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Reduction of Claustrophobia and Patient Motion After Training of MRI Personnel in Comfort TalkTM

Primary Purpose

Claustrophobia, Complication of Diagnostic Procedure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comfort Talk®
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 MRI departments and facilities, Noncompletion of MRI

Eligibility Criteria

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

Inclusion Criteria:

  • Facilities performing MRI examinations
  • Facilities capturing data on noncompletion of MRI scans
  • Facilities willing to have their personnel trained
  • Facilities with personnel interested and willing to be trained
  • Facilities able to obtain IRB review

Exclusion Criteria:

  • Facilities not performing MRI examinations
  • Facilities not capturing data on noncompletion of MRI scans
  • Facilities not willing to have their personnel trained
  • Facilities unable to obtain IRB review

Sites / Locations

  • Tufts Medical Center
  • Boston Medical Center
  • Hypnalgesics, LLC
  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Comfort Talk® Training

Arm Description

The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests

Outcomes

Primary Outcome Measures

Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (All Scheduled Patients)
The sites will be followed for an average of one year after training in Comfort Talk and non-completion rates will be compared to the baseline values of non-completion among all scheduled patients.
Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (Showing-Up Patients Only)
The change in non-completion rate of MRI scans, obtained for the year prior to Comfort Talk® training at baseline, to the average one year post training was assessed

Secondary Outcome Measures

Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training
The sites will be followed for an average of one year after training in Comfort Talk and no-show rates will be compared to the baseline values of non-completion among all scheduled patients which were also collected over 1 year.

Full Information

First Posted
October 24, 2011
Last Updated
April 12, 2017
Sponsor
Hypnalgesics, LLC
Collaborators
Tufts Medical Center, Boston Medical Center, Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT01563198
Brief Title
Reduction of Claustrophobia and Patient Motion After Training of MRI Personnel in Comfort TalkTM
Official Title
Amelioration of Claustrophobia and Disruptive Patient Motion in MR Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
February 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hypnalgesics, LLC
Collaborators
Tufts Medical Center, Boston Medical Center, Ohio State University

4. Oversight

Data Monitoring Committee
No

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 staff working in MRI facilities to provide Comfort Talk® promises to enable patients to complete and obtain high quality imaging without medication, which will increase comfort and reduce sedation risks for the patients, and increase efficiency and reduce loss of revenue for the facilities.
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, or are exposed to risks of pharmacologic sedation, including death. The imaging facilities in turn, typically cannot fill the suddenly vacated examination slots in time before the next scheduled patient and thus incur considerable lost revenue and efficiency. 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 MRI staff to use advanced rapport skills and comforting language to help patients. Phase I will design and perform a formative evaluation of a Comfort Talk® Training intervention so that definitive testing of the hypothesized benefits for the intervention can be accomplished in Phase II. In Specific Aim 1 the Comfort TalkTM intervention sequence will be designed to include training in advanced rapport skills, using basic comforting language and avoiding negative language for all facility staff (including receptionists, technologists, nurses, and physicians). A core of licensed healthcare professionals will be taught how to guide patients in self-hypnotic relaxation techniques, using scripts, found to be safe and effective in the radiology department. Techniques are designed to easily integrate into the normal workflow without adding time. Training will include 2x8 hrs live at three test sites. Acceptance, observation of staff behavior, qualitative feedback, and rates of noncompletion will be used to assess efficacy of training, guide prototype development, and develop train-the-trainer materials. Using in-market piloting techniques, niche applications with their metrics will be explored to develop situation-specific supplemental materials. In Aim 2 an interactive web-based electronic platform will be developed to supplement training and provide post-training support. It will provide scenarios and practice applications, guided dialogue options, functions for online live interactive classes, and interface with smartphones. The prototype will be beta-tested with 20 experts in hypnosis and refined through user input from the test sites. Aim 3 is to conduct a formative evaluation of the entire Comfort Talk® intervention. Effects will be evaluated in 3-months intervals and compared to baseline performance. Criteria will include acceptance, qualitative feedback, content mastery, staff behavior, rates of noncompletion, patient recall and satisfaction. Additional metrics identified through in-market exploration will be analyzed for their potential as economic drivers and evaluation instruments.

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
MRI departments and facilities, Noncompletion of MRI

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97712 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comfort Talk® Training
Arm Type
Experimental
Arm Description
The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests
Intervention Type
Behavioral
Intervention Name(s)
Comfort Talk®
Other Intervention Name(s)
Self-hypnotic relaxation, nonpharmacologic analgesia, nonpharmacologic anxiolysis, patient sedation without medication
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (All Scheduled Patients)
Description
The sites will be followed for an average of one year after training in Comfort Talk and non-completion rates will be compared to the baseline values of non-completion among all scheduled patients.
Time Frame
Baseline average of one year plus post training average one year = 2 years
Title
Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (Showing-Up Patients Only)
Description
The change in non-completion rate of MRI scans, obtained for the year prior to Comfort Talk® training at baseline, to the average one year post training was assessed
Time Frame
Baseline average of one year plus post training average one year = 2 years
Secondary Outcome Measure Information:
Title
Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training
Description
The sites will be followed for an average of one year after training in Comfort Talk and no-show rates will be compared to the baseline values of non-completion among all scheduled patients which were also collected over 1 year.
Time Frame
Baseline average of one year plus post training average one year = 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Facilities performing MRI examinations Facilities capturing data on noncompletion of MRI scans Facilities willing to have their personnel trained Facilities with personnel interested and willing to be trained Facilities able to obtain IRB review Exclusion Criteria: Facilities not performing MRI examinations Facilities not capturing data on noncompletion of MRI scans Facilities not willing to have their personnel trained Facilities unable to obtain IRB review
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
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Hypnalgesics, LLC
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02446
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
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
result
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
result
Links:
URL
http://www.ComfortTalk.com
Description
Explanation of Comfort TalkTM and access to Post-Training Support Module
URL
http://ComfortTalk.com
Description
Sponsor website and background information; description of techniques used

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Reduction of Claustrophobia and Patient Motion After Training of MRI Personnel in Comfort TalkTM

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