duke sites at baseline were used as the control in a pre- to post-training comparison		The same 6 Duke sites represented at baseline formed the experimental group after Comfort Talk training in a pre- to post- training comparison
All Cause Mortality
	Comfort Talk® Training (OSU)		Control (OSU)		Baseline = Control (Duke)		Comfort Talk® Training (Duke)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11650 (0%)		0/8605 (0%)		0/4446 (0%)		0/9658 (0%)
Serious Adverse Events
	Comfort Talk® Training (OSU)		Control (OSU)		Baseline = Control (Duke)		Comfort Talk® Training (Duke)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11650 (0%)		0/8605 (0%)		0/4446 (0%)		0/9658 (0%)
Other (Not Including Serious) Adverse Events
	Comfort Talk® Training (OSU)		Control (OSU)		Baseline = Control (Duke)		Comfort Talk® Training (Duke)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11650 (0%)		0/8605 (0%)		0/4446 (0%)		0/9658 (0%)

Limitations/Caveats

Because of considerable staff cuts at Duke right personnel rotated among all sites so that randomization based on training could not be maintained. Therefore a pre/post training comparison was done. OSU collected data electronically, Duke by diary.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.