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



Status:Active, not recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:August 2011
End Date:August 2016

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Amelioration of Claustrophobia and Disruptive Patient Motion in MR Imaging

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 TalkTM 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.

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 TalkTM 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 TalkTM 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.

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
We found this trial at
4
sites
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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