Amelioration of Claustrophobia and Disruptive Patient Motion in MR Imaging

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43AT006296-01A1
Agency Tracking Number: R43AT006296
Amount: $640,032.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCCAM
Solicitation Number: PA08-071
Solicitation Year: 2011
Award Year: 2011
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
157 IVY ST, BROOKLINE, MA, 02446-3906
DUNS: 830040700
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 (978) 404-9724
Business Contact
Phone: (978) 404-9724
Research Institution
DESCRIPTION (provided by applicant): 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. Thesepatients 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 thenext 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 trainingMRI 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 (includingreceptionists, 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 assessefficacy 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 withSmartphones. 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 willbe analyzed for their potential as economic drivers and evaluation instruments. PUBLIC HEALTH RELEVANCE: Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still. Trainingstaff 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.

* Information listed above is at the time of submission. *

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