NCT02427737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

September 12, 2019

Completed
Last Updated

September 12, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

April 20, 2015

Results QC Date

October 16, 2017

Last Update Submit

August 6, 2019

Conditions

ClaustrophobiaComplication of Diagnostic Procedure

Keywords

Magnetic Resonance ImagingPatient satisfactionDiagnostic Imaging

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • Incompletions (Duke)

    Patients who cannot complete their scan

    9 months (3 months baseline, 6 months post training)

Secondary Outcomes (14)

  • No-shows in Q4FY15 = Baseline Quarter (OSU)

    1 quarter

  • No-shows in Q1FY16 (OSU)

    1 quarter

  • No-shows in Q2FY16 (OSU)

    1 quarter

  • No-shows in Q3FY16 (OSU)

    1 quarter

  • Trend of No-shows Over All Quarters (OSU)

    4 quarters

  • +9 more secondary outcomes

Study Arms (2)

Comfort Talk® Training

EXPERIMENTAL

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

Control

NO INTERVENTION

MRI sites not trained in Comfort Talk®.

Interventions

Comfort Talk® TrainingBEHAVIORAL

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.

Also known as: Self-hypnotic relaxation, Nonpharmacologic analgesia, Nonpharmacologic anxiolysis, Patient sedation without medication
Comfort Talk® Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must routinely perform MRI examinations
  • Must capture data on noncompletion of MRI scans

You may not qualify if:

  • No dedicated MRI unit
  • Unable to reliably capture data on noncompletion of MRI scans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hypnalgesics, LLC

Brookline, Massachusetts, 02446, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (10)

  • 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.

    PMID: 19734060BACKGROUND

  • 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.

    PMID: 24261356BACKGROUND

  • 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.

    PMID: 23471099BACKGROUND

  • 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.

    PMID: 21474702BACKGROUND

  • 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.

    PMID: 15733657BACKGROUND

  • 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.

    PMID: 11818602BACKGROUND

  • 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.

    PMID: 10801169BACKGROUND

  • 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.

    PMID: 27126735BACKGROUND

  • 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.

    PMID: 28461168RESULT

  • 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.

    PMID: 29530323RESULT

MeSH Terms

Conditions

ClaustrophobiaPatient Satisfaction

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Limitations and 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.

Results Point of Contact

Title
Elvira V. Lang, MD (PI of SBIR grant sponsoring site-PIs); CEO
Organization
Hypnalgesics, LLC d/b/a Comfort Talk
drevlang@ComfortTalk.com
617 734 9087

Study Officials

  • Elvira V Lang, MD

    Hypnalgesics, LLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 28, 2015

Study Start

April 1, 2015

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

September 12, 2019

Results First Posted

September 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(3)