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Comfort Talk and Economic Outcomes in MRI (ComfortTalk®)

Primary Purpose

Claustrophobia, Complication of Diagnostic Procedure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comfort Talk® Training
Sponsored by
Hypnalgesics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Claustrophobia focused on measuring Magnetic Resonance Imaging, Patient satisfaction, Diagnostic Imaging

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hypnalgesics, LLC
  • Duke University Medical Center
  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Comfort Talk® Training

Control

Arm 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.

MRI sites not trained in Comfort Talk®.

Outcomes

Primary Outcome Measures

Equipment Utilization Q4FY15 = Baseline Quarter (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization in Q1FY16 (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization in Q2FY16 (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization in Q3FY16 (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization Over All Quarters (OSU)
Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available
Incompletions (Duke)
Patients who cannot complete their scan

Secondary Outcome Measures

No-shows in Q4FY15 = Baseline Quarter (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
No-shows in Q1FY16 (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
No-shows in Q2FY16 (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
No-shows in Q3FY16 (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Trend of No-shows Over All Quarters (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
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.
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.
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.
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.
Oral Sedation Rate (Duke)
Patients who receive medical sedation on site
IV Sedation Rate (Duke)
Number of patients who receive intravenous (IV) sedation on site
General Anesthesia Rate (Duke)
Number of patients who receive general anesthesia on site
Disruptive Motion (Duke)
Patients on site who disrupt the scan by motion
No-shows (Duke)
Scheduled patients who do not show for their MRI examinations.

Full Information

First Posted
April 20, 2015
Last Updated
August 6, 2019
Sponsor
Hypnalgesics, LLC
Collaborators
Ohio State University, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02427737
Brief Title
Comfort Talk and Economic Outcomes in MRI
Acronym
ComfortTalk®
Official Title
Amelioration of Claustrophobia and Disruptive Patient Motion in MRI Imaging (Phase 2 Randomized Training of Sites)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hypnalgesics, LLC
Collaborators
Ohio State University, Duke University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claustrophobia, Complication of Diagnostic Procedure
Keywords
Magnetic Resonance Imaging, Patient satisfaction, Diagnostic Imaging

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comfort Talk® Training
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
MRI sites not trained in Comfort Talk®.
Intervention Type
Behavioral
Intervention Name(s)
Comfort Talk® Training
Other Intervention Name(s)
Self-hypnotic relaxation, Nonpharmacologic analgesia, Nonpharmacologic anxiolysis, Patient sedation without medication
Intervention Description
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.
Primary Outcome Measure Information:
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
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
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
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
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
Title
Incompletions (Duke)
Description
Patients who cannot complete their scan
Time Frame
9 months (3 months baseline, 6 months post training)
Secondary Outcome Measure Information:
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
Title
No-shows in Q1FY16 (OSU)
Description
Quarterly number of scheduled patients who do not show up for their appointments
Time Frame
1 quarter
Title
No-shows in Q2FY16 (OSU)
Description
Quarterly number of scheduled patients who do not show up for their appointments
Time Frame
1 quarter
Title
No-shows in Q3FY16 (OSU)
Description
Quarterly number of scheduled patients who do not show up for their appointments
Time Frame
1 quarter
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
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
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
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
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
Title
Oral Sedation Rate (Duke)
Description
Patients who receive medical sedation on site
Time Frame
9 months (3 months baseline, 6 months post training)
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)
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)
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)
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)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elvira V Lang, MD
Organizational Affiliation
Hypnalgesics, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hypnalgesics, LLC
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02446
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19734060
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.
Results Reference
background
PubMed Identifier
24261356
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.
Results Reference
background
PubMed Identifier
23471099
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.
Results Reference
background
PubMed Identifier
21474702
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.
Results Reference
background
PubMed Identifier
15733657
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.
Results Reference
background
PubMed Identifier
11818602
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.
Results Reference
background
PubMed Identifier
10801169
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.
Results Reference
background
PubMed Identifier
27126735
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.
Results Reference
background
PubMed Identifier
28461168
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.
Results Reference
result
PubMed Identifier
29530323
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.
Results Reference
result

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Comfort Talk and Economic Outcomes in MRI

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